Management of osteoarthritis in consultations study: the development of a complex intervention in primary care
| ISRCTN | ISRCTN06984617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06984617 |
| Secondary identifying numbers | 10104 |
- Submission date
- 04/07/2011
- Registration date
- 04/07/2011
- Last edited
- 27/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis (OA) is the most common type of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. One of the most effective ways to treat long-term illnesses is by giving the sufferer the tools and skills to manage their conditions day-to-day. NICE provides extensive guidelines for self-management of OA however it has been found that they are not always used in standard care. Generally, people are willing to participate in self-management of their condition, however many people feel that they need more support from healthcare professionals to do this. It is thought that by providing GP’s with the necessary tools to support self-management of OA could help more people to manage their condition effectively. Using a special template the consultations given to people suffering from OA could make consultations more consistent (model OA consultation, MOAC); ensuring that self-management of the disease is successfully promoted by healthcare professionals. The aim of this study is to find out whether the MOAC is a practical way of promoting self-management of OA.
Who can participate?
GP surgeries which are members of West Midlands North PCRN or a Keele Research Network Practice, and adults with a diagnosis of OA who attend these practices.
What does the study involve?
The study is made up of two parts. In the first part of the study, the existing care that is given to OA sufferers is monitored in all participating GP surgeries by reviewing patient records and completing questionnaires with patients and healthcare professionals. In the second part of the study the participating GP surgeries are randomly allocated into two groups. For those in the first group (intervention group), healthcare professionals receive additional training to help them to better implement the OA treatment recommendations. Patients at these practices are also given an information book to help them manage their condition. Surgeries in the second group (control group) do not receive any additional training and provide only usual care to patients. At the end of the study period, patient notes are reviewed in both groups to assess the standard of care being given.
What are the possible benefits and risks of participating?
Although no direct benefit from taking part in this study can be guaranteed, what we learn from the study should help us to treat people with osteoarthritis in the future. People with joint problems do occasionally feel that even filling in a brief questionnaire can cause some discomfort, although this should be short-lasting and does not indicate any underlying change in their condition. If an interview topic brings back unhappy memories or distressing thoughts that participants do not wish to discuss, the topic will not be followed up again during the interview.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
May 2011 to February 2014
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Jacqueline Gray
j.gray@cphc.keele.ac.uk
Contact information
Scientific
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
| j.gray@cphc.keele.ac.uk |
Study information
| Study design | Both; Interventional and Observational; Design type: Diagnosis, Process of Care, Screening, Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact s.hill@cphc.keele.ac.uk to request a patient information sheet |
| Scientific title | Management of Osteoarthritis in Consultations Study: the development of a complex intervention in primary care (MOSAICS): a pilot cluster randomised controlled trial |
| Study acronym | MOSAICS |
| Study objectives | The MOSAICS Study is a mixed methods study which investigates the feasibility, acceptability and impact of implementing a new approach to supporting self management for osteoarthritis (OA) in primary care. 1. To develop and pilot a new model of supported self management [i.e. a Model OA Consultation (MOAC) and guidebook] in primary care 2. Carry out a cross sectional survey of the local population to establish current uptake of NICE core recommendations in people aged 45 years and over with joint pain 3. Carry out anonymised medical record reviews to describe the current patterns of management of OA in primary care, and to describe any change in management following introduction of a structure template to support a model OA consultation. 4. Carry out an evaluation of the new approach using qualitative interviews and structured observations with patients and the primary healthcare team. |
| Ethics approval(s) | North West 1 Research Ethics Committee-Cheshire, First MREC approval date 14/10/2010, ref: 10/H1017/76 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases |
| Intervention | A Joint Pain/OA Consult Temp: Template developed to record Quality Indicators for OA. To be used as part of routine consultations for patients presenting with a working diagnosis of OA (knee, hip, hand and foot) in primary care; A Model OA Consultation, a three pronged 'Model OA Consultation' has been developed and will be implemented in the four intervention practices. The model includes consultation with the GP, consultation with the practice nurse, (educational intervention and self management support) and an opportunistic consultation with other health care professionals. An osteoarthritis guidebook, developed using national guidelines and experiential knowledge by a multi disciplinary group in collaboration with patients living with OA. The patient guidebook will be used as a resource for self care management of their OA, and to act as a reinforcement of verbal information given by health care professionals during the model consultation sessions. Training packages for health care professionals (HCPs) in the intervention practices will receive training developed from 1. The results of two previously conducted consensus exercises on the consent and style of a model OA consultation and 2. Theoretical models to guide self management of OA. Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Test the feasibility of using quality indicators for OA as the primary outcome measure; Timepoint(s): At 21 months |
