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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National University, Singapore
Sponsor:
Information provided by (Responsible Party):
Priscilla How, Pharm.D., BCPS, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01509690
First received: January 6, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Stage 5 Chronic Kidney Disease
Other: Multidisciplinary, intensive and collaborative care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National University, Singapore:

Primary Outcome Measures:
  • Clinical (mortality and morbidity) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)


Secondary Outcome Measures:
  • Laboratory outcomes [ Time Frame: One year ] [ Designated as safety issue: No ]
    Lab results

  • Economic outcomes [ Time Frame: One year ] [ Designated as safety issue: No ]
    Direct and indirect medical costs

  • Patient-reported outcomes [ Time Frame: One-year ] [ Designated as safety issue: No ]
    KDQOL and other social support questionnaires


Estimated Enrollment: 150
Intervention Details:
    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.

    Other Name: No specific study drugs, devices or procedures are involved
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509690

Contacts
Contact: Priscilla P How, Pharm.D., BCPS 65-516-4906 priscillahow@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Priscilla P How, Pharm.D., BCPS    (65)6516-4906      
Principal Investigator: Priscilla P How, Pharm.D., BCPS         
Sponsors and Collaborators
National University, Singapore
Investigators
Principal Investigator: Priscilla P How, Pharm.D., BCPS National University, Singapore
  More Information

No publications provided

Responsible Party: Priscilla How, Pharm.D., BCPS, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01509690     History of Changes
Other Study ID Numbers: DSRB Domain E/2011/1772
Study First Received: January 6, 2012
Last Updated: August 19, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University, Singapore:
Incident
Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014