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

NCT ID: NCT02723370

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Initial Intervention

Staff will receive the intervention during the initial intervention period.

Group Type EXPERIMENTAL

Staff multi-component implementation strategy

Intervention Type BEHAVIORAL

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.

Delayed Intervention

Staff will receive the intervention during the replication study.

Group Type EXPERIMENTAL

Staff multi-component implementation strategy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

BJC HealthCare

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Lobb

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Lobb, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

References

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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.

Reference Type BACKGROUND
PMID: 26050105 (View on PubMed)

Other Identifiers

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R21CA184282

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201401089

Identifier Type: -

Identifier Source: org_study_id

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