De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

NCT05389397 | Completed

• 1 other identifier: 1789503-1
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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.

Conditions

Polyp of Colon

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who respond with a 10-year surveillance interval change

  2 months following outreach intervention

Secondary Outcomes (1)

• Percentage of patients requesting a physician appointment

  2 months following outreach intervention

Study Arms (3)

Mailed Letter

PLACEBO COMPARATOR

Behavioral: Outreach

Secure Message

ACTIVE COMPARATOR

Behavioral: Outreach

Telephone Outreach

ACTIVE COMPARATOR

Behavioral: Outreach

Interventions

Outreach BEHAVIORAL

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

Mailed Letter; Secure Message; Telephone Outreach

Eligibility Criteria

• Age: 54 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 38191014 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Community-Institutional Relations

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Public Relations; Organization and Administration; Health Services Administration

Study Officials

• Jeffrey K Lee, MD

  Kaiser Permanente

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 25, 2022
• Study Start: May 12, 2022
• Primary Completion: September 5, 2022
• Study Completion: September 8, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)