NCT05631873

Brief Summary

Screening for colorectal cancer can reduce its incidence and mortality but is a complex, error-prone process. The value of screening with colonoscopy is in removing pre-cancerous polyps that increase one's risk for future cancer. Abnormal results are common, and failure to receive recommended follow-up undermines the benefits of screening, violates the trust that patients place in their providers, and increases medicolegal risk. This proposal seeks to ensure that the foundation of safety systems, the recommendations for the follow-up interval reflect current guideline recommendations and are accurately updated. Specifically, the investigators will implement and evaluate in a randomized trial a new colonoscopy result letter as part of usual care that automatically updates the recommended follow-up interval in the patient's health record compared to the current result letter format.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

November 18, 2022

Last Update Submit

March 11, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Implement a new process using a structured result letter template to set the electronic health record follow-up interval after a screening colonoscopy.

    Provider level: any use (yes/no) of the structured result template letter among all randomized providers

    6 months

  • Implement a new process using a structured result letter template to set the electronic health record follow-up interval after a screening colonoscopy.

    Patient level: agreement (yes/no) will be assessed between the follow-up interval specified in the patient result letter and the colonoscopy health maintenance topic modifier

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Assistance with implementing Epic Smartlist

Control

NO INTERVENTION

Interventions

A research assistant helps GI providers add a new SmartList in to patient letters in Epic EHR that auto populates the colonoscopy recommendation time interval in patient records

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • GI specialists will include those who perform screening and surveillance colonoscopies for colorectal cancer screening at MGH

You may not qualify if:

  • Not currently performing colonoscopies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Atlas SJ, Palchaudhuri S, Harris KA, Gallagher KL, He W, Rubins D, Chang Y, Haas JS, Richter JM. A Randomized Controlled Trial to Improve the Accuracy of Follow-Up Surveillance Time Intervals in the Electronic Health Record After a Colonoscopy for Colorectal Cancer Screening. Am J Gastroenterol. 2025 Apr 23. doi: 10.14309/ajg.0000000000003497. Online ahead of print.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School; Director of the Practice-Based Research & Quality Improvement Network

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

November 18, 2022

Primary Completion

September 30, 2023

Study Completion

March 11, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations