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

Primary Purpose

Stage 5 Chronic Kidney Disease

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Multidisciplinary, intensive and collaborative care
Sponsored by
National University of Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stage 5 Chronic Kidney Disease focused on measuring Incident, Hemodialysis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • National University HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Laboratory outcomes
Lab results
Economic outcomes
Direct and indirect medical costs
Patient-reported outcomes
KDQOL and other social support questionnaires

Full Information

First Posted
January 6, 2012
Last Updated
April 14, 2015
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01509690
Brief Title
Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
Official Title
Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 5 Chronic Kidney Disease
Keywords
Incident, Hemodialysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Multidisciplinary, intensive and collaborative care
Other Intervention Name(s)
No specific study drugs, devices or procedures are involved
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical (mortality and morbidity)
Description
Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Laboratory outcomes
Description
Lab results
Time Frame
One year
Title
Economic outcomes
Description
Direct and indirect medical costs
Time Frame
One year
Title
Patient-reported outcomes
Description
KDQOL and other social support questionnaires
Time Frame
One-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: transient HD patients patients with poor cognitive function or are not able to complete the PRO questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priscilla P How, Pharm.D., BCPS
Phone
65-516-4906
Email
priscillahow@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscilla P How, Pharm.D., BCPS
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla P How, Pharm.D., BCPS
Phone
(65)6516-4906
First Name & Middle Initial & Last Name & Degree
Priscilla P How, Pharm.D., BCPS

12. IPD Sharing Statement

Learn more about this trial

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

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