Pilots
Project 1: Cohort Study of Patients with Ventricular Assist Devices to Determine Symptoms of Patients and their Caregivers
Principal Investigator:
Nathan Goldstein, MD, Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine
Co-Investigators:
R. Sean Morrison, MD, Department of Geriatrics and Palliative Medicine, Icahn School of Medicine
Deborah Ascheim, MD, Department of Health Evidence and Policy, Icahn School of Medicine
Background and Specific Aims: Heart Failure (HF) is a chronic illness typically associated with multiple co-morbidities, and it is a leading cause of death in the United States. While medical management is the mainstay therapy for patients with HF, ventricular assist devices (VADs) are increasingly used to treat HF patients with end-stage disease. Originally approved as a temporary therapy to “bridge” patients as they waited for cardiac transplantation, VADs are now implanted in patients whose eligibility for transplant is unclear (bridge to candidacy) or ineligible for transplantation (destination therapy). The use of LVADs is expected to increase in the years to come, especially as devices become smaller and are increasingly associated with better survival and fewer post-implantation complications (e.g. infection, bleeding, stroke). While these devices have been shown to improve survival and quality of life in patients with advanced HF, there are little data exploring the non-HF physical symptoms (e.g. pain) of patients with these devices or the psychological symptoms of these patients and their caregivers. This project is a 4-center prospective cohort study of patients with recently implanted VADs and their caregivers to:
Aim 1: Evaluate baseline prevalence and change over time of physical (pain and quality of life) and psychological (depression, anxiety, panic disorder) characteristics and symptoms in patients with VADs.
Aim 2: Evaluate baseline prevalence and change over time of psychological (depression, anxiety, posttraumatic stress disorder) symptoms in caregivers of patients with ventricular assist devices.
Aim 2.1: Determine prevalence of prolonged grief disorder among caregivers of patients with VADs who die.
The project will enroll 100 patients immediately after VAD implantation at Mount Sinai, Columbia-Presbyterian, University of Pennsylvania, and Jewish Hospital (Louisville, KY) Medical Centers to determine baseline prevalence of symptoms of both patients and their caregivers using validated instruments, and then follow them for up to 12 months to determine how these characteristics change. For those patients who die during the course of the study, the project will perform after-death interviews with caregivers. This project will be the first comprehensive exploration dedicated to determining the non-HF-related physical and psychological symptoms of patients with VADs and their caregivers. These data will be also be used to support a future R01 grant application for a randomized controlled trial evaluating whether automatic palliative care consultation at time of device implant improves outcomes for patients with VADs and their caregivers.
To disseminate this information to researchers interested in geriatric palliative care through: a) presentations and publications, b) the National Palliative Care Research Center (www.npcrc.org) and other major national initiatives; and c) development of a web site with links to PROMIS and related web sites.
Project 2: Couple-focused Symptom Management Intervention for Older Lung Cancer Patients & Their Spousal Caregivers
Principal Investigator:
Hoda Badr, PhD, Department of Oncological Sciences, Icahn School of Medicine
Co-Investigators:
Juan Wisnivesky, MD, General Internal Medicine, Icahn School of Medicine
William H. Redd, PhD, Department of Oncological Sciences, Icahn School of Medicine
Background and specific aims: Cancer is a disease of the elderly; 50% of all cancer patients are over the age of 65, and this number is growing rapidly as the population ages. LC patients experience more debilitating symptoms than other cancer patients and better approaches to symptom management are needed in this population. With the increasing reliance on outpatient care, spouses and intimate partners are playing a more critical role in the care of cancer patients. However, the spousal caregivers of LC patients are also likely to be elderly and LC couples often leave the hospital with knowledge deficits that can impede effective symptom management and care. Currently, there are no programs that: a) take a couples’ approach to LC pain and symptom management; b) provide practical strategies couples can use to discuss cancer-related symptoms and concerns; and c) are designed to specifically address the pain/symptom management needs of older LC patients and their partners. Thus, the specific aims of this study are to:
- Use focus groups to develop and refine a couple-focused intervention for older lung cancer (LC) patients and their partners that prepares and educates couples about LC symptoms, teaches them techniques for effective symptom management and home care, and teaches communication skills that couples can use to effectively problem-solve cancer-related concerns and coordinate care.
- Pilot test the intervention in a small randomized controlled trial (RCT) vs. a usual care control group and to explore whether couples in the intervention group experience better patient (i.e., symptom burden, symptom distress, functional disability, general QOL), partner (caregiver strain, competence, QOL), and relationship outcomes (i.e., relationship satisfaction and intimacy).
