Reducing medication-related harm in older people
| ISRCTN | ISRCTN16864276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16864276 |
| IRAS number | 305313 |
| Secondary identifying numbers | IRAS 305313, CPMS 52514 |
- Submission date
- 01/05/2022
- Registration date
- 20/05/2022
- Last edited
- 23/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Principal Investigator
Senior Lecturer in Geriatrics, BSMS
Brighton and Sussex Medical School
Audrey Emerton Building
Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273 523368 |
|---|---|
| khalid.ali10@nhs.net |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 41683_PIS_V2_16Mar22.pdf |
| Scientific title | Implementation of a medicine management plan (MMP) to reduce medication-related harm (MRH) in older people post-hospital discharge: a randomised controlled trial |
| Study acronym | PRIME-3 |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Reducing medication-related harm (MRH) in older adults within 8 weeks post-discharge from the hospital |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 684 |
| Total final enrolment | 682 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 17/06/2022 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Eastern Road
Brighton
BN2 5BE
United Kingdom
Kings Avenue
Ashford
TN23 1LX
United Kingdom
Exeter
EX2 5DW
United Kingdom
Gillingham
ME7 5NY
United Kingdom
Sponsor information
University/education
Falmer House
Brighton
BN1 9QF
England
United Kingdom
| Phone | +44 (0)1273 872748 |
|---|---|
| researchsponsorship@sussex.ac.uk | |
| Website | http://www.sussex.ac.uk/ |
"ROR" |
https://ror.org/00ayhx656 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Both protocol and the study results paper will be submitted for publication to an open-access journal to maximise reaching a wide audience. The protocol will be published within 3 months of the study starting and the study results paper, as well as being presented at scientific conferences, will be published within 18 months of the study starting. The academic community will be informed about the study through the research team links with the KSS-CRN, the National Ageing Research Network, and the BGS. The chief investigator (CI) is the ageing specialty lead in KSS-CRN and well placed to report study outputs to the national and international scientific community. Dissemination activities will be supported by University of Sussex Impact Acceleration team. The study participants, the KSS academic community, the national aging speciality group and the care home community (via the Enabling Research in Care Homes (ENRICH) platform) will be notified of study updates with a newsletter every 4 months. During the study, if new information relevant to continued participation becomes available during the study period, then the study team will send this information to the participant through their preferred choice (email or post). We consider this an unlikely possibility; this study trials a one-off intervention rather than a continuous one, and there will be no interim analyses. The findings will be disseminated in collaboration with several organisations: the Brighton and London Chapters for ‘’Ageing 2.0; the Ageing Well: Changing the conversation platform’’; the KSS AHSN and national AHSN network; the National Medicine Optimisation Network; the KSS Chief Pharmacy network; the KSS Medicine Safety Network and the NHS Improvement Patients Safety Collaborative Medicine Safety Programme. Additionally, the study team have connections with Healthwatch Brighton & Hove and the U3A group. The service evaluation of the proposed study will provide knowledge of the enablers and barriers to scale up the study regionally and nationally. The National Adoption committee will work with Policy@Sussex and the ARC-KSS to continue to build awareness about the study and its findings. To sustain the impact of the study beyond the life of the study itself, we will continue working with the study partners, their organisations and commissioning groups in Sussex and nationwide to lobby for wider national implementation of the study findings. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 16/03/2022 | 11/05/2022 | No | Yes |
| Protocol file | version 10 | 16/01/2022 | 11/05/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
23/06/2022: The recruitment start date was changed from 01/06/2022 to 17/06/2022.
11/05/2022: Trial's existence confirmed by the HRA.
