Improving Communication About Pain and Opioids

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629197
• Other study ID #: 970014
• Secondary ID: 5K23DA043052A18-
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2020
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Communication Research
• Opioid Use
• Pain, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis Family Medicine Clinic	Sacramento	California
United States	University of California Davis Internal Medicine Clinic	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High-risk opioid prescribing	Prevalence of high-risk opioid prescribing as measured by chart review	Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Primary	Clinician use of targeted communication skills	Compare frequency of use of targeted communication skills for residents in the Intervention vs Control arm (using coding of recorded visits to assess skill use)	Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Primary	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	8 weeks
Secondary	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.	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.	8 weeks
Secondary	Difficult Doctor-Patient Relationship Questionnaire	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 visits.	Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Secondary	Patient experience score	Difference in patient experience for patients who saw Intervention vs Control physicians (measured by post-visit patient agreement with treatment plan, patient trust, and patient assessment of clinician communication skills). Patient experience will be a "standardized average" of 3 different scales: Patient assessment of physician communication skills is a subscale of the CAHPS (Consumer Assessment of Health Plan Survey) Adult Visit Survey. Range is 0-12, with higher indicating better communication skills.; Patient agreement with treatment plan scale. Range is 3-21, with higher being greater agreement).; Brief Wake Forest Patient Trust in Physician Scale. Range is 5-25, with higher being greater trust.	8 weeks
Secondary	Physicians' overall appraisal of the standardized patient Intervention	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 averaged to give an overall score; higher values indicate more positive appraisal.	1-3 months
Secondary	Change in physician communication self efficacy	Change in 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 each statement. Higher values indicate greater 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.	Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).