NCT07032376

A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
BEHAVIORAL	Survey	All participants will complete a baseline survey and have medical information collected.
BEHAVIORAL	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.

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-06-24
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States