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

• ClinicalTrials.gov Identifier: NCT01581008
• Recruitment Status: Completed
• First Posted: April 19, 2012
• Results First Posted: November 11, 2014
• Last Update Posted: August 31, 2018
• Sponsor: VA Office of Research and Development
• Collaborator: University of Iowa
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Heart Failure (CHF)	Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness; Behavioral: Psychospiritual	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study
• Study Start Date: October 2011
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Collaborative Care to Alleviate Symptoms and Adjust to Illness; 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; 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 Name: Palliative symptom management and psychosocial care
Active Comparator: Psychospiritual; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Cohort Retention [ Time Frame: 3 months ]
   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 :

1. Was Depression Addressed? [ Time Frame: 3 months ]
   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?"
2. Participation Rates [ Time Frame: 7 months ]
   The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.
3. Adherence to the Study Protocol (CASA Arm Only) [ Time Frame: 3 months ]

   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?

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Colorado

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, United States, 80220

Sponsors and Collaborators

VA Office of Research and Development

University of Iowa

Investigators

• Principal Investigator: David Bekelman, MD MPH; VA Eastern Colorado Health Care System, Denver, CO

More Information

Publications of Results:

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.

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01581008
• Other Study ID Numbers: RRP 11-239; CRICC Pilot ( Other Grant/Funding Number: Denver REAP (CRICC) Pilot Grant )
• First Posted: April 19, 2012
• Results First Posted: November 11, 2014
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Keywords provided by VA Office of Research and Development:

palliative care; heart failure; delivery of health care

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases