Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-20 @ 9:37 PM
Study NCT ID:
NCT04601194
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
Sponsor:
Organization:
Raw JSON
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Scores range from 0 to 100, with higher numbers indicating greater activation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Altarum Consumer Engagement (ACE) Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coaching and Virtual Provider Group', 'description': 'Mental Health Coaching and assigned practice with a Virtual Provider Program\n\nCoaching and Virtual Provider Program Practice: 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'The 12-item Altarum Consumer Engagement (ACE) Measure assesses commitment, informed choice, and navigation. 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Scores range from 1 to 5, with higher number reflecting greater self-management.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Recovery Assessment Scale (Brief Version)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coaching and Virtual Provider Group', 'description': 'Mental Health Coaching and assigned practice with a Virtual Provider Program\n\nCoaching and Virtual Provider Program Practice: 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Recovery attitudes will be assessed using the total score of the 20-item Brief version of the Recovery Assessment Scale. Using the average score, the scale ranges from 1 to 5, with 5 indicating greater self-reported recovery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 subjects were lost to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coaching and Virtual Provider Group', 'description': 'Mental Health Coaching and assigned practice with a Virtual Provider Program\n\nCoaching and Virtual Provider Program Practice: 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coaching and Virtual Provider Group', 'description': 'Mental Health Coaching and assigned practice with a Virtual Provider Program\n\nCoaching and Virtual Provider Program Practice: 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Mental Health Diagnosis', 'classes': [{'categories': [{'title': 'Anxiety Disorders (Anxiety Disorder, Panic Disorder, Post-traumatic Stress Disorder)', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Bipolar Disorder', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Schizophrenia (Schizophrenia, Schizoaffective Disorder, Chronic Schizophrenia)', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Major Depressive Disorder', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Other (Difficulty Controlling Anger, Adjustment Disorder)', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Marital Status', 'classes': [{'categories': [{'title': 'Single, never married', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Currently married or living with a partner', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Separated or divorced', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Widowed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Level of Education', 'classes': [{'categories': [{'title': 'Less than high school/GED', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'High school degree/GED', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Some college coursework', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Bachelors degree', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Employment Status', 'classes': [{'categories': [{'title': 'Paid Employment', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Casual Work', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Student', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unemployed and looking for work', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unemployed and not looking for work', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Disabled', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Other: Retired and Disabled', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Housing', 'classes': [{'title': 'Homeless (includes in shelter)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Staying with friends or family temporarily', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Structured congregate living (e.g., nursing home, group home, residential facility)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Semi-independent living (staff member lives on site or foster family care)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Living with family (not spouse)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Own apartment or house-with spouse, living as married, with friends', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Own apartment or house-alone', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caretaking responsibilities for a child or children less than 18 years in same household', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 886970, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-17T15:44', 'hasProtocol': True}, {'date': '2021-09-17', 'size': 267094, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-17T15:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2020-10-19', 'resultsFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-09', 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Activation Measure for Mental Health (PAM-MH)', 'timeFrame': 'Baseline, 3 months', 'description': "The 13-item Patient Activation Measure for Mental Health (PAM-MH) assesses patient knowledge, skill, and confidence for self-managing one's chronic health condition. Scores range from 0 to 100, with higher numbers indicating greater activation."