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

Understanding Variability in Success of Quality Improvement for Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Behavioral: Staff multi-component implementation strategy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46184
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Intervention; Staff will receive the intervention during the initial intervention period.	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.
Experimental: Delayed Intervention; Staff will receive the intervention during the replication study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); BJC HealthCare
• Investigators: Principal Investigator: Rebecca Lobb, ScD, MPH, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Health Literacy; Colonoscopy; Colorectal neoplasms; Evidence Based Practice; Quality of Healthcare; Teach-Back Communication
• Other Study ID Numbers: 201401089; R21CA184282 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO