May 2, 2019: Cost-Effectiveness Analysis of STOP CRC Trial Finds Wide Variation Across Health Centers

A cost-effectiveness analysis of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, revealed wide variation across participating health centers. The study’s findings reflect the complexity of implementing an intervention in pragmatic research involving community health clinics with diverse patient populations, clinic structures, and resources.

The study was published recently in Preventive Medicine.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federal qualified health centers in California and Oregon. Intervention clinics embedded a tool in the electronic health record to identify patients who were overdue for screening and mailed a fecal immunochemical test (FIT) kit to these patients. Screening rates were higher overall in intervention clinics than in clinics that practiced usual care, despite low and highly variable rates of implementation of the program among participating clinics.

In the subsequent cost-effectiveness study, variability in program implementation was likewise a key factor in the results. Intervention delivery costs were highly variable across health centers, and the incremental cost-effectiveness of the intervention was diminished somewhat because usual care clinics generated more colonoscopies than intervention clinics after abnormal FIT results.

The study has implications for the design of implementation strategies in pragmatic trials that are embedded in diverse community health centers.

The STOP CRC trial was supported within the NIH Collaboratory by a cooperative agreement from the National Cancer Institute and received logistical and technical support from the NIH Collaboratory Coordinating Center. Download a study snapshot of the STOP CRC trial, and learn more about the NIH Collaboratory Demonstration Projects.

August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool

The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, were published online this week in JAMA Internal Medicine. The analysis found that colorectal cancer screening rates were higher in community clinics that implemented a mailed fecal immunochemical test (FIT) outreach program than in clinics that practiced usual care. The improved screening rates occurred despite low and highly variable rates of implementation of the program among participating clinics.

Almost half of eligible adults in the United States are not up to date with recommended screening for colorectal cancer, the second leading cause of cancer-related deaths. Screening rates are especially low among racial/ethnic minority and low-income populations, including those served at federal qualified health center clinics.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federally qualified health centers. The intervention involved embedding a tool in the electronic health record to identify patients who were overdue for colorectal cancer screening, mailing a FIT kit and reminder letter to eligible patients, and implementing a practice improvement process at participating clinics. Of the 26 clinics in the study, 13 received the intervention and 13 practiced usual care.

Compared with clinics that practiced usual care, intervention clinics had a significantly higher proportion of participants who completed a FIT (3.4 percentage points) and any colorectal cancer screening (3.8 percentage points). The higher screening rates occurred despite another important finding of the study, that low rates of implementation of the intervention were common. Higher rates of implementation were correlated with higher rates of FIT completion.

The STOP CRC experience offers lessons on how to use electronic health records to improve guideline-based screening. In a recent NIH Collaboratory Grand Rounds, investigators Dr. Gloria Coronado and Dr. Beverly Green presented findings from the trial and lessons from the implementation of the intervention. Download a study snapshot about the STOP CRC trial.

Additional reading:

Read the press release from the Kaiser Permanente Center for Health Research: Community Health Centers Can Help Boost Rates of Colorectal Cancer Screening, Kaiser Permanente Study Shows

Read Dr. Beverly Green’s blog post on the Kaiser Permanente Washington Health Research Institute’s Healthy Findings blog: Community Health Centers Can Boost Colon Cancer Screening

Applying PRECIS Ratings to Collaboratory Pragmatic Trials

A new article published in the journal Trials provides a look at how the  Pragmatic–Explanatory Continuum Indicator Summary, or PRECIS, rating system can be applied to clinical trials designs in order to examine where a given study sits on the spectrum of explanatory versus pragmatic clinical trials.

The PRECIS-2 criteria are used to rate study designs as more or less “pragmatic” according to multiple domains that include participant eligibility, recruitment methods, setting, organization, analysis methods, primary outcomes, and more. In this context, “pragmatic” refers to trials that are designed to study a therapy or intervention in a “real world” setting similar or identical to the one in which the therapy will actually be used. Pragmatic trials stand in contrast to explanatory trials, which are typically designed to demonstrate the safety and efficacy of an intervention under highly controlled conditions and in carefully selected groups of participants, but which may also be difficult to generalize to larger or more varied populations.

Schematic of PRECIS-2 Wheel used to evaluate where a given trial design resides upon the explanatory-pragmatic spectrum.
PRECIS-2 Wheel.  Kirsty Loudon et al. BMJ 2015;350:bmj.h2147. Copyright 2015 by British Medical Journal Publishing Group. Used by permission.

Clinical trials are almost never wholly “explanatory” or wholly “pragmatic.” Instead, many studies exist somewhere on a spectrum between these two categories. However, understanding how these different attributes apply to trials can help researchers design studies that are optimally fit for purpose, whether that purpose is to describe a biological mechanism (as in an explanatory trial) or to show how effective an intervention is when used across a broad population of patients (as in a pragmatic trial).

In their article in Trials, authors Karin Johnson, Gila Neta, and colleagues  applied PRECIS-2 criteria to 5 pragmatic clinical trials (PCTs) being conducted through the NIH Collaboratory. Each trial was found to rate as “highly pragmatic” across the multiple PRECIS-2 domains, highlighting the tool’s potential usefulness in guiding decisions about study design, but also revealing a number of challenges in applying it and interpreting the results.

Study authors Johnson and Neta will be discussing their findings during the NIH Collaboratory’s Grand Rounds on Friday, January 22, 2016 (an archived version of the presentation will be available the following week).


Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016;17(1):32. doi: 10.1186/s13063-016-1158-y. PMID: 26772801. PMCID: PMC4715340.
You can read more about the NIH Collaboratory PCTs featured as part of this project at the following links:

ABATE (Active Bathing to Eliminate Infection)

LIRE (A pragmatic trial of Lumbar Image Reporting with Epidemiology)

PPACT (Collaborative Care for Chronic Pain in Primary Care)

STOP-CRC (Strategies & Opportunities to Stop Colon Cancer in Priority Populations)

TIME (Time to Reduce Mortality in End-Stage Renal Disease)
Additional Resources

An introductory slide set on PCTs (by study author Karin Johnson) is available from the Living Textbook:

Introduction to Pragmatic Clinical Trials
The University of Colorado Denver - Anschutz Medical Campus publishes an electronic textbook on pragmatic trials:

Pragmatic Trials: A workshop Handbook

 

 

 

STOP CRC Study Featured on NPR Health Blog


The Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study was recently featured on National Public Radio’s Shots Blog, which is devoted to coverage and discussion of health and healthcare issues.

Picture of U.S. stop sign.
Public-domain image via Wikimedia Commons.

STOP CRC, which is exploring innovative approaches for increasing colon cancer screening rates among low-income and minority populations, is one of the seven UH2 pilot projects supported by the NIH Collaboratory. The demonstration phase of the project will be conducted within a pair of health centers that are part of OCHIN, a community-based network of Federally Qualified Health Centers.

More information about about STOP CRC is available here.