CASA: Care and Support Access in HIV Disease

NCT02136680 | Completed Results DMC

• 1 other identifier: HP-00058180
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

HIV disease; palliative care; educational intervention

Outcome Measures

Primary Outcomes (3)

• Mental Health: Rosenberg Self-Esteem Scale

  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.

  Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1

• Quality of Life: McGill Quality of Life Scale

  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).

  Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1

• Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale

  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.

  Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1

Secondary Outcomes (2)

• 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

• Adherence

  Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1

Study Arms (2)

Patients at Intervention Site

ACTIVE COMPARATOR

Staff receives CASA Education

Other: CASA Education

Patients at CONTROL site

NO INTERVENTION

Staff does not receive CASA Education

Interventions

CASA Education OTHER

Basic palliative care competencies for outpatient use.

Patients at Intervention Site

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The specific patient population being addressed in this study is HIV positive young men who have sex with men (yMSM). We are targeting HIV positive yMSM because they are at high risk for poor personal outcomes and are currently recognized as a significant barrier in efforts to prevent HIV infection in Baltimore, one of 20 US cities with high HIV prevalence.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• acute illness requiring medical attention
• cognitive impairment

Sponsors & Collaborators

• University of Maryland: lead
• Patient-Centered Outcomes Research Institute: collaborator
• New York University: collaborator

Study Sites (1)

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 26188088 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Due to the duration of the study, while it was feasible to obtain short-term follow-up of participants, it was not possible because of an extension of the recruitment period to obtain long-term follow-up data on the complete panel sample.

Results Point of Contact

• Title: Dr. Carla Alexander
• Organization: University of Maryland Baltimore, School of Medicine

calexand@medicine.umaryland.edu

410-328-7129

Study Officials

• Carla S Alexander, MD

  University of Maryland School of Medicine-Institute of Human Virology

  PRINCIPAL INVESTIGATOR

• Victoria H Raveis, PhD

  New York University, College of Dentistry - Psychosocial Research Unit on Health, Aging and the Community

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 13, 2014
• Study Start: July 1, 2014
• Primary Completion: May 31, 2017
• Study Completion: March 31, 2019
• Last Updated: June 4, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)