- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871739
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians
A Pilot Randomized Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is limited evidence on approaches to training clinicians to engage patients in shared decision making for common medical tests and treatments. The purpose of the study is to compare the effectiveness of different approaches to shared decision making (SDM) skills training. Participants will be randomly assigned to either receive two decision aids or a webinar to review. Participants will also be randomly assigned to receive feedback on standardized patient interaction rating their shared decision making skills and highlighting opportunities for improvement or not. Clinician participants will be assigned to one of four intervention groups using a 2x2 factorial design:
Group 1: Decision aid viewing with feedback Group 2: Decision aid viewing and no feedback Group 3: webinar with feedback Group 4: webinar and no feedback
The pilot study will provide evidence on the comparative effectiveness and feasibility on training formats to determine if:
- Clinicians improved in SDM communication skills
- Clinicians have an increased confidence to use SDM with their patients
- The training is acceptable to clinicians
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults 18 and older
- English speaking
- Physician
- Nurse Practitioner
- Physician Assistant
- Registered Nurse
Exclusion Criteria:
- Not clinically active (research faculty only)
- Medical Trainees
- Medical Students
- Medical Assistants
- Social Workers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will receive 3 decisions aids to review.
Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
|
Experimental: DA viewing with no SPI Feedback
Group 2 receives three decision aids.
This group does not receive any feedback from the SPI.
|
Participants will receive 3 decisions aids to review.
|
Experimental: 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.
|
Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
Experimental: 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.
|
1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Braddock's Informed Decision Making Score
Time Frame: 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.
|
Baseline (before intervention) and 4-6 weeks (after intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
- Davis D. Does CME work? An analysis of the effect of educational activities on physician performance or health care outcomes. Int J Psychiatry Med. 1998;28(1):21-39. doi: 10.2190/UA3R-JX9W-MHR5-RC81.
- Price EL, Bereknyei S, Kuby A, Levinson W, Braddock CH 3rd. New elements for informed decision making: a qualitative study of older adults' views. Patient Educ Couns. 2012 Mar;86(3):335-41. doi: 10.1016/j.pec.2011.06.006. Epub 2011 Jul 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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