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

• Preliminary estimate of intervention effect (summative evaluation) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Pre-post-measurement of outcomes using KCCQ, ESAS, PHQ-9, GAD-7, adoption of orders by PCPs, Spiritual well-being
• Participation rates [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
  We will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.
• Adherence to the study protocol (PSMPC arm only) [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]

  We 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?

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.

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:

1. A palliative symptom management and psychosocial care (PSMPC) intervention that includes

   1. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
   2. 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
   3. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
2. 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:

1. Examine intervention feasibility and determine preliminary estimates of intervention effect

   1. Determine patient participation rates and cohort retention
   2. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
2. 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.

• Other: CASA: Collaborative Care to Improve Symptoms and Adjust to Illness
  A palliative symptom management and psychosocial care (PSMPC) intervention 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 Name: Palliative symptom management and psychosocial care
• Behavioral: Psychospiritual intervention
  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.

• Experimental: Arm 1
  A palliative symptom management and psychosocial care (PSMPC) intervention 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.
  Intervention: Other: CASA: Collaborative Care to Improve Symptoms and Adjust to Illness
• Active Comparator: Arm 2
  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.
  Intervention: Behavioral: Psychospiritual intervention

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:

  1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
  2. a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
  3. taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
  4. BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
  5. 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.