Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Observational Cohort
This cohort will complete a baseline survey.
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All participants will complete a baseline survey and have medical information collected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity to Ordering Pelvic Floor Diagnostics and/or Treatment
Time Frame: 1 day
|
Results reflect the number of participants for whom anorectal physiology testing and/or pelvic floor physical therapy was ordered or performed at the baseline routine-care gastroenterology office appointment.
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1 day
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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)
Time Frame: Week 12
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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.
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Week 12
|
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Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL)
Time Frame: Week 26
|
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
Investigators
- Principal Investigator: Eric Shah, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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