Person-centred care for patients with two or more chronic conditions
| ISRCTN | ISRCTN12216776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12216776 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 315161 |
| Protocol serial number | RG_20-015, IRAS 315161 |
| Sponsor | University of Birmingham |
| Funder | Burdett Trust for Nursing |
- Submission date
- 31/08/2022
- Registration date
- 30/09/2022
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Multimorbidity is the presence of two or more long-term health conditions. The prevalence of multimorbidity increases substantially with age and has a significant impact in primary care. People with progressive multimorbid illness and their families often suffer complex and multiple symptoms. Palliative care has developed to meet these complex needs and address their physical and psychological symptoms and provide social, practical, and spiritual support. There is strong evidence that palliative care improves patient outcomes and enables patients to remain at home while saving costs. The hospice movement has provided a model of good palliative care for those with advanced progressive disease, however, there are marked diversity and inequities in the provision of this care.
Palliative care and primary health care share common principles and emphasise the continuity of care and solidarity (accompaniment), respecting patients’ values and preferences, responding to social suffering, and paying attention to both patients and their families. The aim of this study is to improve person-centred nurse-led care for primary care patients with progressive multimorbid illnesses.
Who can participate?
Patients aged 55 years or older with two or more chronic conditions receiving care from the two primary care sites and their family caregivers
What does the study involve?
This study is a mixed-methods study which will develop and pilot a telehealth approach (IPOS-APP) in primary care, to better identify and address complex unmet needs of patients and families in primary care, reduce unnecessary emergency hospital admissions, and improve patients’ experience of primary care.
What are the possible benefits and risks of participating?
This project promotes the implementation of a telehealth approach in primary care and has enormous implications for public health policy and clinical practice, particularly in response to the current COVID-19 pandemic. It leads directly to patient benefit through early identification and management of unmet needs and symptoms, and provides stakeholder views and an evidence-based implementation strategy for a full evaluation of IPOS-APP routine use in primary care. No risks are anticipated.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
April 2022 to August 2023
Who is funding the study?
The Burdett Trust for Nursing (UK)
Who is the main contact?
Dr Ping Guo, p.guo@bham.ac.uk
Contact information
Principal investigator
Institute of Clinical Sciences
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-0979-7047 |
|---|---|
| Phone | +44 (0)1214143230 |
| p.guo@bham.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | This is a mixed-method project at two primary care sites. It applies the first two stages of the Medical Research Council (MRC) framework for developing and evaluating complex interventions, i.e. development, feasibility and piloting |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Improving person-centred nurse-led care for primary care patients with progressive multimorbid illness |
| Study objectives | A telehealth approach (a mobile app IPOS-APP and clinician portal) is feasible to implement in primary care to early identify priority symptoms and concerns among patients with multimorbid illness. |
| Ethics approval(s) | Approved 16/08/2022, East of England - Essex Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048106; Essex.REC@hra.nhs.uk), ref: 22/EE/0148 |
| Health condition(s) or problem(s) studied | People have two or more chronic conditions |
| Intervention | A telehealth approach (IPOS-APP) will be tested in primary care, to better identify and address complex unmet needs of patients and families in primary care, reduce unnecessary emergency hospital admissions, and improve patients’ experience of primary care. This IPOS-APP is not a medical device as it is designed based on the validated Integrated Patient care Outcome Scale (IPOS) questionnaire for patients (or caregivers) to self-report symptoms and needs of the patients and to facilitate good self-care for the patients. The questionnaire has previously been paper-based and used in routine clinical care to support the needs assessment process. The change in this study is its delivery on an app aligned with the priority for digitalisation in health. The IPOS-APP is being used within its intended purpose and is a means of delivering the IPOS questionnaire. Surveys and interviews will be conducted to assess the feasibility and acceptability of the IPOS-APP. Data captured within the APP include a patient-reported outcome measure – the Integrated Patient care Outcome Scale (IPOS). The patient participants will use the IPOS patient version, and caregiver