Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05577026 |
| Other study ID # |
Smartaval2022-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2023 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Region Stockholm |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
