52637336 true OASIS (optimising an intervention for sensory hallucinations): a novel adaptation of the coping strategy enhancement intervention, for hallucinatory experiences in the context of dementia OASIS The Coping Strategy Enhancement (CSE) intervention is yet to be utilised and evaluated in the dementia population. Hallucinatory experiences are common among PLWD, who often present with multi-modal experiences; the previous literature has shown that the CSE can be effective for multi-modal hallucinations, which is particularly applicable to the dementia population. In addition, the risk of side effects from anti-psychotic medication warrants the development of more non-pharmacological interventions. Therefore, this study will focus on the adaptation and application of the CSE intervention to the dementia population, with the inclusion of caregivers. For this study, caregivers will be exclusively family carers, as their extensive knowledge of the PLWD will facilitate an active role in delivering the intervention. Background and study aims Hallucinations are a common experience for people living with dementia (PLWD), often leading to significant distress. While anti-psychotic medications have been used to manage these experiences, they have not focused on reducing the associated distress, and there are currently no non-pharmacological interventions available to support PLWD and their family carers. The Coping Strategy Enhancement (CSE) intervention, effective across various populations, has yet to be applied to the dementia population. The study aims to develop an adapted version of the CSE intervention tailored for addressing hallucinations in PLWD and to evaluate its feasibility through a single-arm trial in real-world settings. It seeks to assess the initial effectiveness of the adapted intervention in reducing distress caused by hallucinations in PLWD and their caregivers. Additionally, the study will gather and analyse qualitative data on participant experiences to refine future research and interventions. Ensuring the safe delivery of the adapted CSE intervention within community settings is also a key objective. Who can participate? Participants will be PLWD aged 60 to 90 years old, carers of PLWD aged 18 years old and over and clinicians who work with PLWD What does the study involve? The study will involve focus groups with PLWD, their carers, and clinicians to help develop adaptations of the psychological intervention for coping with hallucinatory experiences. The study will be conducted across two sites in Sussex and the North of England. Participants will receive four therapy sessions with a clinical psychologist, followed by a final assessment and exit interviews. What are the possible benefits and risks of participating? Benefits include meeting with people in focus groups that have similar life experiences. Trial participants will receive a therapy that has the potential to reduce distress from hallucinations. Also, monetary compensation will be given to focus group participants (carers and PLWD dyads only, in both phases 1+4), which will be set at £20 per session, per individual; this compensation will be awarded in the form of a Mark's and Spencer's voucher, provided by Brighton and Sussex Medical School, Centre for Dementia Studies. Travel compensation will also be provided, with a cap of up to £25 per person per session. Fuel costs will be calculated at 45p per mile. A travel expenses form will be required to be filled out, and funds will be paid directly into the participants’ bank accounts. The researcher will provide the travel expenses forms on the day of the focus groups. Trial participants will be reimbursed for their time in pre and post-intervention meetings to collect baseline data and deliver exit interviews, at £20 per individual, per meeting. There will be no monetary reimbursement for participation in the four intervention sessions, as it is deemed that there is a benefit in receiving the therapeutic intervention. Travel compensation will also be provided, with a cap of up to £25 per person, per meeting. Fuel costs will be calculated at 45p per mile. There may be risks associated with the topics of conversation in the focus groups as well as the intervention that relates to hallucinatory experiences, which may be difficult to discuss at times. This will be mitigated by reminding participants that they can take a break or withdraw at any point in the study. The chief investigator, educational supervisor and psychologists are very experienced in supporting people that are experiencing any distress, so are qualified to manage these situations. Where is the study run from? Sussex Partnership Foundation Trust When is the study starting and how long is it expected to run for? October 2023 to March 2026 Who is funding the study? National Institute for Health and Care Research (NIHR), Applied Research Collaboration (ARC) for Kent, Surrey and Sussex (KSS) Who is the main contact? Miss Amaani Al-Azzawi, a.al-azzawi1@uni.bsms.ac.uk Professor Mark Hayward, mark.hayward@spft.nhs.uk 1. Recruitment Effectiveness: Demographic representativeness of recruited participants measured using an analysis of recruitment strategies and eligibility criteria after the recruitment phase 2. Participant Retention: Retention rate and reasons for attrition measured using an evaluation of retention strategies and analysis of attrition trends throughout the intervention period, with a final assessment at study completion 3. Intervention Completion and Exposure: The number of sessions attended by participants measured by monitoring attendance and engagement levels through session logs and exit interviews continuously throughout phases 2+3, with final analysis post-intervention 4. Intervention Acceptability: Participant feedback on acceptability measured using qualitative data through semi-structured exit interviews at the end of phases 2+3 5. Safety Monitoring: Incidence of adverse events and serious adverse events measured by auditing and monitoring adverse events with causality assessment continuously throughout the study, with final review at study completion The research on the clinical outcome measures to be used in the single-arm feasibility trial has not been finalised, as the decisions will also depend on the conversations and discussions with focus group participants (family carers, PLWD and clinicians) in phase 1. The following suggested secondary outcome measures will be assessed at baseline and post-intervention: 1. Adaptation for Hallucinatory Experiences: The severity and frequency of hallucinatory experiences across all five senses measured using the Adapted Hamilton Program for Voices Questionnaire (HPSVQ). 2. Family Carer Quality of Life: The quality of life of family carers measured using the C-DEMQOL questionnaire 3. The Person with Dementia's Quality of Life: The quality of life of the person with dementia measured using the DEM-QOL questionnaire 4. Carer Burden: Level of burden experienced by the carer measured using the Zarit Carer Burden Interview 5. Depression Symptom Severity: The severity of depression symptoms measured using the PHQ-9 self-report measure 6. Anxiety Symptom Severity: Severity of anxiety symptoms measured using the GAD-7 measure Ethics approval required Yorkshire & The Humber- Leeds West REC

2 Redman Place, Stratford

London United Kingdom E20 1JQ 24/YH/0126 10.1186/ISRCTN52637336 336425 CPMS: 60832 336425 60832 Non-randomized single-arm feasibility/pilot study Interventional Non randomised study Treatment 2026-03-31T00:00:00.000Z United Kingdom England Centre for Dementia Studies