| Secondary outcome measures | 1. A trial of paracetamol at up to 4 g/day prior to treatment with oral non steroidal anti-inflammtory drugs (NSAIDs) or opiate analgesics; Timepoint(s): At 15 and 21 months 2. Advice about weight loss; Timepoint(s): At 15 and 21 months 3. Cost utility analysis compare template & model plus template; Timepoint(s): At 3,6 and 12 and 21 months 4. Does training change HCP behaviour; Timepoint(s): Immediately after training and 6 months after training 5. Practice Level outcome measures: Frequency and pattern of Read coding of OA and joint pain; Timepoint(s): At 15 and 21 months 6. Practice Level outcome measures: Frequency of OA consultations with other health professionals; Timepoint(s): At 15 and 21 months 7. Practice Level outcome measures: Medication use for OA and joint pain; Timepoint(s): At 15 and 21 months 8. Prescription of a proton pump inhibitor (PPI) during NSAID therapy; Timepoint(s): At 15 and 21 months 9. Records of being offered information on exercise or activity; Timepoint(s): At 15 and 21 months 10. Records of being offered information on referral to a physiotherapist; Timepoint(s): At 15 and 21 months 11. Records of being offered information on referral to an exercise programme; Timepoint(s): At 15 and 21 months 12. Records of being offered information on the condition (OA); Timepoint(s): At 15 and 21 months 13. Topical NSAIDs prior to treatment with oral NSAIDs or opiate analges; Timepoint(s): At 15 and 21 months |
| Overall study start date | 11/05/2011 |
| Completion date | 13/02/2014 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 15000; UK Sample Size: 15000 |
| Key inclusion criteria | General Practitioners (GP) practices 1. Member of West Midlands North PCRN or a Keele Research Network Practice 2. At least two GPs willing to undertake the study as per protocol i.e. act as a control or intervention practice 3. Willing, and able, to allow one (or for preference two - to allow for cross cover) of their practice nurses to be trained to deliver MOAC 2 and then deliver it in the practice 4. Willing, and able, to allow a PCRN employed nurse trained to deliver MOAC 2 working in their practice 5. Uses the EMIS GO computerised consultation system 6. For the implementation study and evaluation studies additional inclusion criteria are: As above plus 6.1. GP who has received training and has delivered MOAC 1 6.2. Nurse who has received training and has delivered MOAC 2 6.3. Nurse consenting to observation and audio recording of the MOAC 2 consultation 6.4. Members of the multidisciplinary team who have delivered the MOAC 3 intervention 6.5. Practice Manager in intervention practices 6.6. Administrators in intervention practices Patients 1. Males and females 2. 45 years and over 3. Registered with a MOSAICS study practice 4. Consenting to further contact from the study team and medical record review from their response in the Population Survey 5. For the evaluation studies additional criteria are: 5.1. Patients from the intervention practices who have consulted a GP, been given a diagnosis of OA and received the model OA consultation (MOAC) 5.2. To be invited to take part in an individual or group interview participants must have completed the MOSAICS Consultations Questionnaires 5.3. Audio recording and observation of MOAC 2 consultations will only be carried out if a patient has given prior consent to do so Target Gender: Male & Female ; Lower Age Limit 45 years |
| Key exclusion criteria | GP Practices 1. Single handed GP practices 2. Single handed practice nurse 3. Unable to physically accommodate MOAC 2 consultations Patients Excluded via GP screen of practice list. 1. Unable to give fully informed consent e.g. learning difficulties or dementia 2. Resident in a care or nursing home 3. History of serious disease e.g. malignancy, terminal illness 4. Unable to consult in the general practice surgery 6. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) 7. Pregnancy |
| Date of first enrolment | 11/05/2012 |
| Date of final enrolment | 11/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ST5 5BG
United Kingdom
Sponsor information
University/education
Keele
Newcastle
ST5 5BG
England
United Kingdom
"ROR" |
https://ror.org/00340yn33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Protocol published in 2014. Population survey, trial, template and qualitative publications scheduled for submission in 2016 and 2017. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/08/2014 | Yes | No | |
| Results article | results | 01/05/2015 | Yes | No | |
| Results article | results | 21/12/2016 | Yes | No | |
| Results article | results | 01/10/2017 | Yes | No | |
| Results article | results | 29/12/2017 | Yes | No | |
| Results article | results | 01/01/2018 | Yes | No | |
| Results article | results | 01/07/2018 | Yes | No |
Editorial Notes
27/07/2018: Publication reference added.
14/02/2018: Publication reference added.
20/10/2017: Publication reference added.
19/10/2017: Publication reference added.
08/06/2017: Publication reference added.
25/07/2016: The MOSAICS study has two key parts: a population survey that took place between May 2011 and April 2012 and a cluster randomised trial that took place between May 2012 and February 2014. The recruitment dates have been corrected accordingly. Information about dissemination was also added.
