An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
UPHOLDS
Project UPHOLDS: An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
2 other identifiers
interventional
64
1 country
1
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 advancing heart failure. Using a 2x2x2x2 factorial design, 64 adults with advancing 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedStudy Start
First participant enrolled
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
February 5, 2026
February 1, 2026
2 years
May 18, 2023
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility of Intervention Delivery and Data Collection
Proportion of participants who complete assigned intervention components and study-related assessments.
Baseline to 24 weeks
Acceptability of Intervention and Study Procedures
Through qualitative interviews, participant reported experiences with the UPHOLDS intervention and trial procedures.
Baseline to 24 weeks
Secondary Outcomes (3)
Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12
12 and 24 weeks after baseline
Financial toxicity using the Comprehensive score for financial Toxicity
12 and 24 weeks after baseline
Mood using the Hospital Anxiety and Depression Scale
12 and 24 weeks after baseline
Study Arms (16)
Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up calls
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Basic palliative care coaching + outpatient visit + 1 monthly follow-up call
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Basic palliative care coaching + outpatient visit + 4 monthly follow-up calls
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup calls
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions,1 telehealth session on strategies to address healthcare-related financial toxicity, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Advanced palliative care coaching + outpatient visit + 1 monthly follow-up call
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and a single monthly follow-up call
Advanced palliative care coaching + outpatient visit + 4 monthly follow-up calls
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, one-time Comprehensive Specialty Outpatient Palliative Care Clinic guided by the National Consensus Project for Quality Palliative Care Guidelines, and monthly follow-up calls for 4 months
Basic palliative care coaching + financial coaching + 1 monthly follow-up call
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, and a single monthly follow-up call
Basic palliative care coaching + financial coaching + 4 monthly follow-up calls
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, 1 telehealth session on strategies to address healthcare-related financial toxicity, and monthly follow-up calls for 4 months
Basic palliative care coaching + 1 monthly follow-up call
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and a single monthly follow-up call
Basic palliative care coaching + 4 monthly follow-up calls
EXPERIMENTAL4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and monthly follow-up calls for 4 months
Advanced palliative care coaching + financial coaching + 1 monthly follow-up call
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, and a single monthly follow-up call
Advanced palliative care coaching + financial coaching + 4 monthly follow-up calls
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, 1 telehealth session on strategies to address healthcare-related financial toxicity, and monthly follow-up calls for 4 months
Advanced palliative care coaching + 1 monthly follow-up call
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions, and a single monthly follow-up call
Advanced palliative care coaching + 4 monthly follow-up calls
EXPERIMENTAL8 telehealth sessions on principles of self-care, symptom management, and advanced care planning: This component level will expand the depth and topic range of content offered in the 4 sessions into eight 20-30 minute sessions and monthly follow-up calls for 4 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) Age ≥50 years; 2) Living with heart failure, defined as New York Heart Association Class II-IV or American Heart Association Stage C/D OR Recent hospitalization with primary diagnosis of acute, decompensated heart failure (discharged \< last 6 months); 3) English speaking; 4) Willingness to participate in intervention and complete data collection calls; 5) Telephone access.
You may not qualify if:
- \) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 18, 2023
First Posted
May 30, 2023
Study Start
August 15, 2024
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share