A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
NCT ID: NCT07032376
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
109 participants
INTERVENTIONAL
2025-08-20
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Chronic constipation
Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.
Survey
All participants will complete a baseline survey and have medical information collected.
Rectal Expulsion Device use
During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.
In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.
Interventions
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Survey
All participants will complete a baseline survey and have medical information collected.
Rectal Expulsion Device use
During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.
In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.
Eligibility Criteria
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Inclusion Criteria
* Participant is able to participate in pelvic floor physical therapy
Exclusion Criteria
* Participant has been scheduled for a test called an anorectal manometry in the past
* Participant has been scheduled to see a pelvic floor physical therapist in the past
* Participant is pregnant
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Responsible Party
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Eric Shah
Associate Professor of Internal Medicine
Principal Investigators
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Eric Shah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00228948b
Identifier Type: -
Identifier Source: org_study_id
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