Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-18 @ 1:35 PM
Study NCT ID:
NCT02307903
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-05', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of centers that have satisfied each of the set structure criteria.', 'timeFrame': 'Five years', 'description': 'Interim analysis will evaluate in October, 2010; October, 2011; October, 2012; October, 2013; October, 2014'}, {'measure': 'The proportion of patients who have complied with the HD PPP process of care.', 'timeFrame': 'Five years', 'description': 'Interim analysis will evaluate in June, 2011; December, 2011; December, 2012; December, 2013; December, 2014'}, {'measure': 'The proportion of patients who have adequate HD measured by the Kt/V.', 'timeFrame': 'Five years', 'description': 'Interim analysis will evaluate in June, 2011; December, 2011, December, 2012; December, 2013; December, 2014'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes include decompensation episodes, pre-dialysis serum calcium level, blood pressure (BP), LDL-C, patient mortality and adverse clinical events.', 'timeFrame': 'Five years', 'description': 'Baseline, 6, 12, 24, 36, 48 months after enrolment'}, {'measure': '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', 'timeFrame': 'Five years', 'description': 'Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.'}, {'measure': '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.', 'timeFrame': 'Five years', 'description': 'Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['end-stage renal failure (ESRF)'], 'conditions': ['End-stage Renal Failure (ESRF)']}, 'referencesModule': {'references': [{'pmid': '26215978', 'type': 'RESULT', '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.'}, {'pmid': '27148742', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27401348', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nMain 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\n\nData 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.\n\nResults: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.\n\nConclusion: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients currently being followed up at the HA on haemodialysis, peritoneal dialysis, or are new ESRF cases will be recruited.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02307903', 'acronym': 'QoC HDPPP', 'briefTitle': 'Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Evaluation of Quality of Care - Haemodialysis Public-Private-Partnership, Hospital Authority (HA)', 'orgStudyIdInfo': {'id': 'HKCTR-1188'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'End-stage renal failure (ESRF)', 'description': 'end-stage renal failure (ESRF)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong Island', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.26302, 'lon': 114.18419}}], 'overallOfficials': [{'name': 'Cindy L.K. Lam, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong'}, {'name': 'Julie Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Professor Cindy L.K. Lam', 'investigatorAffiliation': 'The University of Hong Kong'}}}}