Clinical trial NCT06352827: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
Official title: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Constipation
Keywords: Questionnaires
Gastroenterology care
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-04-08
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be enrolled in the observational intervention group first.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
timeFrame: Day 1 (Baseline = initial appointment after consent)
measure: Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment
timeFrame: Day 1 (Baseline = initial appointment after consent)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Eric Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: