Administrative information
Title {1} |
SupportPrim – A computerized clinical decision support system for stratified care for patients with musculoskeletal pain in general practice – Study Protocol for a randomized controlled trial
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Trial registration {2a and 2b} | Clinical registry: ISRCTN: 14,067,965 Ethical approval: The Regional Ethical Committee for medical and health research defined the study outside the Norwegian Health Research Act, and thus, the study does not need an ethical approval reference: REC North Norway 376,060 |
Protocol version {3} | 27.02.2023—“1.0—SupportPrim – A computerized clinical decision support system for stratified care for patients with musculoskeletal pain in general practice – Study Protocol for a randomized controlled trial” |
Funding {4} | The study was funded by the research council of Norway (ref 303,331) |
Author details {5a} | Lars Christian Naterstad Lervik 1–3, Ottar Vasseljen2, Bjarne Austad1,2, Kerstin Bach4, Anita Formo Bones2, Fredrik Granviken2, Jonathan C. Hill5, Pål Jørgensen2, Torbjørn Øien1−3, Paola Marin Veites4, Danielle A. Van der Windt5, Ingebrigt Meisingset2,6 1.General Practice Research Unit, Norwegian University of Science and Technology (NTNU) 2.Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU) 3.Hallset Legesenter AS 4.Department of Computer Science, Norwegian University of Science and Technology (NTNU) 5.School of Medicine, Primary Care Centre Versus Arthritis, Keele University 6.Unit for Physiotherapy Services, Trondheim Municipality, Trondheim, Norway |
Name and contact information for the trial sponsor {5b} | The trial sponsor is the Research Council of Norway (ref 303,331)—Post@forskningsradet.no |
Role of sponsor {5c} | The trial sponsor have no role in study design, collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication, including authority over these activities |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Stratified care intervention
Design and content of the CDSS
Login and patient overview
The patient profile screen
The clinical examination screen
The treatment recommendations screen
Advice and guidance
Work adaptation and sick leave options
Medication relevant for musculoskeletal pain complaints
Referrals to primary or secondary health care, and imaging
GP`s workflow in the CDSS
Control group
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Educating the general practitioners
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcomes
Secondary outcomes
Participant timeline {13}
Study period | ||||||||
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Enrolment | Baseline | Follow-up | ||||||
Timepoint week | 0 | 2 | 4 | 8 | 12 | 26 | 52 | |
Eligibility screen | X | |||||||
Informed consent | X | |||||||
Allocation | X | |||||||
Intervention | ||||||||
CDSS for stratified care | X | |||||||
Assessments | ||||||||
SMS | X | X | X | |||||
Questionnaires | X | X | X |
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Plans for assessment and collection of outcomes {18a}
Questionnaire | Baseline | 2a | 4a | 8a | 12 | 26 | 52 |
---|---|---|---|---|---|---|---|
Demographic variables/background | X | ||||||
EQ-5D (health/life quality) | X | X | X | ||||
Sleep and vitality item from 15D | X | X | X | ||||
Patient specific functional scale | X | X | X | ||||
Pain intensity (NRS) | X | X | X | X | X | ||
Pain mapping | X | X | X | ||||
Workability | X | X | X | X | X | X | |
Sick leave | X | X | X | ||||
Anxiety for pain in physical activity (1 question from Tampa Scale) | X | X | X | X | |||
Örebro Screening Form | X | ||||||
Medication | X | X | X | ||||
Expectation (2 questions) | X | ||||||
Received treatment last 12 months and effect of treatment | X | ||||||
Global perceived effect (1 question) | X | X | X | X | X | ||
Patient-therapist relationship | X | X | |||||
Benefits and expectations to GP fulfilled? | X | X | |||||
Adherence to treatment plan | X | X | |||||
Most imp. reason for success/non-success | X | ||||||
Still receiving treatment from the GP? | X | ||||||
Other current diseases or ailments | X | ||||||
Red flags | X | ||||||
Description of childhood | X | ||||||
Health literacy 2 questions | X | ||||||
Physical activity HUNT | X | X | X | ||||
HSCL-10 (emotional distress) | X | X | X | ||||
Pain self-efficacy, 2 questions | X | X | X | X | X | ||
The Keele STarT MSK Tool | X | ||||||
Musculoskeletal Health Questionnaire (MSK-HQ) | X | X | X |
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Data collection and management
Participant and clinician reported information
Registration of treatment prescribed by the GP
Confidentiality {27}
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Analysis of the primary outcome
Analysis of secondary outcomes
Interim analyses {21b}
Methods for additional analyses (e.g., subgroup analyses) {20b}
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The first 9 recruited participants compared to the participants numbered 10 and above for each GP
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Participants with two or less MSK pain sites versus participants with 3 or more MSK pain sites at baseline
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Participants with less than 1.85 points versus participants with 1.85 points or higher in Hopkins Symptom Checklist (HSCL-10) at baseline
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Participants with scores < 8 vs ≥ 8 on the work ability scale at baseline
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Based on user data of the CDSS (clicks in the CDSS); GPs with number of clicks in the lower vs the upper quartile in the intervention group to see if higher uptake of the CDSS is important
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Comparing effectiveness in the five phenotype groups as defined by our previous work [27]