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Table 1 List of Specific Aims, Hypotheses, and Objectives for the Study

From: Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial

Specific Aim 1: Test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF in rural WV.
Hypothesis 1a. The intervention group HF patients will rate greater improvement on: (a) confidence and preparedness in management of their severe HF (status, breathlessness, anxiety, and depression); (b) increased numbers of signed decisions about their preferred EOLPC options for advanced HF; (c) increased numbers of signed advance directives, compared to control group patients at 6 months.
Hypothesis 1b. The intervention group family caregivers will rate greater improvement on: (a) quality of life (physical, mental), (b) confidence and preparedness in providing home HF EOLPC, and (c) home care burden, compared to control group caregivers at 6 months.
Specific Aim 2: Assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials.
Aim 2a. Evaluate the quality of EOLPC of the FamPALcare intervention measured via (1) patient/family caregiver intervention helpfulness questionnaire responses; (2) multidisciplinary healthcare professionals’ and rural community leaders’ focus group research on the FamPALcare outcomes; and (3) determination of FamPALcare implementation cost using traditional tabulated cost minimization analysis.
Aim 2b. Collect participant recruitment, enrollment, and retention rates to determine future recruitment strategies and understand reasons for non-participation to maintain good rates in rural clinical studies. The fidelity of the FamPALcare intervention will be assessed using trained research nurse observer checklists.