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| Name | Class |
|---|---|
| Helse Fonna | OTHER |
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Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder pain in general practice.
A simplified and evidence-based algorithm for examination and treatment of patients with shoulder pain will be developed and implemented in general practice. The purpose is to improve quality of care and provide GPs with a simplified and efficient tool to handle patients with common shoulder- related pain. The study is a stepped-wedge, cluster-randomized trial with a hybrid design including a effectiveness, cost and implementation assessment of a guideline-based intervention in clinical practice (2). General practitioners in Norway will be recruited and the GP offices will be randomized to the time of crossover from current treatment as usual (TAU) to the implementation of the intervention. The intervention is a tailored strategy that includes workshops for general practitioners covering information and access to a decision support tool, an education program where the general practitioner learn an evidence-based approach to shoulder pain and access to patient information materials. Outcomes will be measured at patient and GP levels, using self-report questionnaires, focus group interviews and register based data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management. |
|
| Treatment as usual (TAU) | Active Comparator | The participants enrolled in the control period will receive treatment as offered in general practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evidence based treatment strategy | Other | Evidence-based clinical examination and treatment plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Pain and Disability Index (SPADI) | 13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability). | Change from 0 to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the EuroQol quality of life measure (EQ5D-5L) | Health related quality of life ((0 (death) - 1.0 (perfect health)) | Change from 0 weeks to 52 weeks |
| Patient reported quality of care index (treatment according to the guideline intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Brief illness perception questionnaire (BIPQ) | Illness perception 0-80 where a higher score reflects a more threatening view of the illness | Measured at 0, 6, 12, 52 weeks, Primary time point of interest is 12 weeks and analysing changescore from 0 to 12 weeks. |
| Pain self-efficacy questionnaire (PSEQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels G Juel, MD, PhD | Department of General practice, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Research and innovation, Helse Fonna, Norway | Haugesund | Vestland | 5504 | Norway | ||
| Department of General Practice, University of Oslo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22310560 | Background | Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. | |
| 28637737 | Background | Artus M, van der Windt DA, Afolabi EK, Buchbinder R, Chesterton LS, Hall A, Roddy E, Foster NE. Management of shoulder pain by UK general practitioners (GPs): a national survey. BMJ Open. 2017 Jun 21;7(6):e015711. doi: 10.1136/bmjopen-2016-015711. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2021 | May 19, 2026 |
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Stepped wedge randomized study
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Outcome assessor will be blinded for treatment allocation. Randomization will be done after recruitment of GPs. GPs and study coordinators and outcome evaluators will be blinded to the allocation sequence with only the allocation of the next GP surgery being revealed by randomization list holder approximately 6 weeks before each intervention implementation point.
| Targeted patient information package | Other | GPs will in cooperation with the patients tailor a information package targeted to the patients needs regarding their clinical shoulder diagnosis and individual implications and needs (Pain, sleep, exercises etc.). |
|
| Treatment as usual (TAU) | Other | Usual care as provided by the GP |
|
Patient reported content of treatment measured on six items according to treatment prescribed by the GP measured on 5-item Likert scales. Sum score above 18 points regarded as consultation of high quality according to guideline intervention.
