Viewing Study NCT02136680



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Study NCT ID: NCT02136680
Status: COMPLETED
Last Update Posted: 2019-06-04
First Post: 2014-05-05

Brief Title: CASA Care and Support Access in HIV Disease
Sponsor: University of Maryland
Organization: University of Maryland Baltimore

Study Overview

Official Title: CASA Care and Support Access Study for Implementation of a Palliative Approach With HIV Treatment
Status: COMPLETED
Status Verified Date: 2019-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CASA
Brief Summary: This is an investigator-initiated study to measure the impact of an educational intervention on the basic palliative approach for a multidisciplinary staff team at an outpatient HIV clinic The study aims to 1 refine a curriculum for non-palliative care clinicians caring for persons living with HIV disease early in the disease trajectory 2 assess the impact of the palliative approach educational intervention on outcomes for 2 target populations a patients mental health quality of life health-related quality of life and secondarily retention in care and viral suppression and b staff burn-out and caregiving stress It is hypothesized that training outpatient HIV staff in palliative care competencies will improve care provided that might in turn improve clinical outcomes for HIV patients receiving care at that clinic Quantitative data will be augmented by qualitative interviews of selected staff and patients at both clinics in the final year of the study to appreciate response to the intervention
Detailed Description: Evidence exists in African populations that palliative care delivered early in the HIV disease trajectory can improve symptom management and mental health This study represents a proof of principle for HIV care delivery in the US using observed distillation of critical palliative elements

Care and Support Access CASA is a complex multidisciplinary care strategy in which a palliative approach is integrated into the delivery of standard HIV care using an iterative teaching method and on-site mentored training of site-based care teams CASA will implement patient-centeredness into HIV treatment at the practice setting to improve patient-level outcomes for persons with HIVAIDS known to have difficulty in engaging in care initiating antiretroviral therapy ART and remaining in routine follow-up This lack of retention puts them at high risk for experiencing health-related symptoms and poor quality of life QOL

The study design is quasi-experimental with longitudinal observation of the HIV positive young men who have sex with men yMSM population and staff who deliver their care at two HIV outpatient clinics We use mixed methods surveys and qualitative interviews with the patients and staff at both clinics

The Specific Aims are

1 To refine deliver and determine the acceptability and applicability of an interdisciplinary professional education program for a site-based multidisciplinary health care team on the integration of basic palliative care domains fundamental to patient-centered care with standard HIV care

2 To obtain insights regarding the CASA experience and to describe and measure the impact of early integration of a palliative approach upon yMSM relative to a improvement of mental health status health-related quality of life and overall quality of life b increased retention in care and viral suppression

3 To describe and measure the impact upon staff of the early integration of the palliative approach with regard to a reducing work-related stress and b burn-out

The anticipated impact of the CASA study will be to improve clinical practice with regard to engagement and retention of difficult to engage and retain patient populations by introducing a basic palliative approach to care management

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None