Pain, ChronicNCT03629197
Improving Communication About Pain and Opioids
A study testing Clinicians - Communication skills training and Patient seeing trained clinician in people with Pain, Chronic and Communication Research, run by University of California, Davis at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Communication Research, Opioid Use
- What is being tested?
- Clinicians - Communication skills training and Patient seeing trained clinician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active cancer
- hospice
- do not speak English
- prisoners
- pregnant women
- unable to consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis Family Medicine Clinic
Sacramento, California, 95817
University of California Davis Internal Medicine Clinic
Sacramento, California, 95817
About this study
Official title: A Clinician Training Intervention to Improve Pain-related Communication, Pain Management and Opioid Prescribing in Primary Care
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.
Read the detailed 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).
- Conditions
- Pain, Chronic, Communication Research, Opioid Use
- Being tested
- Clinicians - Communication skills training, Clinician Control, Patient seeing trained clinician, Patient seeing control clinician
- Keywords
- primary care, chronic pain, patient-physician communication, opioid analgesics, standardized patients
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinicians - Communication skills trainingBehavioural
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 ControlOther
Physician will review materials based on CDC opioid prescribing guidelines.
Patient seeing trained clinicianBehavioural
patient with a scheduled visit with a clinician who received the communication training.
Patient seeing control clinicianOther
patient with a scheduled visit with a clinician who did not receive the communication training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Patient seeing control clinician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 8 weeks
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 (worse) visits. Physicians complete this measure for each study patient.
Measured: Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Patient Experience Score
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).
Measured: 8 weeks
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 reported as the percentage who agree or strongly agree with each statement.
Measured: 1-3 months
Physician Communication Self-efficacy
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.
Measured: Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Aug 2018
- Primary completion5 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Physicians will be randomized to receive the intervention versus control; patients will be recruited to see study physicians; patients will not be randomized.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stephen G Henry, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629197
- Sponsor's protocol ID
- 970014
- Other IDs
- 5K23DA043052, A18-0560
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2018
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinician Training Intervention to Improve Pain-related Communication, Pain Management and Opioid Prescribing in Primary Care
- ClinicalTrials.gov ID
- NCT03629197
- Acronym / sponsor ID
- 970014
- Conditions
- Pain, Chronic, Communication Research, Opioid Use
- Keywords
- primary care, chronic pain, patient-physician communication, opioid analgesics, standardized patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Physicians will be randomized to receive the intervention versus control; patients will be recruited to see study physicians; patients will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| Clinicians - Communication skills training | Experimental | Behavioral: Clinicians - Communication skills trainingIntervention 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. |
| Clinician Control | Active comparator | Other: Clinician ControlControl 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. |
| Patient seeing trained clinician | Experimental | Behavioral: Patient seeing trained clinicianPatients 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. |
| Patient seeing control clinician | Active comparator | Other: Patient seeing control clinicianPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (6 listed)
- active cancer
- hospice
- do not speak English
- prisoners
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinicians - Communication skills trainingIntervention 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 | Behavioural | Clinicians - Communication skills training |
| Clinician ControlPhysician will review materials based on CDC opioid prescribing guidelines. | Other | Clinician Control |
| Patient seeing trained clinicianpatient with a scheduled visit with a clinician who received the communication training. | Behavioural | Patient seeing trained clinician |
| Patient seeing control clinicianpatient with a scheduled visit with a clinician who did not receive the communication training. | Other | Patient seeing control clinician |
Primary outcome
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.
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.
5 secondary outcomes
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
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).
Patient Experience Score
Time frame: 8 weeks
Physicians' Overall Appraisal of the Standardized Patient Intervention
Time frame: 1-3 months
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen G Henry, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinicians - Communication skills training and Patient seeing trained clinician in people with Pain, Chronic and Communication Research, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.