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Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate | Experimental | Patients will complete a family health history platform at enrollment |
|
| Delayed | Active Comparator | Patients will complete a family health history platform 12 months following enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family health history platform (MeTree) | Behavioral | Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening | Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Recommended Colorectal Cancer Screening | Among patients who received a referral, the percentage who received recommended colorectal cancer screening. | 12 months |
| Number of Patients Who Received Referral for Genetic Consultation |
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Inclusion Criteria:
Primary care provider inclusion criteria:
Patient inclusion criteria:
Exclusion Criteria:
n/a (contained within inclusion criteria)
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| Name | Affiliation | Role |
|---|---|---|
| Corrine I. Voils, PhD | William S. Middleton Memorial Veterans Hospital, Madison, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States | ||
| William S. Middleton Memorial Veterans Hospital, Madison, WI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31590688 | Result | Goldstein KM, Fisher DA, Wu RR, Orlando LA, Coffman CJ, Grubber JM, Rakhra-Burris T, Wang V, Scheuner MT, Sperber N, Datta SK, Nelson RE, Strawbridge E, Provenzale D, Hauser ER, Voils CI. An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial. Trials. 2019 Oct 7;20(1):576. doi: 10.1186/s13063-019-3659-y. | |
| 36307642 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate | Patients will complete MeTree at enrollment MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree |
| FG001 | Delayed | Patients will complete MeTree 12 months following enrollment MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate | Patients will complete MeTree at enrollment MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree |
| BG001 | Delayed |
| 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 | Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening | Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform. | The analysis sample is the number of patients who completed the family health history assessment, as risk level was necessary to determine risk-appropriate referrals. | Posted | Count of Participants | Participants | 12 months |
|
12 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 | Immediate | Patients completed the family history platform at enrollment Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corrine Voils, PhD | William S Middleton Memorial Veterans Hospital | 608-256-1901 | 12208 | corrine.voils@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2020 | Jun 25, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2018 | Jun 25, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation. |
| 12 months |
| Madison |
| Wisconsin |
| 53705-2254 |
| United States |
| Derived |
| Voils CI, Coffman CJ, Wu RR, Grubber JM, Fisher DA, Strawbridge EM, Sperber N, Wang V, Scheuner MT, Provenzale D, Nelson RE, Hauser E, Orlando LA, Goldstein KM. A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer. J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28. |
Patients will complete MeTree 12 months following enrollment MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree |
| 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 |
|
| Ever had a colonoscopy or sigmoidoscopy | Count of Participants | Participants |
|
Patients will complete MeTree 12 months following enrollment MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree |
|
|
|
| Secondary | Number of Participants Who Received Recommended Colorectal Cancer Screening | Among patients who received a referral, the percentage who received recommended colorectal cancer screening. | Analytic sample is participants who had a referral for colorectal cancer screening | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Number of Patients Who Received Referral for Genetic Consultation | Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation. | Subgroup of veterans who received a recommendation for genetic counseling from the family health history platform | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 2 |
| 252 |
| 0 |
| 252 |
| 0 |
| 252 |
| EG001 | Delayed | Patients completed the family history platform 12 months following enrollment Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree | 0 | 253 | 0 | 253 | 0 | 253 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |