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CASA: Care and Support Access in HIV Disease

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University of Maryland

Status

Completed

Conditions

HIV/AIDS

Treatments

Other: CASA Education

Study type

Interventional

Funder types

Other

Identifiers

NCT02136680
HP-00058180

Details and patient eligibility

About

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.

Full 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 HIV/AIDS 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.

  1. 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.

  2. 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.

Enrollment

197 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

PATIENTS -

Inclusion Criteria:

  • HIV positive
  • men who have sex with men attending one of 2 study site clinics
  • 18-35 years

Exclusion Criteria:

  • acute illness requiring medical attention
  • cognitive impairment

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

197 participants in 2 patient groups

Patients at Intervention Site
Active Comparator group
Description:
Staff receives CASA Education
Treatment:
Other: CASA Education
Patients at CONTROL site
No Intervention group
Description:
Staff does not receive CASA Education

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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