Clinical trial NCT01581008: Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study
Official title: Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure (CHF)
Keywords: palliative care
heart failure
delivery of health care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Iowa
First posted: 2012-04-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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:

1. A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) 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.

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:

  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.

Primary outcomes:
measure: Cohort Retention
timeFrame: 3 months
Secondary outcomes:
measure: Was Depression Addressed?
timeFrame: 3 months
measure: Participation Rates
timeFrame: 7 months
measure: Adherence to the Study Protocol (CASA Arm Only)
timeFrame: 3 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver, CO
name: David Bekelman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekelman DB, Hooker S, Nowels CT, Main DS, Meek P, McBryde C, Hattler B, Lorenz KA, Heidenreich PA. Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial. J Palliat Med. 2014 Feb;17(2):145-51. doi: 10.1089/jpm.2013.0143. Epub 2013 Dec 11.
citation: Hooker SA, Ross K, Masters KS, Park CL, Hale AE, Allen LA, Bekelman DB. Denver Spirited Heart: Mixed-Methods Pilot Study of a Psychospiritual Intervention for Heart Failure Patients. J Cardiovasc Nurs. 2017 May/Jun;32(3):226-235. doi: 10.1097/JCN.0000000000000337.