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

NCT ID: NCT02307903

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2017-04-30

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.

Detailed Description

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Conditions

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End-stage Renal Failure (ESRF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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End-stage renal failure (ESRF)

end-stage renal failure (ESRF)

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Cindy L.K. Lam

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cindy L.K. Lam, MD

Role: STUDY_CHAIR

Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

Julie Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong Island, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Wan EY, Chen JY, Choi EP, Wong CK, Chan AK, Chan KH, Lam CL. Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis. Health Qual Life Outcomes. 2015 Jul 29;13:108. doi: 10.1186/s12955-015-0308-3.

Reference Type RESULT
PMID: 26215978 (View on PubMed)

Chen JY, Choi EP, Wan EY, Chan AK, Tsang JP, Chan KH, Lo WK, Lui SL, Chu WL, Lam CL. Validation of the Disease-Specific Components of the Kidney Disease Quality of Life-36 (KDQOL-36) in Chinese Patients Undergoing Maintenance Dialysis. PLoS One. 2016 May 5;11(5):e0155188. doi: 10.1371/journal.pone.0155188. eCollection 2016.

Reference Type RESULT
PMID: 27148742 (View on PubMed)

Chen JY, Wan EY, Chan KH, Chan AK, Chan FW, Lam CL. Evaluation of the quality of care of a haemodialysis public-private partnership programme for patients with end-stage renal disease. BMC Nephrol. 2016 Jul 11;17(1):79. doi: 10.1186/s12882-016-0284-9.

Reference Type RESULT
PMID: 27401348 (View on PubMed)

Other Identifiers

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HKCTR-1188

Identifier Type: -

Identifier Source: org_study_id

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