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IIR 12-378 – HSR Study

IIR 12-378
Impact of family history and decision support on high-risk cancer screening
Corrine I. Voils, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, WI
Funding Period: October 2014 - March 2020
Although family health history (FHH) is commonly accepted as an important risk factor for common, chronic diseases, it is rarely used in clinical practice as part of a structured risk assessment. To facilitate use of FHH in primary care, the Genomic Medicine Model (GMM) was developed. The GMM 1) provides education to physicians, patients, and communities on the importance of FHH; 2) contains a health IT-based platform (MeTree) that uses patient-entered data to risk-stratify patients and generate risk-stratified, evidence-based preventive care recommendations for physicians and patients; and 3) provides resources to patients and providers to effectively interpret FHH information and adhere to recommendations. Collection of FHH to inform preventive care for colorectal cancer (CRC) in VA is important because patients at higher risk for CRC are not well-characterized or documented in VA and high-risk versus average-risk prevention strategies currently are not systematically assessed or measured.

The goal of this study is to evaluate the feasibility and effectiveness of the GMM for identifying patients at increased risk for CRC. This goal will be achieved in a 4-year mixed methods study with the following aims: Aim 1: Determine whether FHH collection via MeTree improves identification of patients at higher familial risk for CRC by comparing rates of high-risk identification in the medical record prior to study enrollment to rates of high-risk identification following MeTree completion. Aim 2: Evaluate whether providing decision support to patients and PCPs improves risk-appropriate PCP referrals for, and patient uptake of, CRC screening/surveillance. Aim 3: Assess experience with decision support and effects on workflow from PCPs, and obtain information to inform eventual implementation in the VA healthcare system from administrative leaders, via qualitative interviews. Aim 4: Conduct cost-consequence and budget-impact analyses of implementing FHH collection and GMM decision support in VA.

Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of CRC, and have some knowledge of FHH. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting FHH of CRC 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 FHH 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.

We have not analyzed any data at this time as data collection is still ongoing.

The Veterans Health Administration (VA) currently has no system-wide, comprehensive, validated method for assessing family health history (FHH) or providing decision support. A standardized FHH assessment accompanied by decision support facilitates 3 important objectives: 1) identification of patients at higher risk, 2) genetic consultation referral for patients at risk for hereditary cancer syndromes, and 3) recommendation of guideline-based preventive care for patients of all risk levels. Receipt of appropriate preventive care can help prevent improve early detection of deadly diseases, ultimately improving the lives of Veterans and reducing health care costs to the VA healthcare system.

External Links for this Project

NIH Reporter

Grant Number: I01HX001082-01A1

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Journal Articles

  1. 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. [view]

DRA: Cancer
DRE: Genomics
Keywords: Clinical Diagnosis and Screening, Decision Support
MeSH Terms: none

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