CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 286 enrolled
Drug / intervention
ISOP Intervention with the Nurse Care Managerbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02791399
NCT02791399N/ACompleted

A Patient-Centered Intervention to Improve Opioid Safety

VA Office of Research and Development·interventional·Posted Jun 6, 2016·Updated Jul 27, 2023

In Brief

A clinical study evaluating ISOP Intervention with the Nurse Care Manager for Opioid Safety and 2 related conditions. Completed, enrolled 286 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 6, 2016
Enrollment StartMar 23, 2016
Primary CompletionOct 15, 2019
Study CompletionOct 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.1 years ago

Interventions

ISOP Intervention with the Nurse Care Managerbehavioral

A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.