Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants:
- •- Participant has Chronic constipation as a main symptom
Exclusion Criteria
- •Participants:
- •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 12 months
- •Participant has been scheduled to see a pelvic floor physical therapist in the past 12 months
- •Participant is pregnant
Arms & Interventions
Chronic constipation
Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.
Intervention: Survey (Behavioral)
Chronic constipation
Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.
Intervention: Rectal Expulsion Device use (Behavioral)
Outcomes
Primary Outcomes
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
Time Frame: 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
Time Frame: Day 1 (Baseline = initial appointment after consent)]
Fidelity to ordering pelvic floor treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Eric Shah
Associate Professor of Internal Medicine
University of Michigan