An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

Chronic Illness Clinical Trial

— UPHOLDS  

Official title:

Project UPHOLDS: An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879887
• Other study ID #: IRB-300011233
• Secondary ID: 4R00NR019854-03
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Kayleigh Curry, MPH
• Phone: 205-996-0107
• Email: kayleigh[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness
• Heart Failure
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Behavioral:
• UPHOLDS (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering)
UPHOLDS is a multicomponent, lay palliative care coach-led supportive care intervention designed to improve quality of life in individuals with advanced heart failure. In a series of weekly, one-on-one, 15-20 minute sessions, participants receive psychoeducation on palliative care principles (problem solving, self-care, symptom management, and advanced care planning), financial coaching (orientation to normalizing financial distress, introducing healthcare-related financial terms, exploring financial needs and steps to discussing finances in care decisions, and identifying financial resources in the health system and community), a one-time specialty palliative care outpatient clinic visit, as well as monthly follow-up.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Delivery and Data Collection	Proportion of participants who complete assigned intervention components and study-related assessments.	Baseline to 24 weeks
Primary	Acceptability of Intervention and Study Procedures	Through qualitative interviews, participant reported experiences with the UPHOLDS intervention and trial procedures.	Baseline to 24 weeks
Secondary	Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12	12 items total; Measures changes in the quality of life, 5 domains: physical limitations, symptoms, self-efficacy, social interference, and quality of life.	12 and 24 weeks after baseline
Secondary	Financial toxicity using the Comprehensive score for financial Toxicity	10 items total; Measures level of concern regarding cost and resources.	12 and 24 weeks after baseline
Secondary	Mood using the Hospital Anxiety and Depression Scale	14 items; measures symptoms of anxiousness and depressed mood. 7 items measure anxiety (e.g., feeling tense, restless, worried) and 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down. Subscale score ranges: 0-21; higher scores=worse anxiety or depressive symptoms. Total score range: 0-42; higher scores=worse overall distress.	12 and 24 weeks after baseline