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Research Question
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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 OA in primary care.
This study will;
Develop and pilot a new model of supported self management (i.e. a Model OA Consultation and guidebook) in Primary Care.
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.
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.
Carry out an evaluation of the new approach using qualitative interviews and structured observations with patients and the primary healthcare team. (from UKCRN Portfolio)
Additional lay summaries...
Lay summary under review 3 (from ISRCTN)
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Ethics Approval
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North West 1 Research Ethics Committee-Cheshire, First MREC approval date 14/10/2010, ref: 10/H1017/76
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Study Design
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Both; Interventional and Observational; Design type: Diagnosis, Process of Care, Screening, Treatment, Qualitative
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
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Participants Inclusion Criteria
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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
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Participants Exclusion Criteria
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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
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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Planned Sample Size: 15000; UK Sample Size: 15000
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Completed
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Newcastle under Lyme
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Interventions
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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)
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Primary Outcome Measures
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Test the feasibility of using quality indicators for OA as the primary outcome measure; Timepoint(s): At 21 months
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Secondary Outcome Measures
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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 utlility 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
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Website
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