End-stage Renal Failure (ESRF)QoC HDPPPNCT02307903
Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority
An observational study of End-stage Renal Failure (ESRF), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Failure (ESRF)
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients currently being followed up at the HA on haemodialysis, peritoneal dialysis, or are new ESRF cases will be recruited.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- End-stage Renal Failure (ESRF)
- Keywords
- end-stage renal failure (ESRF)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| End-stage renal failure (ESRF) | end-stage renal failure (ESRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Five years
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2010
- Primary completionSep 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal Failure (ESRF)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Study chair, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong KongJulie Chen, MD, Principal investigator, Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307903
- Sponsor's protocol ID
- HKCTR-1188
- Acronym
- QoC HDPPP
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2013
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26215978Chen 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.
PubMed 27148742Chen 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.
PubMed 27401348
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority (HA)
- ClinicalTrials.gov ID
- NCT02307903
- Acronym / sponsor ID
- QoC HDPPP / HKCTR-1188
- Conditions
- End-stage Renal Failure (ESRF)
- Keywords
- end-stage renal failure (ESRF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Sep 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-stage renal failure (ESRF) | – | –end-stage renal failure (ESRF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients currently being followed up at the HA on haemodialysis, peritoneal dialysis, or are new ESRF cases will be recruited.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 26215978Wan 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.
- Results publication: PubMed 27148742Chen 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.
- Results publication: PubMed 27401348Chen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L.K. Lam, MD study chair
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
Julie Chen, MD principal investigator
Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Failure (ESRF), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of centers that have satisfied each of the set structure criteria. (time frame: Five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.