De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

NCT ID: NCT05389397

Last Updated: 2023-09-14

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

604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-09-08

Brief Summary

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The purpose of this study is to compare the effectiveness of three standard of care outreach approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of the new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.

Detailed Description

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Conditions

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Polyp of Colon

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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Mailed Letter

Group Type PLACEBO_COMPARATOR

Outreach

Intervention Type BEHAVIORAL

Mailed letter, secure message or telephone outreach will be used depending on arm enrolled

Secure Message

Group Type ACTIVE_COMPARATOR

Outreach

Intervention Type BEHAVIORAL

Mailed letter, secure message or telephone outreach will be used depending on arm enrolled

Telephone Outreach

Group Type ACTIVE_COMPARATOR

Outreach

Intervention Type BEHAVIORAL

Mailed letter, secure message or telephone outreach will be used depending on arm enrolled

Interventions

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Outreach

Mailed letter, secure message or telephone outreach will be used depending on arm enrolled

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Kaiser Permanente Northern California (KPNC) membership\>12 months
* Primary medical center is either KP San Rafael, KP San Francisco, KP San Leandro, or KP Walnut Creek
* 54-70 years of age at time of 5-year surveillance colonoscopy interval
* A baseline colonoscopy with a finding of 1-2 small tubular adenomas and are due for their 5-year surveillance procedure in 2022
* Average risk for CRC
* A valid mailing address, kp.org account (i.e., KPNC's secure messaging portal), and telephone number at time of study enrollment.

Exclusion Criteria

* More than 12 months of membership prior to index colonoscopy, and indications that would make an individual above average risk for CRC, such as: adenoma with advanced histology on colonoscopy, adenoma \>10 mm on colonoscopy, family history of CRC, prior history of colonoscopy, prior history of adenomas or colon polyp diagnoses, history of IBD, history of hereditary polyposis syndrome, 3 or more adenomas, adenoma 10 mm in size or greater, adenoma with advanced histology, and any sessile serrated polyp or traditional serrated adenoma
Minimum Eligible Age

54 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey K Lee, MD

Role: STUDY_CHAIR

Kaiser Permanente

Locations

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Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

References

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Lee JK, Koripella PC, Jensen CD, Merchant SA, Fox JM, Chang SX, Dang CH, Velayos FS, Boparai ES, Evans NS, Leung LJ, Badalov JM, Quesenberry CP, Corley DA, Levin TR. Randomized Trial of Patient Outreach Approaches to De-implement Outdated Colonoscopy Surveillance Intervals. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1315-1322.e7. doi: 10.1016/j.cgh.2023.12.027. Epub 2024 Jan 6.

Reference Type DERIVED
PMID: 38191014 (View on PubMed)

Other Identifiers

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1789503-1

Identifier Type: -

Identifier Source: org_study_id

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