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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK134752-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic constipation | Experimental | Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Behavioral | All participants will complete a baseline survey and have medical information collected. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment | Fidelity to ordering pelvic floor diagnostics | Day 1 (Baseline = initial appointment after consent)] |
| Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment | Fidelity to ordering pelvic floor treatment | Day 1 (Baseline = initial appointment after consent)] |
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Inclusion Criteria Participants:
- Participant has Chronic constipation as a main symptom
Exclusion Criteria Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Shah, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Rectal Expulsion Device use | Behavioral | 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. |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |