Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants:
- •- Participant has Chronic constipation as a main symptom
排除标准
- •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
研究组 & 干预措施
Chronic constipation
Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.
干预措施: Survey (Behavioral)
Chronic constipation
Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.
干预措施: Rectal Expulsion Device use (Behavioral)
结局指标
主要结局
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
时间窗: 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
时间窗: Day 1 (Baseline = initial appointment after consent)]
Fidelity to ordering pelvic floor treatment
次要结局
未报告次要终点
研究者
Eric Shah
Associate Professor of Internal Medicine
University of Michigan