Trial Outcomes & Findings for A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians (NCT NCT02871739)
NCT ID: NCT02871739
Last Updated: 2019-02-08
Results Overview
Transcripts from standardized patient interactions (SPI) will be scored using Braddock's Informed Decision Making (IDM) framework to assess shared decision making skills. Scores with the Braddock's Informed Decision Making Framework range from 0 to 9; the higher scores are better. We subtracted the scores of the baseline SPI collected before the intervention from the second SPI collected 4-6 weeks later, after the intervention, to determine the change in IDM score for each participant and then compared change scores across study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline (before intervention) and 4-6 weeks (after intervention)
Results posted on
2019-02-08
Participant Flow
Participant milestones
| Measure |
DA Viewing With SPI Feedback
Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
DA viewing: Participants will receive 3 decisions aids to review.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
DA Viewing With no SPI Feedback
Group 2 receives three decision aids. This group does not receive any feedback from the SPI.
DA viewing: Participants will receive 3 decisions aids to review.
|
Webinar With SPI Feedback
Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
Webinar With no SPI Feedback
Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
7
|
|
Overall Study
Completed First SPI
|
3
|
5
|
4
|
6
|
|
Overall Study
Completed Second SPI
|
3
|
4
|
4
|
5
|
|
Overall Study
Complete Final Survey
|
3
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
DA Viewing With SPI Feedback
Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
DA viewing: Participants will receive 3 decisions aids to review.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
DA Viewing With no SPI Feedback
Group 2 receives three decision aids. This group does not receive any feedback from the SPI.
DA viewing: Participants will receive 3 decisions aids to review.
|
Webinar With SPI Feedback
Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
Webinar With no SPI Feedback
Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DA Viewing With SPI Feedback
n=6 Participants
Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
DA viewing: Participants will receive 3 decisions aids to review.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
DA Viewing With no SPI Feedback
n=6 Participants
Group 2 receives three decision aids. This group does not receive any feedback from the SPI.
DA viewing: Participants will receive 3 decisions aids to review.
|
Webinar With SPI Feedback
n=4 Participants
Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
Webinar With no SPI Feedback
n=7 Participants
Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
4 participants
n=4 Participants
|
7 participants
n=7 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline (before intervention) and 4-6 weeks (after intervention)Transcripts from standardized patient interactions (SPI) will be scored using Braddock's Informed Decision Making (IDM) framework to assess shared decision making skills. Scores with the Braddock's Informed Decision Making Framework range from 0 to 9; the higher scores are better. We subtracted the scores of the baseline SPI collected before the intervention from the second SPI collected 4-6 weeks later, after the intervention, to determine the change in IDM score for each participant and then compared change scores across study arms.
Outcome measures
| Measure |
DA Viewing With SPI Feedback
n=3 Participants
Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
DA viewing: Participants will receive 3 decisions aids to review.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
DA Viewing With no SPI Feedback
n=4 Participants
Group 2 receives three decision aids. This group does not receive any feedback from the SPI.
DA viewing: Participants will receive 3 decisions aids to review.
|
Webinar With SPI Feedback
n=4 Participants
Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
Webinar With no SPI Feedback
n=5 Participants
Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.
Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
|---|---|---|---|---|
|
Change in Braddock's Informed Decision Making Score
|
2.00 score on a scale
Standard Deviation 1.29
|
1.25 score on a scale
Standard Deviation 2.06
|
1.00 score on a scale
Standard Deviation 0.82
|
3.20 score on a scale
Standard Deviation 1.79
|
Adverse Events
DA Viewing With SPI Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DA Viewing With no SPI Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Webinar With SPI Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Webinar With no SPI Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen Sepucha
Massachusetts General Hospital Health Decision Sciences Center
Phone: 617-724-3350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place