participants will use the IPOS caregiver version as a proxy. It takes approximately 5-7 minutes to complete. Each participant will have individual login details and won’t have access to data reported by others. They use the IPOS-APP to self-report needs and symptoms monthly for 3 months, and staff will use the clinician portal to make timely decisions and clinically manage patients according to the results of the IPOS. Patient outcomes including physical, psychological, social, and spiritual symptoms, information and practical needs will be measured by the IPOS-APP. A baseline measure will be taken when the participants first log in. After this, the participants (including patient participants and caregiver participants) will receive a reminder to self-complete and submit the questionnaire via the IPOS-APP at least monthly for 3 months. The research team will monitor the patients’ IPOS data over 3 months to evaluate improvements in patients’ health status. In between, the questionnaire will remain unlocked to allow as many questionnaires as they wish to submit (optional), through which the researchers can assess the acceptability and usage of the APP. A sub-sample of participants will be interviewed to explore their experiences of using the IPOS-APP and clinician portal. Recruitment will take place for the first 3 months and follow-up will continue for 3 months. The patient demographic data will be collected separately, and no identifiable data will be collected on the IPOS-APP. The anonymised data will be extracted from the IPOS-APP for analysis and interview data will be analysed using NVivo. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patients’ needs, symptoms and concerns are measured using the app version of the Integrated Patient care Outcome Measure (IPOS) at baseline, 1, 2 and 3 months |
| Key secondary outcome measure(s) |
Collected through interviews which will be conducted close to 3 months or soon after 3 months: |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 49 |
| Key inclusion criteria | Patient participants are eligible for inclusion in the study if: 1. They are 55 years of age or older who are receiving care in the participating primary care sites 2. People have two or more chronic conditions 3. All participants have no serious self-reported cognitive impairment and are cognitively capable of participating in the study 4. Those who are able to read and speak English fluently and who have access to a smartphone Family caregivers are eligible to participate if they are 18 years old or above and currently providing support for a patient who is receiving care in one of the study sites but cannot self-report on the IPOS-APP due to disability or other reasons. Any healthcare professionals working at the participating GP sites will be eligible to take part in this project including nurses, GPs, pharmacists, and so on. Those who have experience of using the clinician portal will be invited for interviews. |
| Key exclusion criteria | Patient participants: 1. Patients who are outside of stated age range and outside of stated GP sites 2. Do not have multimorbidity 3. Are considered by nurses too ill to be approached 4. Those who are not able to read and speak English 5. Have no access to a smartphone Caregiver participants: 1. Family caregivers who are under 18 years old 2. Caring for patients with no multimorbidity 3. Outside of stated GP sites 4. Not able to read and speak English 5. No access to a smartphone Healthcare professionals: Those who have not got a chance to use the clinician portal will be excluded to take part in the interviews |
| Date of first enrolment | 09/01/2023 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Smethwick
Birmingham
B66 3NR
United Kingdom
73 Yardley Green Road
Birmingham
B9 5PU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Individual participant data cannot be shared publicly because of the risk of violating privacy. Data access requests can be sent to the project lead via Dr Ping Guo (p.guo@bham.ac.uk) from researchers who meet the criteria for access to confidential data. Anonymised IPOS data and interview data will become available after the publication. For any further analysis, separate consent from participants and ethical approvals will need to be obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Digital technology to optimise care access and quality for patients with multimorbidity; (poster number P 1.005) | 07/06/2023 | 09/04/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Poster results | Abstract: 3.312 | 09/05/2024 | 09/04/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/04/2025: publication references added.
20/03/2024: The intention to publish date was changed from 31/03/2024 to 31/03/2025.
19/07/2023: The overall study end date was changed from 31/07/2023 to 31/08/2023.
16/03/2023: The recruitment end date was changed from 31/03/2023 to 30/04/2023.
13/12/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2022 to 09/01/2023.
2. The recruitment end date was changed from 31/12/2022 to 31/03/2023.
3. The overall trial end date was changed from 31/03/2023 to 31/07/2023.
09/09/2022: Trial's existence confirmed by the HRA.
