--- title: Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes nct_id: NCT04317274 overall_status: COMPLETED phase: NA sponsor: Massachusetts General Hospital study_type: INTERVENTIONAL primary_condition: Colorectal Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04317274.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04317274" ct_last_update_post_date: 2024-01-05 last_seen_at: "2026-05-12T06:52:33.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes **NCT ID:** [NCT04317274](https://clinicaltrials.gov/study/NCT04317274) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 401 - **Lead Sponsor:** Massachusetts General Hospital - **Collaborators:** University of Massachusetts, Boston - **Conditions:** Colorectal Cancer, High Cholesterol - **Start Date:** 2020-03-13 - **Completion Date:** 2020-04-08 - **CT.gov Last Update:** 2024-01-05 ## Brief Summary This study will recruit subjects online and randomly assigned them to one of four arms. The arms vary by clinical decision (colorectal cancer screening or treatment of high cholesterol) by video order (poor shared decision making followed by good or good shared decision making followed by poor). Participants will view two videos and complete the Shared Decision Making process survey along with a few other measures after each video. Our main hypothesis is that respondents watching the good shared decision making videos will score higher on the Shared Decision Making Process survey compared to those watching the poor videos. ## Detailed Description Study staff are working with a national sampling firm to recruit subjects and obtain 400 responses. Subjects were randomly assigned to one of four arms. (1) Colorectal cancer screening good shared decision making video then poor video second (2) Colorectal cancer screening poor shared decision making video then good video (3) Treatment of high cholesterol good video then poor video and (4) Treatment of high cholesterol poor shared decision making video first then good video. Participants completed measures of Shared Decision Making after each video. The sample size was determined to ensure sufficient power to detect differences between the good and the poor shared decision making videos in this repeated measure design and analyses were planned to be separate for each arm (i.e. one analysis for the colorectal cancer screening videos and a separate parallel analysis of the statins for high cholesterol video). To detect an eta2 effect size of .04 with an alpha of 0.05 with 80% power would require 190 observations per clinical condition. Study staff rounded this to 200 observations per clinical condition, for a total required sample size of 400 patients. The interventions were short Shared Decision Making Videos that were developed as part of two training courses on shared decision making by investigators at Massachusetts General Hospital. For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items for the two clinical conditions and orders. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Then, study staff examine discriminant validity of the measure by examining whether scores for the good videos are higher then for the poor videos. Further, study staff will examine concurrent validity with the alternative shared decision making measure. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * Speak English * No prior diagnosis of colorectal cancer * No history of heart attack * No history of stroke Exclusion Criteria: * None ``` ## Arms - **High Cholesterol Good Video First** (EXPERIMENTAL) — Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second. - **Colorectal Cancer Good Video First** (EXPERIMENTAL) — Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second. - **High Cholesterol Poor Video First** (EXPERIMENTAL) — Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. - **Colorectal Cancer Poor Video First** (EXPERIMENTAL) — Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. ## Interventions - **Good high cholesterol video** (BEHAVIORAL) — The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around treatment of high cholesterol. - **Poor high cholesterol video** (BEHAVIORAL) — The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around treatment of high cholesterol. - **Good colon cancer screening video** (BEHAVIORAL) — The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around screening for colorectal cancer. - **Poor colon cancer screening video** (BEHAVIORAL) — The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around screening for colorectal cancer. ## Primary Outcomes - **Shared Decision Making Process Score** _(time frame: Immediately after viewing each video (typically within 15 minutes of watching the video))_ — The Shared Decision Making Process is a short, 4-item patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred. ## Secondary Outcomes - **Shared Decision Making Questionnaire (SDM-Q-9)** _(time frame: Immediately after viewing each video (typically within 15 minutes of watching the video))_ - **Healthcare Provider Treatment Recommendation** _(time frame: Immediately after viewing each video (typically within 15 minutes of watching the video))_ - **Patient Treatment Preference** _(time frame: Immediately after viewing each video (typically within 15 minutes of watching the video))_ - **Adapted Controlled Preference Item** _(time frame: Immediately after viewing each video (typically within 15 minutes of watching the video))_ ## Locations (1) - Massachusetts General Hospital, Boston, Massachusetts, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04317274.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04317274* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*