An interventional study of CASA Education in HIV/AIDS, sponsored by University of Maryland. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by University of Maryland · Not applicable, Interventional, and Health services research
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.
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 197 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Maryland is the lead sponsor of 3 studies on the registry; none are open to participants now.
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PATIENTS -
Inclusion Criteria:
Exclusion Criteria:
Staff receives CASA Education
Other: CASA Education
Staff does not receive CASA Education
Basic palliative care competencies for outpatient use.
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
Viral Load Suppressed
Patient is HIV viral load suppressed, as abstracted from patient electronic medical records.
Time frame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
Adherence
Self-reported adherence over the past month by an item from the Adult Aids Clinical Trials Group (AACTG) questionnaire.
Time frame: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
Patients were recruited between July 2014 and June of 2016. Enrollment took place in 2 separate HIV outpatient clinics where most clinic attendees were known to be HIV positive.
| Milestone | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Started | 112 | 85 |
| Interview 1 | 112 | 85 |
| Interview 2 | 97 | 70 |
| Interview 3 | 80 | 56 |
| Completed | 80 | 56 |
| Not completed | 32 | 29 |
| Withdrew: No longer interested | 1 | 1 |
| Withdrew: No longer receiving care at clinic | 3 | 5 |
| Withdrew: Moved away | 5 | 4 |
| Withdrew: Unable to schedule | 17 | 16 |
| Withdrew: Study ended before interview due | 6 | 3 |
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.
| [Units on a scale] | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Baseline | 3.2 ± 0.6 | 3.2 ± 0.6 |
| FU1 | 3.2 ± 0.5 | 3.1 ± 0.6 |
| FU2 | 3.1 ± 0.6 | 3.0 ± 0.6 |
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).
| [Units on a scale] | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Baseline: Global QOL Item | 6.9 ± 2.4 | 6.7 ± 2.6 |
| Baseline: Summary QOL Score | 7.0 ± 2.1 | 6.9 ± 2.1 |
| FU1: Global QOL Item | 7.3 ± 2.3 | 7.1 ± 2.5 |
| FU1: Summary QOL Score | 7.0 ± 2.2 | 6.9 ± 2.3 |
| FU2: Global QOL Item | 7.2 ± 2.5 | 6.4 ± 2.8 |
| FU2: Summary QOL Score | 7.1 ± 2.3 | 6.2 ± 2.2 |
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.
| [Units on a scale] | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Baseline | 8.9 ± 7.0 | 8.4 ± 6.6 |
| FU1 | 8.4 ± 6.4 | 9.5 ± 7.0 |
| FU2 | 8.5 ± 7.1 | 8.5 ± 6.5 |
Patient is HIV viral load suppressed, as abstracted from patient electronic medical records.
| Participants | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Baseline — Not Virally Suppressed | 43 | 32 |
| Baseline — Viral Load Suppressed | 59 | 52 |
| FU1 — Not Virally Suppressed | 25 | 20 |
| FU1 — Viral Load Suppressed | 48 | 44 |
| FU2 — Not Virally Suppressed | 18 | 19 |
| FU2 — Viral Load Suppressed | 50 | 36 |
Self-reported adherence over the past month by an item from the Adult Aids Clinical Trials Group (AACTG) questionnaire.
| Participants | Patients at Intervention Site | Patients at CONTROL Site |
|---|---|---|
| Baseline — Not Adherent | 53 | 39 |
| Baseline — Adherent | 59 | 45 |
| FU1 — Not Adherent | 42 | 41 |
| FU1 — Adherent | 55 | 29 |
| FU2 — Not Adherent | 34 | 33 |
| FU2 — Adherent | 46 | 22 |
Collected over Up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients at Intervention Site | 0/112 (0%) | 0/112 (0%) | 0/112 (0%) |
| Patients at CONTROL Site | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| Age, Continuous(years) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| Mean | 28 ± 4.2 | 30 ± 3.5 | 29 ± 3.9 |
| Age, Customized(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| 18 - 25 | 29 | 11 | 40 |
| 26 - 30 | 44 | 39 | 83 |
| 31 - 35 | 39 | 35 | 74 |
| Sex: Female, Male(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 112 | 85 | 197 |
| Race/Ethnicity, Customized(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| Black, non-Hispanic | 93 | 61 | 154 |
| Hispanic | 11 | 7 | 18 |
| White, non-Hispanic | 2 | 9 | 11 |
| Other, non-Hispanic | 0 | 4 | 4 |
| Multiracial, non-Hispanic | 6 | 4 | 10 |
| Region of Enrollment(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| United States | 112 | 85 | 197 |
| HIV Risk Group(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| Sex | 89 | 63 | 152 |
| Sex (Female Only) | 3 | 0 | 3 |
| IV Drug Usage | 2 | 1 | 3 |
| Transfusion | 1 | 0 | 1 |
| Sex and IV Drug Usage | 2 | 6 | 8 |
| Sex, IV Drug Usage and Transfusion | 9 | 7 | 16 |
| Other | 1 | 1 | 2 |
| Don't know | 3 | 7 | 10 |
| IV Drug Usage Risk Factor(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| No | 97 | 71 | 168 |
| Yes | 13 | 14 | 27 |
| HIV Treatment Regimen(Participants) | Patients at Intervention Site | Patients at CONTROL Site | Total |
|---|---|---|---|
| No Treatment | 1 | 1 | 2 |
| 1 Pill/Day | 91 | 53 | 144 |
| 2 or More Pills/Day | 19 | 28 | 47 |
| No Medical Info | 1 | 3 | 4 |
2 further baseline measures are reported on the registry.
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