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

This study has been completed.
Sponsor:
Collaborator:
University of Iowa/Iowa VAMC
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01581008
First received: October 31, 2011
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Chronic Heart Failure (CHF)
Other: CASA: Collaborative Care to Improve Symptoms and Adjust to Illness
Behavioral: Psychospiritual intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Cohort Retention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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?


Estimated Enrollment: 45
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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.

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 (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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581008

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Iowa/Iowa VAMC
Investigators
Principal Investigator: David Bekelman, MD MPH VA Eastern Colorado Health Care System, Denver
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01581008     History of Changes
Other Study ID Numbers: RRP 11-239, CRICC Pilot
Study First Received: October 31, 2011
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
palliative care
heart failure
delivery of health care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014