Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT01509690|
Recruitment Status : Unknown
Verified April 2015 by Priscilla How, Pharm.D., BCPS, National University, Singapore.
Recruitment status was: Recruiting
First Posted : January 13, 2012
Last Update Posted : April 15, 2015
Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.
Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.
Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.
|Condition or disease||Intervention/treatment||Phase|
|Stage 5 Chronic Kidney Disease||Other: Multidisciplinary, intensive and collaborative care||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients|
Other: Multidisciplinary, intensive and collaborative care
No specific study drugs, devices or procedures are involved.
Subjects will be seen in a multidisciplinary, intensive management clinic involving a renal physician, a clinical pharmacist trained in renal pharmacotherapy and a renal coordinator. The main aim of this clinic is to provide multidisciplinary, intensive and consistent care in the first 3 to 4 months after HD initiation to streamline the management of the patients. Specific objectives of this clinic include providing patients with educational materials and information to enable a better understanding of their disease process, providing uniform anemia and renal bone disease management, increasing permanent HD access [arteriovenous (AV) fistula or graft] placement, increasing transplant referrals, providing suitable vaccinations to all patients, as well as reducing hospitalizations for fluid overload, uncontrolled hypertension and anemia-related complications.
- Clinical (mortality and morbidity) [ Time Frame: One year ]Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
- Laboratory outcomes [ Time Frame: One year ]Lab results
- Economic outcomes [ Time Frame: One year ]Direct and indirect medical costs
- Patient-reported outcomes [ Time Frame: One-year ]KDQOL and other social support questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509690
|Contact: Priscilla P How, Pharm.D., BCPSemail@example.com|
|National University Hospital||Recruiting|
|Contact: Priscilla P How, Pharm.D., BCPS (65)6516-4906|
|Principal Investigator: Priscilla P How, Pharm.D., BCPS|
|Principal Investigator:||Priscilla P How, Pharm.D., BCPS||National University, Singapore|