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OpenTrials
Completed

NCT Number: NCT03629197

Improving Communication About Pain and Opioids

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Communication Research Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Family Medicine Clinic, Sacramento, California, United States

Loading trial locations.

About this study

The only intervention in the randomized controlled trial (RCT) will be clinician education. This RCT will not directly manipulate or influence patient care. Therefore, this study is minimal risk. The only foreseeable patient risks relate to data confidentiality and privacy.

The investigators will recruit approximately 48 primary care clinicians for the pilot RCT. The study goal is to enroll 24 residents and 48 patients (2 patient visits per resident). However, based on previous experience with similar recruitment methods in these clinics, only about 50% of enrolled clinicians will ultimately have visits with study patients. Thus, it will be necessary to over-enroll clinicians because the investigators expect a large proportion of residents will have to be dropped from study due to not seeing any study patients. After enrollment, clinicians will complete a brief questionnaire including demographics and self efficacy regarding communicating with patients about chronic pain and opioids.

Randomization assignment will take place after all clinicians have provided informed consent and enrolled, to prevent randomization status from influencing enrollment decisions. Randomization assignment will be done by study personnel after all clinicians have been recruited. Randomization is at the clinician level. Because of the nature of the intervention, it is not possible to blind subjects or investigators to randomization assignment. However, patients will be unaware of clinicians' randomization assignment.

Intervention clinicians will complete 2 standardized patient visits during regular clinic time. The first visit will include viewing an 8-10 minute video summarizing the key communication skills, a 10-12 minute roll-play session to practice using these skills, and 8-10 minutes of constructive feedback. The second video will have only roll-play and feedback. Control clinicians will receive a written summary of the 2016 Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines which include recommendations for best practices for use of opioids to treat chronic non-cancer pain. To the extent possible, the investigators will use CDC-produced materials for the control group. CDC guidelines will serve as an attention control. Intervention clinicians will complete a brief questionnaire evaluating the intervention. Some time later, enrolled clinicians will see 2 patients who've been screened and enrolled by the research team and who've agreed to allow a previously scheduled visit with pcp to be audio recorded. Data will include the audio recording transcripts, a pre-visit and post-visit patient questionnaire and a clinician post-visit questionnaire.

2 months after each patient's visit, a research assistant will call patients and obtain 2-month follow up data (e.g. Brief Pain Inventory).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 18-80 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

Exclusion criteria

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

Treatment and study plan

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

Clinician Control

Other

Physician will review materials based on CDC opioid prescribing guidelines.

Patient seeing trained clinician

Behavioral

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

Patient seeing control clinician

Other

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

Primary outcomes

  1. Clinician Number of Targeted Behaviors Per Visit

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

    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.

  2. 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

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

    Brief Pain Inventory (BPI) Short Form -- Pain Severity subscale has 4 survey questions / categories, asking patients to rate the severity of their pain on a 0-10 scale (with 0 being No Pain and 10 being Worst Possible Pain). The 4 Categories are, A. At it's worst in the last 24 hours, B. At it's best in the last 24 hours, C. Pain on average, D. Pain right now. Results are averaged to give an overall score (0-10) with higher scores indicating worse outcomes.

  2. Difficult Doctor-Patient Relationship Questionnaire

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

    Comparison of difficult doctor-patient encounter scale for Intervention vs Control physicians. Difficult doctor-patient relationship scale has 10 items scored from 1-6. The overall scale range is 10-60, with higher values indicating more difficult (worse) visits. Physicians complete this measure for each study patient.

  3. Patient Experience Score

    Time frame: 8 weeks

    Patient experience score for patients who saw Intervention and Control physicians, measured by post visit patient agreement with treatment plan, patient trust, and patient assessment of clinician communication skills. Patient experience is a standardized composite average of three validated scales:

    Consumer Assessment of Healthcare Providers and Systems (CAHPS) Adult Visit Survey communication subscale, range 0 to 12, with higher scores indicating better communication.

    Patient Agreement with Treatment Plan Scale, range 3 to 21, with higher scores indicating greater agreement.

    Brief Wake Forest Physician Trust Scale, range 5 to 25, with higher scores indicating greater trust.

    The three scales were standardized and averaged into a single composite score. The theoretical composite score ranges from -4.5 to 0.6, with higher scores indicating a better patient experience. Results are reported separately for each study arm as mean (standard deviation).

  4. Physicians' Overall Appraisal of the Standardized Patient Intervention

    Time frame: 1-3 months

    Physician reported assessment of intervention. Investigators will ask for physicians' evaluation of the feasibility, acceptability, and utility of the intervention. Investigators will offer 10 value statements about the intervention. Physicians will select 1 from the following choices: strongly agree, agree, neutral, disagree, strongly disagree. Results will be reported as the percentage who agree or strongly agree with each statement.

  5. Physician Communication Self-efficacy

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

    Physician self-efficacy for communication skills for Intervention vs Control physicians. These questions ask about physicians' confidence related to managing chronic non-cancer pain in primary care. Physicians will be asked to rate how strongly they agree or disagree with 8 statements (each on 1-5 scale. Higher values indicate greater (better) self-efficacy. Baseline and post-visit ratings of self efficacy will be computed, and we will measure change in self efficacy (post-visit self efficacy minus baseline self efficacy) for Control vs Intervention physicians. Overall score range will be 1-5, with higher numbers indicating better self efficacy.

Other outcomes

  1. High-risk Opioid Prescribing

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

    Prevalence of high-risk opioid prescribing as measured by chart review; defined either as being prescribed 90MME or more OR being prescribed opioids plus benzodiazepines 2 months after study completion based on chart review

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Clinician Training Intervention to Improve Pain-related Communication, Pain Management and Opioid Prescribing in Primary Care

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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