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Completed

NCT Number: NCT02805712

Focused Palliative Care Intervention in Advanced Heart Failure

This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Secondary objectives include assessing the impact of this intervention on documentation of advanced care planning and end of life preferences, symptom burden, quality of life and health care utilization.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.

Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic Heart Failure (NYHA II-IV)
  • Hospitalized or recently for acute decompensation with at least one of the following high-risk features
  • Prior hospitalization for Heart Failure (HF) within 1 year
  • Age > 80 years
  • Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/m2)
  • Systolic Blood Pressure < 100 mm Hg
  • Serum sodium < 130 meq/L
  • Cardiogenic Shock (Cardiac Index < 2.0)
  • Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
  • Ability to Provide Informed Consent
  • Permission of attending physician

Exclusion criteria

  • Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
  • Already enrolled in hospice or receiving outpatient palliative care

Treatment and study plan

Verbal Information and Discussion

Other

Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.

Control

Other

The control group will receive usual written care material and a palliative care consult if ordered by physician.

Primary outcomes

  1. Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?

    Time frame: 6 months

    Assessment tool: Patient Preferences Questionnaire.

Secondary outcomes

  1. Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?

    Time frame: 6 months

    Chart review of Advanced Care Planning documents and written notes by members of clinical team.

  2. Is there an impact on symptom burden through a palliative care intervention?

    Time frame: Three months

    Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  3. Is there an impact on perceived level of illness through a palliative care intervention?

    Time frame: 6 months

    Assessment tool: EQ visual analogue scale (EQ-VAS)

  4. Is there an impact on overall patient well being through a palliative care intervention?

    Time frame: Three months

    Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)

  5. Is there an impact on depression through a palliative care intervention?

    Time frame: 6 months

    Assessment tool: Patient Health Questionnaire (PHQ-8)

  6. Is there an impact on anxiety through a palliative care intervention?

    Time frame: 6 months

    Assessment tool: General Anxiety Disorder (GAD-7)

  7. Is there an impact on cost of treatment through a palliative care intervention?

    Time frame: 6 months

    Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2016
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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