}], 'secondaryOutcomes': [{'measure': 'Altarum Consumer Engagement (ACE) Measure', 'timeFrame': 'Baseline, 3 months', 'description': 'The 12-item Altarum Consumer Engagement (ACE) Measure assesses commitment, informed choice, and navigation. Scores range from 0-4, with higher scores indicating more engagement.'}, {'measure': 'Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)', 'timeFrame': 'Baseline, 3 months', 'description': "The 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI-5) measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit; scores range from 1-10. The questionnaire is rated on a 10-point Likert scale, with higher scores indicating higher perceived efficacy in the interactions."}, {'measure': 'Illness Management and Recovery (IMR) Scale', 'timeFrame': 'Baseline, 3 months', 'description': 'Illness self management will be assessed with the consumer-rated Illness Management and Recovery (IMR) Scale; items are rated on a 5-point behaviorally anchored scale and averaged. Scores range from 1 to 5, with higher number reflecting greater self-management.'}, {'measure': 'Recovery Assessment Scale (Brief Version)', 'timeFrame': 'Baseline, 3 months', 'description': 'Recovery attitudes will be assessed using the total score of the 20-item Brief version of the Recovery Assessment Scale. Using the average score, the scale ranges from 1 to 5, with 5 indicating greater self-reported recovery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serious mental illness', 'shared decision making-psychiatric medications', 'mental health'], 'conditions': ['Mental Illness', 'Shared Decision Making']}, 'descriptionModule': {'briefSummary': 'GET PrEPD-Psychiatry is a mixed-methods, developmental study to adapt a shared decision making (SDM) intervention to be specific for psychiatry decisions (Aim 1, previously completed), evaluate its feasibility and acceptability (Aim 2), and examine potential mechanisms of change and preliminary outcomes (Aim 3) of this innovative intervention to increase SDM and self-management for adults with serious mental illness (SMI). In line with National Institute of Mental Health (NIMH) priorities, we are examining whether GET PrEPD-Psychiatry engages the target mechanisms that putatively underlie the intervention (i.e., patient activation and communication self-efficacy; Aim 3). Aim 1 used approximately 200 deidentified transcripts from our prior study of SDM in psychiatry to cull language used in decision-making. These conversations were then used to program the Virtual Provider to represent common interactions and decisions in psychiatric visits. Iterative testing of the use of the Virtual Provider has been completed and feedback was obtained from our psychiatry consultants to refine the program. For Aim 2, we will recruit up to 40 patients to participate in GET PrEPD-Psychiatry (4 weekly goal setting/coaching sessions, coupled with Virtual Provider training and practice). We will assess participant satisfaction and utility ratings, as well as track their use (frequency and time-on-task) of the Virtual Provider program. For Aim 3, we will follow enrolled patient participants, interviewing them at baseline and approximately 3 months later. We hypothesize that participants will have significantly 1) improved mechanisms of change, demonstrated by increases in self-reported activation and communication self-efficacy, 2) improved SDM, and 3) improved self-management and recovery attitudes. The Narrative Evaluation of Intervention Interview (NEII), completed at approximately 3 months, will be used as a qualitative interview guide to understand the acceptability and impact of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Current patient at the participating mental health center\n* English speaking\n* Willingness to participate in weekly coaching sessions, engage in practice with the Virtual Provider program\n\nExclusion Criteria:\n\n* Under 18 years of age\n* No reasonable access to use of internet on a computer\n* Inability or unwillingness to use a computer (necessary for Virtual Provider Program practice)\n* Never or rarely uses a computer or similar device (based on self-report)\n* Very or somewhat uncomfortable using a computer or similar device (based on self-report)'}, 'identificationModule': {'nctId': 'NCT04601194', 'acronym': 'GET-PrEPD', 'briefTitle': 'Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study', 'orgStudyIdInfo': {'id': '2010326129'}, 'secondaryIdInfos': [{'id': '1R34MH118314', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH118314', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coaching and Virtual Provider Group', 'description': 'Mental Health Coaching and assigned practice with a Virtual Provider Program', 'interventionNames': ['Behavioral: Coaching and Virtual Provider Program Practice']}], 'interventions': [{'name': 'Coaching and Virtual Provider Program Practice', 'type': 'BEHAVIORAL', 'description': '4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice', 'armGroupLabels': ['Coaching and Virtual Provider Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Sandra Eskenazi Mental Health Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Michelle Salyers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'Eskenazi Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michelle Salyers', 'investigatorAffiliation': 'Indiana University'}}}}