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De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389397
Recruitment Status : Completed
First Posted : May 25, 2022
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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
Polyp of Colon Behavioral: Outreach Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 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Official Title: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas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
Actual Primary Completion Date : September 5, 2022
Actual Study Completion Date : September 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percentage of patients who respond with a 10-year surveillance interval change [ Time Frame: 2 months following outreach intervention ]

Secondary Outcome Measures :
  1. Percentage of patients requesting a physician appointment [ Time Frame: 2 months following outreach intervention ]

Eligibility Criteria
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Ages Eligible for Study:   54 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389397


Locations
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United States, California
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Study Chair: Jeffrey K Lee, MD Kaiser Permanente
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT05389397    
Other Study ID Numbers: 1789503-1
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical