Colorectal CancerNCT04317274
Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
A study testing Good high cholesterol video, Poor high cholesterol video and Good colon cancer screening video in people with Colorectal Cancer and High Cholesterol, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, High Cholesterol
- What is being tested?
- Good high cholesterol video, Poor high cholesterol video and Good colon cancer screening video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 8 Apr 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak English
- No prior diagnosis of colorectal cancer
- No history of heart attack
- No history of stroke
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer, High Cholesterol
- Being tested
- Good high cholesterol video, Poor high cholesterol video, Good colon cancer screening video, Poor colon cancer screening video
- Medical subject headings
- Colorectal Neoplasms, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good high cholesterol videoBehavioural
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 videoBehavioural
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 videoBehavioural
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 videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Good high cholesterol video; Behavioral: Poor high cholesterol video |
| 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. Receives: Behavioral: Good colon cancer screening video; Behavioral: Poor colon cancer screening video |
| 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. Receives: Behavioral: Good high cholesterol video; Behavioral: Poor high cholesterol video |
| 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. Receives: Behavioral: Good colon cancer screening video; Behavioral: Poor colon cancer screening video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making Process Score
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.
Measured: Immediately after viewing each video (typically within 15 minutes of watching the video)
Secondary outcomes (4)
Shared Decision Making Questionnaire (SDM-Q-9)
The SDM-Q9 is a 9-item patient reported measure of the amount of shared decision making that occurs in an interaction. Items are scored on a six-point Likert scale from 0 (completely disagree) to 5 (completely agree); items are summed up to a total raw score between 0-45. The score is then transformed to range from 0-100 where higher values indicate a better shared decision making process occurred.
Measured: Immediately after viewing each video (typically within 15 minutes of watching the video)
Healthcare Provider Treatment Recommendation
Single item asking what the healthcare provider recommended the patient do in the video
Measured: Immediately after viewing each video (typically within 15 minutes of watching the video)
Patient Treatment Preference
Single item asking what the patient in the video wanted to do
Measured: Immediately after viewing each video (typically within 15 minutes of watching the video)
Adapted Controlled Preference Item
Single item asking the participant who made the ultimate decision in the video. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.
Measured: Immediately after viewing each video (typically within 15 minutes of watching the video)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start13 Mar 2020
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
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.
- Other trials for Colorectal CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Subjects were randomly assigned to one of the two clinical conditions (colorectal cancer screening or high cholesterol) then randomly assigned to view the two videos in one of two orders. Participants either viewed the good shared decision making video first (and the poor shared decision making video second) or the poor shared decision making video first (and the good shared decision making video second). Thus we used a 2 (clinical condition; colorectal cancer screening v. high cholesterol) x 2 (video; good v. poor) x 2 (order; good first v. poor first) factorial design.
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Boston
- 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
- NCT04317274
- Sponsor's protocol ID
- 2019P001434
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2020
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
- ClinicalTrials.gov ID
- NCT04317274
- Acronym / sponsor ID
- 2019P001434
- Conditions
- Colorectal Cancer, High Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects were randomly assigned to one of the two clinical conditions (colorectal cancer screening or high cholesterol) then randomly assigned to view the two videos in one of two orders. Participants either viewed the good shared decision making video first (and the poor shared decision making video second) or the poor shared decision making video first (and the good shared decision making video second). Thus we used a 2 (clinical condition; colorectal cancer screening v. high cholesterol) x 2 (video; good v. poor) x 2 (order; good first v. poor first) factorial design.
| Arm | Type | Receives |
|---|---|---|
| High Cholesterol Good Video First | Experimental | Behavioral: Good high cholesterol video, Behavioral: Poor high cholesterol videoParticipants 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 | Behavioral: Good colon cancer screening video, Behavioral: Poor colon cancer screening videoParticipants 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 | Behavioral: Good high cholesterol video, Behavioral: Poor high cholesterol videoParticipants 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 | Behavioral: Good colon cancer screening video, Behavioral: Poor colon cancer screening videoParticipants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Speak English
- No prior diagnosis of colorectal cancer
- No history of heart attack
- No history of stroke
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Good high cholesterol videoThe short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around treatment of high cholesterol. | Behavioural | High Cholesterol Good Video First, High Cholesterol Poor Video First |
| Poor high cholesterol videoThe 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. | Behavioural | High Cholesterol Good Video First, High Cholesterol Poor Video First |
| Good colon cancer screening videoThe short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around screening for colorectal cancer. | Behavioural | Colorectal Cancer Good Video First, Colorectal Cancer Poor Video First |
| Poor colon cancer screening videoThe 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. | Behavioural | Colorectal Cancer Good Video First, Colorectal Cancer Poor Video First |
Primary outcome
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.
4 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good high cholesterol video, Poor high cholesterol video and Good colon cancer screening video in people with Colorectal Cancer and High Cholesterol, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 1 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 5 Jan 2024). 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?
Shared Decision Making Process Score (time frame: Immediately after viewing each video (typically within 15 minutes of watching the video)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.