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Clinical Trials/NCT01581008
NCT01581008
Completed
N/A

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

VA Office of Research and Development1 site in 1 country31 target enrollmentOctober 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure (CHF)
Sponsor
VA Office of Research and Development
Enrollment
31
Locations
1
Primary Endpoint
Cohort Retention
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
December 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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:
  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Was Depression Addressed?(3 months)
  • Participation Rates(7 months)
  • Adherence to the Study Protocol (CASA Arm Only)(3 months)

Study Sites (1)

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