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

University of Michigan

Status

Completed

Conditions

Constipation

Treatments

Behavioral: Survey

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06352827

HUM00228948

1K23DK134752-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Participants:

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

Exclusion Criteria Participants:

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