Improving Colonoscopy Quality for Colorectal Cancer Screening in the National VA Healthcare System

• ClinicalTrials.gov Identifier: NCT04389957
• Recruitment Status: Enrolling by invitation
• First Posted: May 15, 2020
• Last Update Posted: December 24, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

High quality screening colonoscopy is critical for colorectal cancer (CRC) prevention in Veterans. There is significant variability in colonoscopy quality in VA that is directly linked to differences in CRC incidence and death. The investigators developed the VA Endoscopy Quality Improvement Program (VA-EQuIP) that the National GI program office will implement using centralized quality measurement and reporting for adenoma detection rates (ADR), bi-annual audit and feedback with provider benchmarking to local and national performance, and collaborative learning to support colonoscopy quality improvement. Using a cluster randomized controlled trial, the investigators will study the implementation of VA-EQuIP and determine the efficacy of its intervention on adenoma detection rates, which are directly linked to CRC incidence and death.

Condition or disease
Colorectal Neoplasms

Detailed Description:

Colorectal cancer (CRC) prevention is a top VA priority. Veterans are highly impacted by CRC, the third most common cancer diagnosed5,6 with a 3-year mortality rate of 35%.5 Colonoscopy screening can save lives, and is the cornerstone of effective prevention. The National Polyp Study showed that removal of adenomas during screening colonoscopy decreases the subsequent development of CRC by up to 90% and death by up to 50% in comparison to historical controls. In VA, colonoscopy is the primary CRC screening modality with over 200,000 colonoscopies performed each year.9 Eighty-two percent of Veterans are up-to-date on CRC screening, with 89% having a colonoscopy.9 However, the quality of those VA colonoscopies is unknown.

High quality colonoscopy is critical for CRC prevention. Observational studies found significant rates of CRC even after normal colonoscopy, likely due to colonoscopists' varied performance in detecting and removing polyps.11,15 Among Medicare beneficiaries, approximately 7% of all CRC occurred in individuals who had colonoscopy that apparently missed the CRC diagnosis. A pooled analysis from eight surveillance studies suggested 52% of incident CRCs after colonoscopy were due to missed lesions.16 These interval cancers highlight the need to focus on colonoscopy quality indicators.11,15,17,18 Adenoma detection rate (ADR) significantly varies by provider and has been strongly linked to both CRC incidence and mortality. In essence, polyps that are not found cannot be removed for CRC prevention. ADR, defined as the proportion of screening colonoscopies performed by a physician that has one or more histologically-confirmed adenomatous polyps or CRC, is the primary benchmark for colonoscopy inspection quality. Increasing ADR correlates with a lower risk of interval and fatal CRC.10,11 A landmark US study of 314,872 colonoscopy exams showed marked variability in providers' ability to detect polyps, with the ADR ranging from 7.4 to 52.5%.10 In patients of providers with the highest ADRs, as compared with those in the lowest, the adjusted hazard ratios (HR) for fatal interval CRC was 0.38 (95% CI, 0.22 to 0.65).10 Each 1% increase in ADR was associated with a decrease risk of 3% for interval CRC and 5% for CRC death.10 Using the methods the team developed19, the investigators have powerful pilot results showing colonoscopy quality variability in the VA and direct association with CRC death. From 1999-2011, there were 634,331 Veterans with baseline colonoscopy performed by one of 3101 colonoscopists with ADRs ranging from 13-79%. In patients who had a colonoscopy without polyps found, the higher the provider ADR, the more protected the patient was from developing future CRC: adjusted HR (adjHR) 0.57 for incident (95%CI: 0.42-0.79; ptrend< 0.001) and 0.73 for fatal (95%CI: 0.50-1.06; p=0.047) CRC for the highest vs. lowest ADR quintile. Among individuals who had a colonoscopy with polypectomy, increasing ADR was also associated with reduced risk: adjHRs 0.46 for incident (95%CI: 0.34-0.62; ptrend< 0.001) and 0.53 for fatal (95%CI: 0.34-0.84; ptrend=0.006) CRC for the highest vs. lowest quintile. A 5% absolute increase in ADR was associated with relative reductions in fatal CRC risk of 4% after normal colonoscopy (adjHR 0.96, 95%CI: 0.95-0.97) and 6% after polypectomy (adjHR 0.94; 95%CI: 0.89-0.98) Other important quality metrics, including bowel preparation quality20-23 and cecal intubation rate11 also impact patient outcomes with poor bowel preparation and incomplete examinations associated with missed lesions24 and need for earlier repeat procedures.

