A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
- Conditions
- Constipation
- Registration Number
- NCT07032376
- Lead Sponsor
- University of Michigan
- Brief Summary
This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.
- Detailed Description
This registration is (Implementation Phase) for the registered study "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 109
- Participant has Chronic constipation as a main symptom
- Participant is able to participate in pelvic floor physical therapy
- Participant has taken narcotic pain medication in the past 30 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment Day 1 (Baseline = initial appointment after consent)] Fidelity to ordering pelvic floor diagnostics
Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment Day 1 (Baseline = initial appointment after consent)] Fidelity to ordering pelvic floor treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Michigan🇺🇸Ann Arbor, Michigan, United StatesBrenda AyalaContact734-936-4780beayala@umich.eduEric Shah, MDPrincipal Investigator