De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

Polyp of Colon Clinical Trial

— DESIRE  

Official title:

De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389397
• Other study ID #: 1789503-1
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: September 8, 2023

Study information

• Verified date: September 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: September 8, 2023
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 54 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyps
• Polyp of Colon

Intervention

Behavioral:
• Outreach
Mailed letter, secure message or telephone outreach will be used depending on arm enrolled

Locations

Country	Name	City	State
United States	Kaiser Permanente San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who respond with a 10-year surveillance interval change		2 months following outreach intervention
Secondary	Percentage of patients requesting a physician appointment		2 months following outreach intervention