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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Behavioral: Survey

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Participant has Chronic constipation as a main symptom from Michigan Medicine gastroenterology clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observational Cohort; This cohort will complete a baseline survey.	Behavioral: Survey; All participants will complete a baseline survey and have medical information collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL)	This is a 28-question tool that participants complete with higher scores indicate worse constipation symptoms. Answers selected range from Not at all or None of the time 0 - All of the time or Extremely 4, (scoring ranges from 0-112). The responder definition is a minimal clinically important difference of score reduction in at least 1.0 (range 0 to 4) compared to baseline.	Week 12
Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL)	This is a 28-question tool that participants complete with higher scores indicate worse constipation symptoms. Answers selected range from Not at all or None of the time 0 - All of the time or Extremely 4, (scoring ranges from 0-112). The responder definition is a minimal clinically important difference of score reduction in at least 1.0 (range 0 to 4) compared to baseline.	Week 26

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eric Shah, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Questionnaires; Gastroenterology care
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: HUM00228948; 1K23DK134752-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No