Focused Palliative Care Intervention in Advanced Heart Failure
Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ: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.
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The control group will receive usual written care material and a palliative care consult if ordered by physician.
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実験的: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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
時間枠:6 months
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Assessment tool: Patient Preferences Questionnaire.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
時間枠:6 months
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Chart review of Advanced Care Planning documents and written notes by members of clinical team.
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6 months
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Is there an impact on symptom burden through a palliative care intervention?
時間枠:Three months
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Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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Three months
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Is there an impact on perceived level of illness through a palliative care intervention?
時間枠:6 months
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Assessment tool: EQ visual analogue scale (EQ-VAS)
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6 months
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Is there an impact on overall patient well being through a palliative care intervention?
時間枠:Three months
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Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
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Three months
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Is there an impact on depression through a palliative care intervention?
時間枠:6 months
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Assessment tool: Patient Health Questionnaire (PHQ-8)
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6 months
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Is there an impact on anxiety through a palliative care intervention?
時間枠:6 months
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Assessment tool: General Anxiety Disorder (GAD-7)
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6 months
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Is there an impact on cost of treatment through a palliative care intervention?
時間枠:6 months
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Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
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6 months
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協力者と研究者
捜査官
- 主任研究者:Akshay S Desai, MPH, MD、Brigham and Women's Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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