CASA: Care and Support Access in HIV Disease

Not Applicable

Completed

Conditions: HIV/AIDS

Interventions: Other: CASA Education

Registration Number: NCT02136680

Lead Sponsor: University of Maryland

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 197

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients at Intervention Site	CASA Education	Staff receives CASA Education

Primary Outcome Measures

Name	Time	Method
Quality of Life: McGill Quality of Life Scale	Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1	The McGill Quality of Life Questionnaire (MQOL) is a measure of quality of life for persons with advanced/serious illness. The MQOL consists of 16-items plus a global quality of life item, each with a 2-day time frame and has demonstrated validity and other measurement properties for use with palliative care populations. There are four subscales (psychological symptoms, existential well-being, support, and physical symptoms) and a summary quality of life score that weights these domains equally. Items are scored zero (worst) to 10 (excellent).
Mental Health: Rosenberg Self-Esteem Scale	Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1	Rosenberg Self-Esteem Scale: The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is well validated and has been used in a wide variety of populations, including persons living with HIV/AIDS. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Scores for individual items varied in range from 1 to 4, with higher scores indicative of greater self-esteem. Summary score is reflective of the mean score across all items.
Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale	Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1	The Palliative Outcome Scale (POS) is a 10-item multidimensional well-being tool well validated for use in palliative care settings that measures the 3-day period prevalence and intensity of pain, other physical symptoms, patient anxiety, family/friends anxiety, information sufficiency, sharing feelings with family/friends, feeling life is worthwhile, self-worth, wasted time, and personal affairs, i.e. the physical/social/spiritual/psychological problems in line with the World Health Organization (WHO) definition of palliative care. Eight of the 10 items use a five-point Likert-like scale, and the remaining two items use a three-point scale. Scores for respondents' ratings on all items can range from 0 (indicating no problem) to 4 (indicating a very severe or overwhelming problem). The overall profile score is the sum of the scores from each of the 10 questions and can therefore range from zero to 40. Higher scores are indicative of greater problems.

Secondary Outcome Measures

Name	Time	Method
Adherence	Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1	Self-reported adherence over the past month by an item from the Adult Aids Clinical Trials Group (AACTG) questionnaire.
Viral Load Suppressed	Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1	Patient is HIV viral load suppressed, as abstracted from patient electronic medical records.