End-stage Renal Failure (ESRF) Clinical Trial
— QoC HDPPPOfficial title:
Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority (HA)
| Verified date | September 2017 |
| Source | The University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | April 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | The University of Hong Kong | Hong Kong Island |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong | Hospital Authority, Hong Kong |
Hong Kong,
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 — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |