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Improving Communication About Pain and Opioids

NCT03629197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-11-12

No results posted yet for this study

Summary

The overall goal of this protocol is to pilot test a clinician training intervention that uses standardized patients (trained actors playing patient roles) as instructors who impart communication skills to primary care clinicians. This project will conduct a pilot clinical trial of the intervention developed by the primary investigator in order to evaluate intervention feasibility and generate data to plan a subsequent fully-powered, multisite trial. Primary care clinicians will be randomized to receive either the intervention or control; 48 patients (2 per clinician) will then be recorded during clinic visits with study clinicians and will provide data on post-visit perceptions and health outcomes. Study hypotheses are that visits with clinicians who receive the intervention (versus control) will be associated with more frequent use of targeted communication skills, lower probability of high-risk opioid prescribing, higher patient-reported agreement with treatment plan, and lower pain interference 2 months later.

Conditions

  • Pain, Chronic
  • Communication Research
  • Opioid Use

Interventions

BEHAVIORAL

Communication skills training

Intervention components include an 8-10 minute instructional video, a pocket card and pamphlet, and 2 standardized patient visits with role-play and feedback by the standardized patient

OTHER

Attention control

Physician will review materials based on CDC opioid prescribing guidelines.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Stephen G Henry, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-08-08
Completion
2020-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629197 on ClinicalTrials.gov