| 0 week (after 1. visit to general practitioner) |
| Global patient perceived effect of treatment outcome (GPE) | 1 item (7-point) ( 0 = worse than ever, 7 =I have become completely well) | Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks. |
Self efficacy for pain 0-60 where higher score reflects higher self efficacy for pain. |
| Measured at 0, 6, 12, 52 weeks, primary time point of interest is 12 weeks analysing change score from 0 to 12 weeks. |
| Work disability patient reported | Sick leave reported as whole days away from work | Measured at 0, 6, 12, 52 weeks |
| Örebro Musculoskeletal Pain Screening Questionnaire (Short) | Psychosocial, prognostic factors for musculoskeletal pain. The total score will range between 1 and 100, with a score >50 indicating higher estimated risk for future work disability | Measured at 0 weeks |
| Pateint reported frequency of therapy due to shoulder pain in primary and secondary health care | Reported number of consultations by GPs, specialists (orthopeds, rheumatologists, physiatrists or neurologists), physiotherapists, chiropractists and alternative therapists, injections and surgery. | Measured at 0, 6, 12, 52 weeks |
| Patient reported frequency of use of supplemental investigations in primary and secondary health care. | Number of investigations; blood tests and radiology (Projectional radiograph, CT, MRI) | Measured at 0, 6, 12, 52 weeks |
| Patient reported direct economical expences due to shoulder pain | Patient reported use of medication reported as type of medication and frequency last week | Measured at 0, 6, 12, 52 weeks |
| Patient reported indirect economical expences due to shoulder pain; travel distance to therapy | Patient reported travel distance to therapy measured in km | Measured at 0, 6, 12, 52 weeks |
| Patient reported indirect economical expences due to shoulder pain; time away for therapy measured in hours | Patient reported time away for therapy measured in hours | Measured at 0, 6, 12, 52 weeks |
| Patient reported indirect economical expences due to shoulder pain; time away for work measured in hours. | Patient reported time away from work measured in hours | Measured at 0, 6, 12, 52 weeks |
| Patient reported indirect economical expences due to shoulder pain; production loss. | Patient reported production loss measured as patient estimated per cent production loss due to shoulder pain. A higher number means a higher loss of production. | Measured at 0, 6, 12, 52 weeks |
| Work disability from the Norwegian Labour and Welfare Administration registry | Registry data | Measured at 52 weeks |
| Global patient perceived satisfaction with treatment | 1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied | Measured at 6, 12, 52 weeks |
| Patient experience questionnaire (PEQ) | 4 subscales (communication, emotions, outcome, barriers) with 4 items measured on 4 or 7 point Likert scales. A high score represents a good communication experience, positive emotions, positive consultation outcome, no communication barriers. | Measured at 0 weeks |
| Patient Shoulder Outcome Expectancies | 1 item measured on a 7-point Likert scale. A higher score indicate higher patient perceived outcome expectancy. | Measured at 0 week, 12 weeks |
| Patient interview (qualitative) | Qualitative interview with selected patients, feasibility/ barriers and facilitators | Measured at 52 weeks |
| Implementation process assesment tool (IPAT) | Measurement of the implementation process from the perspective of the GPs | Measured at 2 weeks, 12 weeks |
| GPs self-efficacy for handling patients with shoulder pain according to guideline care | 9 items measured on 6-point Likert scales analysing change in individual items and sum score before and 12 weeks after educational outreach. A higher score indicates higher self-efficacy | Measured at 0 week, 2 weeks,12 weeks |
| GPs global perceived satisfaction with workshop (GP) | 10 item measured on 5-point Likert scales concerning satisfaction with the different topics and content of the work shop.We will analyze individual items. A higher score indicate higher satisfaction. | Measured at 0 weeks |
| GPs global perceived satisfaction, benefit, usability and frequency of use of the intervention (GP) | 4 item measured on 5-point Likert scales. We will analyze individual items. A higher score indicate higher satisfaction, benefit, usability and frequency of use of the intervention. | Measured at 12 weeks |
| GPs use of the intervention in daily practice; degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement (GP) | 4 items measured on 7-point Likert scales. We will analyze individual items. A higher score indicate higher degree of use in daily practice and a higher degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement. | Measured at 12 weeks |
| GP focus groups | Qualitative interview with selected GPs, feasibility/ barriers and facilitators | Measured at 52 weeks |
| Oslo |
| 0450 |
| Norway |
| 34996788 | Derived | Ekeberg OM, Pedersen SJ, Natvig B, Brox JI, Biringer EK, Endresen Reme S, Engebretsen KB, Joranger P, Mdala I, Juel NG. Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study). BMJ Open. 2022 Jan 7;12(1):e051656. doi: 10.1136/bmjopen-2021-051656. |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D002062 | Bursitis |
| D000070636 | Rotator Cuff Injuries |
| D063806 | Myalgia |
| D019534 | Shoulder Impingement Syndrome |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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