Clinical trial NCT05879887: An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
Official title: Project UPHOLDS: An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Chronic Illness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-05-30
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2x2 full factorial pilot randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advanced heart failure. Using a 2x2x2x2 factorial design, 64 adults with advanced heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

Detailed description: A priority NINR, nursing, and palliative care focus is how to best support patients with advanced AHA Stage C/D heart failure (HF). HF, a progressive condition, affecting 6.2 million U.S. adults results in reduced quality of life (QOL), high symptom burden, and unpredictable disease trajectory.There is a critical need to develop effective and scalable early palliative care (PC) interventions for patients with advanced HF, especially in the Southeastern U.S., where there is a high proportion of underserved groups (e.g., African-Americans, rural dwellers) who experience high HF morbidity and mortality.However, few interventions have been tested and demonstrated effectiveness- and none have been widely translated to practice.

Recent major systematic reviews and research agendas identify developing efficacious and scalable HF PC interventions as a key research priority. However, these efforts are stymied by a lack of understanding "active" PC interventions components. Traditional RCTs treat interventions as "bundled" packages, making it hard to assess definitively which intervention components are most essential for efficacy and efficiency. Hence, innovative methods are needed to efficiently test multiple intervention components simultaneously. To address this problem, prior work has developed and refined intervention components for underresourced Southern older adults with advanced HF (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering -Project UPHOLDS).

Based on Ferrans' Health-Related QOL Model, we will use the highly innovative Multiphase Optimization Strategy (MOST)1 strategy to pilot test via a factorial design the individual UPHOLDS components with underresourced, older adults with advanced HF (n=64) who will be randomized to receive different levels of the following UPHOLDS intervention components: 1) outpatient PC consultation (Yes vs. No), 2) lay navigator PC coaching sessions addressing self-care, symptom management, communication, problem solving, decision-making, and advance care planning (4 vs. 8 weekly telephone sessions), 3) financial coaching session addressing financial distress and resources (Yes vs. No) and 4) monthly maintenance follow-up phone calls (1 vs. 4 calls).

Aim 1: Using the innovative MOST factorial design, determine UPHOLDS feasibility, acceptability, enrollment, retention, and completion rates in participants (n=64) for 24 weeks. Feasibility: \>80% of participants will be enrolled, retained, and will complete all measures and all intervention components. Acceptability: Positive post-intervention interviews.

Aim 2: Explore the preliminary efficacy of individual intervention components and component interaction on patient outcomes at 12- and 24- weeks after baseline including a) QOL using the Kansas City Cardiomyopathy Scale (primary outcome) b) financial toxicity using the Comprehensive score for financial toxicity, and c) mood using the Hospital Anxiety and Depression Scale.

Aim 3 (Exploratory): Explore mediators and moderators (e.g., sociodemographics, self-management skills, financial well-being, self-efficacy) of the relationship between intervention components and patient outcomes

Eligibility criteria: Inclusion Criteria:

1) Age ≥50 years; 2) Living with advanced heart failure, defined as New York Heart Association Class III-IV or American Heart Association Stage C/D; 2) Recent hospitalization with primary diagnosis of acute, decompensated heart failure (discharged \< last 6 months); 3) Identifies as a member of a NIH-designated U.S. health disparity population or primary residence in a rural RUCA zip code; 4) English speaking; 5) Willingness to participate in intervention and complete data collection calls; 6) Telephone access.

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Exclusion Criteria:

1) Self-reported severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, or active substance abuse; 2) LVAD placement; 3) Non-cardiac terminal illness; 4) Previous palliative care consultation; 5) Receiving hospice

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Primary outcomes:
measure: Feasibility of Intervention Delivery and Data Collection
timeFrame: Baseline to 24 weeks
measure: Acceptability of Intervention and Study Procedures
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12
timeFrame: 12 and 24 weeks after baseline
measure: Financial toxicity using the Comprehensive score for financial Toxicity
timeFrame: 12 and 24 weeks after baseline
measure: Mood using the Hospital Anxiety and Depression Scale
timeFrame: 12 and 24 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: