Back to resultsDe-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)
Primary Purpose
Polyp of Colon
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outreach
Sponsored by
About this trial
This is an interventional health services research trial for Polyp of Colon
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
Sites / Locations
- Kaiser Permanente San Francisco Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Mailed Letter
Secure Message
Telephone Outreach
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients who respond with a 10-year surveillance interval change
Secondary Outcome Measures
Percentage of patients requesting a physician appointment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389397
Brief Title
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Acronym
DESIRE
Official Title
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Colon
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
604 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mailed Letter
Arm Type
Placebo Comparator
Arm Title
Secure Message
Arm Type
Active Comparator
Arm Title
Telephone Outreach
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Outreach
Intervention Description
Mailed letter, secure message or telephone outreach will be used depending on arm enrolled
Primary Outcome Measure Information:
Title
Percentage of patients who respond with a 10-year surveillance interval change
Time Frame
2 months following outreach intervention
Secondary Outcome Measure Information:
Title
Percentage of patients requesting a physician appointment
Time Frame
2 months following outreach intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey K Lee, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
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