MedTrace Logo

Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients

NCT01509690 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Stage 5 Chronic Kidney Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Priscilla P How, Pharm.D., BCPS · National University of Singapore

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509690 on ClinicalTrials.gov