NCT02723370

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46,184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

March 15, 2016

Last Update Submit

January 6, 2017

Conditions

Keywords

Quality of HealthcareColorectal neoplasmsHealth LiteracyTeach-Back CommunicationEvidence Based PracticeColonoscopy

Outcome Measures

Primary Outcomes (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.

    5 month intervention period

Secondary Outcomes (1)

  • Adoption of Evidence Based Practices

    At baseline and after 5 month intervention period

Study Arms (2)

Initial Intervention

EXPERIMENTAL

Staff will receive the intervention during the initial intervention period.

Behavioral: Staff multi-component implementation strategy

Delayed Intervention

EXPERIMENTAL

Staff will receive the intervention during the replication study.

Behavioral: Staff multi-component implementation strategy

Interventions

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 InterventionInitial Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26050105BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsTeach-Back Communication

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCommunicationBehavior

Study Officials

  • Rebecca Lobb, ScD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 30, 2016

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share