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Transitional Palliative Care in End-stage Heart Failure

21 août 2017 mis à jour par: Frances Kam Yuet WONG, The Hong Kong Polytechnic University

Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure

Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life.

There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden.

In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program.

Hypothesis

  • there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group
  • there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

As described

Type d'étude

Interventionnel

Inscription (Réel)

84

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Hong Kong
      • Hong Kong, Hong Kong
        • Grantham Hospital
      • Hong Kong, Hong Kong
        • Haven of Hope Hospital
      • Hong Kong, Hong Kong
        • United Christian Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Ability to speak Cantonese
  • Living within the hospital service area
  • Ability to be contacted by phone

  • Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:

    (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy

Exclusion Criteria:

  • Discharged to nursing home or other institution
  • Inability to communicate
  • Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Usual Care + Transitional Care Model
Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership
Comportemental: Transitional Care Model
Symptom assessment and management, care goal setting, post-discharge support
Comportemental: Usual care
Usual care is the routine practice in the hospital
Comparateur actif: Usual Care
Usual care
Comportemental: Usual care
Usual care is the routine practice in the hospital

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Healthcare utilization
Délai: up to 12 months
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data
up to 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Life
Délai: baseline, 1 month, 3 months, 6 months, 12 month
Change from baseline in quality of life on the palliative specific McGill Quality of Life Questionnaire Hong Kong version (MQOL-HK) at 1 month; change from baseline in MQOL-HK at 3 months; change from baseline in MQOL-HK at 6 months; change from baseline in MQOL-HK at 12 months
baseline, 1 month, 3 months, 6 months, 12 month
Quality of Life
Délai: Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in quality of life on the heart failure specific Chronic Heart Failure Questionnaire-Chinese version (CHQ) at 1 month; change from baseline in CHQ score at 3 months; change from baseline in CHQ score at 6 months; change from baseline in CHQ score at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months
Functional status
Délai: Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in functional status on the Palliative Performance Scale (PPS) at 1 month; change from baseline in PPS at 3 months; change from baseline in PPS at 6 months; change from baseline in PPS at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months
Symptom intensity
Délai: Baseline, 1 month, 3 month, 6 month, 12 month
Change from baseline in symptom intensity on the Edmonton Symptom Assessment System (ESAS) at 1 month; change from baseline in ESAS score at 3 month; change from baseline in ESAS score at 6 month; change from baseline in ESAS score at 12 month.
Baseline, 1 month, 3 month, 6 month, 12 month
Satisfaction with care
Délai: 1 month, 3 months, 6 months, 12 months
Change from 1 month in satisfaction with care on the 15-item questionnaire developed by the principal investigator which validity confirmed by an expert panel and reported test-retest reliability of .87 (Sat-care) at 3 month; change from 1 month in Sat-care score at 6 months; change from 1 month in Sat-care score at 12 months
1 month, 3 months, 6 months, 12 months
Caregiver burden
Délai: Baseline, 1 month, 3 months, 6 months, 12 months
Change from baseline in caregiver burden on the Zarit Caregiver Burden Scale (ZCBS) at 1 month; change from baseline in ZCBS score at 3 months; change from baseline in ZCBS score at 6 months; change from baseline in ZCBS score at 12 months
Baseline, 1 month, 3 months, 6 months, 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Hong Kong Polytechnic University

Les enquêteurs

  • Chercheur principal: Frances KY Wong, The Hong Kong Polytechnic University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2013

Achèvement primaire (Réel)

1 février 2016

Achèvement de l'étude (Réel)

1 décembre 2016

Dates d'inscription aux études

Première soumission

7 mars 2014

Première soumission répondant aux critères de contrôle qualité

12 mars 2014

Première publication (Estimation)

13 mars 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PolyU5492

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