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

5. september 2017 oppdatert av: Professor Cindy L.K. Lam, The University of Hong Kong

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

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.

Studieoversikt

Status

Fullført

Studietype

Observasjonsmessig

Registrering (Faktiske)

125

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Hong Kong Island, Hong Kong
        • The University of Hong Kong

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Sixty patients currently being followed up at the HA on HD, PD, or are new ESRF cases will be recruited. Both PD and new ESRF cases must fulfill certain inclusion criterion to take part in the study. The PD patients will be enrolled into the HD PPP if they have poor ultrafiltration, inadequate dialysis, or with frequent bacterial/fungal peritonitis that failed to put back on PD; whereas new ESRF patients will be enrolled if they have previously had multiple/extensive abdominal surgeries or have any abdominal pathology that makes PD not feasible. 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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
End-stage renal failure (ESRF)
end-stage renal failure (ESRF)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The proportion of centers that have satisfied each of the set structure criteria.
Tidsramme: Five years
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.
Tidsramme: Five years
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.
Tidsramme: Five years
Interim analysis will evaluate in June, 2011; December, 2011, December, 2012; December, 2013; December, 2014
Five years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical outcomes include decompensation episodes, pre-dialysis serum calcium level, blood pressure (BP), LDL-C, patient mortality and adverse clinical events.
Tidsramme: Five years
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
Tidsramme: Five years
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.
Tidsramme: Five years
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Five years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Studiestol: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
  • Hovedetterforsker: Julie Chen, MD, Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2010

Primær fullføring (Faktiske)

1. september 2016

Studiet fullført (Faktiske)

1. april 2017

Datoer for studieregistrering

Først innsendt

28. august 2013

Først innsendt som oppfylte QC-kriteriene

1. desember 2014

Først lagt ut (Anslag)

4. desember 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HKCTR-1188

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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