Constipation
Conditions
Keywords
Questionnaires, Gastroenterology care, Rectal Expulsion Device (RED)
Brief summary
This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.
Detailed description
This registration is (Implementation Phase) for the registered study "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.
BEHAVIORALRectal Expulsion Device use
During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit. In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants: \- Participant has Chronic constipation as a main symptom
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 12 months * Participant has been scheduled to see a pelvic floor physical therapist in the past 12 months * Participant is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment | Day 1 (Baseline = initial appointment after consent)] | Fidelity to ordering pelvic floor diagnostics |
| Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment | Day 1 (Baseline = initial appointment after consent)] | Fidelity to ordering pelvic floor treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Shah, MD
University of Michigan
Outcome results
None listed