Overview

This trial is active, not recruiting.

Condition hiv
Treatments family-centered advance care planning, healthy living control
Sponsor Children's Research Institute
Collaborator Georgetown University
Start date April 2013
End date October 2017
Trial size 444 participants
Trial identifier NCT01775436, 1R01NR01405201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Two-60 to 90 minute sessions scheduled one week apart. Session 1: Developmental History: Goal: To take a non-medical developmental history. The Research Assistant (RA)-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention.
family-centered advance care planning FACE
Two-60 to 90 minute sessions scheduled one week apart. Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care & prepare the surrogate to be able to fully represent the patient's wishes. Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have.
healthy living control HLC
Session 1: Developmental History: Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention.
(Experimental)
Two-60 to 90 minute sessions scheduled one week apart. Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care & prepare the surrogate to be able to fully represent the patient's wishes. Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have.
family-centered advance care planning FACE
Two-60 to 90 minute sessions scheduled one week apart. Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care & prepare the surrogate to be able to fully represent the patient's wishes. Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have.
healthy living control HLC
Session 1: Developmental History: Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention.

Primary Outcomes

Measure
Statement of Treatment Preferences
time frame: Baseline and 3, 6, 12, 18 month post-intervention

Secondary Outcomes

Measure
Lyon Advance Care Planning Survey (Patient and Surrogate Version)
time frame: at baseline
Palliative Care Outcome Scale (POS)
time frame: Baseline, and 3, 6, 12 and 18 month post-intervention
Medical Outcomes Study-HIV (MOS-HIV)
time frame: Baseline, and 3, 6, 12 and 18 month post-intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
Principal investigator Maureen E Lyon, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Research Institute.