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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve the quality of life for individuals with advanced heart failure by testing various combinations of palliative care interventions, including the UPHOLDS program. Participants will receive telehealth coaching sessions on self-care and symptom management, financial coaching, specialty outpatient visits, and monthly follow-up calls. It targets individuals aged 50 and older who have experienced recent hospitalizations due to heart failure. The trial focuses on enhancing life by managing symptoms and planning care. As an unphased trial, it provides a unique opportunity to explore innovative care strategies that could enhance daily living.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that palliative care is generally safe and well-tolerated for patients with advanced heart failure. Studies indicate that this type of care can reduce symptoms, improve patients' satisfaction with their care, and even lower medical costs. For example, palliative care often includes support for managing symptoms and making medical decisions, easing stress for patients and their families.

Unlike drugs or surgery, palliative care doesn't carry the same risks. Instead, it focuses on improving quality of life through support and education. This includes discussing what matters most to patients, assisting with self-care, and planning for future care needs. Overall, evidence suggests that palliative care is a safe option for enhancing life for people with advanced heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UPHOLDS trial for advanced heart failure because it explores different palliative care approaches that go beyond the traditional focus on medications and procedures. Unlike standard treatments, which often center on managing symptoms with drugs like beta-blockers and ACE inhibitors, UPHOLDS offers a holistic approach through telehealth sessions that emphasize problem-solving, self-care, and advanced care planning. Some variations even include financial coaching to tackle healthcare-related financial burdens, and outpatient visits guided by national quality palliative care guidelines. This trial aims to find out if these comprehensive, supportive strategies can improve quality of life for patients with advanced heart failure.

What evidence suggests that this trial's treatments could be effective for advanced heart failure?

Research has shown that palliative care can improve life for people with advanced heart failure. Studies have found that this care helps manage symptoms and increases patient satisfaction. For instance, patients receiving palliative care often experience better emotional well-being and fewer symptoms than those who do not. Some studies also suggest that palliative care can lead to better overall health. This trial will explore various palliative care strategies, including different combinations of coaching, follow-up calls, and outpatient visits, to determine their effectiveness in enhancing the lives of those with advanced heart failure. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40126019/

Effectiveness of Palliative Care in Advanced Heart Failure This meta-analysis investigates the impact of palliative care interventions on QoL, psychological well-being, symptom burden, and mortality in adults with ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ehf2.15243

Elements of effective palliative care interventions in ... The efficacy of palliative care in advanced heart failure was mixed. Five studies reported significant improvement in health outcomes compared with the usual ...

3. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.109.869123

Palliative Care in the Treatment of Advanced Heart Failure Palliative care improves outcomes, including patient and family satisfaction with care and symptom management. Patients who receive in-home ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527320340766

Prevalence of advanced heart failure and use of palliative ... Almost one in four patients admitted with heart failure has advanced disease. Advanced heart failure is associated with the elderly and comorbidities.

5. internationaljournalofcardiology.com internationaljournalofcardiology.com/article/S0167-5273(20)34076-6/abstract

Prevalence of advanced heart failure and use of palliative ... Almost one in four patients admitted with HF met criteria of advanced disease. They were older and had more comorbidities. Specialist palliative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3786355/

Palliative Care and Hospice in Advanced Heart Failure - PMC Palliative care can complement traditional care to improve symptom amelioration, patient-caregiver communication, emotional support, and medical decision ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/9781119784395.ch17

Palliative Care in Advanced Heart Failure This chapter will outline the global challenge of advanced heart failure and the importance of palliative care for this group of patients.

8. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-015-0124-y

Living with and dying from advanced heart failure Half of all HF patients die within four years of diagnosis, and more than 50 % of those with severe heart failure die within one year [10].

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11791178/

Palliative Care and Hospice for Heart Failure Patients Patients who have advanced HF, typically categorized as NYHA class III or IV should be considered for specialty palliative care referral, ...