De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)

• ClinicalTrials.gov Identifier: NCT05389397
• Recruitment Status: Completed
• First Posted: May 25, 2022
• Last Update Posted: September 14, 2023
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Kaiser Permanente

Tracking Information

• First Submitted Date: May 16, 2022
• First Posted Date: May 25, 2022
• Last Update Posted Date: September 14, 2023
• Actual Study Start Date: May 12, 2022
• Actual Primary Completion Date: September 5, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 20, 2022): Percentage of patients who respond with a 10-year surveillance interval change [ Time Frame: 2 months following outreach intervention ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 20, 2022): Percentage of patients requesting a physician appointment [ Time Frame: 2 months following outreach intervention ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
• Official Title: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
• 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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Polyp of Colon

Intervention

Behavioral: Outreach

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

Study Arms

• Placebo Comparator: Mailed Letter
  Intervention: Behavioral: Outreach
• Active Comparator: Secure Message
  Intervention: Behavioral: Outreach
• Active Comparator: Telephone Outreach
  Intervention: Behavioral: Outreach

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2023): 604
• Original Estimated Enrollment (submitted: May 20, 2022): 600
• Actual Study Completion Date: September 8, 2023
• Actual Primary Completion Date: September 5, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 54 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05389397
• Other Study ID Numbers: 1789503-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kaiser Permanente
• Original Responsible Party: Same as current
• Current Study Sponsor: Kaiser Permanente
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Jeffrey K Lee, MD; Kaiser Permanente

• PRS Account: Kaiser Permanente
• Verification Date: September 2023