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NCT Number: NCT02307903

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

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.

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Key information

Conditions

End-stage Renal Failure (ESRF) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Hong Kong

Hong Kong Island, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The proportion of centers that have satisfied each of the set structure criteria.

    Time frame: Five years

    Interim analysis will evaluate in October, 2010; October, 2011; October, 2012; October, 2013; October, 2014

  2. The proportion of patients who have complied with the HD PPP process of care.

    Time frame: Five years

    Interim analysis will evaluate in June, 2011; December, 2011; December, 2012; December, 2013; December, 2014

  3. The proportion of patients who have adequate HD measured by the Kt/V.

    Time frame: Five years

    Interim analysis will evaluate in June, 2011; December, 2011, December, 2012; December, 2013; December, 2014

Secondary outcomes

  1. Clinical outcomes include decompensation episodes, pre-dialysis serum calcium level, blood pressure (BP), LDL-C, patient mortality and adverse clinical events.

    Time frame: Five years

    Baseline, 6, 12, 24, 36, 48 months after enrolment

  2. 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

    Time frame: Five years

    Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.

  3. 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.

    Time frame: Five years

    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Official study title

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

Acronym: QoC HDPPP

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Dec 4, 2014
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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