HIV/AIDS
Conditions
Keywords
HIV disease, palliative care, educational intervention
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.
Interventions
OTHERCASA Education
Basic palliative care competencies for outpatient use.
Sponsors
Patient-Centered Outcomes Research Institute
New York University
University of Maryland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Potential participants were identified initially by age and gender, recruited and, if eligible, retained as study participants. We solicited referrals of eligible patients from primary care providers or designated clinic staff, and reviewed appointment schedules at both sites. Initial contact was made by the participant's primary care provider.
Participants by arm
| Arm | Count |
|---|---|
| Patients at Intervention Site Staff receives CASA Education: Basic palliative competencies for outpatient use. | 112 |
| Patients at CONTROL Site Staff does not receive CASA Education: Patients at this site receive their usual care. | 85 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Moved away | 5 | 4 |
| Overall Study | No Longer Interested | 1 | 1 |
| Overall Study | No longer receiving care at clinic | 3 | 5 |
| Overall Study | Study ended before interview due | 6 | 3 |
| Overall Study | Unable to schedule | 17 | 16 |
Baseline characteristics
| Characteristic | Total | Patients at CONTROL Site | Patients at Intervention Site |
|---|---|---|---|
| Adherence Adherent | 104 Participants | 45 Participants | 59 Participants |
| Adherence Missing Info | 1 Participants | 1 Participants | 0 Participants |
| Adherence Not adherent | 92 Participants | 39 Participants | 53 Participants |
| Age, Continuous | 29 years STANDARD_DEVIATION 3.9 | 30 years STANDARD_DEVIATION 3.5 | 28 years STANDARD_DEVIATION 4.2 |
| Age, Customized 18 - 25 | 40 Participants | 11 Participants | 29 Participants |
| Age, Customized 26 - 30 | 83 Participants | 39 Participants | 44 Participants |
| Age, Customized 31 - 35 | 74 Participants | 35 Participants | 39 Participants |
| HIV Risk Group Don't know | 10 Participants | 7 Participants | 3 Participants |
| HIV Risk Group IV Drug Usage | 3 Participants | 1 Participants | 2 Participants |
| HIV Risk Group Other | 2 Participants | 1 Participants | 1 Participants |
| HIV Risk Group Sex | 152 Participants | 63 Participants | 89 Participants |
| HIV Risk Group Sex and IV Drug Usage | 8 Participants | 6 Participants | 2 Participants |
| HIV Risk Group Sex (Female Only) | 3 Participants | 0 Participants | 3 Participants |
| HIV Risk Group Sex, IV Drug Usage and Transfusion | 16 Participants | 7 Participants | 9 Participants |
| HIV Risk Group Transfusion | 1 Participants | 0 Participants | 1 Participants |
| HIV Treatment Regimen 1 Pill/Day | 144 Participants | 53 Participants | 91 Participants |
| HIV Treatment Regimen 2 or More Pills/Day | 47 Participants | 28 Participants | 19 Participants |
| HIV Treatment Regimen No Medical Info | 4 Participants | 3 Participants | 1 Participants |
| HIV Treatment Regimen No Treatment | 2 Participants | 1 Participants | 1 Participants |
| IV Drug Usage Risk Factor No | 168 Participants | 71 Participants | 97 Participants |
| IV Drug Usage Risk Factor Yes | 27 Participants | 14 Participants | 13 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 154 Participants | 61 Participants | 93 Participants |
| Race/Ethnicity, Customized Hispanic | 18 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Multiracial, non-Hispanic | 10 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Other, non-Hispanic | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 11 Participants | 9 Participants | 2 Participants |
| Region of Enrollment United States | 197 Participants | 85 Participants | 112 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 197 Participants | 85 Participants | 112 Participants |
| Viral Load Suppressed No | 70 Participants | 31 Participants | 39 Participants |
| Viral Load Suppressed Unknown | 20 Participants | 4 Participants | 16 Participants |
| Viral Load Suppressed Yes | 107 Participants | 50 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 85 |
| other Total, other adverse events | 0 / 112 | 0 / 85 |
| serious Total, serious adverse events | 0 / 112 | 0 / 85 |
Outcome results
Primary
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
Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients at Intervention Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | FU1 | 8.4 [Units on a scale] | Standard Deviation 6.4 |
| Patients at Intervention Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | FU2 | 8.5 [Units on a scale] | Standard Deviation 7.1 |
| Patients at Intervention Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | Baseline | 8.9 [Units on a scale] | Standard Deviation 7 |
| Patients at CONTROL Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | FU2 | 8.5 [Units on a scale] | Standard Deviation 6.5 |
| Patients at CONTROL Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | FU1 | 9.5 [Units on a scale] | Standard Deviation 7 |
| Patients at CONTROL Site | Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale | Baseline | 8.4 [Units on a scale] | Standard Deviation 6.6 |
Comparison: Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Groupp-value: 0.213Regression, Linear
Comparison: Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.561Regression, Linear
p-value: 0.008Regression, Linear
Primary
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
Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients at Intervention Site | Mental Health: Rosenberg Self-Esteem Scale | Baseline | 3.2 [Units on a scale] | Standard Deviation 0.6 |
| Patients at Intervention Site | Mental Health: Rosenberg Self-Esteem Scale | FU1 | 3.2 [Units on a scale] | Standard Deviation 0.5 |
| Patients at Intervention Site | Mental Health: Rosenberg Self-Esteem Scale | FU2 | 3.1 [Units on a scale] | Standard Deviation 0.6 |
| Patients at CONTROL Site | Mental Health: Rosenberg Self-Esteem Scale | Baseline | 3.2 [Units on a scale] | Standard Deviation 0.6 |
| Patients at CONTROL Site | Mental Health: Rosenberg Self-Esteem Scale | FU1 | 3.1 [Units on a scale] | Standard Deviation 0.6 |
| Patients at CONTROL Site | Mental Health: Rosenberg Self-Esteem Scale | FU2 | 3.0 [Units on a scale] | Standard Deviation 0.6 |
Comparison: Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Groupp-value: 0.4Regression, Linear
Comparison: Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.022Regression, Linear
Comparison: Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.347Regression, Linear
Primary
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
Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | FU2: Summary QOL Score | 7.1 [Units on a scale] | Standard Deviation 2.3 |
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | FU1: Summary QOL Score | 7.0 [Units on a scale] | Standard Deviation 2.2 |
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | Baseline: Global QOL Item | 6.9 [Units on a scale] | Standard Deviation 2.4 |
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | FU2: Global QOL Item | 7.2 [Units on a scale] | Standard Deviation 2.5 |
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | FU1: Global QOL Item | 7.3 [Units on a scale] | Standard Deviation 2.3 |
| Patients at Intervention Site | Quality of Life: McGill Quality of Life Scale | Baseline: Summary QOL Score | 7.0 [Units on a scale] | Standard Deviation 2.1 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | FU2: Summary QOL Score | 6.2 [Units on a scale] | Standard Deviation 2.2 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | Baseline: Global QOL Item | 6.7 [Units on a scale] | Standard Deviation 2.6 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | Baseline: Summary QOL Score | 6.9 [Units on a scale] | Standard Deviation 2.1 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | FU1: Global QOL Item | 7.1 [Units on a scale] | Standard Deviation 2.5 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | FU1: Summary QOL Score | 6.9 [Units on a scale] | Standard Deviation 2.3 |
| Patients at CONTROL Site | Quality of Life: McGill Quality of Life Scale | FU2: Global QOL Item | 6.4 [Units on a scale] | Standard Deviation 2.8 |
Comparison: Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Groupp-value: 0.959Regression, Linear
Comparison: Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.021Regression, Linear
Comparison: Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.454Regression, Linear
Comparison: Change in Summary QOL from Baseline to First Follow-upp-value: 0.774Regression, Linear
Comparison: Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.018Regression, Linear
Comparison: Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Groupp-value: 0.362Regression, Linear
Secondary
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
Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1. There was 1 case for which adherence data was missing for the patient.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients at Intervention Site | Adherence | Baseline | Not Adherent | 53 Participants |
| Patients at Intervention Site | Adherence | Baseline | Adherent | 59 Participants |
| Patients at Intervention Site | Adherence | FU1 | Not Adherent | 42 Participants |
| Patients at Intervention Site | Adherence | FU1 | Adherent | 55 Participants |
| Patients at Intervention Site | Adherence | FU2 | Not Adherent | 34 Participants |
| Patients at Intervention Site | Adherence | FU2 | Adherent | 46 Participants |
| Patients at CONTROL Site | Adherence | FU2 | Not Adherent | 33 Participants |
| Patients at CONTROL Site | Adherence | Baseline | Not Adherent | 39 Participants |
| Patients at CONTROL Site | Adherence | FU1 | Adherent | 29 Participants |
| Patients at CONTROL Site | Adherence | Baseline | Adherent | 45 Participants |
| Patients at CONTROL Site | Adherence | FU2 | Adherent | 22 Participants |
| Patients at CONTROL Site | Adherence | FU1 | Not Adherent | 41 Participants |
Secondary
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
Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1. There were 11 cases for which viral load information was missing from the patient medical records.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients at Intervention Site | Viral Load Suppressed | Baseline | Not Virally Suppressed | 43 Participants |
| Patients at Intervention Site | Viral Load Suppressed | Baseline | Viral Load Suppressed | 59 Participants |
| Patients at Intervention Site | Viral Load Suppressed | FU1 | Not Virally Suppressed | 25 Participants |
| Patients at Intervention Site | Viral Load Suppressed | FU1 | Viral Load Suppressed | 48 Participants |
| Patients at Intervention Site | Viral Load Suppressed | FU2 | Not Virally Suppressed | 18 Participants |
| Patients at Intervention Site | Viral Load Suppressed | FU2 | Viral Load Suppressed | 50 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | FU2 | Not Virally Suppressed | 19 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | Baseline | Not Virally Suppressed | 32 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | FU1 | Viral Load Suppressed | 44 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | Baseline | Viral Load Suppressed | 52 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | FU2 | Viral Load Suppressed | 36 Participants |
| Patients at CONTROL Site | Viral Load Suppressed | FU1 | Not Virally Suppressed | 20 Participants |