DepressionNCT02871739
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians
A study testing Webinar, DA viewing and SPI feedback in people with Depression and Low Back Pain, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Low Back Pain
- What is being tested?
- Webinar, DA viewing and SPI feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 and older
- English speaking
- Physician
- Nurse Practitioner
- Physician Assistant
- Registered Nurse
Who cannot join
- Not clinically active (research faculty only)
- Medical Trainees
- Medical Students
- Medical Assistants
- Social Workers
About this study
Official title: 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.
Read the 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
- Conditions
- Depression, Low Back Pain
- Being tested
- Webinar, DA viewing, SPI feedback
- Keywords
- Communication skills training, Shared Decision Making, Decision making, Decision Aids, lung cancer screening
- Medical subject headings
- Depression, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebinarBehavioural
1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
DA viewingBehavioural
Participants will receive 3 decisions aids to review.
SPI feedbackBehavioural
Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DA viewing; Behavioral: 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. Receives: 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. Receives: Behavioral: Webinar; Behavioral: 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. Receives: Behavioral: Webinar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before intervention) and 4-6 weeks (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners HealthCare
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871739
- Sponsor's protocol ID
- 2016P000470
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2016
- Last updated
- 8 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25222632Davis 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.
PubMed 9617647Price 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.
PubMed 21757315
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians
- ClinicalTrials.gov ID
- NCT02871739
- Acronym / sponsor ID
- 2016P000470
- Conditions
- Depression, Low Back Pain
- Keywords
- Communication skills training, Shared Decision Making, Decision making, Decision Aids, lung cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Partners HealthCare
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 8 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DA viewing with SPI Feedback | Experimental | Behavioral: DA viewing, Behavioral: SPI feedbackGroup 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 with no SPI Feedback | Experimental | Behavioral: DA viewingGroup 2 receives three decision aids. This group does not receive any feedback from the SPI. |
| Webinar with SPI Feedback | Experimental | Behavioral: Webinar, Behavioral: SPI feedbackGroup 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 with no SPI Feedback | Experimental | Behavioral: WebinarGroup 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18 and older
- English speaking
- Physician
- Nurse Practitioner
- Physician Assistant
Key exclusion criteria (5 listed)
- Not clinically active (research faculty only)
- Medical Trainees
- Medical Students
- Medical Assistants
- Social Workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Webinar1 hour online, interactive webinar that covers shared decision making skills in clinical encounters. | Behavioural | Webinar with SPI Feedback, Webinar with no SPI Feedback |
| DA viewingParticipants will receive 3 decisions aids to review. | Behavioural | DA viewing with SPI Feedback, DA viewing with no SPI Feedback |
| SPI feedbackRating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction | Behavioural | DA viewing with SPI Feedback, Webinar with SPI Feedback |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25222632Legare 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.
- Background: PubMed 9617647Davis 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.
- Background: PubMed 21757315Price 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Webinar, DA viewing and SPI feedback in people with Depression and Low Back Pain, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Braddock's Informed Decision Making Score (time frame: Baseline (before intervention) and 4-6 weeks (after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.