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

NCT ID: NCT06352827

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2025-08-08

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.

Detailed Description

Per the NIH requirements the study team added the following language and also updated the registration to be an interventional study. The study will enroll adult patients with chronic constipation prior to appointment with a gastroenterologist that have not received anorectal function testing or treatment in the past. The study team will assess patients' constipation symptoms and then monitor whether providers order anorectal function testing or treatment as a primary outcome. Source data will be derived from the medical record to provide quality assurance. The sample size is necessary to evaluate this outcome measure while accounting for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. The statistical analysis plan will be descriptive with reporting of our binary primary endpoints given the nature of this being a pilot study.

Registration NCT07032376 (Implementation Phase) is part of this registration, "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.

Conditions

Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Observational Cohort

This cohort will complete a baseline survey.

Group Type: OTHER

Survey

Intervention Type: BEHAVIORAL

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

Interventions

Survey

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participant has Chronic constipation as a main symptom
• Participant is able to participate in pelvic floor physical therapy

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Eric Shah

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23DK134752-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00228948

Identifier Type: -

Identifier Source: org_study_id