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Safe Prescription of Opioids in Primary Care

Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05577026
Enrollment
52
Registered
2022-10-13
Start date
2023-02-09
Completion date
2027-03-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction, Narcotic-Related Disorders, Opioid-Related Disorders

Keywords

Early Intervention, Educational, Prescription Drugs, Opioids, Primary Health Care

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.

Interventions

BEHAVIORALEducational 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.

BEHAVIORALGeneral information on treatment guidelines

Written information on guidelines and recommendations regarding prescription of opioids.

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Eligibility criteria apply to primary health care centers. 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

Design outcomes

Primary

MeasureTime frameDescription
Change in opioid prescriptions12 monthsChange in prescription of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)

Secondary

MeasureTime frameDescription
Change in opioid types12 monthsChange in type of opioids prescribed by drug class (ATC code)
Change in opioid prescriptions24 monthsChange in prescriptions of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORJohan Franck, MD, PhD

Region Stockholm / SLSO

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026