Brighton and Sussex Medical School, University of Sussex

Brighton England BN1 9PX St Nicholas Hospital

Jubilee Road Gosforth

Newcastle upon Tyne England NE3 3XT RE914@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Focus Group Participants - Phases 1+ 4 (Co-Adapt and Co-evaluate) Family carers: 1. Lived experience of caring for a PLWD 2. Able to communicate in English 3. Age 18+ years old PLWD: 1. Lived experience of dementia 2. Able to communicate in English Clinicians: 1. Lived experience for working in an NHS clinical environment with PLWD 2. Able to communicate in English Trial Participants - Phases 2+3 (Single-Arm feasibility trial and data collection and analysis) PLWD: 1. Have received a clinical diagnosis of dementia 2. A score between 36 and 81 on the ACE III test 3. Have reported hallucinatory experiences 4. Have a family carer that can also participate in the intervention 5. Deemed to have capacity 6. Age 60-90 years old 7. Able to communicate in English Family carers 1. To be a family carer of someone who has had a clinical diagnosis of dementia 2. A minimum of 10 hours contact time per week with the PLWD (excluding time for meetings with lead researcher and the therapy sessions) 3. For their relative to also be able to participate in the intervention 4. To be able to participate in the intervention and engage with the materials outside of the clinical contact sessions 5. Able to communicate in English 6. Age 18+ years old Mixed 18 Years 90 Years All 39 20 Focus Group Participants- Phases 1+ 4 (Co-Adapt and Co-evaluate) Family carer: 1. No lived experience of caring for a PLWD 2. Not able to communicate in English 3. Under age 18 years old PLWD: 1. No lived experience of dementia 2. Not able to communicate in English Clinicians: 1. No lived experience of working in an NHS clinical environment with PLWD 2. Not proficient in English Trial Participants - Phases 2+3 (Single-arm feasibility trial and data collection and analysis) PLWD: 1. No clinical dementia diagnosis 2. A score lower than 36 or higher than 81 on the ACE III test 3. No reports of hallucinatory experiences 4. Does not have a family carer that can participate in the intervention 5. Not deemed to have capacity 6. < 60 or 90< years old 7. Not able to communicate in English Family carer: 1. Not a family carer of someone who has had an official diagnosis of dementia 2. To have a less than 10 hours contact time per week with the PLWD (excluding time for meetings with lead researcher and the therapy sessions) 3. If their relative is not able to participate in the intervention 4. Not proficient in in English 5. Under age 18 years old 2024-09-02T00:00:00.000Z 2025-10-31T00:00:00.000Z Dementia Mental and Behavioural Disorders Methodology Justification: This research study will follow the guidelines from the Medical Research Council (MRC) framework for the development of complex interventions; the process will be iterative. This study design has been chosen, as it was a priority of the researcher to ensure that experts by experience were key in the development and evaluation of the adapted CSE. A small single-arm feasibility is justified by the fact that this is the first study of its kind, and feasibility is required to be tested before moving to larger sample sizes. Design: Phase 1- Co-Adapt focus groups • This first phase will inform the adaptations made to the CSE intervention, through consultation with dyads of family carers and PLWD dyads, or individual PLWD or family carers and clinicians that work with PLWD. • Two separate focus groups will be facilitated. For each group, there will be 2-3 sessions. • The 2 groups will be: 1. Family Carer and PLWD dyads or individuals. 2. Clinicians. - Sample sizes- maximum for 6-8 participants per group. This will allow collective conversation to be easily held and ensure that voices are heard in the group, whilst allowing for diversity of experience. Phase 2- Single-Arm Feasibility Trial • The adapted version of the CSE will then be tested in a single-arm feasibility trial with 12-18 dyads of PLWD and carer. (total N=24-36). • Participants will complete a baseline assessment before the delivery of the four sessions of the intervention with a clinical psychologist. • This will be a multi-site trial, with an additional site outside of the SPFT, in CNTW. Phase 3 – Data collection and analysis • A final assessment meeting will take place. • Quantitative will be collected from participants who complete the CSE intervention. • Qualitative data will be collected through exit interviews with all participants, including the psychologists who delivered the intervention. These will take place virtually or face-to-face in participant homes or an NHS site. • Qualitative data will be analysed using the framework method. Phase 4 – Co-Evaluate • Further consultation with focus groups from Phase 1 about additional adaptation in the light of learning from Phases 2 and 3. • Co-evaluation of the adapted CSE intervention. • Discussion of lessons learnt. • Suggestions for a revised intervention for future research. Setting: This project will take place within the Centre for Dementia Studies, based at the Brighton and Sussex Medical School. It is being funded by the National Institute for Health and Care Research (NIHR), and Applied Research Collaboration (ARC) for Kent, Surrey and Sussex (KSS). The KSS ARC currently has a theme of “Living well with dementia” to become a leading region for dementia health care research and to further translate this into helping PLWD live and age well; this project has been designed to support this current theme. This study will be sponsored by and delivered within SPFT, with a second site (CNTW) recruiting participants within Phases 2 and 3. A scoping review was completed and funded by Research England, before the creation of this project, to explore the current issues surrounding accessing support for hallucinations in the context of dementia. Results found that there was a need for the development of specialised dementia support in hallucinations. Procedure: Phase 1- Co-Adapt. Two focus groups will be recruited for this phase of the study: Family carers and PLWD dyads and clinicians who work with PLWD. For the sake of clarity, those who engage in Phases 1+4 of the research will be referred to as focus group participants. Those who engage in the trial (phase 2+3) will be referred to as trial participants. For the recruitment of family carers and PLWD for phase 1, contact will be made to support groups for carers of PLWD, the DCG for SPFT, and third-sector organisations; this will include Age UK and Alzheimer’s Society. With regards to the recruitment of clinicians for the phase 1 focus groups, the opportunity to participate will be advertised within the Dementia Services of SPFT. Sussex Partnership NHS Foundation Trust has the Everyone Counts scheme in place for consent to contact about research opportunities. The Everyone Counts scheme is viewed as being a task in the public interest and as such has been approved by the SPFT Trust Board after consultation with the Information Governance Lead. Members of the Research & Development Department will contact potential eligible participants, to discuss the study and invite them to take part. The report