Implementation of Evidence Based Practices for Colonoscopy: The Strategies to Improve Colonoscopy Study

Colonoscopy Clinical Trial

— STIC  

Official title:

Understanding Variability in Success of Quality Improvement for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723370
• Other study ID #: 201401089
• Secondary ID: R21CA184282
• Status: Completed
• Phase: N/A
• First received: March 15, 2016
• Last updated: January 6, 2017
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of physician education about evidence based practices for colonoscopy alone, versus physician education plus a multi-component staff implementation strategy to improve adequacy of bowel preparation. Additionally the investigators will examine implementation factors that influence adoption of the evidence based practices.

Description:

Over 14 million colonoscopies are performed annually in the U.S. About 25% of patients that undergo colonoscopy have inadequate bowel preparation, an impediment to identifying cancer and pre-cancerous growths. The adenoma miss rate for patients with inadequate bowel preparation can be as high as 48%. The primary goal of the Strategies to Improve Colonoscopy (STIC) study is to conduct formative research on a multi-component implementation strategy to increase staff adoption of evidence-based practices (i.e. split-dosing of the medication, low-literacy materials, teach-back) for educating patients and improving the adequacy of bowel preparation for colonoscopy.

Investigators will compare the effect of physician education about evidence based practices for colonoscopy alone, versus education plus a staff implementation toolkit to improve quality of colonoscopy (i.e. adequacy of bowel preparation). Physicians in both study groups will receive education on the evidence-based practices. Staff who work for physicians in the initial intervention group will receive a multi-component implementation strategy for the evidence-based practices, consisting of staff education, a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, a consultation to integrate materials and teach-back into workflow, and a website with additional training and patient materials. The initial intervention period will be followed by a replication study where the delayed intervention group will receive the intervention.

Investigators will compare change in colonoscopy quality outcomes from before to after implementation of interventions for the two study groups: a) overall; and for b) Medicaid versus other insurance using administrative and medical record data with interrupted time series analysis. Investigators will also examine factors that influence adoption of the evidence based practices using structured physician, staff and patient surveys.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46184
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physicians who perform colonoscopies at 6 participating endoscopy centers

• Staff who work for participating physicians and provide education for bowel preparation before colonoscopy

• Patients who had an outpatient colonoscopy at a participating endoscopy center during study period

Exclusion Criteria:

• none

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Behavioral:
• Staff multi-component implementation strategy
Staff will receive a multi-component implementation strategy for evidence based practices (EBPs) for colonoscopy, including split-dosing of bowel preparation, low literacy education materials for patients, and teach-back procedure. The implementation strategy includes a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, consultation to integrate materials and teach-back into workflow and a website with additional training and patient materials.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	BJC HealthCare, National Cancer Institute (NCI)

References & Publications (1)

Ramsey AT, Maki J, Prusaczyk B, Yan Y, Wang J, Lobb R. Using segmented regression analysis of interrupted time series data to assess colonoscopy quality outcomes of a web-enhanced implementation toolkit to support evidence-based practices for bowel preparation: a study protocol. Implement Sci. 2015 Jun 7;10:85. doi: 10.1186/s13012-015-0276-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with adequate of bowel preparation as indicated by a Boston Bowel Preparation Scale (BBPS) score > 6 or an Aronchick scale score of fair or better.		5 month intervention period	No
Secondary	Adoption of Evidence Based Practices	Staff report of how frequently they use the EBPs and toolkit. 5 point likert scale from 1 (Never) to 5 (Always).	At baseline and after 5 month intervention period	No