Safe Prescription of Opioids in Primary Care

NCT ID: NCT05577026

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2027-03-31

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.

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders; Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Educational intervention with 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.

Group Type: EXPERIMENTAL

Educational intervention and prescription feedback

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

General information on treatment guidelines

Intervention Type: BEHAVIORAL

Written information on guidelines and recommendations regarding prescription of opioids.

Standard care

The 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention and prescription feedback

Brief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months.

Intervention Type: BEHAVIORAL

General information on treatment guidelines

Written information on guidelines and recommendations regarding prescription of opioids.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan Franck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm / SLSO

Locations

Akademiskt Primärvårdscentrum, Solnavägen 1D

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Smartaval2022-01

Identifier Type: -

Identifier Source: org_study_id