Clinical trial NCT01775436: Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
Official title: Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: palliative care
HIV/AIDS
quality of life
adherence
spiritual
threat appraisal
treatment congruence
treatment preferences
dialysis
hospitalization
communication
family intervention
Family Centered Advance Care Planning
decision making
advance care planning
end of life
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: George Washington University
name: VA Medical Center
name: Medstar Health Research Institute
First posted: 2013-01-25
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Statement of Treatment Preferences
timeFrame: Baseline and 3, 6, 12, 18 month post-intervention
Secondary outcomes:
measure: Lyon Advance Care Planning Survey (Patient and Surrogate Version)
timeFrame: at baseline
measure: Palliative Care Outcome Scale (POS)
timeFrame: Baseline, and 3, 6, 12 and 18 month post-intervention
measure: Medical Outcomes Study-HIV (MOS-HIV)
timeFrame: Baseline, and 3, 6, 12 and 18 month post-intervention
Other outcomes:
measure: HIV Dementia Scale
timeFrame: Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
measure: Psychological Interview
timeFrame: Baseline to screen to determine eligibility
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up
measure: Medication Adherence Self Report Inventory (MASRI)
timeFrame: Baseline and 3, 6, 12 and 18 month follow-up
measure: Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted)
timeFrame: Baseline and 3, 6, 12 and 18-month post intervention
measure: Brief Religious Coping Questionnaire (Brief RCOPE)
timeFrame: Baseline and 3, 6, 12 and 18-month post-intervention
measure: Satisfaction Scale
timeFrame: Immediately following Session 1 and Session 2, week 2 and week 3 of the study
measure: Longitudinal Satisfaction Questionnaire
timeFrame: 3, 6, 12 and 18 month post-intervention
measure: Medical Chart Abstraction
timeFrame: Baseline and 3, 6, 12 and 18 month post intervention
measure: Threat Appraisal Scale (TAS)
timeFrame: Baseline, 3, 6, 12 and 18 month post-intervention
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC)
state: District of Columbia
city: Washington
country: United States
facility: MedStar Health Research Institute/Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Maureen E Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kimmel AL, Wang J, Scott RK, Briggs L, Lyon ME. FAmily CEntered (FACE) advance care planning: Study design and methods for a patient-centered communication and decision-making intervention for patients with HIV/AIDS and their surrogate decision-makers. Contemp Clin Trials. 2015 Jul;43:172-8. doi: 10.1016/j.cct.2015.06.003. Epub 2015 Jun 2.
citation: Lyon ME, Squires L, D'Angelo LJ, Benator D, Scott RK, Greenberg IH, Tanjutco P, Turner MM, Weixel TE, Cheng YI, Wang J. FAmily-CEntered (FACE) Advance Care Planning Among African-American and Non-African-American Adults Living With HIV in Washington, DC: A Randomized Controlled Trial to Increase Documentation and Health Equity. J Pain Symptom Manage. 2019 Mar;57(3):607-616. doi: 10.1016/j.jpainsymman.2018.11.014. Epub 2018 Nov 23.
citation: Curtin KB, Cheng YI, Wang J, Scott RK, Squires L, Benator DA, Lyon ME; Palliative Care Consortiums. Quality of life of persons living with HIV and congruence with surrogate decision-makers. Qual Life Res. 2019 Jan;28(1):47-56. doi: 10.1007/s11136-018-2002-5. Epub 2018 Sep 15.
citation: Lyon ME, Squires L, Scott RK, Benator D, Briggs L, Greenberg I, D'Angelo LJ, Cheng YI, Wang J. Effect of FAmily CEntered (FACE(R)) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial. AIDS Behav. 2020 Dec;24(12):3359-3375. doi: 10.1007/s10461-020-02909-y.
citation: Grill KB, Wang J, Cheng YI, Lyon ME. The Role of Religiousness and Spirituality in Health-related Quality of Life of Persons Living with HIV: A Latent Class Analysis. Psycholog Relig Spiritual. 2020 Nov;12(4):494-504. doi: 10.1037/rel0000301. Epub 2020 Jan 30.