[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07032376":3,"trial-entities:NCT07032376":81,"trial-summary:NCT07032376":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":15,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":62,"locations":65,"central_contacts":74,"overall_officials":75,"references":79,"see_also_links":80},"NCT07032376","HUM00228948b","A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation","Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2","ENROLLING_BY_INVITATION","2027-02","2025-09","2026-05-06","2025-08-20","University of Michigan","OTHER",null,"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.",[19],"Constipation",[21,22,23],"Questionnaires","Gastroenterology care","Rectal Expulsion Device (RED)","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[27],"NA",{"count":29,"type":30},109,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Survey","All participants will complete a baseline survey and have medical information collected.",[37],"Chronic constipation",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Rectal 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.\n\nIn 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.",[37],[43,47],{"measure":44,"description":45,"timeFrame":46},"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)]",{"measure":48,"description":49,"timeFrame":46},"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",[],"ALL","18 Years",false,{"inclusion":55,"exclusion":56,"raw_text":61},[],[57,58,59,60],"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","Inclusion Criteria Participants:\n\n\\- Participant has Chronic constipation as a main symptom\n\nExclusion Criteria Participants:\n\n* Participant has taken narcotic pain medication in the past 30 days\n* Participant has been scheduled for a test called an anorectal manometry in the past 12 months\n* Participant has been scheduled to see a pelvic floor physical therapist in the past 12 months\n* Participant is pregnant",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":13,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Ann Arbor","Michigan","48109","United States",{"lat":72,"lon":73},42.27756,-83.74088,[],[76],{"name":77,"affiliation":13,"role":78},"Eric Shah, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[37],[],{"nct_id":4,"found":53,"summary":15,"prompt_version":15}]