Polyp of ColonDESIRENCT05389397
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
A study testing Outreach in people with Polyp of Colon, run by Kaiser Permanente at 1 site in United States.
Trial 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new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated… Read more about this study
- Who is it for?
- Ages 54 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 54 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
About this study
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.
- Conditions
- Polyp of Colon
- Being tested
- Outreach
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutreachBehavioural
Mailed letter, secure message or telephone outreach will be used depending on arm enrolled
| Study group | Role | What they receive |
|---|---|---|
| Mailed Letter | Placebo comparator | Not described Receives: Behavioral: Outreach |
| Secure Message | Active comparator | Not described Receives: Behavioral: Outreach |
| Telephone Outreach | Active comparator | Not described Receives: Behavioral: Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who respond with a 10-year surveillance interval change
Measured: 2 months following outreach intervention
Secondary outcomes (1)
Percentage of patients requesting a physician appointment
Measured: 2 months following outreach intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 May 2022
- Primary completion5 Sep 2022
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey K Lee, MD, Study chair, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389397
- Sponsor's protocol ID
- 1789503-1
- Acronym
- DESIRE
- Status last verified
- Sep 2023
- First submitted
- 16 May 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JK, Koripella PC, Jensen CD, Merchant SA, Fox JM, Chang SX, Dang CH, Velayos FS, Boparai ES, Evans NS, Leung LJ, Badalov JM, Quesenberry CP, Corley DA, Levin TR. Randomized Trial of Patient Outreach Approaches to De-implement Outdated Colonoscopy Surveillance Intervals. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1315-1322.e7. doi: 10.1016/j.cgh.2023.12.027. Epub 2024 Jan 6.
PubMed 38191014
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
- ClinicalTrials.gov ID
- NCT05389397
- Acronym / sponsor ID
- DESIRE / 1789503-1
- Conditions
- Polyp of Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mailed Letter | Placebo comparator | Behavioral: Outreach |
| Secure Message | Active comparator | Behavioral: Outreach |
| Telephone Outreach | Active comparator | Behavioral: Outreach |
Who may qualify
- Ages
- 54 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutreachMailed letter, secure message or telephone outreach will be used depending on arm enrolled | Behavioural | Mailed Letter, Secure Message, Telephone Outreach |
Primary outcome
Percentage of patients who respond with a 10-year surveillance interval change
Time frame: 2 months following outreach intervention
1 secondary outcome
Percentage of patients requesting a physician appointment
Time frame: 2 months following outreach intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 38191014Lee JK, Koripella PC, Jensen CD, Merchant SA, Fox JM, Chang SX, Dang CH, Velayos FS, Boparai ES, Evans NS, Leung LJ, Badalov JM, Quesenberry CP, Corley DA, Levin TR. Randomized Trial of Patient Outreach Approaches to De-implement Outdated Colonoscopy Surveillance Intervals. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1315-1322.e7. doi: 10.1016/j.cgh.2023.12.027. Epub 2024 Jan 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey K Lee, MD study chair
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach in people with Polyp of Colon, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who respond with a 10-year surveillance interval change (time frame: 2 months following outreach intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.