of potential participants is only accessible to a limited number of authorised individuals in the research department. Those who express interest in participating in the focus groups, phases 1+4, will be sent the participant information sheet (PIS) for the study and can contact the researcher. If interested the participant will meet with the researcher where consent will be given, and eligibility will be confirmed. If consent will need to be taken over the phone, the researcher will follow the protocol for taking remote consent. A copy of the remote consent forms will be sent via secure postal service to the participants. To ensure accessibility to the study, those that require easy-read versions of the participant documents, will be able to request these, before meeting with the researcher. Easy-read versions will include the use of inclusive graphics, simplified language and larger text. Following this stage, if consent is given, focus group participants will be invited to join the appropriate focus group meeting. For both focus groups, there will be 2-3 focus group meetings held, each lasting up to a maximum of 2 hours; this will allow for processing and reflection between sessions. The location and method of holding these meetings will be determined by the ease of accessibility of travel for focus group participants and the physical geographical distribution of them; the meetings will either take place face-to-face or virtually via a Microsoft Teams or Zoom call. Depending on the preferences of the focus group participants, the first session may take place in person and then following this, the groups could be held virtually; an initial face-to-face meeting will aid in focus group participants feeling more comfortable in the group and foster familiarity with each other and the researcher. Before the focus group meetings, the focus group participants will be sent, electronically, the intervention protocol of the CSE. The meetings will be structured as such 1) to review the existing intervention protocol of the CSE intervention and the associated materials, 2) to offer suggestions for adaptation to the intervention protocol to be appropriate for PLWD and their carers 3) to discuss the potential relevant outcome measures that could be used in the adapted intervention protocol. As the dyads (PLWD + family carer) and clinicians have different roles and associated statuses in the healthcare system, the focus groups will be kept separate to enable less censored communication between focus group participants. Similarities in the experiences of group members may also generate some positive group effects of empathy which will be less hindered if the groups are kept separate. A member from each of the groups will be appointed as a representative and will meet with the lead researcher after the adaptations have been made to do a ‘final check’ of adapted intervention before the single-arm feasibility trial; this will help to ensure that ideas and comments have not been misinterpreted. This representative will be chosen based on whoever volunteers first. Monetary compensation will be given to focus group participants (carers and PLWD dyads only), which will be set at £20 per session, per individual; this compensation will be awarded in the form of a Marks and Spencer's voucher, provided by Brighton and Sussex Medical School, Centre for Dementia Studies. Travel compensation will also be provided, with a cap of up to £25 per person, per session. Fuel costs will be calculated at 45p per mile. A travel expenses form will be required to be filled out, and funds will be paid directly into focus group participants’ bank accounts. The researcher will provide the travel expenses forms on the day of the focus groups. For clarity, the adapted intervention will hereon be referred to as the C-DEM-CSE (Carer-Dementia Coping Strategy Enhancement). Phase 2- Single-arm Feasibility Trial The C-DEM-CSE will then be tested in a single-arm feasibility trial with 12-18 dyads of PLWD and carer. (total N=24- 36). Trial participants for this phase of the study will be recruited from a variety of Dementia Care Services and Memory Assessment Clinics in SPFT and CNTW. In SPFT, the referral pathway will be as follows: (1) Referral from the most relevant healthcare professional to the Dementia Research Unit, Crowborough. (2) contact will then be passed to the researcher whereby all further liaison will happen. The referral pathway for the CNTW site will have two routes. Route (1) Direct referral from the most relevant healthcare professional to the research team, DeNDRoN (Dementias and Neurodegeneration Research Network, CNTW). Route (2) The research case register will be scanned for potential participants and the research team will then contact the individual and their most relevant healthcare professional and participation in the trial will be discussed. A formal referral will then be sought. The aim for the sample size recruitment will be a total of 12-18 dyads of PLWD and carer (total N=24-36) across both SPFT and CNTW. This will be exclusively limited to informal family carers due to the level of engagement and familiarity with the PLWD that is required for the intervention (see inclusion and exclusion criteria for further detail). Recruitment will be advertised through the usual communication channels as used in Phase 1. Once recruitment is complete, trial participants (both PLWD and carer) will be issued with a participant information sheet. All participants will be offered to access the easy-to-read versions of PIS and consent forms before meeting with the researcher. Easy-read versions will include the use of inclusive graphics, simplified language and larger text. Following this, a meeting will be arranged with a researcher where eligibility will be confirmed. This will be achieved by checking against set criteria and delivering Addenbrooke’s Cognitive Examination III (ACE), which is a test widely used in memory assessment clinics and studies. It is a comprehensive test which covers 5 individual domains: attention, memory, verbal fluency, language and visuospatial abilities. The researcher in SPFT and research assistants in CNTW will be trained to deliver the ACE effectively by staff within SPFT memory clinic services. The ACE III provides an overall score out of 100, with higher scores indicating higher cognitive function. Any PLWD that scores below 36 or above 81 will not be eligible for participation, as this is outside the range of mild-moderate dementia. Informed dyadic consent will be taken on separate forms, requiring individual signatures from each person (PLWD and family carer) to ensure that the autonomy of decision-making is upheld and respected. The form will state that in the event of one individual from the dyad losing capacity during the study, or wishing to withdraw, then the whole dyad will be withdrawn; any data previously collected will be retained. If consent will need to be taken over the phone, the researcher will follow the protocol for taking remote consent. A copy of the remote consent forms will be sent via postal service to the participants. Baseline demographic measures will be collected from those who choose to participate. At this stage, the outcome measures will also be