Safe Prescription of Opioids in Primary Care
Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial
1 other identifier
interventional
52
1 country
1
Brief Summary
Opioid analgesics are commonly prescribed addictive narcotics intended for the treatment of pain. Inappropriate prescription of opioids in quantities and for conditions which lack clinical evidence contributes to the risk of misuse and addiction. The majority of opioid prescriptions are written by physicians (general practitioners) in primary health care (PHC). PHC is thus an important setting for efforts to encourage the safe and appropriate prescription of opioids. Increasing knowledge of pain treatment recommendations, risks of opioids, and guidelines for the prescription of opioids may decrease inappropriate prescription, and thereby risk of tolerance, dependence, and addiction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedStudy Start
First participant enrolled
February 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedFebruary 19, 2026
August 1, 2025
2.1 years
October 4, 2022
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in opioid prescriptions
Change in prescription of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
12 months
Secondary Outcomes (2)
Change in opioid types
12 months
Change in opioid prescriptions
24 months
Other Outcomes (2)
Change in number of patients with opioid prescriptions
12 months
Change in initial opioid prescriptions
12 months
Study Arms (3)
Educational intervention with prescription feedback
EXPERIMENTALHealthcare personnel will participate in a brief educational intervention with information regarding treatment guidelines, recommendations, and risks of prescribing opioids. The presentation will include benchmarking on clinic opioid prescription patterns compared to other primary health centers, followed by targeted feedback on prescription patterns over the subsequent 12 months. Standardized materials will be provided, including a patient-provider agreement, outline of a patient treatment plan, and recommendations of how shared routines at the center can be improved.
Written information on guidelines
ACTIVE COMPARATORThe manager at each PHC center in the active control group will receive written information on treatment guidelines for pain management. These centers will not receive the intervention, consisting of the onsite educational visit and targeted prescription feedback.
Standard care
NO INTERVENTIONThe passive control group will consist of PHC centers that met the eligibility criteria for the study but did not actively participate in the study. Care as usual will proceed at the centers. Prescription data will be gathered directly from regional registers and databases; thus there will be no need to communicate directly with the centers. This arm will be used only if the General Data Protection Regulation continues to allow access to regional registers and databases in primary health care.
Interventions
Brief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months.
Written information on guidelines and recommendations regarding prescription of opioids.
Eligibility Criteria
You may qualify if:
- Employs at least two full-time physicians
- Has at least 3000 listed patients
- Has a regional care agreement (contract)
- Connected to the regional quality register (Stockholm County)
You may not qualify if:
- In operation for less than 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmlead
Study Sites (1)
Akademiskt Primärvårdscentrum, Solnavägen 1D
Stockholm, 113 65, Sweden
Related Publications (1)
Kruger C, Franck J, Hallgren J, Af Winklerfelt Hammarberg S, Norman C, Niper A, Westman J. Improved opioid prescribing in primary care: protocol for a cluster randomised pragmatic trial. BMJ Open. 2025 Dec 17;15(12):e110818. doi: 10.1136/bmjopen-2025-110818.
PMID: 41407431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan Franck, MD, PhD
Region Stockholm / SLSO
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 13, 2022
Study Start
February 9, 2023
Primary Completion
March 3, 2025
Study Completion (Estimated)
March 1, 2027
Last Updated
February 19, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Data for this study will be gathered from regional registers and health care databases. For permission to access these data, interested parties should contact Region Stockholm.