DESIRE: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

Sponsor
Kaiser Permanente (Other)
Overall Status
Recruiting
CT.gov ID
NCT05389397
Collaborator
(none)
600
1
3
6.6
90.4

Study Details

Study Description

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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Outreach
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Mailed Letter

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

Active Comparator: Secure Message

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

Active Comparator: Telephone Outreach

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients who respond with a 10-year surveillance interval change [2 months following outreach intervention]

Secondary Outcome Measures

  1. Percentage of patients requesting a physician appointment [2 months following outreach intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
54 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente San Francisco Medical Center San Francisco California United States 94115

Sponsors and Collaborators

  • Kaiser Permanente

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT05389397
Other Study ID Numbers:
  • 1789503-1
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022