HIV Infections Clinical Trial
Official title:
Family Centered Advanced Care Planning (FCACP)
This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.
More than 30,000 adolescents in the United States die annually from the effects of chronic
illnesses. The anxiety from facing a terminal illness often hinders adolescents in making
decisions about their own end-of-life (EOL) care. Although minors' preferences are not
legally binding, legislature, research, and professional guidelines all recommend that
adolescent patients become involved in EOL decisions as part of routine intervention while
they are stable. Family Centered Advance Care Planning (FCACP) is an intervention that
facilitates EOL discussion among adolescents, their families, and their care providers. This
pilot study will examine FCACP's effects on adaptive coping, psychological adjustment,
quality of life, and plans and actions in HIV infected adolescents. The study will also
provide feedback used for improving the FCACP Web site.
This study will include HIV or AIDS infected adolescents ranging in age from 14 to 21 who
will jointly enroll with a selected surrogate older than 21. The adolescent/surrogate pairs
will be randomly assigned to receive either the FCACP intervention or a health education
control intervention. Pairs not immediately ready to participate will form an observational
group. Pairs in the FCACP group will meet with a trained facilitator weekly for a 60- to
90-minute session for a total of 3 weeks. During the first session, participants will take
the Lyon Advance Care Planning Survey. The second session will consist of the Respecting
Choices Interview, where patients will discuss treatment preferences. The Family
Problem-Solving session will be last, culminating with the patient's completion of an
advance directive. The control groups will follow the same meeting schedule, but will
receive health education sessions, not FCACP sessions. Standardized self-report measures
will be administered upon entry, after completion of the sessions, and at a 3-month follow
up. Usage data will also be analyzed regarding feasibility and acceptability of FCACP as a
standard treatment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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