Explaining osteoarthritis: development of a patient explanation package (PEP-OA)
| ISRCTN | ISRCTN16795883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16795883 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RG-0291-19 IPCHS; CPMS: 42528 |
| Sponsor | Keele University |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 25/09/2019
- Registration date
- 02/10/2019
- Last edited
- 24/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is common, but healthcare professionals often do not have the right words to help patients understand the condition. This can result in patients feeling that their condition is being trivialised or negative beliefs about osteoarthritis, even before they have been diagnosed with it. Because osteoarthritis can cause pain upon moving the affected joint, patients often worry about, or may avoid, doing exercise (which is recommended to help joint pain) and patients can also doubt whether they can improve their symptoms. The aim of this study is to improve osteoarthritis explanations for patients to help their understanding of their condition and make sense of the management approaches suggested to them.
Who can participate?
Work packages 1 and 2: patients aged 47 or older who have consulted at their GP practice over the last 2 years with osteoarthritis
Work package 3:
Patients - responding to work packages 1 and 2 who give consent to future contact
Lay people - people aged 45 and older who have not had a diagnosis of osteoarthritis (potential patients in the future)
Healthcare professionals - those providing care to patients with osteoarthritis
What does the study involve?
The researchers will create a Patient Explanation Package for OsteoArthritis (PEP-OA) and the supporting package in four steps. Possible statements for an osteoarthritis explanation will be identified by professionals and patients. Patients will be asked which are the most important for all people with osteoarthritis. The most important statements will be tested to find out which have the most positive impact for patients. Draft explanations (made from the most important statements) will be developed and then tested among people with and without osteoarthritis and among healthcare professionals who would explain OA in their day-to-day role. The researchers will develop and test written and cartoon versions of a core explanation which will be relevant to all patients with osteoarthritis, and additional written statements that can be used to tailor the core information to individual patients. Once tested, the feedback and learning will allow the researchers to finalise PEP-OA. A package will be developed and evaluated to support healthcare professionals to find out about the content and importance of PEP-OA and to make use of PEP-OA.
What are the possible benefits and risks of participating?
There may be no direct benefits from taking part. However, participants may get a better understanding of osteoarthritis and will be contributing to the development of improved explanations for patients with osteoarthritis. This will help to deliver better care and reduce uncertainty among patients with osteoarthritis in the future. It is not expected that there will be any risks from taking part in the study. Participants are free to decline to take part in sections of the discussions and/or to answer questions if they feel uncomfortable.
Where is the study run from?
NHS North Staffordshire via Keele University (UK)
When is the study starting and how long is it expected to run for?
April 2019 to March 2022
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Clare Jinks
c.jinks@keele.ac.uk
Contact information
Scientific
School of Primary, Community and Social Care
Primary Care Centre Versus Arthritis
Keele University
Keele
ST5 5BG
United Kingdom
 ORCID ID |
0000-0002-5757-1854 |
|---|---|
| Phone | +44 (0)1782 734870 |
| e.cottrell@keele.ac.uk |
Scientific
School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom
| ORCID ID |
0000-0002-3407-2446 |
|---|---|
| c.jinks@keele.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | A variety of observational approaches will be used: adapted nominal group technique, conjoint survey questionnaire and think aloud interviews to develop the patient education package for osteoarthritis |
| Secondary study design | Qualitative research |
| Study type | Participant information sheet |
| Scientific title | Explaining osteoarthritis: development and implementation of a multimedia Patient Explanation Package |
| Study acronym | PEP-OA |
| Study objectives | To improve osteoarthritis explanations for patients to: 1. Help their understanding of their condition 2. Make sense of the management approaches suggested to them |
| Ethics approval(s) | Approved 22/08/2019, East of England - Cambridge East Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)207 104 8101; Email: NRESCommittee.EastofEngland-CambridgeEast@nhs.net), REC ref: 19/EE/0221, IRAS Project ID: 252365 |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | WP1: A stakeholder co-design workshop with ongoing individual feedback will develop potential explanation statements within domains of the underpinning conceptual framework. Through a patient adapted nominal group technique consensus on priority explanation statements within each domain will be reached. WP2: A partial-profile conjoint analysis patient study will estimate the extent to which new, prioritised, explanation statements are preferred over currently used/available statements. WP3: Using the results of WP1 and WP2, the patient advisory group (PAG) will develop draft core (written and animated) and important additional (written) explanation statements. Think-aloud qualitative interviews will establish the comprehension and acceptability of the draft explanations. The core and important additional explanation statements will be finalised through co-design with the PAG. WP4: Communities of practice approach will be used to develop knowledge mobilisation materials to support dissemination and implementation of the explanations. Early usage, acceptability and self-report impact data will be collected. |
| Intervention type | Other |
| Primary outcome measure(s) |
WP1 - Adapted nominal group technique to collect 11 prioritised explanation statements to be taken forward for testing in the conjoint analysis. |
| Key secondary outcome measure(s) |
n/a |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 339 |
| Key inclusion criteria | Work package 1 & 2: 1. Patients aged ≥47 2. Have consulted in their general practice in the last two years 3. Have a recorded consultation coded relating to osteoarthritis Work package 3: 1. Patients who responded with consent-to-future contact in earlier stages of the research will be eligible for inclusion. In this way we are ensuring that the patients have recently consulted with a problem pertaining to osteoarthritis 2. Lay people aged 45 years or older who do not have a diagnosis of osteoarthritis (and thus are potential future patients) 3. Healthcare professionals who, in their usual clinical roles, give diagnoses to patients with osteoarthritis. These are likely to include, but may not exclusively be, General Practitioners, Primary Care Nurses and Physiotherapists |
| Key exclusion criteria | Work package 1 & 2: patients with 1. Severe mental illness 2. Rheumatoid arthritis 3. Psoriatic arthritis 4. Ankylosing spondylitis 5. Gout 6. Polymyalgia rheumatica 7. Moderate to severe learning disabilities 8. Dementia 9. Record that they lack capacity 10. Record that they are on the palliative care register 11. Recorded dissent to share their data 12. Inability to speak English Work package 3: 1. Patients will only be excluded if they indicate they no longer wish to participate or if they have developed any of the exclusion conditions since the original search 2. Lay people will excluded if they report that they have previously been diagnosed with osteoarthritis 3. Healthcare professionals will be excluded if, in their clinical role, they have not provided a diagnosis of osteoarthritis to a patient in the last 6 months |
| Date of first enrolment | 07/10/2019 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
David Weatherall Building
Keele
ST5 5BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during this current study will be available upon request from primarycare.datasharing@keele.ac.uk. Core data will be available immediately after main publication. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question/objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
2. The overall trial end date was changed from 31/07/2021 to 31/03/2022.
3. Contact details updated.
4. The intention to publish date was changed from 01/09/2021 to 01/05/2022.
15/10/2020: Following public health guidance, recruitment for this study was paused on 27/03/2020 and reopened to recruitment for work package 2 on 14/08/2020.
01/10/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)
