Colonoscopy AdherenceNCT01172080
Utility Analysis of an Endoscopy Follow-up System
A study testing protocol of reminders regarding due colonoscopy in people with Colonoscopy Adherence, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. Read more about this study
- Who is it for?
- Ages Up to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Adherence
- What is being tested?
- protocol of reminders regarding due colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2011
- 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 Up to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- due for a repeat surveillance colonoscopy for follow up of polyps during the study time period
Who cannot join
- not due for a repeat surveillance colonoscopy for follow up of polyps during the study time period
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. When follow-up tests are recommended months to years into the future, there is a high likelihood that the test will either be delayed or not performed resulting in the potential for poor outcomes and litigation. For this reason, there is a clear need for systems to be developed which automatically trigger patient communication when the date of a recommended follow-up test is approaching. The investigators propose to design a protocol for ensuring that patients are reminded to schedule follow-up tests and that this communication is documented in the online medical record. This work will provide the foundation for the creation of systems that significantly improve patient care, and can be easily adapted for use in many clinical departments and institutions.
Aim 1. To use patient focus groups to help design a system for improving adherence to endoscopy follow up recommendations
Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the system on a cohort of patients due for a surveillance colonoscopy.
- Conditions
- Colonoscopy Adherence
- Being tested
- protocol of reminders regarding due colonoscopy
- Keywords
- colonoscopy, adherence, reminders, quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocol of reminders regarding due colonoscopyOther
Participants receive two standardized letters followed by a phone call if they have not scheduled or completed their upcoming due colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Participants in this group are monitored for adherence to colonoscopy recommendations. |
| intervention | Experimental | Participants to receive a protocol of reminder letters and a phone call regarding due follow up colonoscopy Receives: Other: protocol of reminders regarding due colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of individuals scheduling colonoscopy
Measured: within three months of due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionOct 2011
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 Colonoscopy AdherenceStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Leffler, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172080
- Sponsor's protocol ID
- 2010P000113
- Status last verified
- Mar 2018
- First submitted
- 28 Jul 2010
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Leffler DA, Neeman N, Rabb JM, Shin JY, Landon BE, Pallav K, Falchuk ZM, Aronson MD. An alerting system improves adherence to follow-up recommendations from colonoscopy examinations. Gastroenterology. 2011 Apr;140(4):1166-1173.e1-3. doi: 10.1053/j.gastro.2011.01.003. Epub 2011 Jan 13.
PubMed 21237167
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility Analysis of an Endoscopy Follow-up System
- ClinicalTrials.gov ID
- NCT01172080
- Acronym / sponsor ID
- 2010P000113
- Conditions
- Colonoscopy Adherence
- Keywords
- colonoscopy, adherence, reminders, quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jul 2010 (estimated)
- 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.
Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. When follow-up tests are recommended months to years into the future, there is a high likelihood that the test will either be delayed or not performed resulting in the potential for poor outcomes and litigation. For this reason, there is a clear need for systems to be developed which automatically trigger patient communication when the date of a recommended follow-up test is approaching. The investigators propose to design a protocol for ensuring that patients are reminded to schedule follow-up tests and that this communication is documented in the online medical record. This work will provide the foundation for the creation of systems that significantly improve patient care, and can be easily adapted for use in many clinical departments and institutions.
Aim 1. To use patient focus groups to help design a system for improving adherence to endoscopy follow up recommendations
Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the system on a cohort of patients due for a surveillance colonoscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Participants in this group are monitored for adherence to colonoscopy recommendations. |
| intervention | Experimental | Other: protocol of reminders regarding due colonoscopyParticipants to receive a protocol of reminder letters and a phone call regarding due follow up colonoscopy |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- due for a repeat surveillance colonoscopy for follow up of polyps during the study time period
Key exclusion criteria (1 listed)
- not due for a repeat surveillance colonoscopy for follow up of polyps during the study time period
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 |
|---|---|---|
| protocol of reminders regarding due colonoscopyParticipants receive two standardized letters followed by a phone call if they have not scheduled or completed their upcoming due colonoscopy | Other | intervention |
Primary outcome
percentage of individuals scheduling colonoscopy
Time frame: within three months of due date
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 19 Mar 2018.
- Derived from this study: PubMed 21237167Leffler DA, Neeman N, Rabb JM, Shin JY, Landon BE, Pallav K, Falchuk ZM, Aronson MD. An alerting system improves adherence to follow-up recommendations from colonoscopy examinations. Gastroenterology. 2011 Apr;140(4):1166-1173.e1-3. doi: 10.1053/j.gastro.2011.01.003. Epub 2011 Jan 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protocol of reminders regarding due colonoscopy in people with Colonoscopy Adherence, run by Beth Israel Deaconess Medical Center 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 1 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 19 Mar 2018. 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. 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 individuals scheduling colonoscopy (time frame: within three months of due date). 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 NCT01172080, 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 19 Mar 2018.