- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02213198
Improving Transitional Care Experiences in Mental Health
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim 1: To compare EFC to SC with respect to linkage to TCC services. Hypothesis A: Patients referred to EFC will exhibit a significantly greater rate of attendance at their TCC intake appointment than SC patients.
Aim 2: To compare EFC to SC with respect to patient participation in outpatient treatment.
Hypothesis B: Patients referred to EFC will report significantly greater shared decision-making in their TCC prescriber appointments than SC patients.
Hypothesis C: Patients referred to EFC will exhibit significantly greater attendance at post-intake scheduled TCC appointments than SC patients.
Hypothesis D: Patients referred to EFC will exhibit a significantly greater rate of attendance at initial post-TCC scheduled mental health appointments than SC patients.
Aim 3: To compare Engagement-focused Care (EFC) to Standard Care (SC) with respect to patients' long term quality of life.
Hypothesis E: Patients who receive EFC will exhibit significantly greater quality of life than SC patients six months after TCC termination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- UTHSCSA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Serious mental illness including (schizophrenia, schizoaffective disorder, mood disorders, anxiety disorders), referral from inpatient psychiatric unit or emergency service at the time of discharge to the Transitional Care Clinic, ability to sign informed consent
Exclusion Criteria:
- Unable to complete assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Engagement Focused Care
Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention
|
Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching.
For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.
|
ACTIVE_COMPARATOR: Standard Care
Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.
|
Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Quality of Life
Time Frame: baseline, 3 months and 6 months
|
The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health.
It is one of the most psychometrically sound QoL instruments for use in mental illness.
The subjective scale assesses quality of life from the perspective of the patient.
Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 .
Scores range from 1-7.
Higher scores indicate better quality of life
|
baseline, 3 months and 6 months
|
Engagement in Treatment
Time Frame: 6 months
|
Whether patient kept appointment post TCC
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dawn I Velligan, PhD, University of Texas
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IH-1304-6506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Standard Treatment Versus Engagement Focused Treatment
-
Hospital de Transplante Doutor Euryclides de Jesus...CompletedAnal Continence After High-Intensity Focused Ultrasound (HIFU) TreatmentBrazil
-
Drexel UniversityCompletedAcceptance-based Treatment | Standard Behavioral TreatmentUnited States
-
EyeTechCareCompletedGlaucoma Treatment Using Focused UltrasoundChina
-
VA Office of Research and DevelopmentCompletedSuicidal Ideation | Treatment EngagementUnited States
-
Peking UniversityRecruitingLiver Metastasis Colon Cancer | MSS | ctDNA Genotype | Failed From Standard TreatmentChina
-
AltruBio Inc.CompletedSteroid-refractory Acute Graft-versus-Host Disease | Treatment-refractory Acute Graft-versus-Host DiseaseUnited States
-
NycomedCompletedStandard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
-
Ataturk UniversityUnknownThis Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment.Turkey
-
PrecirixActive, not recruitingAdvanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care TreatmentUnited States, Canada
-
University Hospital, ToursSwedish Orphan Biovitrum; INSERM CIC-P 1415, University Hospital Center of...TerminatedCOVID-19 Infection | ANAKINRA Treatment | Optimized Standard of Care (oSOC)France
Clinical Trials on Engagement focused care
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston UniversityCompleted
-
The University of Texas Health Science Center,...Not yet recruitingNutrition in High-Risk PregnancyUnited States
-
Thammasat UniversityCompleted
-
The University of Texas Health Science Center,...US Department of Health and Human Services, Administration on Community LivingRecruitingDepression in Old AgeUnited States
-
University of Notre DameIndiana University School of Medicine; Savana SignaturesRecruiting
-
University of Colorado, DenverAmerican Heart AssociationCompletedPatient Engagement | Heart Failure With Reduced Ejection Fraction | Patient Activation | Medication OptimizationUnited States
-
University of Maryland, BaltimoreNational Institute of Nursing Research (NINR); National Institute on Aging...CompletedPain | DementiaUnited States
-
University of California, San FranciscoNational Institute on Drug Abuse (NIDA)Recruiting
-
Brown UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingMaternal DepressionUnited States
-
Centers for Disease Control and PreventionCompletedColorectal CancerUnited States