Clinical trial NCT02136680: CASA: Care and Support Access in HIV Disease
Official title: CASA: Care and Support Access Study for Implementation of a Palliative Approach With HIV Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV disease
palliative care
educational intervention
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: New York University
First posted: 2014-05-13
Enrollment: 197
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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.

Eligibility 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

Primary outcomes:
measure: Mental Health: Rosenberg Self-Esteem Scale
timeFrame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
measure: Quality of Life: McGill Quality of Life Scale
timeFrame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
measure: Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale
timeFrame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
Secondary outcomes:
measure: Viral Load Suppressed
timeFrame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
measure: Adherence
timeFrame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine-Institute of Human Virology
name: Carla S Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University, College of Dentistry - Psychosocial Research Unit on Health, Aging and the Community
name: Victoria H Raveis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander CS, Pappas G, Amoroso A, Lee MC, Brown-Henley Y, Memiah P, O'Neill JF, Dix O, Redfield RR; Members of the AIDSRelief Consortium of PEPFAR. Implementation of HIV Palliative Care: Interprofessional Education to Improve Patient Outcomes in Resource-Constrained Settings, 2004-2012. J Pain Symptom Manage. 2015 Sep;50(3):350-61. doi: 10.1016/j.jpainsymman.2015.03.021. Epub 2015 Jul 16.
citation: Alexander CS, Raveis VH, Karus DG, Lee MC, Tagle MC, Brotemarkle R, et al. Patient centered care for persons with HIV disease: Protocol review for CASA study (Care and Support Access) early in chronic disease management. Journal of Palliative Care & Medicine 7:300, 2017. doi: 10.4172/2165-7386.1000300