Nctid:
NCT06225219
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>300}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-06-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-24", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2023-11-13", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of times chaplain is requested by patient or provider", "timeFrame"=>"1 year", "description"=>"Number of request from the patients or provider for chaplain"}, {"measure"=>"Usefulness, feasibility, and reception of screening mechanism for GCAC staff", "timeFrame"=>"1 year", "description"=>"Develop a screening mechanism that allow GCAC staff to identify patients who could benefit from spiritual and emotional support."}, {"measure"=>"Themes discussed during meeting between chaplain and patient", "timeFrame"=>"1 year", "description"=>"Explore themes from patient conversations with a chaplain"}, {"measure"=>"Number of meetings/conversations pertaining to each theme identified", "timeFrame"=>"1 year", "description"=>"Theme identified for the number of meetings/conservations"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Emotional Disorder"]}, "descriptionModule"=>{"briefSummary"=>"In 2019, a full-time chaplain was placed in the Golden Cross Academic Clinic (GCAC), with the chaplain's focus being in the primary care internal medicine department. While research exists regarding chaplains in the inpatient setting, research regarding the presence of a full-time chaplain in a primary care setting as well as the topics patients discuss with that chaplain are limited.", "detailedDescription"=>"A few studies conducted in the hospital setting have shown what topics patients typically discuss with a chaplain. In the article, \"Patients and Loved Ones' Expectations of Chaplain Services. Munchausen and colleagues present that the two highest-rated services performed by chaplains were spiritual and emotional support. This study also found that patients wanted to see a chaplain for the following reasons: to be listened to, to be with in times of anxiety, to offer support to loves ones, to remind of God's care and presence, to pray, for religious rituals, to assist with the understanding of advance care planning documents, and to counsel regarding moral or ethical decisions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patient at the GCAC who are \\> 18 years old\n\n• Met with a member of the on-staff chaplaincy during a visit to GCAC", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* • Patient at the GCAC who are \\> 18 years old\n\n * Met with a member of the on-staff chaplaincy during a visit to GCAC\n\nExclusion Criteria:\n\n* • Patient did not meet with a member of the on-staff chaplaincy during a visit to GCAC"}, "identificationModule"=>{"nctId"=>"NCT06225219", "briefTitle"=>"Establishing the Chaplain Role in a Primary Care Clinic Setting", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Establishing the Chaplain Role in a Primary Care Clinic Setting", "orgStudyIdInfo"=>{"id"=>"024.CHP.2022.D"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Counseling", "type"=>"BEHAVIORAL", "otherNames"=>["Chaplain interventions", "Model of holistic care"], "description"=>"To introduce a model of holistic care to the patient populations served by the GCAC through chaplain interventions that focus on spiritual and emotional health."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Colette Ngo Ndjom, MS", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681", "phoneExt"=>"71281"}, {"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"217-947-4681"}, {"name"=>"Andrew Dowden, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Methodist Dallas Medical Center", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "centralContacts"=>[{"name"=>"Bethany Brauer, MPH", "role"=>"CONTACT", "email"=>"MHSIRB@mhd.com", "phone"=>"214-947-4681"}, {"name"=>"Colette Ngo Ndjom, MS", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-4681"}], "overallOfficials"=>[{"name"=>"Andrew Dowden, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Midlothian Medical Center"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR", "ANALYTIC_CODE"], "timeFrame"=>"2 years", "ipdSharing"=>"YES", "description"=>"Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