Audit and feedback of colonoscopy quality improves performance and outcomes. The VA Surgical Quality Improvement Program (VASQIP) is an example of a VA nationwide reporting system that formed to focus on quality and has led to a decrease in mortality of 47% in patients 30 days after surgery.25-27 VASQUIP provides information to providers for self-assessment and quality improvement purposes.25 There is similarly strong evidence that providing colonoscopy performance feedback12,28,29 improves quality and patient outcomes.12,28 Kahi and colleagues showed in a single-center VA setting that a quarterly report card improved colonoscopy quality.28 Most recently, in a large prospective European cohort study evaluating annual feedback and quality benchmark indicators on screening colonoscopy performance,12 the majority of the endoscopists (74.5%) increased their annual ADR. Moreover, individuals examined by endoscopists in the highest ADR quintile (> 24.6%) had significantly lower risk of interval CRC and death. When compared with no increase in ADR, reaching or maintaining the highest quintile ADR decreased adjusted hazard ratios for interval and fatal CRC to 0.27 (95% CI, 0.12-0.63; P = .03), and 0.18 (95% CI, 0.06-0.56; P = .03).

Quality Gap: Quality reporting improves patient outcomes. The national VA healthcare system currently lacks a reliable, efficient program to routinely measure and report colonoscopy quality.13 Accurate measurement of quality metrics is challenging, because validated quality metrics are not available in structured VA data from VA CDW. The challenge is multifactorial. Colonoscopy procedure documentation resides in text notes in Vista/CPRS or endoscopic reporting software. The commonly used VA endoscopy note writer software programs (i.e. Endopro�, Provation�, etc) do not facilitate tracking pathology data and quality measurement. None of the current VA endoscopy reporting programs link to VA pathology data (to determine ADR); and production-level pathology data is not in the CDW. Thus, within VA, there has not been a reliable, efficient way to track critical procedure and pathology results to measure colonoscopy quality and ensure optimal protection from CRC incidence and death for Veterans.

Proposed Solution and Rationale for Study: The foundation of VA-EQuIP is a novel natural language processing (NLP) algorithm and informatics reporting infrastructure that the investigators developed to measure the quality of colonoscopies performed by individual VA colonoscopists.30 The team will evaluate a national quality improvement program to better understand how and why such a program is effective or ineffective in different contexts. This study is critically needed to allow us to perform a rigorous evaluation to answer implementation science questions and to advance the clinical and epidemiologic knowledge on the impact of colonoscopy quality on CRC mortality. Leveraging the informatics investment made by HSR&D as well as the National GI Program office partnership in quality improvement initiatives, the roll out of VA-EQuIP is a rare opportunity to study, in real time, the deployment and impact of a large-scale learning health system initiative. Most existing performance measures are calculated at the facility level. The concept of calculating metrics from individual provider procedures and comparing these metrics not only with local peers but with national providers represents a profound culture shift. This is where implementation science becomes essential, especially with respect to stakeholder engagement, adaptation and tailoring.

A primary justification for this study is that VA-EQuIP has a high probability of improving a quality metric outcome (ADR) directly associated with CRC death, one of the most common cancers in Veterans. A randomized controlled trial of this magnitude is an opportunity to show, for the first time, that even small improvements in clinical performance from audit and feedback can save Veterans lives, since even a 1% increase in ADR translates to a 3% reduction in interval cancer death. The proposal for a randomized program evaluation is a tremendous opportunity to determine the large scale effect of the audit and feedback strategy on changes in the colonoscopy quality metrics of individual endoscopists over time. The evaluation of VA-EQuIP implementation will identify factors associated with effective implementation and colonoscopy quality improvement (impact) at VA sites. Prior and planned work builds toward long-term goal to reduce mortality in Veterans by increasing early detection of CRC and inform national quality improvement initiatives such as remediation training for continual low performing endoscopists.

