NCT02871739

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

February 8, 2019

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

August 9, 2016

Results QC Date

December 15, 2017

Last Update Submit

September 18, 2018

Conditions

Keywords

Communication skills trainingShared Decision MakingDecision makingDecision Aidslung cancer screening

Outcome Measures

Primary Outcomes (1)

  • Change in Braddock's Informed Decision Making Score

    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)

Study Arms (4)

DA viewing with SPI Feedback

EXPERIMENTAL

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 viewingBehavioral: SPI feedback

DA viewing with no SPI Feedback

EXPERIMENTAL

Group 2 receives three decision aids. This group does not receive any feedback from the SPI.

Behavioral: DA viewing

Webinar with SPI Feedback

EXPERIMENTAL

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: WebinarBehavioral: SPI feedback

Webinar with no SPI Feedback

EXPERIMENTAL

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

Interventions

WebinarBEHAVIORAL

1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.

Webinar with SPI FeedbackWebinar with no SPI Feedback
DA viewingBEHAVIORAL

Participants will receive 3 decisions aids to review.

DA viewing with SPI FeedbackDA viewing with no SPI Feedback
SPI feedbackBEHAVIORAL

Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction

DA viewing with SPI FeedbackWebinar with SPI Feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 and older
  • English speaking
  • Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse

You may not qualify if:

  • Not clinically active (research faculty only)
  • Medical Trainees
  • Medical Students
  • Medical Assistants
  • Social Workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 25222632BACKGROUND
  • 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.

    PMID: 9617647BACKGROUND
  • 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.

    PMID: 21757315BACKGROUND

MeSH Terms

Conditions

DepressionLow Back Pain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Karen Sepucha
Organization
Massachusetts General Hospital Health Decision Sciences Center

Study Officials

  • Karen Sepucha, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Health Decision Sciences Center

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 18, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2019

Results First Posted

February 8, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share