Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority

Study Overview
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Brief Summary
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Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and maintain electrolyte balance, which is lethal unless they are given renal replacement therapy (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the HA has introduced the haemodialysis public-private partnership (HD PPP) programme to shorten the waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new service provision model that purchases healthcare services from non-Government healthcare organizations. The evaluation on the quality of care (QOC) is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care of the University of Hong Kong 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 HD PPP programme is achieved. Each HD PPP participating hospitals and centers will be invited to complete a structure evaluation questionnaire. Sixty patients who have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP will be included. The participants will be followed up by telephone to evaluate the effect of the programme on quality of life (QOL), patient enablement, and global rating of change in health condition. Data on the process of care and clinical outcomes of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between HD PPP subjects and control group will be compared by independent sample t-test or Chi-square test. Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HD PPP can achieve equivalent QOC as the usual HA care in order to guide service planning and policy decision making for patients with ESRF.

Official Title
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Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority (HA)

Conditions
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End-stage Renal Failure (ESRF)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients currently being followed up at the HA on haemodialysis, peritoneal dialysis, or are new ESRF cases will be recruited. Exclusion Criteria: Patients who do not have a good vascular access, are not hemodynamically stable for HD, are not mentally sound, ambulatory and independent, are unable to understand and communicate in Chinese language, or refuse to give consent will be excluded from the HD PPP programme.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| End-stage renal failure (ESRF)<br>end-stage renal failure (ESRF) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of centers that have satisfied each of the set structure criteria. | Interim analysis will evaluate in October, 2010; October, 2011; October, 2012; October, 2013; October, 2014 | Five years | 
| The proportion of patients who have complied with the HD PPP process of care. | Interim analysis will evaluate in June, 2011; December, 2011; December, 2012; December, 2013; December, 2014 | Five years | 
| The proportion of patients who have adequate HD measured by the Kt/V. | Interim analysis will evaluate in June, 2011; December, 2011, December, 2012; December, 2013; December, 2014 | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes include decompensation episodes, pre-dialysis serum calcium level, blood pressure (BP), LDL-C, patient mortality and adverse clinical events. | Baseline, 6, 12, 24, 36, 48 months after enrolment | Five years | 
| Patient reported outcomes (PRO) are measured by the change in Short Form -12v2 scores, the Patient ennoblement index and Global Rating of Change Scale scores | Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire. | Five years | 
| Service utilization outcomes are measured by General Out-patient Clinics consultation, renal Specialist Out-patient Clinics consultation, A&E attendance rates and hospitalization rate in the past 12 months. | Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years. | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal failure (ESRF)