Trial Outcomes & Findings for Improving Communication About Pain and Opioids (NCT NCT03629197)
NCT ID: NCT03629197
Last Updated: 2026-07-27
Results Overview
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.
COMPLETED
NA
95 participants
Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
2026-07-27
Participant Flow
Clinician participant recruitment began in August 2018. Patient participant recruitment began in December 2018. Recruitment occurred at two academic primary care clinics at the University of California Davis Health.
Participant milestones
| Measure |
Communication Skills Training
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.
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.
Patient participants will be assigned to the arm of the study clinician they see for their study visit.
|
Control
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
Patient participants will be assigned to the arm of the study clinician they see for their study visit.
|
|---|---|---|
|
Clinician Participants
STARTED
|
24
|
23
|
|
Clinician Participants
COMPLETED
|
24
|
21
|
|
Clinician Participants
NOT COMPLETED
|
0
|
2
|
|
Patient Participants
STARTED
|
26
|
22
|
|
Patient Participants
COMPLETED
|
25
|
21
|
|
Patient Participants
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Communication Skills Training
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.
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.
Patient participants will be assigned to the arm of the study clinician they see for their study visit.
|
Control
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
Patient participants will be assigned to the arm of the study clinician they see for their study visit.
|
|---|---|---|
|
Clinician Participants
Withdrawal by Subject
|
0
|
2
|
|
Patient Participants
opioids not prescribed by primary care clinician
|
1
|
1
|
Baseline Characteristics
This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
Baseline characteristics by cohort
| Measure |
Communication Skills Training
n=46 Participants
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.
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.
Patients will be assigned to the arm of the clinician they see for their study visit. Each study clinician can see up to 2 study patients.
|
Control
n=37 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
Patients will be assigned to the arm of the clinician they see for their study visit. Each study clinician can see up to 2 study patients.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 2.6 • n=21 Participants • refers to clinician participants
|
29.5 years
STANDARD_DEVIATION 2.6 • n=16 Participants • refers to clinician participants
|
29.6 years
STANDARD_DEVIATION 2.6 • n=37 Participants • refers to clinician participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=21 Participants • numbers refer to clinician participants
|
7 Participants
n=16 Participants • numbers refer to clinician participants
|
25 Participants
n=37 Participants • numbers refer to clinician participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=21 Participants • numbers refer to clinician participants
|
9 Participants
n=16 Participants • numbers refer to clinician participants
|
12 Participants
n=37 Participants • numbers refer to clinician participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=21 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
1 Participants
n=16 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
1 Participants
n=37 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
9 Participants
n=21 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
5 Participants
n=16 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
14 Participants
n=37 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
1 Participants
n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
1 Participants
n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
|
Race/Ethnicity, Customized
Hispanic White
|
4 Participants
n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
2 Participants
n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
6 Participants
n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
|
Race/Ethnicity, Customized
Multi-racial / other
|
3 Participants
n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
3 Participants
n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
6 Participants
n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only the patient participants.
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=21 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
10 Participants
n=16 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
18 Participants
n=37 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
|
Race/Ethnicity, Customized
Multi-race / other
|
4 Participants
n=21 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
0 Participants
n=16 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
4 Participants
n=37 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
|
Brief Pain Index
Interference
|
7.4 units on a scale
STANDARD_DEVIATION 1.9 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
6.2 units on a scale
STANDARD_DEVIATION 2.5 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
6.9 units on a scale
STANDARD_DEVIATION 2.2 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
Brief Pain Index
Intensity
|
7.3 units on a scale
STANDARD_DEVIATION 1.8 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
6.4 units on a scale
STANDARD_DEVIATION 1.8 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
6.9 units on a scale
STANDARD_DEVIATION 1.8 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
VR-12
Mental component score
|
39.0 units on a scale
STANDARD_DEVIATION 11.9 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
43.9 units on a scale
STANDARD_DEVIATION 11.3 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
41.2 units on a scale
STANDARD_DEVIATION 11.8 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
VR-12
Physical component score
|
24.3 units on a scale
STANDARD_DEVIATION 7.8 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
24.0 units on a scale
STANDARD_DEVIATION 7.7 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
24.2 units on a scale
STANDARD_DEVIATION 7.7 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
PHQ-8
|
10.0 units on a scale
STANDARD_DEVIATION 6.8 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
10.6 units on a scale
STANDARD_DEVIATION 6.1 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
10.3 units on a scale
STANDARD_DEVIATION 6.4 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
GAD-7
|
9.6 units on a scale
STANDARD_DEVIATION 6.4 • n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
8.0 units on a scale
STANDARD_DEVIATION 5.0 • n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
8.9 units on a scale
STANDARD_DEVIATION 5.8 • n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
Prescribed opioid daily dose (MME)
|
30 milligram morphine equivalents
n=25 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
21.7 milligram morphine equivalents
n=21 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
30 milligram morphine equivalents
n=46 Participants • This measure includes patient participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only patient participants.
|
|
Self-efficacy for chronic pain management
|
2.8 units on a scale
STANDARD_DEVIATION 0.5 • n=21 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
2.9 units on a scale
STANDARD_DEVIATION 0.4 • n=16 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
2.9 units on a scale
STANDARD_DEVIATION 0.5 • n=37 Participants • This measure includes clinician participants only. The Overall Number of Baseline Participants includes both patient participants (Communication Skills Training=25, Control=21, Total=46) and clinician participants (Communication Skills Training=21, Control=16, Total=37). Therefore, the Number Analyzed for this measure reflects only clinician participants.
|
PRIMARY outcome
Timeframe: Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).Population: primary care physicians
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.
Outcome measures
| Measure |
Communication Skills Training
n=24 Participants
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.
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
|
Control
n=21 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
Clinician Number of Targeted Behaviors Per Visit
|
3.5 # of targeted behaviors per visit
Standard Deviation 2.8
|
2.8 # of targeted behaviors per visit
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: This outcome includes patient participants only. Results are reported separately for the Communication Skills Training and Control arms; no arm/group data have been combined.
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.
Outcome measures
| Measure |
Communication Skills Training
n=25 Participants
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.
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
|
Control
n=21 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
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
|
6.3 units on a scale
Standard Deviation 2.8
|
5.8 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: patients
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.
Outcome measures
| Measure |
Communication Skills Training
n=25 Participants
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.
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
|
Control
n=21 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
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.
|
6.5 units on a scale
Standard Deviation 2.3
|
6.0 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).Population: patient visits
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.
Outcome measures
| Measure |
Communication Skills Training
n=21 Participants
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.
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
|
Control
n=16 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
Difficult Doctor-Patient Relationship Questionnaire
|
25.8 units on a scale
Standard Deviation 12.3
|
22.8 units on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: patients
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).
Outcome measures
| Measure |
Communication Skills Training
n=25 Participants
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.
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
|
Control
n=21 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
Patient Experience Score
|
-0.1 units on a scale
Standard Deviation 1.1
|
0.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 1-3 monthsPopulation: physicians who participated in / were randomized to the intervention group
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.
Outcome measures
| Measure |
Communication Skills Training
n=21 Participants
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.
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
|
Control
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention quality
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention helpful
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention easy to understand
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention relevant
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention would lead to improved patient care
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
will use skills learned in intervention
|
21 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
intervention disrupted patient flow
|
2 Participants
|
—
|
|
Physicians' Overall Appraisal of the Standardized Patient Intervention
standardized patients were realistic
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).Population: primary care physicians
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.
Outcome measures
| Measure |
Communication Skills Training
n=21 Participants
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.
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
|
Control
n=16 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
Physician Communication Self-efficacy
|
3.8 units on a scale
Standard Deviation 0.6
|
3.4 units on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).Population: patients
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
Outcome measures
| Measure |
Communication Skills Training
n=25 Participants
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.
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
|
Control
n=21 Participants
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.
Attention control: Physician will review materials based on CDC opioid prescribing guidelines.
|
|---|---|---|
|
High-risk Opioid Prescribing
|
6 Participants
|
2 Participants
|
Adverse Events
Communication Skills Training
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place