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

NCT01739686 | Completed DMC

• 2 other identifiers: 5R01NR013422-0211-0969
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Heart Failure

Keywords

Quality of Life; Symptoms; Palliative care; Symptom management; Disease management; Health delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (9)

• Difference in Patient Health Questionnaire-9 (PHQ-9) score

  6 months

• Difference in symptom distress, measured using the General Symptom Distress Scale

  6 months

• Difference in Self-care of Heart Failure Index (SCHFI)

  12 months

• Difference in Satisfaction with Healthcare

  6 months

• Difference in pain using the PEG

  6 months

Study Arms (2)

CASA Intervention

EXPERIMENTAL

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.

Other: CASA Intervention

Usual Care

NO INTERVENTION

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.

Interventions

CASA Intervention OTHER

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.

CASA Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \[Pain; Depression; Fatigue; Breathlessness\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Denver Research Institute: lead
• VA Eastern Colorado Health Care System: collaborator
• University of Colorado, Denver: collaborator
• Denver Health Medical Center: collaborator
• University of Iowa: collaborator

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

VA Eastern Colorado Health Care System(ECHCS)

Denver, Colorado, 80220, United States

Location

Related Publications (4)

• Doyon K, Flint K, Albright K, Bekelman D. Improving Benefit and Reducing Burden of Informal Caregiving for Patients With Heart Failure: A Mixed Methods Study. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):406-412. doi: 10.1097/JCN.0000000000001137. Epub 2024 Sep 27.

  PMID: 39348302 DERIVED

• Graney BA, Portz JD, Bekelman DB. "I Felt Like I Mattered": Caring is a key ingredient of collaborative care for chronic illness. Chronic Illn. 2024 Sep;20(3):383-394. doi: 10.1177/17423953241264862. Epub 2024 Jul 23.

  PMID: 39043359 DERIVED

• 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.

  PMID: 29482218 DERIVED

• 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.

  PMID: 27634669 DERIVED

Study Officials

• David Bekelman, MD, MPH

  Denver Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: December 3, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

US (3)