Palliative Care for Advanced Heart Failure

(UPHOLDS Trial)

Overseen By Margaret Armstrong, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe mental illness, Dementia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment UPHOLDS for advanced heart failure?

Research shows that palliative care can improve symptoms and quality of life for patients with advanced heart failure, suggesting that treatments like UPHOLDS may be beneficial. Palliative care has been shown to help with treatment outcomes and support both patients and their families. ^{1 2 3 4 5}

Is palliative care safe for people with advanced heart failure?

Palliative care is generally considered safe for people with advanced heart failure, as it focuses on improving quality of life and managing symptoms. It is recommended by major cardiovascular societies and involves a holistic approach to care. ^{5 6 7 8 9}

How is the UPHOLDS treatment different from other treatments for advanced heart failure?

The UPHOLDS treatment is unique because it focuses on palliative care, which is a holistic approach that addresses not just physical symptoms but also the emotional and spiritual needs of patients with advanced heart failure. This approach can improve quality of life, reduce hospital visits, and help with planning for end-of-life care, which is not typically the focus of standard heart failure treatments. ^{6 10 11 12 13}

Eligibility Criteria

This trial is for adults over 50 with advanced heart failure, recently hospitalized for it, and either part of a health disparity group or living in rural areas. They must speak English, be willing to participate fully, and have phone access.

Inclusion Criteria

Identifies as a member of a NIH-designated U.S. health disparity population or primary residence in a rural RUCA zip code

Willingness to participate in intervention and complete data collection calls

English speaking

Exclusion Criteria

I have a left ventricular assist device (LVAD) implanted.

I have a terminal illness that is not related to heart disease.

I have had a consultation for palliative care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive palliative care coaching, financial coaching, and outpatient visits based on randomization. Coaching sessions vary between 4 to 8 telehealth sessions, with additional financial coaching and outpatient visits as applicable.

24 weeks

4-8 telehealth sessions, 1 outpatient visit, 1-4 monthly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of quality of life, financial toxicity, and mood.

4 weeks

Treatment Details

Interventions

• UPHOLDS

Trial Overview The UPHOLDS intervention aims to improve life quality in older adults with advanced heart failure through palliative care coaching. It tests different combinations of psychoeducation sessions, financial coaching, specialty consultations, and follow-up calls.

Participant Groups

Group I: Basic palliative care coaching + outpatient visit + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group II: Basic palliative care coaching + outpatient visit + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group III: Basic palliative care coaching + financial coaching + outpatient visit + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group IV: Basic palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group V: Basic palliative care coaching + financial coaching + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group VI: Basic palliative care coaching + financial coaching + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group VII: Basic palliative care coaching + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group VIII: Basic palliative care coaching + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group IX: Advanced palliative care coaching + outpatient visit + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group X: Advanced palliative care coaching + outpatient visit + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group XI: Advanced palliative care coaching + financial coaching + outpatient visit + 4 monthly followup calls Experimental Treatment 1 Intervention

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

Group XII: Advanced palliative care coaching + financial coaching + outpatient visit + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group XIII: Advanced palliative care coaching + financial coaching + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group XIV: Advanced palliative care coaching + financial coaching + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Group XV: Advanced palliative care coaching + 4 monthly follow-up calls Experimental Treatment 1 Intervention

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

Group XVI: Advanced palliative care coaching + 1 monthly follow-up call Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

Patients with heart failure (HF) are referred to palliative care (PC) later in their hospital stay compared to cancer patients, with an average delay of 4.6 days before consultation, which may limit the benefits of symptom management.

Despite being less likely to be referred for non-pain symptoms, patients with HF reported significant improvements in dyspnea after PC consultation, indicating that early involvement of PC could enhance symptom relief and overall care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. Liu, AY., O'Riordan, DL., Marks, AK., et al.[2020]

In a study involving 150 patients with advanced heart failure, all participants were on multiple medications (polypharmacy) at the start, and this number increased over time for both standard care and palliative care groups.

The palliative care intervention did not significantly reduce the number of medications compared to standard care, indicating that while palliative care aims to improve quality of life, it may not impact the overall medication burden in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience. Granger, BB., Tulsky, JA., Kaufman, BG., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Utility of the integrated palliative care outcome scale (IPOS): a cross-sectional study in hospitalised patients with heart failure. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The impact of palliative care on clinical and patient-centred outcomes in patients with advanced heart failure: a systematic review of randomized controlled trials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Characteristics for a tool for timely identification of palliative needs in heart failure: The views of Dutch patients, their families and healthcare professionals. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Palliative Care in Acute Heart Failure. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Palliative care in heart failure. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Palliative Care Consultation Affects How and Where Heart Failure Patients Die. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Hospitalisations for heart failure: increased palliative care referrals - a veterans affairs hospital initiative. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The palliative care in heart failure trial: rationale and design. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

The provision of home-based palliative care for those with advanced heart failure. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Patterns of Palliative Care Referral in Patients Admitted With Heart Failure Requiring Mechanical Ventilation. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Palliative care and hospice in advanced heart failure. [2021]