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

• Statement of Treatment Preferences [ Time Frame: Baseline and 3, 6, 12, 18 month post-intervention ] [ Designated as safety issue: No ]
  Measured by the Statement of Treatment Preferences. This measure was adapted using experts and community advisory board. It is a tool to express values and goals related to future medical decisions regarding frequently occurring situations specific to HIV/AIDS.Multiple Time Frames are needed as the Primary Outcome measure is going to report a change over time, per Aim 1: "to sustain congruence in treatment preferences between PLWA and their surrogate over time" compared to controls.
  
  

• Lyon Advance Care Planning Survey (Patient and Surrogate Version) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  A 31-item instrument that assesses palliative care needs of PLWA of Black and non Black PLWA in DC metropolitan area
  
  
• Palliative Care Outcome Scale (POS) [ Time Frame: Baseline, and 3, 6, 12 and 18 month post-intervention ] [ Designated as safety issue: No ]
  This scale is a valid and reliable measure of patient's current health, social and psychological status.We are conducting a longitudinal study and therefore looking at multiple time frames for change in palliative care over time.
  
  
• Medical Outcomes Study-HIV (MOS-HIV) [ Time Frame: Baseline, and 3, 6, 12 and 18 month post-intervention ] [ Designated as safety issue: No ]
  Measures HIV specific Health Related Quality of Life; general health perceptions; pain; physical, role, cognitive and social functioning; mental health; energy/fatigue; health distress and quality of life. This is a longitudinal study requiring multiple time frames so we can report change in quality of life over time, related to HIV specific symptoms.
  
  

• HIV Dementia Scale [ Time Frame: Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention ] [ Designated as safety issue: No ]
  Rapid screener to identify HIV dementia, which is an exclusion criteria. However, once enrolled in the study we will track changes in status over time, per the longitudinal nature of this study.
  
  
• Psychological Interview [ Time Frame: Baseline to screen to determine eligibility ] [ Designated as safety issue: No ]
  Questions to screen for homicidality and psychosis
  
  
• Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up ] [ Designated as safety issue: No ]
  Patients or surrogates who present with severe depression or suicidality are excluded from this study. However, once enrolled levels of depressive symptoms will be monitored over the course of this longitudinal study.
  
  
• Medication Adherence Self Report Inventory (MASRI) [ Time Frame: Baseline and 3, 6, 12 and 18 month follow-up ] [ Designated as safety issue: No ]
  Validated self-report measure of medication adherence, using the Visual Analogue Scale for estimated adherence in the past month. Measured multiple times as part of this longitudinal study.
  
  
• Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) [ Time Frame: Baseline and 3, 6, 12 and 18-month post intervention ] [ Designated as safety issue: No ]
  Assesses the construct of spiritual functioning, specifically subscales for Forgiveness, Values and Believes will be used for study purposes.
  
  
• Brief Religious Coping Questionnaire (Brief RCOPE) [ Time Frame: Baseline and 3, 6, 12 and 18-month post-intervention ] [ Designated as safety issue: No ]
  Assesses positive and negative religious coping methods. Study will use 14-item version.
  
  
• Satisfaction Scale [ Time Frame: Immediately following Session 1 and Session 2, week 2 and week 3 of the study ] [ Designated as safety issue: No ]
  Process measure developed in pilot study to assess satisfaction.
  
  
• Longitudinal Satisfaction Questionnaire [ Time Frame: 3, 6, 12 and 18 month post-intervention ] [ Designated as safety issue: No ]
  Process measure to assess longitudinal satisfaction with future decision making.
  
  
• Medical Chart Abstraction [ Time Frame: Baseline and 3, 6, 12 and 18 month post intervention ] [ Designated as safety issue: No ]
  Mode of transmission, Cluster of Differentiation 4 (CD4) count, viral load, hospitalization, emergency room visit or dialysis since last study visit.
  
  
• Threat Appraisal Scale (TAS) [ Time Frame: Baseline, 3, 6, 12 and 18 month post-intervention ] [ Designated as safety issue: No ]
  Threat Appraisal Scale (TAS)is a questionnaire administered to the adolescent during baseline assessment only. This measure will retrospectively estimate the adolescent's threat appraisal of cancer when adolescent learned of cancer diagnosis. Test-retest reliability for this measure ranges from .68 in younger children to .93 in older children. TAS scores are found to demonstrate a high degree of agreement with children's open-ended descriptions of negative life events, indicating adequate convergent validity of this measure. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly to the way in which the event threatens the child's commitments, goals, or values. Higher threat appraisals should lead to negative arousal and coping and to increased psychological symptoms.
  
  

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.