Heart Failure Clinical Trial
Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study
Summary
The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.
Full Description
The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are:
A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes
evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and
brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
The specific aims of the study are to:
Examine intervention feasibility and determine preliminary estimates of intervention effect
Determine patient participation rates and cohort retention
Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
Obtain qualitative feedback from study participants, the persons providing the intervention, and providers/leaders in primary care, mental health, palliative care, chaplaincy, and hospital operations.
Eligibility Criteria
Inclusion Criteria:
eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
be at least 18 years of age, able to read and understand English,
have consistent access to a telephone
at least one of the following:
Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
estimated creatinine clearance 30-80 mL/min.
Exclusion Criteria:
previous diagnosis of dementia;
active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
comorbid metastatic cancer, given the focus on heart failure palliative care;
nursing home resident; and
diagnosis of bipolar disorder or schizophrenia.
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There is 1 Location for this study
Denver Colorado, 80220, United States
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