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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06352827
• Other study ID #: HUM00228948
• Secondary ID: 1K23DK134752-01
• Status: Enrolling by invitation
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 109
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Participants:

• Participant has Chronic constipation as a main symptom

Exclusion Criteria Participants:

• Abdominal pain is the main symptom

• Bloating is the main symptom

• 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

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• Surveys
All participants will complete surveys and have medical information collected.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment		Day 1 (initial appointment after consent)
Primary	Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment		Day 1 (initial appointment after consent)
Primary	Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM)	This is a 12-question tool that participants complete regarding constipation with higher scores indicate worse constipation symptoms. Answers selected range from Absent 0 - Very Severe 4, (scoring ranges from 0-48). The responder definition is a minimal clinically important difference of score reduction in at least 0.75 (range 0 to 4) compared to baseline.	Week 12
Primary	Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM)	This is a 12-question tool that participants complete regarding constipation with higher scores indicate worse constipation symptoms. Answers selected range from Absent 0 - Very Severe 4, (scoring ranges from 0-48). The responder definition is a minimal clinically important difference of score reduction in at least 0.75 (range 0 to 4) compared to baseline.	Week 26
Secondary	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
Secondary	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