administered which will create a pre-intervention data set. The trial participants will then complete the C-DEM-CSE, as informed by phase 1. The intervention will be delivered by therapists who have been trained in the delivery of CSE. Please see the intervention protocol for the current non-adapted version of the CSE intervention. The therapists that will deliver the intervention in SPFT will be Prof Mark Hayward and Dr Kirstie Chandler. They both have significant experience working in a variety of mental healthcare settings and patient groups. Prof Mark Hayward is the Director of Research at SPFT and is the lead for the Sussex Voices Clinic; Dr Kirstie Chandler has a wealth of experience in psychosis research including delirium in dementia and currently works in Specialist Older Adult Mental Health Services (SOAMHS), SPFT. Both of their backgrounds and experiences will suit the nature of the research study. Each therapist will deliver the intervention to approximately 3 of the dyads. There will also be a therapist based in CNTW, Dr Katharina Reichelt, at the CNTW trust, who will deliver the intervention to 6 of the dyads. This therapist will be trained by the chief investigator in the delivery of the C-DEM-CSE and will have regular contact with the research team based in Sussex; the 3 therapists will meet regularly for clinical supervision, facilitated by the chief investigator, Dr Mark Hayward. Phase 3 - Data collection and analysis Upon completion of the intervention, trial participants will be asked to meet for a final assessment where post-intervention outcome measures will be administered so that pre and post-intervention data can be compared and analysed. An exit interview for both the PLWD and the carer will be conducted to gain feedback from the intervention; where appropriate, the interviews will be delivered to the PLWD and the carer separately as it is important that the participants feel that they can express and explore their experiences of the intervention candidly. An exit interview will also be conducted with the therapists who delivered the C-DEM-CSE, to understand their experiences of delivering it to this population. These meetings will take place either face-to-face or virtually depending on the preferences, location and availability of the participants, the researcher (SPFT) and the research assistants (CNTW). Trial participants will be reimbursed for their time in pre- and post-intervention meetings to collect baseline data and deliver exit interviews, at £20 per individual, per meeting. There will be no monetary reimbursement for participation in the four intervention sessions. Travel compensation will also be provided, with a cap of up to £25 per person, per meeting. Fuel costs will be calculated at 45p per mile. All data analysis will be completed by the student researcher. See the analysis plans in the data management section. Phase 4- Co-Evaluate As outlined in Phase 1, the two focus groups will be invited to reconvene, to discuss and evaluate the C-DEM-CSE. As before, the groups will meet separately and then representatives will come together for a final meeting to collectively discuss learnings from phases 2 and 3. Monetary compensation will be provided to focus group participants for this meeting, at the same rates as in Phase 1. Planned Data Analysis Qualitative- Phase 1- Co-Adapt During Phase 1, focus group participants from the focus groups will partake in facilitated discussions and negotiations regarding ideas for adaptations to the CSE intervention. As a group, they will identify key features that they believe should be included or adapted in the intervention. Following this, the use of concept mapping will allow the participants and researcher to group themes that could then translate into proposed adaptations. Each of the two focus groups will produce these maps. The representatives from these two groups will then have a final meeting with the researcher where it will be decided which adaptations go forward into the final design of the C-DEM-CSE. Quantitative- Phase 2- Single-arm feasibility trial Calculating recruitment and retention rates will help to inform the primary feasibility outcomes regarding recruitment, retention, completion/ exposure and acceptability. Quantitative measurements collected pre- and post-intervention will be used to indicate average levels of change with associated 95% Confidence Intervals, but no hypothesis testing will be carried out. This information will be for indicative purposes only. Levels of data completeness will be summarised. Descriptive statistical analyses will be conducted to map the demographical picture of the PLWD and their carers; this data will be explored by mapping it against other demographical reports of PLWD who experience hallucinations. As this is a single-arm feasibility study, an exploratory stance will be adopted to ensure that results and effects are not limited by existing theories or biases. Qualitative – Phase 3- Data collection and analysis Following the exit interviews, anonymised verbatim transcripts will be analysed using the Framework Method which is commonly employed in the evaluation of studies of complex interventions in health research. According to the MRC recommendations, this method of analysis aims to generate a specifically nuanced understanding of the personal experiences of engaging with the C-DEM-CSE intervention, what worked well for the participants and what could be improved upon for further adaptation; through this data, we aim to gain a deeper context around the research questions surrounding reducing distress around hallucinatory experiences and improving quality of life. To maintain careful attention to the idiographic nature of participants’ reflections, leading to an in-depth inductive analysis, we will follow the seven steps of the Framework Method: (1) verbatim transcription, (2) familiarisation, (3) coding, (4) developing an analytical framework, (5) applying the analytical framework to the data, (6) charting data into the framework matrix, and (7) interpreting the data. Within steps four and five, we will tailor and enrich this method by employing a six-stage analytical framework of Foucauldian-informed narrative analysis of principles for analysis (step four) and actions for analysis (step five). Mixed The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository at the Sussex Partnership Foundation Trust. The datasets will be stored in the data repository during the study, and the direct research team will only be able to access this data. Following the closure of the study, the data will be kept for up to 10 years, which is in line with Sussex Partnership Foundation Trust, data storage guidelines. Consent will be sought from participants verbally and on paper. From the point that consent is given, participants will be anonymised and allocated an ID code which will be used thereon. For the dissemination of qualitative work, participant pseudonyms may be used to aid the flow of reading. Stored in non-publicly available repository 3db163eb-9091-44d7-b971-2592d28df279 b7d97ece-4786-40db-8f2e-8bfe6b4c1fc2 4420d9ab-9b29-4855-8be4-29abcc72d57a 0c58df24-8ee6-4529-961d-5968792f3651 Yes Amaani Al-Azzawi https://orcid.org/0009-0002-6912-0396 Public

Room 101, Trafford Centre, Brighton & Sussex Medical School, University of Sussex

Brighton United Kingdom BN1 9RR - a.al-azzawi1@uni.bsms.ac.uk Public Mark Hayward Scientific Principal investigator

Sussex Education Centre, Millview Hospital , Marshall Way

Brighton United Kingdom BN3 7HZ +44 7770331160 mark.hayward@spft.nhs.uk Public Sussex Partnership NHS Foundation Trust Hospital/treatment centre https://ror.org/05fmrjg27 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 16864276 true Implementation of a medicine management plan (MMP) to reduce medication-related harm (MRH) in older people post-hospital discharge: a randomised controlled trial PRIME-3 Current risk stratification in clinical practice for MRH in older adults is based on clinical judgement. Clinical judgement is not useful in predicting medication-related harm (MRH). MRH risk prediction tools are not routinely used in clinical practice, as existing tools have not been assessed for impact and implementation. The PRIME tool has been transparently developed and validated. To satisfy the next stage of risk-prediction model creation, the impact of the tool will be assessed on a new sample of individuals. Targeted interventions at high-risk individuals may be a clinically and cost-effective solution in reducing rates of MRH in older adults. The PRIME team in collaboration with AHSN-KSS will implement a risk-stratification approach linked with the NHS DMS. The study will recruit patients aged 65 and older discharged from four NHS trusts. The control arm will consist of NHS DMS care only. The intervention arm will consist of NHS DMS with a specific medicines management plan (MMP) develop by the team in consultation with patients and carers. The MMP will be made of: 1. A copy of the discharge summary 2. Specific education about possible medication-related harm from the discharge medications. Education will be delivered by the ward pharmacist and/or the ward doctor at the point of discharge. 3. Clear guidance on who to contact (their GP or their community pharmacist) if they experience any MRH. 4. The name and contact of the community pharmacist will be provided by the ward pharmacist. 5. A copy of the percentage/probability of harm from medication calculated using the PRIME study RPT, and presented as a visual analogue scale will be offered to patients and (if available) their carers. See Appendix for document. Research Question: Will a Medicines Management Plan linked to the NHS DMS be more effective than the NHS DMS alone in reducing rates of MRH? Objectives: 1. To measure and compare the rates of MRH in the two groups. 2. To measure the costs of delivering the intervention and any associated MRH-related service use in the two groups across the 8-week study period. To perform modelling to provide national cost estimates. 3. To undertake a process evaluation. Background and study aims Hospital discharge is a high-risk situation for experiencing medication-related harm (MRH). This may be due to side effects, consequences of not taking the medication, or medication errors. Older people at the point of discharge are at higher risk of medication-related harm (MRH). This is due to underlying health conditions, being on multiple medications, and changes in the way the body handles medication with older age. 1 in 3 adults aged 65 and over experience medication-related harm (MRH) in the 8 weeks after discharge, with half of these episodes being potentially preventable. A research team has developed a Risk Prediction Tool (RPT) which is the first objective approach to predict the absolute risk of an older adult experiencing MRH in the 8 weeks after discharge. This absolute risk is presented as a numerical score (percentage). NHS England acknowledged that risk-prediction tools can help in targeting appropriate interventions to those at the greatest risk of harm, and these high-risk groups are the ones most likely to benefit from such interventions. This study aims to reduce medication-related harm in older people after a hospital stay by improving the medicines information that a patient or their carer receives on discharge. Who can participate? Patients over the age of 65 years, admitted to an acute Elderly Care or General Medical Ward and likely to be discharged within 48 hours What does the study involve? Participants will have an equal chance of being allocated to the intervention group (additional information about their own risk and medications plus exchange of information between hospital pharmacists and community pharmacists) or to the usual care group (exchange of information between hospital pharmacists and community pharmacists). All study participants will have their risk related to their medicines calculated using the RPT. The study period is 8 weeks and will take place across multiple hospital sites. At the end of the 8 weeks, participants or their carers will be interviewed over the phone by the study pharmacist to identify if they have experienced MRH. If study participants were re-admitted to hospital in the 8-weeks period after joining the study, they will be assessed to check if the subsequent admission was due to MRH. What are the possible benefits and risks of participating? There are no foreseen risks to taking part in this study. Both groups will receive additional support in handling their medications in the 8-week period after leaving hospital through the NHS discharge medicines service. One group will receive additional medication information, support and advice just before discharge. Participants will be contributing to understanding how we can help protect patients from preventable harm. Where is the study run from? University of Sussex (UK) When is the study starting and how long is it expected to run for? April 2022 to December 2023 Who is funding the study? Applied Research Collaboration Kent, Surrey, and Sussex (ARC KSS) (UK) Who is the main contact? Dr Khalid Ali khalid.ali10@nhs.net The number of participants that had medication-related harm who had only the NHS-discharge medicines services (DMS) and the number of participants with medication-related harm who had both the NHS-DMS with the medicines management plan (MMP), measured using a phone interview at the end of the 8-week period 1. The acceptability of the control and intervention arm among clinicians, service providers, researchers and other health workers involved in discharge planning assessed through focus group interviews during the study period 2. The cost-effectiveness of the intervention will be measured using economic analysis estimating the resources involved in delivering the intervention and treatment of medication-related harm within 8 weeks post-discharge Old ethics approval format Approved 22/03/2022, North West Haydock Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048211, +44 (0)2071048375, +44 (0)2071048248; haydock.rec@hra.nhs.uk), ref: 22/NW/0075 10.1186/ISRCTN16864276 305313 CPMS: 52514 305313 52514 Multicenter interventional randomized controlled trial Interventional Randomised controlled trial Prevention 2023-12-31T00:00:00.000Z United Kingdom England Royal Sussex County Hospital Laboratory

Royal Sussex County Hospital Eastern Road

Brighton England BN2 5BE 690J0@2.16.840.1.113883.2.1.3.2.4.18.48 Royal Devon & Exeter Foundation Hospital

Barrack Road

Exeter England EX2 5DW RK963@2.16.840.1.113883.2.1.3.2.4.18.48 Royal Stoke University Hospital

Newcastle Road

Stoke-on-trent England ST4 6QG RJE01@2.16.840.1.113883.2.1.3.2.4.18.48 Eastbourne District General Hospital

Kings Drive

Eastbourne England BN21 2UD Ormskirk & District General Hospital

Wigan Road

Ormskirk England L39 2JW RVY38@2.16.840.1.113883.2.1.3.2.4.18.48 Princess Royal Hospital

Lewes Road

Haywards Heath England RH16 4EX Royal Berkshire & Battle Hospital (berkshire West Site)

London Road

Reading England RG1 5AN 5QFCA@2.16.840.1.113883.2.1.3.2.4.18.48 Patient 1. Patients must be over the age of 65 years at the time of recruitment, admitted to an acute Elderly Care or General Medical Ward 2. Patients to be identified when they are likely to be discharged within 48 hours 3. Patients need to be registered with a General Practitioner within the areas covered by the recruiting hospitals 4. Informed written consent must be provided from patients with capacity OR personal consultees acting on behalf of patients without capacity Senior 65 Years 120 Years All 684 682 1. Patients lacking capacity and have no consultee to advise 2. Patients that are transferred to other acute healthcare trusts (but excluding step down or intermediate care facilities) 3. Patients who have a short life expectancy, due to a terminal illness 4. Patients who are unable to read/speak/understand English 2022-06-17T00:00:00.000Z 2023-06-01T00:00:00.000Z Reducing medication-related harm (MRH) in older adults within 8 weeks post-discharge from the hospital Other Participants will undergo simple randomization into the two arms: a control arm and an intervention arm. Participants in the control arm will receive the existing NHS Discharge Medicines Service, where patients are given information based on the pharmacists’ assessments of the discharge medications patients will be taking home. The intervention arm will receive the MMP consisting of: 1. A copy of the discharge summary 2. Specific education about possible medication-related harm from the discharge medications. Education will be delivered by the ward pharmacist and/or the ward doctor at the point of discharge. 3. Clear guidance on who to contact (their GP or their community pharmacist) if they experience any MRH. 4. The name and contact of the community pharmacist will be provided by the ward pharmacist. 5. A copy of the percentage/probability of harm from medication calculated using the PRIME study RPT, and presented as a visual analogue scale will be offered to patients and (if available) their carers Participants will be followed up for 8 weeks to find out how many had medication-related harm over the 8 weeks period post-discharge. Other Data sharing will be anonymised data of participants and will be available on request to the corresponding author Dr Khalid Ali via (khalid.ali10@nhs.net). Data will be available to the public after the publication of the findings of the study. Data has been anonymized and consent for publication has been sought from all study participants during recruitment. There are no ethical or legal restrictions associated as per the ethical clearance received from the HRA - ethics committee review. Available on request 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36368938/ (added 29/08/2025) Results

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84b63bbd-3aa7-46f4-af01-2430c5d0f3d9 2815f0d1-355e-4652-a249-e28d680dc310 f4e19200-34bf-4975-84ba-aafbd5ac43b2 Yes Protocol file 41683_PROTOCOL_V10_16Jan22.pdf a5a4cef3-fc64-401c-b8eb-7e6a2048dc5d true application/pdf 1369481 37fc5a2005992c9e726b405a3cca7cd2 Participant information sheet 41683_PIS_V2_16Mar22.pdf 693ffaff-2725-47c8-8826-f7e3a3b3a96e true application/pdf 482050 7ab7b306f15967cb3765b19f1f868797 Statistical Analysis Plan ISRCTN16864276_SAPV10_16Jan22.pdf c51c8f71-e4a3-4320-beea-a9c6978facf1 true application/pdf 894208 69d81e8c783d27089c81d9c8b970beab Other unpublished results ISRCTN16864276 unpublished results.pdf 1298aa23-d73f-4082-bb61-8313d5b70b78 true application/pdf 520135 3cfd14d2f3e6461f57fc2c22994d9260 Khalid Ali Principal investigator

