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

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ClinicalTrials.gov Identifier: NCT02723370
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : January 10, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
BJC HealthCare
Information provided by (Responsible Party):
Rebecca Lobb, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Behavioral: Staff multi-component implementation strategy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Understanding Variability in Success of Quality Improvement for Colonoscopy
Study Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 5 month intervention period ]

Secondary Outcome Measures :
  1. Adoption of Evidence Based Practices [ Time Frame: At baseline and after 5 month intervention period ]
    Staff report of how frequently they use the EBPs and toolkit. 5 point likert scale from 1 (Never) to 5 (Always).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723370


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

Publications:
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Responsible Party: Rebecca Lobb, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02723370     History of Changes
Other Study ID Numbers: 201401089
R21CA184282 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rebecca Lobb, Washington University School of Medicine:
Quality of Healthcare
Colorectal neoplasms
Health Literacy
Teach-Back Communication
Evidence Based Practice
Colonoscopy