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Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial (CASA)

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CASA Intervention
Sponsored by
Denver Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Quality of Life, Symptoms, Palliative care, Symptom management, Disease management, Health delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years of age or older
  • Able to read and understand English
  • Consistent access to a telephone
  • Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
  • A diagnosis of heart failure with at least one of the following:

[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%]

  • Report a low health status (KCCQ-SF≤70)
  • Bothered by at least one target symptom:

[Pain; Depression; Fatigue; Breathlessness]

Exclusion Criteria:

  • Previous diagnosis of dementia
  • Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months
  • Comorbid metastatic cancer
  • Nursing home resident
  • Heart Transplant recipient
  • LVAD recipient

Sites / Locations

  • University of Colorado Hospital
  • Denver Health
  • VA Eastern Colorado Health Care System(ECHCS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CASA Intervention

Usual Care

Arm Description

The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components: A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression. A social worker provides structured counseling targeting adjustment to illness and depression if present. A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. Most of the nurse and social worker visits are by phone.

Patients in the control group will continue to receive care at the discretion of their providers, which may include referral to cardiology, palliative care, or mental health. If patients self-report depression on baseline surveys, this information will be given to their provider, and patients will be given resources. Patients will have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency.

Outcomes

Primary Outcome Measures

Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months.

Secondary Outcome Measures

Difference in Patient Health Questionnaire-9 (PHQ-9) score
The PHQ-9 is a 9-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-9 was developed in medically-ill outpatients, including patients with heart failure.
Difference in symptom distress, measured using the General Symptom Distress Scale
The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms.
Difference in Self-care of Heart Failure Index (SCHFI)
The SCHFI is a valid and reliable 22-item self-report measure of self-care that includes three self-care scales: maintenance, management, and confidence
Difference in Satisfaction with Healthcare
Difference in pain using the PEG
The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).
Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure
Change in Dyspnea
PEG pain measure modified to assess breathlessness
Change in Sheehan Disability Scale
Measure of functioning
Change in Quality of Life at the End of Life (QUAL-E)
The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. We will use the relationship with health care system, preparation, life completion, and global quality of life sub-scales.

Full Information

First Posted
November 16, 2012
Last Updated
July 28, 2017
Sponsor
Denver Research Institute
Collaborators
VA Eastern Colorado Health Care System, University of Colorado, Denver, Denver Health Medical Center, University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01739686
Brief Title
Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Acronym
CASA
Official Title
Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Research Institute
Collaborators
VA Eastern Colorado Health Care System, University of Colorado, Denver, Denver Health Medical Center, University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Quality of Life, Symptoms, Palliative care, Symptom management, Disease management, Health delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CASA Intervention
Arm Type
Experimental
Arm Description
The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components: A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression. A social worker provides structured counseling targeting adjustment to illness and depression if present. A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. Most of the nurse and social worker visits are by phone.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in the control group will continue to receive care at the discretion of their providers, which may include referral to cardiology, palliative care, or mental health. If patients self-report depression on baseline surveys, this information will be given to their provider, and patients will be given resources. Patients will have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency.
Intervention Type
Other
Intervention Name(s)
CASA Intervention
Intervention Description
CASA Intervention The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components: A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression. A social worker provides structured counseling targeting adjustment to illness and depression if present. A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. Most of the nurse and social worker visits are by phone.
Primary Outcome Measure Information:
Title
Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
Description
The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in Patient Health Questionnaire-9 (PHQ-9) score
Description
The PHQ-9 is a 9-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-9 was developed in medically-ill outpatients, including patients with heart failure.
Time Frame
6 months
Title
Difference in symptom distress, measured using the General Symptom Distress Scale
Description
The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms.
Time Frame
6 months
Title
Difference in Self-care of Heart Failure Index (SCHFI)
Description
The SCHFI is a valid and reliable 22-item self-report measure of self-care that includes three self-care scales: maintenance, management, and confidence
Time Frame
12 months
Title
Difference in Satisfaction with Healthcare
Time Frame
6 months
Title
Difference in pain using the PEG
Description
The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).
Time Frame
6 months
Title
Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure
Time Frame
6 months
Title
Change in Dyspnea
Description
PEG pain measure modified to assess breathlessness
Time Frame
6 months
Title
Change in Sheehan Disability Scale
Description
Measure of functioning
Time Frame
12 months
Title
Change in Quality of Life at the End of Life (QUAL-E)
Description
The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. We will use the relationship with health care system, preparation, life completion, and global quality of life sub-scales.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years of age or older Able to read and understand English Consistent access to a telephone Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations A diagnosis of heart failure with at least one of the following: [hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%] Report a low health status (KCCQ-SF≤70) Bothered by at least one target symptom: [Pain; Depression; Fatigue; Breathlessness] Exclusion Criteria: Previous diagnosis of dementia Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months Comorbid metastatic cancer Nursing home resident Heart Transplant recipient LVAD recipient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bekelman, MD, MPH
Organizational Affiliation
Denver Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
VA Eastern Colorado Health Care System(ECHCS)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29482218
Citation
Bekelman DB, Allen LA, McBryde CF, Hattler B, Fairclough DL, Havranek EP, Turvey C, Meek PM. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):511-519. doi: 10.1001/jamainternmed.2017.8667.
Results Reference
derived
PubMed Identifier
27634669
Citation
Bekelman DB, Allen LA, Peterson J, Hattler B, Havranek EP, Fairclough DL, McBryde CF, Meek PM. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial. Contemp Clin Trials. 2016 Nov;51:1-7. doi: 10.1016/j.cct.2016.09.002. Epub 2016 Sep 12.
Results Reference
derived

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Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

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