Safe Prescription of Opioids in Primary Care

Not Applicable

Active, not recruiting

• Conditions: Opioid-Related Disorders; Addiction; Narcotic-Related Disorders
• Interventions: Behavioral: General information on treatment guidelines; Behavioral: Educational intervention and prescription feedback

• Registration Number: NCT05577026
• Lead Sponsor: Region Stockholm

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.

Detailed Description

Opioids are a class of addictive narcotic drugs which can be obtained by prescription for the treatment of pain. There is clinical evidence for the use of opioids for acute, post-operative, and cancer related pain, although guidelines recommend the lowest effective dose and duration be prescribed. There is less evidence for the long-term benefits of opioid therapy for chronic non-cancer pain and the risk for harm and addiction is increased with prolonged use. Patients with long-term treatment may experience only marginal pain reduction and a risk of long-term consequences including tolerance, dependence, and adverse effects such as cognitive disturbance and decline, behavioral problems, emergency visits, accidents, suicide, and drug-related mortality. As the majority of opioids are prescribed by physicians in primary health care, this is an important setting for promoting the safe and appropriate use of prescription opioids.

This trial evaluates whether a brief educational intervention in primary health care (PHC) followed by 12 months of feedback on prescription data changes the prescription of opioids in primary care.

PHC centers in Stockholm County will be invited to participate in the study. Centers that express interest in participating, meet the inclusion criteria, and do not meet the exclusion criteria will be randomized to the intervention or control group. Personnel at the intervention centers will participate in a brief educational intervention followed by 12 months of regular feedback on opioid prescriptions, with benchmarking to other local PHC centers. Centers randomized to the active control group will receive written information on treatment guidelines but will not receive the onsite educational intervention or prescription feedback.

The primary outcome, change in opioid prescription, will be measured at 12 months after intervention start. Data on outcomes and characteristics of participating primary health care centers including prescription before, during and after the intervention will be extracted from regional health care registers and databases and analyzed statistically.

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2023-02-09
• Status Verified: 2024-04
• Primary Completion: 2025-03-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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)

Exclusion Criteria

• In operation for less than 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written information on guidelines	General information on treatment guidelines	The 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.
Educational intervention with prescription feedback	Educational intervention and prescription feedback	Healthcare 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.

Primary Outcome Measures

Name	Time	Method
Change in opioid prescriptions	12 months	Change in prescription of opioids as measured by defined daily dose (DDD)

Secondary Outcome Measures

Name	Time	Method
Change in opioid types	12 months	Change in type of opioids prescribed by drug class (ATC code)
Change in opioid prescriptions	24 months	Change in prescriptions of opioids as measured by defined daily dose (DDD)

Trial Locations

Locations (1)

Akademiskt Primärvårdscentrum, Solnavägen 1D; 🇸🇪 Stockholm, Sweden