Senior Lecturer in Geriatrics, BSMS Brighton and Sussex Medical School Audrey Emerton Building Eastern Road

Brighton United Kingdom BN2 5BE +44 (0)1273 523368 khalid.ali10@nhs.net Public University of Sussex University/education https://ror.org/00ayhx656 Non-commercial Applied Research Collaboration Kent, Surrey, and Sussex (ARC KSS) 12505807 true Trialling an Optimised social Groups intervention in services to Enhance social connecTedness and mental Health in vulnERable young people (TOGETHER): a feasibility study TOGETHER 1. Is it feasible to conduct a randomised controlled trial for the Groups 4 Health (G4H) intervention when delivered to young service-users accessing community, health and/or youth mental health services? 2. Is the G4H intervention feasible to deliver to young service-users involved in community, health and/or youth mental health services? 3. Is the G4H intervention safe and acceptable according to both the young service-users receiving the intervention, and the practitioners delivering the intervention? 4. What changes are indicated to improve the safety, acceptability, accessibility and feasibility of the intervention? Background and study aims: We are testing an intervention called 'Groups 4 Health'. The intervention was designed by a team in Australia to support people to identify and develop connections with new people or social groups. Past research has found that the intervention can help people with their feelings of loneliness, their connections with other people, and their well-being. To understand if the intervention might be helpful for young people in the United Kingdom, it first needs to go through a small pilot research study. This project will help us to learn: 1) What the experience of the intervention is like for young people currently experiencing mental health difficulties 2) What the intervention is like to deliver for members of staff delivering the intervention 3) Do our plans for this research study work? 4) This information will help us to learn whether we can run a larger study to test whether the intervention is helpful. Who can participate? This study is suitable for young people (aged 16-25 years) who are currently experiencing difficulties with their mental health and well-being. What does the study involve? Participants will meet with a researcher at three time points (baseline, 10 week and 14 week post-randomisation). Participants will also be randomised to receive the intervention alongside their usual treatment, or receive their usual treatment only. Participants randomised to receive the intervention, will receive the intervention by a trained practitioner from the community, health and/or youth mental health service they access. What are the possible benefits and risks of participating? This study will involve answering questions about mental health and social wellbeing. Some people in similar research studies have told us they find it interesting or helpful to answer such questions. However, some people can find it difficult or distressing. Some of the questions asked are of a potentially sensitive nature. For example, a small number of questions ask about low mood and suicidal thoughts. We hope that those receiving the Groups 4 Health intervention will find it helpful. However, this cannot be guaranteed. By taking part in this study, participants will help us to learn about how helpful the intervention might be, and whether we should try and test this in a bigger project. Participants will also be helping us to learn how we can optimise the intervention. Where is the study run from? The University of Sussex When is the study starting and how long is it expected to run for? From April 2022 to September 2023 Who is funding the study? The Applied Research Collaboration in Kent, Surrey and Sussex Who is the main contact? Claire Vella c.vella@sussex.ac.uk Feasibility will be measured using the following: 1. Number of potential service-user participants referred each month throughout the recruitment period 2. Number of intervention providers from services involved in the trial aspect of the study who consent to take part each month throughout the recruitment period 3. Number and proportion of referred potential service-user participants who consent to take part in the study each month throughout the recruitment period 4. Number and proportion of referred potential service-user participants found to be eligible each month throughout the recruitment period 5. Number and proportion of consenting eligible participants who are retained in the study post-randomisation at 10 weeks and 14 weeks 6. Number and proportion of survey measures completed by each participant at baseline, 10 weeks, and 14 weeks 7. Number and proportion of consenting eligible service-user participants who take part in all five G4H sessions throughout the 8 week intervention period 8. Number and proportion of intervention adherence components completed for each session and across the whole G4H intervention throughout the 8 week intervention period 9. Number and nature of adverse events experienced by study participants each month throughout the 8 week intervention period 10. Number and proportion of breaks in blinding each month throughout the 14 week study period There are no secondary outcome measures Old ethics approval format Approved 30/03/2022, Berkshire Research Ethics Committee (Temple Quay House, BS1 6PN; +44 (0)207 104 8178; berkshire.rec@hra.nhs.uk), ref: 22/SC/0040 10.1186/ISRCTN12505807 309287 CPMS: 51865 309287 51865 Multicenter interventional blinded feasibility randomized controlled trial Interventional Randomised controlled trial Quality of life 2023-09-30T00:00:00.000Z United Kingdom England Sussex Partnership NHS Foundation Trust

Trust Hq Swandean Arundel Road

Worthing United Kingdom BN13 3EP RX2@2.16.840.1.113883.2.1.3.2.4.18.48 Patient 1. Aged 16 – 25 years old 2. Accessing a community, health and/or youth mental health service involved in the study 3. Experiencing current mental health difficulties (operationalised by a rating of ≤60 on the Global Assessment Scale (GAS)) 4. Able to read, write and speak in English, or are non-English speaking but have access to an interpreter, to the degree they can give informed consent and are able to fully understand and participate in both the assessment questions and intervention content Other 16 Years 25 Years Not Specified 30 1. At immediate and serious risk to self or others (assessed at the point of referral/eligibility review) 2. Currently participating, or be confirmed to participate in another interventional research study in which they are receiving an intervention that targets social isolation or utilises psychological therapy 3. Expected to be discharged, or be known to be unable to seek support from the referring service, in the 16 weeks following a referral to the trial being made (14 week research involvement + 2 weeks allowing for any missed/rearranged meetings) 2022-04-18T00:00:00.000Z 2023-06-30T00:00:00.000Z Social connectedness and mental health in vulnerable young people Mental and Behavioural Disorders 5 session adapted Groups 4 Health (G4H) intervention, delivered by trained practitioners within an ~8 week time frame. Participants are randomised, stratified by site, to receive the intervention alongside treatment as usual, or receive treatment as usual only. Randomisation will be completed by a co-investigator statistician, who will not be involved in the research and intervention delivery, nor data analysis, using the Sealed Envelope online service. One of the trial study coordinators will be unblind during the trial. All other study team members will be blind to the randomisation procedure and allocation sequence. Behavioural The datasets generated during and/or analysed during the current study are/will be available upon request from Claire Vella (c.vella@sussex.ac.uk). The type of data available will be anonymised quantitative and qualitative data, regarding intervention and research process feasibility, and trial outcome data. Participant consent was provided for data sharing for the purposes of research. There are no known other ethical nor legal restrictions. Data will become available from October 2023 for an indefinite period. Available on request 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37582069/ (added 16/08/2023) Protocol

