A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians

September 18, 2018 updated by: Karen Sepucha, Massachusetts General Hospital

A Pilot Randomized Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians

The Health Decision Sciences Center (HDSC) staff has deployed different 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 shared decision making (SDM) skills training courses using standardized patient interactions (SPI) and written evaluations.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: DA viewing
Participants will receive 3 decisions aids to review.
Behavioral: SPI feedback
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.
Behavioral: DA viewing
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.
Behavioral: SPI feedback
Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
Behavioral: Webinar
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.
Behavioral: Webinar
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

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Partners HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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