Constipation
Conditions
Keywords
Questionnaires, Gastroenterology care
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. 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.
Interventions
BEHAVIORALSurvey
All participants will complete a baseline survey and have medical information collected.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will be enrolled in the observational intervention group first.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity to Ordering Pelvic Floor Diagnostics and/or Treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Shah, MD
University of Michigan
Participant flow
Recruitment details
Patients at least 18 years of age that were scheduled to see a gastroenterology provider at the U-M Gastroenterology Clinics for chronic constipation as the primary complaint and that were able to participate in physical therapy were recruited. Individuals that have taken narcotics within the last 30 days, or that have been scheduled for or undergone anorectal manometry testing or seen a pelvic floor physical therapist to treat constipation and those that are pregnant were excluded.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 17.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 92 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 92 |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
None listed