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

NCT07032376 | Enrolling By Invitation

• 2 other identifiers: HUM00228948b1K23DK134752-01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Questionnaires; Gastroenterology care; Rectal Expulsion Device (RED)

Outcome Measures

Primary Outcomes (2)

• Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment

  Fidelity to ordering pelvic floor diagnostics

  Day 1 (Baseline = initial appointment after consent)]

• Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment

  Fidelity to ordering pelvic floor treatment

  Day 1 (Baseline = initial appointment after consent)]

Study Arms (1)

Chronic constipation

EXPERIMENTAL

Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.

Behavioral: Survey; Behavioral: Rectal Expulsion Device use

Interventions

Survey BEHAVIORAL

All participants will complete a baseline survey and have medical information collected.

Chronic constipation

Rectal Expulsion Device use BEHAVIORAL

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.

Chronic constipation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participant has Chronic constipation as a main symptom

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric Shah, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 24, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)