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

NCT06352827 | Completed

• 2 other identifiers: HUM002289481K23DK134752-01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.

Conditions

Constipation

Keywords

Questionnaires; Gastroenterology care

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)

Observational Cohort

OTHER

This cohort will complete a baseline survey.

Behavioral: Survey

Interventions

Survey BEHAVIORAL

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

Observational Cohort

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
• Participant is able to participate in pelvic floor physical therapy

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
• Participant has been scheduled to see a pelvic floor physical therapist in the past
• 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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: Participants will be enrolled in the observational intervention group first.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: July 30, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: May 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)