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80963d1a-7991-42b6-b886-e926088b591e 980cf54a-e1e9-4dc4-a0ed-991b62cdcdb8 d12f69fd-2fca-4b66-aa59-8b2de4424e0e 3a1b7155-2327-476c-9884-05ea2b5e6d1c 966d225f-9b11-4f1a-9174-f836dd180d26 Yes Clio Berry https://orcid.org/0000-0003-1164-9836 Principal investigator

BSMS Teaching Building University of Sussex Brighton East Sussex BN1 9PX

Brighton United Kingdom BN1 9PX +44 (0)1273 641229 c.berry@bsms.ac.uk Public Claire Vella Public

Pevensey 1 Building University of Sussex Falmer

Brighton United Kingdom BN1 9QH +44 (0)7920 086770 c.vella@sussex.ac.uk Public Claire Vella Scientific

Pevensey 1 Building University of Sussex Falmer

Brighton United Kingdom BN1 9QH +44 (0)7920 086770 c.vella@sussex.ac.uk Public University of Sussex University/education https://ror.org/00ayhx656 Non-commercial Applied Research Collaboration - Kent, Surrey & Sussex 14602359 true Primary care implementation of Germ Defence: a digital behaviour change intervention to improve infection control during the COVID-19 pandemic COVID-19 GDI Germ Defence implementation will decrease the number of respiratory tract infection diagnoses - including COVID-19 - recorded in primary care. The Germ Defence digital behaviour change website has already proven effective at reducing the spread of viral infections such as colds and flu (Little et al, 2015). It is possible that Germ Defence could also protect people from other respiratory tract infections and so increase the capability and capacity of the health service to cope with the number of patients using it. However, although the Germ Defence intervention has been updated to be relevant to COVID-19, we have no evidence that it will be effective. By disseminating the intervention randomly via GP practices to patients, we can examine the effects of implementing Germ Defence across primary care for all respiratory tract infections including those with a COVID-19 diagnosis. Background and study aims Recent research into coronavirus has shown that members of the public can play a crucial role in controlling infection outbreaks in their homes by adopting simple behaviours such as handwashing, cleaning surfaces, wearing of face coverings and social distancing. Despite public health advice, evidence shows most people need to change their behaviour to help prevent infection. Germ Defence is an interactive website (https://www.germdefence.org) which uses behaviour change techniques to supplement public health advice. It was developed during the swine 'flu pandemic using theory, evidence and extensive feedback from members of the public. It was then trialled in over 20,000 patients and shown to reduce the number and severity of infections of users and members of their household. Germ Defence has recently been updated for use in the COVID-19 pandemic. The website helps users with pre-planning about effective isolation of an infected household member; personalised goal setting for increasing a range of infection control behaviours; changing the home environment to support new habits and problem-solving to overcome barriers. This study will examine the effects of randomising dissemination of the Germ Defence website via GP practices on rates of respiratory infection including COVID-19 and seasonal 'flu. Who can participate? The researchers are not looking to recruit individual participants for this study. Instead, they will work with GP practices in England and ask them to promote the Germ Defence intervention to all their patients aged 18 and over. What does the study involve? The researchers will contact every GP practice in England and ask them to support this study. This will involve each practice sharing a weblink to Germ Defence website with their adult patients. Half of the practices will be randomly chosen and asked to send out the Germ Defence link to their patients in the Autumn of 2020. These practices will be known as the immediate implementation group or intervention arm. The other half of the practices will be contacted to send out Germ Defence in March 2021. These practices will be known as the delayed implementation group or usual care arm. The researchers will assess usage of the Germ Defence weblink from anonymous data produced by the website. They will then use anonymised NHS data collected as part of routine care to compare whether infection rates are lower in practices that sent Germ Defence information to their patients immediately compared with rates in those that didn’t send the information until later. What are the possible benefits and risks of participating? Germ Defence has been designed so that anyone can use and benefit from its information and ideas on how to lower their risk of catching COVID-19. This includes specific techniques for handwashing (when, where and how to wash hands effectively), keeping a safe distance, and not touching the face, as well as information to help people decide if they need to wear face coverings and how to minimise the amount of virus that they are exposed to. The website also provides advice on how people might look after family and friends who are ill whilst still protecting themselves. The researchers are not aware of any risks that might arise from taking part in the study. Where is the study run from? The study will be run by the University of Bristol with support from colleagues at the University of Southampton, University of Bath, NIHR Applied Research Collaboration West, NIHR Clinical Research Network West of England and NHS Bristol, North Somerset & South Gloucestershire Clinical Commissioning Group (UK) When is the study starting and how long is it expected to run for? October 2020 to March 2021 Who is funding the study? 1. UK Research and Innovation (UKRI) (UK) 2. National Institute of Health Research (NIHR) Applied Research Collaboration (ARC West) (UK) 3. NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation (UK) Who is the main contact? Dr Melanie Chalder germdefence-study@bristol.ac.uk Respiratory tract infection diagnoses measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 1. Incidence of COVID-19 diagnoses measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 2. Incidence of COVID-19 symptom presentation measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 3. Incidence of gastrointestinal infections measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 4. Number of primary care consultations measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 5. Antibiotic usage measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 6. Hospital admissions measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months 7. Uptake of GP practices disseminating Germ Defence to their patients measured using website analytics at baseline and 4 months 8. Usage of Germ Defence by individuals granted access to the website by their GP practice measured using website analytics at baseline and 4 months Old ethics approval format Approved 2/9/2020, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8018; leedswest.rec@hra.nhs.uk), ref: 20/YH/0261 10.1186/ISRCTN14602359 287978 CPMS: 46740, UKRI (MRC) MC_PC_19068, UoB 2020-3213 287978 46740 UKRI (MRC) MC_PC_19068, UoB 2020-3213 Single-centre two-arm cluster randomized controlled trial Interventional Cluster randomised trial Prevention 2021-03-10T00:00:00.000Z United Kingdom England NIHR Clinical Research Network West of England

Whitefriars Lewins Mead

Bristol United Kingdom BS1 2NT NIHR Clinical Research Network North East and North Cumbria

Regent Point Regent Farm Road Gosforth

Newcastle-upon-Tyne United Kingdom NE3 3HD NIHR Clinical Research Network North West Coast

iC1 Liverpool Science Park 131 Mount Pleasant

Liverpool United Kingdom L3 5TF NIHR Clinical Research Network Yorkshire & Humber

