Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study

Conditions
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Chronic Heart Failure (CHF)

Intervention / Treatment
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* Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness
* Behavioral: Psychospiritual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care to Alleviate Symptoms and Adjust to Illness<br>A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) 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 (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider. | Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness<br>* A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) 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 (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.<br>* Other names: Palliative symptom management and psychosocial care;|
| Active Comparator: Psychospiritual<br>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. | Behavioral: Psychospiritual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort Retention | Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Was Depression Addressed? | The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is thoughts that you would be better off dead, or of hurting yourself in some way? | 3 months | 
| Participation Rates | The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial. | 7 months | 
| Adherence to the Study Protocol (CASA Arm Only) | The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as: how often is depression addressed with a treatment plan? how often are care team recommendations placed as orders in the medical record? how often are orders completed? | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, heart failure, delivery of health care