Finally, with upcoming expansion to community care, VA will be making policy decisions about what services should be furnished by VA versus non-VA providers. It is more crucial than ever that health services researchers apply rigorous methods to identify meaningful quality metrics that are linked by evidence to patient outcomes so that these measures of quality will be used to justify such crucial "make versus buy" determinations. It is hopeful that the investigators study will not only improve colonoscopy quality but also provide a framework for assessing the quality of other procedures such as bone marrow biopsy or bronchoscopy.

Study Design

• Study Type: Observational
• Estimated Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Improving Colonoscopy Quality for Colorectal Cancer Screening in the National VA Healthcare System
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2023
• Estimated Study Completion Date: June 1, 2024

Groups and Cohorts

Group/Cohort
Providers; The quantitative surveys will be delivered to the identified local quality stewards (N=73) and providers (N=657) for each enrolled site via the Research Electronic Data Capture (REDCap) platform at baseline (prior to VA-EQuIP) and 12 months following completion of the VA-EQuIP intervention. We will incorporate established methods of maximizing web survey responses, including multiple, carefully-timed, integrated email contacts.
Patients; We expect 69 sites with 571 providers seeing 135,517 patients/year, corresponding to 95 providers/wave and 59 patients/provider/quarter. Patient data is retrospective and informs the primary outcome of provider adenoma detection rate. There is not a direct intervention for patients.

Outcome Measures

Primary Outcome Measures :

1. Provider Adenoma detection rate (for all colonoscopies) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
   Adenoma detection rate is a provider level quality metric. For individual endoscopy providers, the numerator is the number of patients undergoing colonoscopy for any indication in which one or more adenomatous polyps were removed. The denominator is the total number of patients undergoing colonoscopy for each individual provider. Data will be obtained from our operational database for quality measurement and reporting.
2. Provider Screening Adenoma detection rate (Sceening colonoscopies only) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
   Screening Adenoma detection rate is a provider level quality metric. For individual endoscopy providers, the numerator is the number of patients undergoing colonoscopy for colon cancer screening in which one or more adenomatous polyps were removed. The denominator is the total number of patients undergoing colonoscopy for colon cancer screening each individual provider. Data will be obtained from our operational database for quality measurement and reporting (VA-EQuIP).

Secondary Outcome Measures :

1. Cecal intubation rate (provider level) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
   Cecal intubation is a provider level quality metric. The cecal intubation rate is the proportion of colonoscopies with cecal intubation documented in the procedure note.
2. Bowel Preparation Quality (provider level) [ Time Frame: based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
   Bowel preparation quality is determined by each endoscopist for bowel cleanliness allowing polyp visualization and removal. Bowel preparation quality is measured as Adequate or Inadequate by our quality reporting system. For each provider, bowel preparation quality will be calculated with the numerator equal to all colonoscopies with "adequate" preparation quality divided by the denominator of all colonoscopies performed by the provider.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Surveys and interviews will be delivered to identified local endoscopists and GI section chiefs responsible for endoscopy services potentially eligible VA sites. Researchers will recruit section chiefs and endoscopists.

Criteria

Inclusion Criteria:

• Quantitative surveys will be delivered to endoscopy or GI section chiefs responsible for endoscopy services for each enrolled site.
• Qualitative interviews will be conducted with GI section chiefs and individual endoscopists at participating facilities.
• A list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria is suitable for assisting potential participants in identifying clinical studies of interest.

Exclusion Criteria:

-VA facilities without existing colonoscopy procedure or pathology notes in our operational database will not be included in the study.

Contacts and Locations

Locations

United States, California

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States, 94121

United States, Utah

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States, 84148

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Andrew Gawron, MD MS; VA Salt Lake City Health Care System, Salt Lake City, UT
• Principal Investigator: Tonya R. Kaltenbach; San Francisco VA Medical Center, San Francisco, CA

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04389957
• Other Study ID Numbers: SDR 18-148
• First Posted: May 15, 2020
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Quality Improvement; Adenoma; Colonoscopy

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases