search
Back to results

Safe Prescription of Opioids in Primary Care

Primary Purpose

Opioid-Related Disorders, Narcotic-Related Disorders, Addiction

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Educational intervention and prescription feedback
General information on treatment guidelines
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-Related Disorders focused on measuring Early Intervention, Educational, Prescription Drugs, Opioids, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akademiskt Primärvårdscentrum, Solnavägen 1DRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Educational intervention with prescription feedback

Written information on guidelines

Standard care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in opioid prescriptions
Change in prescription of opioids as measured by defined daily dose (DDD)

Secondary Outcome Measures

Change in opioid types
Change in type of opioids prescribed by drug class (ATC code)
Change in opioid prescriptions
Change in prescriptions of opioids as measured by defined daily dose (DDD)

Full Information

First Posted
October 4, 2022
Last Updated
April 3, 2023
Sponsor
Region Stockholm
search

1. Study Identification

Unique Protocol Identification Number
NCT05577026
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Narcotic-Related Disorders, Addiction
Keywords
Early Intervention, Educational, Prescription Drugs, Opioids, Primary Health Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention with prescription feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Written information on guidelines
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention and prescription feedback
Intervention Description
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
Intervention Name(s)
General information on treatment guidelines
Intervention Description
Written information on guidelines and recommendations regarding prescription of opioids.
Primary Outcome Measure Information:
Title
Change in opioid prescriptions
Description
Change in prescription of opioids as measured by defined daily dose (DDD)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in opioid types
Description
Change in type of opioids prescribed by drug class (ATC code)
Time Frame
12 months
Title
Change in opioid prescriptions
Description
Change in prescriptions of opioids as measured by defined daily dose (DDD)
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Change in number of patients with opioid prescriptions
Description
Change in number of patients prescribed opioids (new or continued prescription)
Time Frame
12 months
Title
Change in initial opioid prescriptions
Description
Change in number of patients with initial (new) opioid prescriptions among opioid-naïve patients
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette Westman, RN, PhD
Phone
+46702064451
Email
jeanette.westman@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Krüger, MMSc
Phone
+46701801778
Email
cecilia.kruger@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Franck, MD, PhD
Organizational Affiliation
Region Stockholm / SLSO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademiskt Primärvårdscentrum, Solnavägen 1D
City
Stockholm
ZIP/Postal Code
113 65
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Franck, MD, Prof
Phone
+46739660736
Email
johan.franck@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Jeanette Westman, PhD, Prof
Phone
+46702064451
Email
jeanette.westman@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data for this study will be gathered from regional registers and health care databases. For permission to access these data, interested parties should contact Region Stockholm.

Learn more about this trial

Safe Prescription of Opioids in Primary Care

We'll reach out to this number within 24 hrs