Can the outcome prioritisation tool be used to understand what is most important to patients with multiple long-term health conditions?
| ISRCTN | ISRCTN47104509 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47104509 |
| IRAS number | 272739 |
| Secondary identifying numbers | 0763, IRAS 272739 |
- Submission date
- 10/08/2020
- Registration date
- 28/04/2021
- Last edited
- 30/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The researchers want to understand what matters most to patients aged 45 or above with multiple long-term health conditions. Other researchers have previously created a form called an outcome prioritisation tool to help patients with multiple long-term conditions to express their priorities for their healthcare. This tool has already been used in patients aged over 65, and the researchers would now like to test it in patients age 45 and above with at least two long-term health conditions. This study aims to assess how patients with multiple long-term health conditions feel how effective this form is in helping to record which aspects of their health matter the most to them in their daily lives. The researchers are also interested in understanding whether their priorities may have changed in light of the coronavirus outbreak, and understanding how they may have changed.
Who can participate?
Patients aged 45 or above and have two or more long-term conditions
What does the study involve?
Completing the questionnaire will take about 5 minutes. The questionnaire includes some questions about the participants followed by the outcome prioritisation tool, which is a short questionnaire about participants' healthcare. The researchers will not ask participants to provide any identifiable information unless they request to receive the results.
What are the possible benefits and risks of participating?
Possible benefits are that participants are helped to consider their health outcome priorities and are prompted to communicate them with their healthcare provider. There are no risks identified from participation.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
August 2020 to August 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Harini Sathanapally
hs333@student.le.ac.uk
Contact information
Scientific
Leicester Diabetes Centre
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0001-8283-1411 |
|---|---|
| Phone | +44 (0)116 258 4322 |
| hs333@student.le.ac.uk |
Study information
| Study design | Cross-sectional survey |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Using the outcome prioritisation tool to elicit health outcome priorities of multi-morbid patients in a multi-age and multi-ethnic setting |
| Study objectives | This is a questionnaire study designed to test the use of the Outcome Prioritisation Tool to elicit the health outcome priorities of patients with multi-morbidity and aged 45 or above in a multi-ethnic, East Midlands setting. The researchers also aim to describe the health outcome priorities of patients by clusters of multi-morbidities and by age categories and different ethnic groups. However, in light of the COVID-19 pandemic, the researchers have adapted their questionnaire and recruitment methods to online and remote formats, and amended the questionnaire to collect data on how the priorities of the participant group of interest may have changed in light of the COVID-19 pandemic. The researchers are currently in the process of submitting a substantial amendment for HRA approval for these changes. That patients suffering from underlying chronic diseases are at increased risk of complications and mortality from COVID-19 infection has been well-established. The UK government has taken steps to advocate “shielding measures” for patients with significant underlying chronic health conditions that cause them to be “extremely vulnerable” from COVID-19. Proactive care and advance care planning for patients with multi-morbidity, and in particular, patients in the “extremely vulnerable” group, is now more important than ever, and incorporating the priorities of individual patients is a key part of ensuring that care is patient-centred. The results of this study will make an important contribution towards the provision of proactive and priorities-based care for patients with multi-morbidity, including patients identified to be “extremely vulnerable” from COVID-19. The results of this study will also improve understanding of the impact of the COVID-19 pandemic on health outcome prioritisation of patients with multi-morbidity, which will facilitate clinicians and policy-makers on developing guidance and strategies of delivering of patient-centred care for patients with multi-morbidity both during the COVID-19 pandemic and in the recovery phase of the COVID-19 pandemic. |
| Ethics approval(s) | Approved 25/03/2020, London - Riverside Research Ethics Committee (Level 3 Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8199; riverside.rec@hra.nhs.uk), REC ref: 20/LO/0570 |
| Health condition(s) or problem(s) studied | Multi-morbidity |
| Intervention | The responses to the outcome prioritisation tool will be described by summary statistics and reporting of the highest ranked outcomes. The responses will be separated into before the COVID-19 pandemic and the current situation, and comparisons drawn between the relative ranking of outcomes in both groups to highlight any similarities or differences to prioritisation before the COVID-19 pandemic and in the current situation. The three responses to the Likert scale questions will also be combined and reported out of 100% as an overall mean (SD). Analyses will be carried out using the t-test to look for differences in health outcome priorities and categorical variables in the participants’ demographic information (such as ethnicity). Correlations will be sought between continuous variables in participants' demographic information (such as age) and health outcome priorities. |
| Intervention type | Other |
| Primary outcome measure | Current patient treatment priorities measured using the OPT tool at baseline |
| Secondary outcome measures | Pre-COVID-19 treatment priorities measured using the OPT tool at baseline |
| Overall study start date | 03/08/2020 |
| Completion date | 06/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 884 |
| Key inclusion criteria | 1. Participants who are aged 45 or above and are suffering from at least two defined, long-term physical and/or mental health conditions, with no restriction by ethnicity or gender 2. Participants who are willing to participate in the study |
| Key exclusion criteria | 1. Participants who are aged below 45 years of age 2. Participants not suffering from at least two long-term physical and/or mental health conditions |
| Date of first enrolment | 06/08/2020 |
| Date of final enrolment | 03/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester
LE3 1HN
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)116 258 4099 |
|---|---|
| rgosponsor@le.ac.uk | |
| Website | http://www.le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2.0 | 14/04/2020 | 04/05/2021 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Basic results | 29/08/2023 | No | No |
Additional files
- ISRCTN47104509_PROTOCOL_V2.0_14Apr20.docx
- uploaded 04/05/2021
- ISRCTN47104509_BasicResults.pdf
Editorial Notes
30/08/2023: The intention to publish date has been changed from 06/09/2022 to 31/03/2024.
29/08/2023: The following changes have been made:
1. A basic results summary has been uploaded.
2. The final enrolment number has been added from the results summary.
04/05/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version 2.0, 14 April 2020.
05/10/2020: Trial's existence confirmed by the London - Riverside Research Ethics Committee.
