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| Name | Class |
|---|---|
| Partners HealthCare | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| DA viewing with no SPI Feedback | Experimental | Group 2 receives three decision aids. This group does not receive any feedback from the SPI. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Webinar | Behavioral | 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25222632 | Background | 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. | |
| 9617647 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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 |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before intervention) and 4-6 weeks (after intervention) |
|
Serious and other (not including serious) adverse events were not collected/assessed.
Adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha | Massachusetts General Hospital Health Decision Sciences Center | 617-724-3350 | ksepucha@partners.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 |
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| DA viewing | Behavioral | Participants will receive 3 decisions aids to review. |
|
| SPI feedback | Behavioral | Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction |
|
| 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. |
| 21757315 | Background | 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. |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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 |
| OG003 | 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. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 |
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| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|