Unit 1 Calder Close Calder Park

Wakefield United Kingdom WF4 3BA NIHR Clinical Research Network Greater Manchester

Citylabs 1.0 Nelson Street

Manchester United Kingdom M13 9NQ NIHR Clinical Research Network East MIdlands

Knighton Street Outpatients 1st Floor Leicester Royal Infirmary

Leicester United Kingdom LE1 5WW NIHR Clinical Research Network West MIdlands

Birmingham Research Park Vincent Drive

Birmingham United Kingdom B15 2SQ NIHR Clinical Research Network Thames Valley and South Midlands

Block 8, Nuffield Orthopaedic Centre Old Road Headington

Oxford United Kingdom OX3 6HE NIHR Clinical Research Network Eastern

20 Rouen Road

Norwich United Kingdom NR1 1QQ NIHR Clinical Research Network Kent, Surrey and Sussex

Bevendean House Room BE205 University of Brighton

Falmer United Kingdom BN1 9PH NIHR Clinical Research Network Wessex

Unit 7 Berrywood Business Village Tollbar Way Hedge End

Southampton United Kingdom SO30 2UN NIHR Clinical Research Network South West Peninsula

Plymouth Science Park 1 Davy Road Derriford

Plymouth United Kingdom PL6 8BX. NIHR Clinical Research Network North Thames

170 Tottenham Court Road

London United Kingdom W1T 7HA NIHR Clinical Research Network South London

16th Floor BRC Faculty Guy's Tower Guy's Hospital Great Maze Pond

London United Kingdom SE1 9RT NIHR Clinical Research Network North West London

3rd Floor Administrative Block South Hammersmith Hospital Du Cane Road

London United Kingdom W12 0HT Patient Current inclusion criteria as of 09/10/2020: No individual patients will be recruited to this trial. However, all GP practices in England will be asked to support the study by promoting the use of the Germ Defence website to their adult patients either on 14/10/2020 (intervention arm) or on/after 31/01/2021 (usual care arm) _____ Previous inclusion criteria: No individual patients will be recruited to this trial. However, all GP practices in England will be asked to support the study by promoting the use of the Germ Defence website to their adult patients either on 01/10/2020 (intervention arm) or after 31/01/2021 (usual care arm) Adult All 6822 459 1. GP practices outside England 2. Patients under the age of 18 years 2020-10-01T00:00:00.000Z 2021-03-09T00:00:00.000Z Respiratory tract infections including COVID-19 (SARS-CoV-2 infection) Infections and Infestations Germ Defence is a digital behavioural change intervention to improve infection control. The Germ Defence content was developed using theoretical modelling and qualitative research (Yardley et al. 2011), in line with the person-based approach (Yardley et al., 2015), drawing principally on the theory of planned behaviour (Ajzen, 1985), Leventhal’s common-sense model of illness (Leventhal, 2016) and protection motivation theory (Rippetoe, 1987). Intervention content, design and structure were optimised iteratively using in-depth qualitative ‘think-aloud’ interviews with members of the general public in order to ensure the intervention was accessible, credible and motivating for as many people as possible (Yardley et al. 2015). Based on process evaluations of the original randomised controlled trial (Little et al., 2015) and previous public dissemination activities (Ainsworth et al., 2017), Germ Defence has been updated and streamlined for use since the coronavirus pandemic, including translation into 20 languages (including Traditional and Simple Chinese), and broadening the infection control behaviours that were recommended. The intervention is a single session, designed to be easily accessible with no sign-up or password required, and the consent process placed within the website privacy policy. Data collection is unobtrusive and kept to a minimum to reduce dropout. Germ Defence seeks to increase users’ perceived risk by emphasising the personal and social health consequences of contracting RTIs including COVID-19. These are followed by messages to increase skills and confidence to reduce exposure to the virus. The Germ Defence content is tailored such that a user selects one of four streams that is relevant to the user’s situation: 1. To protect themselves generally 2. To protect others if the user was showing symptoms 3. To protect themselves if household member(s) showed symptoms; or 4. To protect a household member who is at high risk Content is tailored in this way to encourage users to adopt behaviours appropriate to the perceived level and pattern of risk in their household. Clear and detailed advice is then provided for self-isolating, social distancing, disinfecting and/or cleaning, wearing face-coverings, and putting items aside that may have viruses on them such as shopping/packages, to the extent that users feel is appropriate for the perceived risk. These pages also contain ideas and information on how to structure the home and engage in behaviours safely. The website can be accessed for free at https://www.germdefence.org. All GP practices in England will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC) unit. CCGs in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. The researchers will ask staff at GP practices randomised to the intervention arm to share the link to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Patients at GP practices randomised to the usual care arm will receive current standard management for the trial period after which they will be given a link to the Germ Defence intervention by their practices. The outcome data from patients in practices promoting the Germ Defence intervention will be compared with the outcome data of patients in 'usual care' practices as part of this efficient, pragmatic trial. Behavioural Data will not be made available for sharing until after publication of the main results of the study. Thereafter, anonymised data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the Medical Research Council (MRC) Policy on Data Preservation and Sharing regarding scientific quality, ethical requirements and value for money. A minimum requirement with respect to scientific quality will be a publicly available pre-specified protocol describing the purpose, methods and analysis of the secondary research, e.g. a protocol for a Cochrane systematic review. Data requests should be made to the Principal Investigator Dr Jeremy Horwood by emailing germdefence-study@bristol.ac.uk. Available on request 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38049846/ (added 05/12/2023) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33836825/ (added 12/04/2021) Results

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Study website Migrated from study website field

1e3f5997-070e-4b8d-923c-59108195e427 e3386325-1277-4672-acfe-bca2d6ccb74d 1c08f8fa-f1ec-4686-ba94-dd667c3e1ee3 3b6a8b7c-c02b-4d48-ac99-479036239683 248035b4-4542-4347-b725-3e87b0f097e9 f3e193b5-e740-494e-ae48-e4ff9b54cffe Yes Jeremy Horwood https://orcid.org/0000-0001-7092-4960 Scientific

NIHR ARC West 9th floor Whitefriars Lewins Mead

Bristol United Kingdom BS1 2NT - germdefence-study@bristol.ac.uk Public Melanie Chalder https://orcid.org/0000-0003-1964-2815 Public

University of Bristol Canynge Hall 39 Whatley Road

Bristol United Kingdom BS8 2PR - germdefence-study@bristol.ac.uk Public University of Bristol University/education https://ror.org/0524sp257 Non-commercial UK Research and Innovation http://dx.doi.org/10.13039/100014013 National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West) NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation