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Focused Palliative Care Intervention in Advanced Heart Failure

19 juli 2017 uppdaterad av: Akshay Desai, MD, Brigham and Women's Hospital

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

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Brigham and Women's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Control
Participant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending.
The control group will receive usual written care material and a palliative care consult if ordered by physician.
Experimentell: Verbal Information and Discussion
Participants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team. Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate.
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Tidsram: 6 months
Assessment tool: Patient Preferences Questionnaire.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Tidsram: 6 months
Chart review of Advanced Care Planning documents and written notes by members of clinical team.
6 months
Is there an impact on symptom burden through a palliative care intervention?
Tidsram: Three months
Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Three months
Is there an impact on perceived level of illness through a palliative care intervention?
Tidsram: 6 months
Assessment tool: EQ visual analogue scale (EQ-VAS)
6 months
Is there an impact on overall patient well being through a palliative care intervention?
Tidsram: Three months
Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
Three months
Is there an impact on depression through a palliative care intervention?
Tidsram: 6 months
Assessment tool: Patient Health Questionnaire (PHQ-8)
6 months
Is there an impact on anxiety through a palliative care intervention?
Tidsram: 6 months
Assessment tool: General Anxiety Disorder (GAD-7)
6 months
Is there an impact on cost of treatment through a palliative care intervention?
Tidsram: 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.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Akshay S Desai, MPH, MD, Brigham and Women's Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2014

Primärt slutförande (Faktisk)

1 juni 2016

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

20 maj 2016

Först inskickad som uppfyllde QC-kriterierna

17 juni 2016

Första postat (Uppskatta)

20 juni 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2014P001391

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