Clinical trial NCT05577026: Safe Prescription of Opioids in Primary Care
Official title: Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Narcotic-Related Disorders
Addiction
Keywords: Early Intervention, Educational
Prescription Drugs
Opioids
Primary Health Care
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2022-10-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Change in opioid prescriptions
timeFrame: 12 months
Secondary outcomes:
measure: Change in opioid types
timeFrame: 12 months
measure: Change in opioid prescriptions
timeFrame: 24 months
Other outcomes:
measure: Change in number of patients with opioid prescriptions
timeFrame: 12 months
measure: Change in initial opioid prescriptions
timeFrame: 12 months
Locations:
city: Stockholm
country: Sweden
facility: Akademiskt Primärvårdscentrum, Solnavägen 1D
Study officials:
affiliation: Region Stockholm / SLSO
name: Johan Franck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: