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

Primary Purpose

Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Chronic Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UPHOLDS (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure NYHA Class III

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. - 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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm 16

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call

    Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up calls

    Basic palliative care coaching + outpatient visit + 1 monthly follow-up call

    Basic palliative care coaching + outpatient visit + 4 monthly follow-up calls

    Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call

    Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup calls

    Advanced palliative care coaching + outpatient visit + 1 monthly follow-up call

    Advanced palliative care coaching + outpatient visit + 4 monthly follow-up calls

    Basic palliative care coaching + financial coaching + 1 monthly follow-up call

    Basic palliative care coaching + financial coaching + 4 monthly follow-up calls

    Basic palliative care coaching + 1 monthly follow-up call

    Basic palliative care coaching + 4 monthly follow-up calls

    Advanced palliative care coaching + financial coaching + 1 monthly follow-up call

    Advanced palliative care coaching + financial coaching + 4 monthly follow-up calls

    Advanced palliative care coaching + 1 monthly follow-up call

    Advanced palliative care coaching + 4 monthly follow-up calls

    Arm Description

    4 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

    4 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

    4 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

    4 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

    8 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

    8 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

    8 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

    8 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

    4 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

    4 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

    4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and a single monthly follow-up call

    4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and monthly follow-up calls for 4 months

    8 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

    8 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

    8 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

    8 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

    Outcomes

    Primary Outcome Measures

    Feasibility of Intervention Delivery and Data Collection
    Proportion of participants who complete assigned intervention components and study-related assessments.
    Acceptability of Intervention and Study Procedures
    Through qualitative interviews, participant reported experiences with the UPHOLDS intervention and trial procedures.

    Secondary Outcome Measures

    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.
    Financial toxicity using the Comprehensive score for financial Toxicity
    10 items total; Measures level of concern regarding cost and resources.
    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.

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    September 21, 2023
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05879887
    Brief Title
    An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
    Acronym
    UPHOLDS
    Official Title
    Project UPHOLDS: An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute of Nursing Research (NINR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Chronic Illness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    2x2x2x2 full factorial pilot randomized trial
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Basic palliative care coaching + outpatient visit + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Basic palliative care coaching + outpatient visit + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup calls
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + outpatient visit + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + outpatient visit + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Basic palliative care coaching + financial coaching + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Basic palliative care coaching + financial coaching + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    4 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
    Arm Title
    Basic palliative care coaching + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and a single monthly follow-up call
    Arm Title
    Basic palliative care coaching + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    4 telehealth sessions on principles of problem solving, self-care, symptom management, and advanced care planning, and monthly follow-up calls for 4 months
    Arm Title
    Advanced palliative care coaching + financial coaching + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + financial coaching + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + 1 monthly follow-up call
    Arm Type
    Experimental
    Arm Description
    8 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
    Arm Title
    Advanced palliative care coaching + 4 monthly follow-up calls
    Arm Type
    Experimental
    Arm Description
    8 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    UPHOLDS (Utilizing Palliative Care for Heart Failure Optimized using Lay Navigators to Decrease Suffering)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Feasibility of Intervention Delivery and Data Collection
    Description
    Proportion of participants who complete assigned intervention components and study-related assessments.
    Time Frame
    Baseline to 24 weeks
    Title
    Acceptability of Intervention and Study Procedures
    Description
    Through qualitative interviews, participant reported experiences with the UPHOLDS intervention and trial procedures.
    Time Frame
    Baseline to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of Life using the Kansas City Cardiomyopathy Questionnaire- 12
    Description
    12 items total; Measures changes in the quality of life, 5 domains: physical limitations, symptoms, self-efficacy, social interference, and quality of life.
    Time Frame
    12 and 24 weeks after baseline
    Title
    Financial toxicity using the Comprehensive score for financial Toxicity
    Description
    10 items total; Measures level of concern regarding cost and resources.
    Time Frame
    12 and 24 weeks after baseline
    Title
    Mood using the Hospital Anxiety and Depression Scale
    Description
    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.
    Time Frame
    12 and 24 weeks after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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. - 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 -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kayleigh Curry, MPH
    Phone
    205-996-0107
    Email
    kayleigh@uab.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Margaret Armstrong, MSN
    Phone
    205-996-0109
    Email
    mlga@uab.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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