Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle
Condition: HIV
Study type: Interventional

Summary: 
      Our goal is to advance palliative care to adolescents and their families. We hope our study
      will decrease suffering (psychological, spiritual, physical) and increase quality of life
      (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may
      result in families being charged with neglect or court battles over treatment choices. FAmily
      CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their
      families for future medical decisions. We hope to increase families' understanding of their
      teens' wishes for end-of-life care and to decrease conflict. We will also study communication
      and spiritual struggle Families will be randomized into the either the Control (N=65
      families) or FACE Intervention (N=65 families). FACE families will meet with a
      trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart:
      Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2:
      The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families
      will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart:
      Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition.
      Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months
      from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve
      psychological suffering by 1) increasing congruence in treatment preferences between teens
      with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision
      making for future medical treatment in adolescents with AIDS; 3) increasing quality
      communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and
      maximizing QOL.

      Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through
      dimensions of threat appraisal.

      Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have
      less spiritual struggle.

      Hypothesis 4: Spiritual struggle has both direct and indirect effects on
      hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly
      through threat appraisal and HAART adherence.
    

Detailed description: 
      Our goal is to advance palliative care with children and their families aimed at relieving
      suffering (psychological, spiritual, physical) and maximizing quality of life. Left
      unprepared for end-of-life decisions, miscommunication and disagreements may result in
      families being charged with neglect, court battles and even legislative intervention. We
      propose building on our R34, evidence based model, the Family Centered (FACE) Advance Care
      Planning intervention, to test our full theoretical model examining the putative mediators
      and moderators, and spiritual struggle (negative religious coping) with a sicker group and
      adolescents with AIDS in an adequately powered randomized, clinical, 2-arm, controlled trial.
      FACE is a culturally sensitive and developmentally appropriate, manualized family
      intervention based on transactional stress and coping theory, which prepares adolescents with
      HIV/AIDS and their families for end-of-life decision-making through problem solving.
      Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal,
      particularly the way in which an event threatens the child's goals or values. Spiritual
      struggle (negative religious coping) may be a source of distress, causing disparities in
      palliative care and outcomes. We will test the efficacy of the FACE intervention for
      increasing communication and congruence in end-of-life treatment preferences between teens
      with AIDS and their surrogates, and determine if increased congruence can be maintained over
      time. We will also examine the impact of the FACE intervention on decisional conflict,
      quality of communication, and patient quality of life. We will also evaluate hypothesized
      mediators (threat appraisal, HAART adherence) and moderator (spiritual struggle) of study
      outcomes, including hospitalizations. We will recruit from hospital-based clinics and
      randomize 130 adolescent/surrogate dyads (N=260 subjects) to either Control (N=65 dyads) or
      FACE Intervention (N=65 dyads). Participants with HIV dementia, severe depression,
      suicidality or homicidality or in foster care will not be allowed to participate. Three 60-
      to 90-minute sessions will be conducted with a certified interviewer at weekly intervals:
      FACE: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions:
      Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©.
      Control will also be administered in a family group format to control for time, attention,
      and Hawthorn effects: Session 1: Developmental History, Session 2: Safety Tips, and Session
      3: Safety Tips. Standardized self-report measures will be administered at baseline, immediate
      post intervention (3 month), and 6, 12 and 18 month post intervention. Generalized estimating
      equation (GEE) will assess outcomes.
    

Intervention name(s): FAmily CEntered (FACE) ACP; Healthy Living Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care & when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care & prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have.; Active Comparator: Three 60 to 90 minute sessions scheduled one week apart. 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. 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.
3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides.
Other intervention name(s): FACE; HLC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: palliative care; AIDS; adolescents; 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