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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patient (n=800) will randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to determine the extent to which they report shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will also conduct medical chart review to track receipt of colon cancer screening within 6 months.
Intervention arm: In this arm, patients will get a shared decision making information sheet in the mail that describes three screening options: (1) schedule next available colonoscopy, (2) switch to a stool-based test, and (3) delay colonoscopy for a year. Study staff trained in decision coaching will follow up with patients to help them select an option and support implementation.
Control arm: This arm will be a usual care arm. The gastroenterology department department has schedulers calling patients and texting patients to schedule their procedure.
All 800 patients will be followed for their cancer screening outcomes, and a subset n=460 or 230 in each arm will be randomly selected to receive the survey.
Study staff who prepare the intervention mailing and the surveys will not be blinded to the study arm. The staff who enter the data from the paper surveys and who conduct chart review to collect screening will be blinded to the assignment. The statistician analyzing the results will also be blinded to the assignment.
The following hypotheses will be evaluated using an intention to treat approach, so patients will be analyzed based on their assigned arm.
Hypothesis 1: Compared to the control group, patients in intervention arm will report higher shared decision making (primary outcome).
Hypothesis 2: Compared to the control group, patients in the intervention arm will have (2a) stronger intention to follow through with colon cancer screening (whether colonoscopy, stool-based test or other approach) and (2b) will be more likely to have a screening test within 6 months.
Hypothesis 3: Compared to the control group, patients in the intervention arm will have less decisional conflict (SURE score).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Arm | No Intervention | This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. | |
| Shared Decision Making Arm | Experimental | This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making | Behavioral | The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year). The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist). |
| Measure | Description | Time Frame |
|---|---|---|
| Shared Decision Making (SDM) Process Scale Score | short patient reported scale asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4 with higher scores indicating higher shared decision making. | About 8 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| No Decisional Conflict (Number With Score of 4 on SURE Scale) | The 4-item version of the decisional conflict scale, total score ranges from 0-4 and is reported as top score or percentage who score 4 which indicates no decisional conflict. | About 8 weeks after intervention |
| Patient's Preferred Approach to Screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Yes To promote research replicability, transparency and future use of the data, de-identified data sets of the patient survey data will be created and will be available, by request, to outside researchers.
After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.
Three months after the end of the funded grant period, the study materials and de-identified data will be available, by request, from the PI. Once data are placed on an open access service such as ICPSR they will be available indefinitely.
The PI will share a de-identified data set with outside investigators at no cost, according to approved Partners and Massachusetts General Hospital 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.
On ICPSR, individuals must register and agree to ICPSR's Responsible Use statement prior to accessing datasets.
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On June 1, 2020, the co-investigators from the gastroenterology department extracted a list of patients aged 45-75, with preferred language of English or Spanish, who had a screening or surveillance colonoscopy that was cancelled, who had a referral for a screening colonoscopy that had not been processed, or who should have been contacted by the GI department to schedule a screening colonoscopy but had not been due to COVID-19 restrictions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (Control) Arm | This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. |
| FG001 | Shared Decision Making (Intervention) Arm | This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired. Shared Decision Making: The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year). The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period |
| |||||||||||||
| 8-week Follow-up Survey |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (Control) Arm | This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. |
| BG001 | Shared Decision Making (Intervention) Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Shared Decision Making (SDM) Process Scale Score | short patient reported scale asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4 with higher scores indicating higher shared decision making. | This analytic sample was a subset of the initial 798 patients at baseline who completed a survey about 8-weeks after the start of the intervention. | Posted | Mean | Standard Deviation | Score on a scale of 0-4 | About 8 weeks after intervention |
|
Patients were followed for 6 months.
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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 | Usual Care (Control) Arm | This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha | Massachusetts General Hospital | 6177243350 | ksepucha@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2021 | Feb 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2021 | May 12, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Two-armed randomized control trial
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Patients will not be given any information on their assigned arm. Statistician will be blinded to the assignment when analyzing the results.
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|
One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure). We report on the percent of patients who had a clear preference for screening with either a stool card test or colonoscopy and those without a clear preference who chose no screening or not sure. |
| About 8 weeks after intervention |
| Number Reporting "Very Likely" to Follow Through With Screening | One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from Very Unlikely to Very Likely. We report on the percent of patients who selected "Very Likely" to follow through with screening. | About 8 weeks after intervention |
| Colon Cancer Screening Rate | Percentage of patients who had completed colon cancer screening test | 6 months after randomization |
| NOT COMPLETED |
|
This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired.
Shared Decision Making: The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year).
The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired. Shared Decision Making: The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year). The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist). |
|
|
|
| Secondary | No Decisional Conflict (Number With Score of 4 on SURE Scale) | The 4-item version of the decisional conflict scale, total score ranges from 0-4 and is reported as top score or percentage who score 4 which indicates no decisional conflict. | This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention. | Posted | Count of Participants | Participants | About 8 weeks after intervention |
|
|
|
|
| Secondary | Patient's Preferred Approach to Screening | One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure). We report on the percent of patients who had a clear preference for screening with either a stool card test or colonoscopy and those without a clear preference who chose no screening or not sure. | This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention. There were 4 participants missing in the usual care arm and 7 patients missing in the intervention arm due to missing data. | Posted | Count of Participants | Participants | About 8 weeks after intervention |
|
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|
|
| Secondary | Number Reporting "Very Likely" to Follow Through With Screening | One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from Very Unlikely to Very Likely. We report on the percent of patients who selected "Very Likely" to follow through with screening. | This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention. There were 4 participants missing in the usual care arm and 7 patients missing in the intervention arm due to missing data. | Posted | Count of Participants | Participants | About 8 weeks after intervention |
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|
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| Secondary | Colon Cancer Screening Rate | Percentage of patients who had completed colon cancer screening test | At 6 months post-intervention, we assessed whether or not the 798 patients completed a colon cancer screening test. | Posted | Count of Participants | Participants | 6 months after randomization |
|
|
|
|
| 0 |
| 400 |
| 0 |
| 400 |
| 0 |
| 400 |
| EG001 | Shared Decision Making (Intervention) Arm | This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired. Shared Decision Making: The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year). The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist). | 0 | 400 | 0 | 400 | 0 | 400 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |