Nctid:
NCT06223867
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004630", "term"=>"Emergencies"}, {"id"=>"D000013405", "term"=>"Suicide"}, {"id"=>"D000059020", "term"=>"Suicidal Ideation"}, {"id"=>"D000016728", "term"=>"Self-Injurious Behavior"}, {"id"=>"D000013406", "term"=>"Suicide, Attempted"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M7796", "name"=>"Emergencies", "asFound"=>"Emergency", "relevance"=>"HIGH"}, {"id"=>"M19089", "name"=>"Self-Injurious Behavior", "asFound"=>"Self-harm", "relevance"=>"HIGH"}, {"id"=>"M16191", "name"=>"Suicide", "asFound"=>"Suicide", "relevance"=>"HIGH"}, {"id"=>"M2958", "name"=>"Suicide Prevention", "relevance"=>"LOW"}, {"id"=>"M29364", "name"=>"Suicidal Ideation", "asFound"=>"Suicidal Ideation", "relevance"=>"HIGH"}, {"id"=>"M16192", "name"=>"Suicide, Attempted", "asFound"=>"Suicide Attempt", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"Outcome evaluators will be blinded to study condition. It is not possible to blind participants, the research staff enrolling the participant, or the treating clinicians."}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>670}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-23", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2027-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-09", "studyFirstSubmitDate"=>"2023-12-14", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Evidence-Based Practice (EBP) delivery", "timeFrame"=>"During index visit= Day 1", "description"=>"Number of patients receiving evidence based care, including evidence based suicide risk assessment, safety planning, lethal means safety counseling, cognitive behavioral therapy (CBT) coping skills training, suicide education materials, and behavioral health referral resources. Higher count = more EBPs delivered"}, {"measure"=>"Patient target engagement, perceived social support", "timeFrame"=>"12 months after enrollment", "description"=>"Perceived social support (attachment/affiliation) measured by Interpersonal Needs Questionnaire (INQ-15), Likert-type scale, higher scores = stronger social support"}, {"measure"=>"Patient target engagement, suicide-related coping", "timeFrame"=>"12 months after enrollment", "description"=>"Suicide-related coping (behavioral inhibition) measured by Suicide-Related Coping Scale (SRCS), Likert-type scale, higher scores = better ability to cope with suicidal thoughts"}, {"measure"=>"Patient target engagement, behavioral activation", "timeFrame"=>"12 months after enrollment", "description"=>"Behavioral activation (effort) measured by Behavioral Activation Scale (BAS) - Drive sub scale, Likert-type scale, higher scores = greater behavioral activation"}, {"measure"=>"In situ self-injury", "timeFrame"=>"Index visit= Day 1", "description"=>"Intentional Self-Harm behavior during the index ED visit and inpatient stay related to the index visit, binary, In situ self-injury Yes/No"}, {"measure"=>"In situ distress", "timeFrame"=>"Index visit= Day 1", "description"=>"Pre-post distress measure that will use 0 to 10 distress scale at start of enrollment and at 1, 2, 3 hours later. It will assess patient's distress during the index ED"}, {"measure"=>"In situ suicide related coping", "timeFrame"=>"Index visit= Day 1", "description"=>"Pre-post suicide coping measure that will use 0 to 10 coping scale at start of enrollment and at 1, 2, 3 hours later. It will assess patient's suicide-related coping during the index ED"}, {"measure"=>"ED visit satisfaction", "timeFrame"=>"Index visit= Day 1", "description"=>"0 to 10 visit satisfaction scale at start of enrollment and at 1, 2, 3 hours later to assess patient's satisfaction with the ED care during index visit"}, {"measure"=>"Psychiatric symptoms", "timeFrame"=>"Index visit and 12 months after enrollment", "description"=>"Psychiatric symptoms on the diagnostic and statistical manual of mental disorders (DSM-5) Crosscutting measure, Likert-type scale, higher scores = more severe psychiatric symptoms"}, {"measure"=>"Patient reach", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Percentage of eligible patients who initiated Jaspr by answering at least one question on the Suicide Status Interview (SSI) in Jaspr app"}, {"measure"=>"Fidelity", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Percentage of patients who started the Suicide Status Interview (SSI) in Jaspr app and who completed the SSI and a safety plan (fidelity)"}, {"measure"=>"Exposure, time", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total time spent on all components. Measured in minutes"}, {"measure"=>"Exposure, modules", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total number of modules completed"}, {"measure"=>"Costs", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Costs associated with Jaspr preparation, training, deployment, use, workflow changes"}, {"measure"=>"Clinician acceptability", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger clinician acceptability"}, {"measure"=>"Patient acceptability", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger patient acceptability"}, {"measure"=>"Patient appropriateness", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured measure viewing Jaspr as appropriate using the Intervention Appropriateness Measure (IAM), Likert type scale, higher scores = stronger patient ratings of appropriateness"}, {"measure"=>"Feasibility of Jaspr in ED", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured clinician measure; qualitative review of barriers to implementation using Feasibility of Intervention Measure (FIM)"}, {"measure"=>"Usability, clinician", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured measure of clinicians' perception of the usability of Jaspr using the System Usability Scale (SUS) , Likert type scale, higher scores = stronger clinician ratings of usability"}, {"measure"=>"Usability, patient", "timeFrame"=>"Duration of enrollment = 30 months", "description"=>"Structured measure of clinicians' perception of the usability of Jaspr using the System Usability Scale (SUS), Likert type scale, higher scores = stronger patient ratings of usability"}, {"measure"=>"System workflow impact, admissions to psychiatric units", "timeFrame"=>"During index ED visit= Day 1", "description"=>"Of patients who meet eligibility criteria for Jaspr, how many (what percentage) get admitted to a psychiatric unit from the index ED visit, binary, psychiatric hospitalization = yes/No"}, {"measure"=>"System workflow impact, door to behavioral health evaluation", "timeFrame"=>"During index ED visit= Day 1", "description"=>"Of patients who meet eligibility criteria for Jaspr, how long in minutes does it take to get a behavioral health evaluation from when they are registered in the ED, continuous, measured in minutes, higher minutes = longer evaluation wait"}, {"measure"=>"System workflow impact, total length of stay", "timeFrame"=>"During index ED visit= Day 1", "description"=>"Of patients who meet eligibility criteria for Jaspr, how long in minutes does it take for their entire visit from registration to discharge, continuous, measured in minutes, higher minutes = longer total length of stay"}, {"measure"=>"System workflow impact, 28 day revisit", "timeFrame"=>"Within 28 days of index ED visit", "description"=>"Of patients who meet eligibility criteria for Jaspr, how many return to the ED within 28 days, binary, Yes/No"}, {"measure"=>"System workflow impact, clinician perception", "timeFrame"=>"Assessed within 3 months of Jaspr implementation", "description"=>"Clinician perception of workflow impact after Jaspr is implemented, assessed by a structured interview, qualitative descriptions"}], "primaryOutcomes"=>[{"measure"=>"Suicide composite, binary", "timeFrame"=>"12 months after enrollment", "description"=>"Death by suicide OR suicide-related acute care utilization within 12 months after enrollment"}], "secondaryOutcomes"=>[{"measure"=>"Suicidal attempt", "timeFrame"=>"12 months after enrollment", "description"=>"Suicidal attempt measured by the Columbia-Suicide Severity Rating Scale (CSSRS), Suicide attempt present Y/N"}, {"measure"=>"Suicidal behavior", "timeFrame"=>"12 months after enrollment", "description"=>"Suicidal behavior measured by the Columbia-Suicide Severity Rating Scale (CSSRS), including any preparatory, aborted, interrupted, and actual suicidal attempts. Suicidal Behavior present Y/N"}, {"measure"=>"Suicidal ideation severity", "timeFrame"=>"12 months after enrollment", "description"=>"Suicidal ideation severity measured by the Columbia-Suicide Severity Rating Scale (CSSRS). Suicidal Ideation (Highest Level Endorsed 1-5. 1= least severe and 5= highest severity)"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Suicide", "Self-Harm", "Attempt", "Ideation", "Suicidal thought", "Suicidal plan", "Crisis intervention", "Suicide prevention", "Emotional support", "Mental Health", "Behavioral Health", "Psychiatry", "Emergency Department", "Technology", "Mobile Application", "Implementation", "Safety Plan", "Lethal Means"], "conditions"=>["Suicidal Ideation", "Suicide Attempt", "Self Harm"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://reporter.nih.gov/search/ghz0ZwiyvU2Qfb-N0aHjxw/project-details/10577120", "label"=>"The Center for Accelerating Practices to End Suicide through Technology Translation (CAPES)- Signature Project"}]}, "descriptionModule"=>{"briefSummary"=>"This Study will comprehensively evaluate a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.\n\nA Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used", "detailedDescription"=>"This study will evaluate Jaspr's patient-facing tablet-based application (app) during suicide-related ED visits. The app guides patients in completing the Suicide Status Interview, which comprise of an evidence-based Collaborative Assessment \\& Management of Suicidality (CAMS) certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety planning, and lethal means safety counseling. It also offers access to a menu of \"Comfort and Skills\" modules that teaches patients behavioral skills to effectively manage imminent distress, while shared stories offer a library of professionally produced, racially and culturally diverse, inspirational videos of people with suicide-centered lived experience.\n\nSubjects who interact with Jaspr can continue to access their safety plan, comfort and coping skills exercises, and the video library via Jaspr at Home (JAH) mobile application; a summary of the self-administered risk assessment is shared with the clinical team directly through the patient electronic medical record to help guide the treatment plan.\n\nPart A of the study will be an individual, patient-level Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. All subjects will complete a baseline assessment prior to random assignment to one of the the two study conditions. All subjects will receive follow-up phone calls for 12 months after enrollment at weeks 6, 12, 24, 36, and 52. These calls will assess suicide related outcomes and healthcare utilization. In addition, the Massachusetts Department of Public Health (MA DPH) death registry will be reviewed, and each subject's electronic health record will be reviewed.\n\nPart B of the study will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes.\n\nThis ClinicalTrials.gov record will cover only Part A. Part B is summarized in a separate entry."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)\n* Cognitively and emotionally capable of consent and engaging in Jaspr app.\n* Reads English at 6th grade level.\n* Reliable telephone access.\n* Owns a smart phone\n* Lives in Massachusetts\n\nExclusion Criteria:\n\n* Prisoners or in state custody\n* Adults unable to consent\n* Patient \\<18 yeas\n* Enrolled subjects during the 12 month follow-up period"}, "identificationModule"=>{"nctId"=>"NCT06223867", "acronym"=>"Jaspr-PartA", "briefTitle"=>"Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part a", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Massachusetts, Worcester"}, "officialTitle"=>"Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients with Suicidal Risk- Part A: Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"STUDY00000716 Part A"}, "secondaryIdInfos"=>[{"id"=>"1P50MH129701", "link"=>"https://reporter.nih.gov/quickSearch/1P50MH129701", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Enhanced treatment as usual (ETAU) alone", "description"=>"Subjects in this arm will receive the usual care for patients with suicidal risk at UMass Memorial ED that may include a behavioral health evaluation by a trained clinician, and environmental safety precautions dictated by risk level (Mild, Moderate, High). Individuals deemed appropriate for discharge undergo discharge planning and offered a personalized safety plan using the Stanley-Brown Safety Planning Intervention, including lethal means safety counseling.", "interventionNames"=>["Behavioral: ETAU"]}, {"type"=>"EXPERIMENTAL", "label"=>"Jaspr intervention with enhanced treatment as usual (ETAU)", "description"=>"Subjects in this arm will receive ETAU in addition, they will complete a guided Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling on the Jaspr tablet-based app before open access to the Jaspr resource library.\n\nSubjects can sign up to receive JAH mobile app.", "interventionNames"=>["Device: Jaspr App + JAH", "Behavioral: ETAU"]}], "interventions"=>[{"name"=>"Jaspr App + JAH", "type"=>"DEVICE", "description"=>"With assistance form a research coordinator, the subject will complete self-administered suicide risk assessment on the tablet via Jaspr app, then the subject will engage with suicide-related coping skills and resources that the app provides. Subject will continue to have access to the coping skills and videos via a mobile app after discharge.", "armGroupLabels"=>["Jaspr intervention with enhanced treatment as usual (ETAU)"]}, {"name"=>"ETAU", "type"=>"BEHAVIORAL", "otherNames"=>["Enhanced Treatment As Usual"], "description"=>"Usual care for suicidal patients at UMass Memorial ED that may include Behavioral health evaluation by a trained clinician. Environmental safety precautions. Personalized safety upon discharge", "armGroupLabels"=>["Enhanced treatment as usual (ETAU) alone", "Jaspr intervention with enhanced treatment as usual (ETAU)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Edwin D Boudreaux, PhD", "role"=>"CONTACT", "email"=>"Edwin.Boudreaux@umassmed.edu", "phone"=>"508-334-3817"}], "facility"=>"UMass Memorial Health", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}], "centralContacts"=>[{"name"=>"Edwin D Boudreaux, PhD", "role"=>"CONTACT", "email"=>"Edwin.Boudreaux@umassmed.edu", "phone"=>"508-334-3817"}, {"name"=>"Mhd B Rahmoun, MD", "role"=>"CONTACT", "email"=>"Mhd.Rahmoun@umassmed.edu"}], "overallOfficials"=>[{"name"=>"Edwin D Boudreaux, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Massachusetts, Worcester"}]}, "ipdSharingStatementModule"=>{"url"=>"https://nda.nih.gov/edit_collection.html?id=4744", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ANALYTIC_CODE"], "timeFrame"=>"Based on NIMH NDA expectations, investigators will begin sharing data and share data with as long as is expected by NIMH", "ipdSharing"=>"YES", "description"=>"Investigators will comply with the expectations of the NIMH Data Archive (NDA) regarding data components and support documents, including the recommended timeline", "accessCriteria"=>"See NDA application for details."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Massachusetts, Worcester", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Ohio State University", "class"=>"OTHER"}, {"name"=>"Evidence-Based Practice Institute, Seattle, WA", "class"=>"INDUSTRY"}, {"name"=>"Worcester Polytechnic Institute", "class"=>"OTHER"}, {"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}, {"name"=>"University of Colorado, Denver", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Edwin Boudreaux", "investigatorAffiliation"=>"University of Massachusetts, Worcester"}}}}