The study consists of two parts. Part 1 uses fourfocus groups comprising 30 LC patients and their partners to develop and refine a symptom management intervention for older LC couples. Preliminary intervention content is based on Dr. Badr’s previously published studies of couples’ psychosocial adjustment to LC and her research on pain in advanced cancer. The proposed intervention will encourage couples to view LC as a ‘we’ disease, work together as a team to problem-solve and effectively manage symptoms at home, and openly and supportively communicate about both the practical and emotional challenges that can arise as LC progresses. Through its focus on communication and the coordination of care between patients and their partners, the goal of the intervention is to improve patient (i.e., symptom burden, symptom distress, general QOL), partner (caregiver strain, competence, QOL), and relationship outcomes (i.e., relationship satisfaction and intimacy) in LC.
Part 2 will pilot test the intervention in a small randomized controlled trial (RCT) vs. a usual care control group (50 LC couples; 25 couples in each group). Thus, the proposed study will provide estimates of intervention feasibility, acceptability, and preliminary efficacy that will inform planning and provide power and sample size calculations for future larger trials. By taking a coordinated approach to symptom management in LC, teaching communication skills, and addressing the concerns of both partners, the proposed intervention may provide maximum benefit and greatly facilitate the symptom management and adaptation of both elderly LC patients and their spousal caregivers.
Project 3: Palliation of Depression in Nursing Home Residents with Serious Illness: A Non-pharmacological Approach
Principal Investigator:
Joann P. Reinhardt, PhD, Jewish Home Lifecare Institute on Aging
Co-Investigator:
Amy Horowitz, DSW, Department of Social Work, Fordham University
Background and specific aims: Geriatric patients residing in long-term care (LTC) facilities are typically characterized by serious illness, poor life expectancy, and high symptom burden, attributes which parallel those of palliative care patients across health care settings. Among the most distressing symptom clusters for both residents and their family is the experience of significant depressive symptomatology, a common mental health comorbid condition associated with serious chronic illness in later life. The consequences of untreated depression can be devastating and include both the amplification of pain and symptom distress, as well as increased difficulty in treating these symptoms, along with poor quality of life, and impaired capacity for pleasure, meaning, and connection with others. Yet, both palliative care interventions, in general, and treatments for depression, in particular, lack an evidence-base relevant to the nursing home population, and remain largely inadequate to the need in LTC.
The treatment of first choice for depression in nursing homes is typically antidepressant medication. However, the complexity of managing multiple concurrent serious illnesses, along with problems associated with polypharmacy, call for greater consideration of non-pharmacological, psychotherapeutic interventions, and in particular cognitive therapeutic interventions appropriate for residents with no or mild cognitive impairments, who continue to comprise 25-30% of the nursing home population. Yet, randomized trials of psychotherapy in long term care are largely lacking.
This proposed pilot is a feasibility study of Problem Solving Therapy (PST) among 40 nursing home patients to treat sub-syndromal depression in patients with serious life-threatening conditions who reside in LTC facilities. The specific aims of this study are:
- To demonstrate PST implementation fidelity (recruitment, acceptance, and adherence to the protocol) within a nursing home setting
- To identify the potential of PST for nursing home residents with serious chronic illness and sub-threshold depression relative to: (a) Primary outcomes of depression remission and clinically significant reductions in depressive symptoms; and (b) Secondary outcomes of symptom distress (pain, fatigue)
- To estimate the effect size of the PST intervention compared to Usual Care with Social Contact for primary and secondary outcomes
Findings from this study will contribute to the knowledge base on treating emotional disorders in palliative care and provide the pilot data needed for the design of a larger scale, multi-site study of PST in LTC. This study is innovative in several ways. First, it targets older adults with sub-syndromal and minor (rather than major) depression, for who non-pharmacological approaches may be more appropriate but for which limited effectiveness evidence is available.
Second, while there is evidence supporting the effectiveness of PST with depressed elders among primary, acute, and home care patients, no prior research has tested the application of this manualized psychotherapeutic program with a nursing home population. Third, in addition to primary outcome measures of depression remission and symptom reduction, the team is also examining secondary effects of PST on reduction of pain and fatigue, which are both key targets of palliative care and symptoms that can be exacerbated by depression. These data will inform the development of a larger study to test the effect of this non-pharmacological treatment for sub-threshold depression and symptom distress in this complex, medically ill population.