History of Changes for Study: NCT05389397

De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			May 20, 2022	None (earliest Version on record)
2			September 13, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	1789503-1
Brief Title:	De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas (DESIRE)
Official Title:	De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Secondary IDs:

Study Status


Record Verification:	May 2022
Overall Status:	Recruiting
Study Start:	May 12, 2022
Primary Completion:	November 30, 2022 [Anticipated]
Study Completion:	November 30, 2022 [Anticipated]

First Submitted:	May 16, 2022
First Submitted that Met QC Criteria:	May 20, 2022
First Posted:	May 25, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	May 20, 2022
Last Update Posted:	May 25, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Kaiser Permanente
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy.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

Detailed Description:

Conditions


Conditions:	Polyp of Colon
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Health Services Research
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	600 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 [ 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


Minimum Age:	54 Years
Maximum Age:	70 Years
Sex:	All
Gender Based:
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/Locations


Central Contact Person:	Jeffrey K Lee, MD Telephone: 5108915918 Email: jeffrey.k.lee@kp.org
Study Officials:	Jeffrey K Lee, MD Study Chair Kaiser Permanente
Locations:	United States, California
	Kaiser Permanente San Francisco Medical Center [Recruiting] San Francisco, California, United States, 94115 Contact:Contact: Jeffrey K Lee, MD 510-891-5918 jeffrey.k.lee@kp.org

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: