De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)

September 13, 2023 updated by: Kaiser Permanente
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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Kaiser Permanente San Francisco Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who respond with a 10-year surveillance interval change
Time Frame: 2 months following outreach intervention
2 months following outreach intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients requesting a physician appointment
Time Frame: 2 months following outreach intervention
2 months following outreach intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2022

Primary Completion (Actual)

September 5, 2022

Study Completion (Actual)

September 8, 2023

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1789503-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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