Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:October 13, 2013
End Date:March 28, 2017

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Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting
co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance
care planning (ACP) for end-of-life decision, miscommunication and disagreements may result
in families being charged with neglect or court battles over treatment choices, unmet care or
delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g.
gay partners). We hope to increase families' understandings of their family member's wishes
for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care
Planning intervention. We will also study communication, quality of life, and spiritual
struggle. Families will be randomized into either the Control (N=96 families) or the FACE
Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for
two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices
Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet
with a researcher for two 60-minute sessions scheduled one week apart: Session 1:
Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be
administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an
average of 2 years.

AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA
and their surrogates over time, and the effect of the pattern of congruence development
trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations,
dialysis, ER visits).

Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the
pattern of congruence development.

Hypothesis B: Different patterns of congruence development may have different effects on
health care utilization.

Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over
time.

AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE
participants will increase or better maintain psychosocial QOL compared to Controls.

AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify
factors associated with disparities.

Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate
comparable to non Blacks, and at significantly greater rates compared to Controls.

Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting
co-morbidities aimed at relieving suffering and maximizing quality of life. One objective is
to identify variables which influence decision-making with respect to advance care planning
(ACP) for PLWA, as well as to determine the unique person-centered needs of subgroups of
PLWA, as these are unknown. The negative consequences of no ACP or poor ACP include: unmet
care or delivery of unnecessary or unwanted care, conflict erupting in the ICU, or the
importance of non-relative caregivers being dismissed, for example gay partners. A second
objective is to identify a "best approach" for standard of care in ACP, a key component of
palliative care, as an end of life support. This approach may minimize health disparities in
the likelihood of both identifying a surrogate decision-maker and using advance directives.
We propose building on our evidence based, theoretical model, FAmily-CEntered (FACE) Advance
Care Planning intervention, an HIV specific ACP program for Black teens which gained
acceptance and demonstrated efficacy through increased congruence in treatment preferences
and universal complete of advance directives with a surrogate decision-maker. Given the
demonstrated needs and benefits of ACP and the low utilization among adult Black PLWA, we
propose meeting this need by building on our FACE model with adults living with advanced AIDS
and/or life-limiting co-morbidities in Washington, District of Columbia (DC) a city with
endemic HIV and significant health disparities in death rates by race in an
adequately-powered, randomized, clinical, 2-arm, single-blinded, controlled trial. We will
test the efficacy of the FACE intervention for increasing congruence in end-of-life treatment
preferences between PLWA and their surrogate decision-maker, to determine if increased
congruence can be maintained over time. We will also determine if FACE is acceptable to
primarily Black inner city adult PLWA. We will recruit from four hospital-based clinics and
randomize 288 patient/surrogate dyads (N=576 subjects) in a 2:1 ratio to either FACE
Intervention (N=192 dyads) or Control (N=96 dyads). Participants with HIV dementia,
suicidality, homicidality or psychosis will be excluded. Two 60-minuted sessions will be
conducted with a trained/certified facilitator at weekly intervals: FACE Session 1: The
Respecting Choices Interview (R); Session 2: Completion of The Five Wishes (c). Control will
also be administered in a dyadic format: Session 1: Developmental History; Session 2:
Nutrition and Exercise. Standardized self-report measures will be administered at baseline, 3
month post-intervention 6 month post-intervention, 12 month post-intervention, and 18 month
post-intervention. Thus, participants will be followed for an average of 2 years. This will
be the first study to test an ACP model, integrating person-centered (GMM) and
variable-centered analysis (GEE) to assess study outcomes.

Patient Inclusion Criteria:

- HIV positive outpatients or inpatients with detectable viral load (>200 copies) twice
in the past 1 year period OR CD4 count <200 OR with a co-morbidity that may
significantly limit life expectancy, including malignancy, cirrhosis, cardiomyopathy,
etc.

- Patients with AIDS receiving dialysis, inpatients or outpatients

- Patients not in the Intensive Care Unit (ICU)

- Age 21 years or older

- All ethnic groups

- Male or female

- Knows his/her HIV status

- English speaking

- Absence of active psychosis or homicidal or suicidal ideation, determined at baseline
screening by a trained research assistant as assessed by questions from a structured
questionnaire

- Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off
score of <10

- No evidence of developmental delay

- Consent from surrogate

- Consent from persons living with AIDS (PLWA) aged 21 or older

Surrogate Decision-maker inclusion criteria:

- Selected by patient

- Age 18 or older

- Willingness to discuss problems related to HIV and End Of Life (EOL)

- Absence of active psychosis, homicidal ideation, or suicidal ideation determined at
baseline screening by trained RA

- Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off
score of <10

- English speaking

- Consent to participate

- Knows HIV status of patient

Patient Exclusion Criteria:

- Patients in the ICU

- Age under 21 years old

- Patient unaware of HIV status

- Active psychosis or homicidal or suicidal ideation, determined at baseline screening
by a trained research assistant as assessed by questions from a structured
questionnaire

- Presence fo HIV Dementia at baseline

- Developmental delay

- Unable to find willing consented surrogate

Surrogate Decision-maker Exclusion Criteria:

- Surrogate under age of 18 years old

- Unwilling to discuss problems related to HIV and EOL

- Active psychosis or homicidal or suicidal ideation, determined at baseline screening
by a trained research assistant as assessed by questions from a structured
questionnaire

- Not an English speaker

- Unwilling to consent to participate and does not know HIV status of patient
We found this trial at
5
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington, District of Columbia 20052
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