N/A
N=286
A Patient-Centered Intervention to Improve Opioid Safety
Opioid Safety · Prescription Opioid Misuse · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02791399 ↗Enrolled (actual)
286
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Current Opioid Misuse Measure (COMM) — 11.3; 11.9; 9.4; 9.5 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ISOP Intervention with the Nurse Care Manager (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Current Opioid Misuse Measure (COMM) |
11.3; 11.9; 9.4; 9.5; 9.3; 8.6 | <0.05 sig |
| PRIMARY Urine Drug Test |
12.8; 10.9; 7.0; 14.0; 16.2; 10.2 | <0.05 sig |
| SECONDARY Chronic Pain Grade |
65.8; 67.0 | — |
Summary
This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.
Eligibility Criteria
Inclusion Criteria
- Enrollment in primary care at the VA Portland Health Care System
- Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease
- Able to read and write in English
Exclusion Criteria
- Age younger than 18 years old
- On opioid therapy for palliative or end-of-life care
- Current enrollment in an opioid substitution program
- Lack of access to a telephone
Data sourced from ClinicalTrials.gov (NCT02791399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.