Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.

Abstract:

BACKGROUND:Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES:The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS:PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION:This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION:National Clinical Trial (NCT) Identifier: NCT03925883.

journal_name

Contemp Clin Trials

authors

Coronado GD,Johnson ES,Leo MC,Schneider JL,Smith D,Mummadi R,Petrik AF,Thompson JH,Jimenez R

doi

10.1016/j.cct.2019.105920

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

105920

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(19)30636-6

journal_volume

89

pub_type

杂志文章