Improving Communication About Pain and Opioids

NCT03629197 | Completed Results

• 3 other identifiers: 9700145K23DA043052A18-0560
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

primary care; chronic pain; patient-physician communication; opioid analgesics; standardized patients

Outcome Measures

Primary Outcomes (2)

• Clinician Number of Targeted Behaviors Per Visit

  Compare frequency of use of targeted communication behaviors observed per visit for residents in the Intervention vs Control arm (using coding of recorded visits to assess skill use). We first developed a list of targeted communication behaviors that were targeted by our intervention and based on our conceptual model. We developed a coding manual to count the number of unique behaviors in each study visit. We analyzed audio recordings and transcripts from all study visits to count the number of targeted behaviors per each visit. Multiple team members measured communication behaviors in each visit to ensure reliability of this measure.

  Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

• Compare Efficacy of Control vs Intervention by Measuring Changes in the Way Pain Interfered With Patients Lives Using the Brief Pain Inventory - Pain Interference Subscale Survey

  Brief Pain Inventory (BPI) Pain Interference subscale consists of 7 categories relating to how pain interferes with patients' lives. Patients are asked to rate their pain on a zero (Does Not Interfere) to 10 (Completely Interferes) scale. The 7 categories are: 1. General Activity, 2. Mood, 3. Walking Ability, 4. Work, 5. Relationships, 6. Sleep, 7. Enjoyment of life. Results are averaged to give an overall interference rating from 0-10, with higher scores indicating worse pain.

  8 weeks

Secondary Outcomes (5)

• Compare Efficacy of Control vs Intervention by Measuring Changes in the Severity of Patients Pain Using the Brief Pain Inventory - (Short Form) Pain Severity Subscale Which Measures the Severity of the Patient's Pain.

  8 weeks

• Difficult Doctor-Patient Relationship Questionnaire

  Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

• Patient Experience Score

  8 weeks

• Physicians' Overall Appraisal of the Standardized Patient Intervention

  1-3 months

• Physician Communication Self-efficacy

  Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

Other Outcomes (1)

• High-risk Opioid Prescribing

  Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

Study Arms (4)

Clinicians - Communication skills training

EXPERIMENTAL

Intervention clinicians will receive 2 standardized patient visits. The first visit will consist of an 8 minute video on the development of 5 key communication skills, a 10-12 minute role-play session to practice using these skills, and 8-10 minutes of constructive feedback. The 2nd visit will include only the role-play and feedback components. Clinicians will also get a printed pocket card and pamphlet explaining the targeted communication skills in more detail.

Behavioral: Clinicians - Communication skills training

Clinician Control

ACTIVE COMPARATOR

Control clinicians will receive a written summary of the 2016 CDC opioid prescribing guidelines, which include recommendations for best practices for use of opioids to treat chronic non-cancer pain. CDC guidelines will serve as an attention control.

Other: Clinician Control

Patient seeing trained clinician

EXPERIMENTAL

Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has received the communication training will be recruited for this arm.

Behavioral: Patient seeing trained clinician

Patient seeing control clinician

ACTIVE COMPARATOR

Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has NOT received the communication training (Clinician control group) will be recruited for this arm.

Other: Patient seeing control clinician

Interventions

Clinicians - Communication skills training BEHAVIORAL

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

Clinicians - Communication skills training

Clinician Control OTHER

Physician will review materials based on CDC opioid prescribing guidelines.

Clinician Control

Patient seeing trained clinician BEHAVIORAL

patient with a scheduled visit with a clinician who received the communication training.

Patient seeing trained clinician

Patient seeing control clinician OTHER

patient with a scheduled visit with a clinician who did not receive the communication training.

Patient seeing control clinician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Internal Medicine or Family Medicine residents at UC Davis:
• completed ≥1 year of training
• see primary care patients in the Ambulatory Care Center (ACC) building. Clinicians will be recruited through clinic huddles, emails, and presentations at meetings.
• UC Davis Patients:
• years old
• taking opioids (≥1 opioid dose per day) prescribed by their primary care physician for \>90 days to treat chronic musculoskeletal pain
• have an appointment scheduled with a participating clinician at which they report they are likely to discuss pain management

You may not qualify if:

• active cancer
• hospice
• do not speak English
• prisoners
• pregnant women
• unable to consent

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of California Davis Family Medicine Clinic

Sacramento, California, 95817, United States

Location

University of California Davis Internal Medicine Clinic

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephen G Henry
• Organization: University of California Davis

sghenry@ucdavis.edu

19167347005

Study Officials

• Stephen G Henry, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Physicians will be randomized after physician recruitment is complete. This ensures that arm assignment does not impact physicians' decision to participate. Arm assignment will be done using a random number generator. Due to the nature of the intervention, blinding participants (physicians) is not feasible. However, patients will not be aware of their physician's arm assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Physicians will be randomized to receive the intervention versus control; patients will be recruited to see study physicians; patients will not be randomized.

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 14, 2018
• Study Start: August 15, 2018
• Primary Completion: November 5, 2019
• Study Completion: December 31, 2019
• Last Updated: July 27, 2026
• Results First Posted: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)