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

NCT01509690 | Unknown Phase 2

• 1 other identifier: DSRB Domain E/2011/1772
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Incident; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Clinical (mortality and morbidity)

  Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)

  One year

Secondary Outcomes (3)

• Laboratory outcomes

  One year

• Economic outcomes

  One year

• Patient-reported outcomes

  One-year

Interventions

Multidisciplinary, intensive and collaborative care OTHER

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.

Also known as: No specific study drugs, devices or procedures are involved

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients who are newly-initiated on HD and who meet the following criteria will be included in the study:
• male or female 21 years of age or older with stage 5 CKD (eGFR \< 15 ml/min/1.73m2)
• newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic

You may not qualify if:

• transient HD patients
• patients with poor cognitive function or are not able to complete the PRO questionnaires.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Priscilla P How, Pharm.D., BCPS

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla P How, Pharm.D., BCPS

CONTACT

65-516-4906; priscillahow@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 13, 2012
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

SG (1)