Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Evaluation of Quality of Care - Shared-Care Programme, HA (QoC SCP)

2 de novembro de 2017 atualizado por: Professor Cindy L.K. Lam, The University of Hong Kong

Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the shared-care (SC) programme to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the SC programme is achieved. Each SC participating clinic and private medical practitioner (PMP) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the programme will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records.

Main Outcome Measures: The primary outcomes are the proportion of participants who received the criterion process of care and achieved a HbA1c level <7.5%.

Data Analysis: Descriptive statistics on proportions of clinics or subjects meeting the quality of care criteria will be calculated. The outcomes of SC patients will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between SC patients and control group will be compared by independent sample t-test or Chi-square test.

Hypothesis: The QOC of the SC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. The results of this study will provide empirical evidence on whether the HA's SC programme can achieve equivalent QOC as the usual HA care for diabetes mellitus (DM) patients. The information will be used to guide service planning and policy decision making.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

620

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Hksar
      • Hong Kong, Hksar, Hong Kong
        • The University of Hong Kong

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC) for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level would be offered the option of being followed up by a private medical practitioner (PMP) in primary care with a financial subsidy and continuing support from the original SOPC. Each patient in the SC programme will receive an annual assessment and complication screening at the SOPC. The programme encourages long-term patient-doctor relationships in order to develop continuous and holistic care for CD patients. Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.

Descrição

Inclusion Criteria:

  • Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC)for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level.

Exclusion Criteria:

  • Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
DM subjects in Hong Kong

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Change of the proportion of clinics that have satisfied each of the structure criteria.
Prazo: December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
Change of the proportion of patients who have received with the SC criterion process of care.
Prazo: June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
Change of the proportion of patients who have achieved a HbA1c <7.5%.
Prazo: June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014

Medidas de resultados secundários

Medida de resultado
Prazo
Low-density lipoprotein (LDL)
Prazo: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Blood pressure (BP)
Prazo: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Body mass index (BMI)
Prazo: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Cardiovascular complications
Prazo: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
Patient reported outcomes (PRO) measured by the change in Short Form-12 version 2 (SF-12v2) scores at 6 months.
Prazo: Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Patient reported outcomes (PRO) measured by the change in the Patient Enablement Instrument (PEI) scores at 6 months.
Prazo: Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Patient reported outcomes (PRO) measured by the change in the Global Rating Scale (GRS) at 6 months.
Prazo: Baseline and 6 months after the first administration of questionnaire.
Baseline and 6 months after the first administration of questionnaire.
Service utilization outcomes measured by General Outpatient Clinics (GOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Prazo: Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by specialist outpatient clinic (SOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Prazo: Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by accident & emergency (A&E) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Prazo: Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment
Service utilization outcomes measured by hospital attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Prazo: Baseline, 12, 24, 36 and 48 months after enrollment
Baseline, 12, 24, 36 and 48 months after enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2010

Conclusão Primária (Real)

1 de setembro de 2015

Conclusão do estudo (Real)

1 de setembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

24 de outubro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de novembro de 2017

Primeira postagem (Real)

7 de novembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de novembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2017

Última verificação

1 de novembro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • HKCTR-1185

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

3
Se inscrever