Cost Utility Analysis of HD and CAPD in Ministry of Health Dialysis Centres, Malaysia

NCT02862717 | Completed

• 1 other identifier: NMRR-16-1341-30856
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 5

Brief Summary

End-stage renal disease represents a major problem for public health, and is a severe disease affecting hundreds of millions of people in the world and increasing rapidly. It brings about complex implications to social and economic structures of every nation. Providing renal replacement therapy including , peritoneal dialysis and renal transplants for ESRD patients are resource intensive. Possible options have been proposed to ease the burden include early medical intervention to slow the progression of chronic kidney disease in high-risk patients, promotion of renal transplantation, and use of the most cost-effective dialysis therapy without compromising outcome. In Malaysia, despite growing financial pressure in health care system, cost-effectiveness studies of RRT modalities are scarce.The prevalence of ESRD patients on dialysis are approximately 34, 767 as of 2014 and expected to rise significantly in the foreseeable future. Thus, the sustainability of dialysis therapy is uncertain. This study aimed to assess the cost utility of hemodialysis and continuous ambulatory peritoneal dialysis treatment from Malaysia Ministry of Health perspective. One hundred and eighty patients will be recruited from five state hospitals via National Renal Registry. Patients' resource utilization including overhead costs, medications, dialysis consumables and hospitalizations will be recorded using specially designed case report form. Patients' quality of life will be assessed using validated EQ-5D-3L questionnaire. Survival analysis will be conducted based on NRR data. Next, a hypothetical cohort Markov model will be constructed to assess the cost utility of HD and CAPD using varying levels of CAPD use versus current practice. The data collection period is from 1st October 2016 to 30th September 2017. Incremental cost effectiveness ratio is the primary outcome of this study.

Conditions

End Stage Renal Disease

Keywords

Cost effectiveness; cost utility; ESRD; hemodialysis; ICER; Markov model; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Incremental cost effectiveness ratio

  Obtained by dividing the difference between the costs of the two dialysis modalities by the difference in the outcomes (QALY).

  1st October 2016-30th September 2017

Secondary Outcomes (1)

• Incremental cost effectiveness ratio of varying levels of CAPD use versus current practice

  1st October 2016-30th September 2017

Study Arms (2)

Hemodialysis (HD)

HD patients in MOH dialysis centres notified to NRR.

Continuous ambulatory peritoneal dialysis (CAPD)

CAPD patients in MOH dialysis centres notified to NRR.

Eligibility Criteria

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

Study Population

The study population is all ESRD patients on HD or CAPD in MOH dialysis centres and their data are being notified to NRR. The sampling frame is patient commenced dialysis from 2011-2015.

You may qualify if:

• Chronic dialysis
• Alive
• Adult patients above 18 years old
• MOH subsidized patients

You may not qualify if:

• Female pregnant patients
• Patients with cognitive/psychological disorder
• Patients with evident poor mental dexterity
• Patients switch dialysis modality during study period
• Patient underwent kidney transplant during study period
• Patient died during the study period
• Patient transfer to another institution during study period
• Patient with advanced disease i.e. cancer, advanced heart disease
• Only MOH subsidized patients are included in this study. For CAPD, patients sponsored by the Public Service Department, Social Security Organization (SOCSO), Baitumals or NGOs including National Kidney Foundation are excluded due to different reimbursement rates for medications, dialysis solutions and consumables.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (5)

Hospital Sultanah Aminah

Johor Bahru, Johor, 80100, Malaysia

Location

Hospital Tengku Apuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Tengku Ampuan Rahimah

Klang, Selangor, 41200, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Related Publications (16)

• World Health Organization, Global Burden of Disease. 2014. Regional Estimates for 2000-2012, DALY Estimates. Retrieved from http://www.who.int/healthinfo/global_burden_disease/estimates/en/index2.html

  BACKGROUND

• Fresenius Medical Care. 2013. ESRD patients in 2013, "A Global Perspective". Retrieved from http://www.vision-fmc.com/files/ESRD_Patients_in_2013.pdf

  BACKGROUND

• Goh, B.L. and Ong, L.M (Eds).2014. 22nd Report of the Malaysian Dialysis and Transplant Registry. National Renal Registry.

  BACKGROUND

• Institute for Health Metrics and Evaluation (IHME).2013. Malaysia Global Burden of Disease Study 2010 (GBD 2010) Results 1990-2010. Seattle, United States.

  BACKGROUND

• Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.

  PMID: 17568785 BACKGROUND

• United States Renal Data System (USRD). 2015. Chapter 11: Medicare expenditures forperson with ESRD. Retrieved from http://www.usrds.org/2015/view/v2_11.aspx

  BACKGROUND

• Kerr M, Bray B, Medcalf J, O'Donoghue DJ, Matthews B. Estimating the financial cost of chronic kidney disease to the NHS in England. Nephrol Dial Transplant. 2012 Oct;27 Suppl 3(Suppl 3):iii73-80. doi: 10.1093/ndt/gfs269. Epub 2012 Aug 5.

  PMID: 22815543 BACKGROUND

• Green, F. and Ryan, C. 2009. Health care expenditure on chronic kidney disease in Australia, 2009 Cat. no. PHE 117. Canberra: AIHW. Retrieved from http://www.aihw.gov.au/publication-detail/?id=6442468279

  BACKGROUND

• Malaysia National Health Account (MNHA), Planning Division. 2013. Health Expenditure Report 1997-2012. Ministry of Health Malaysia.

  BACKGROUND

• Lim TO, Goh A, Lim YN, Mohamad Zaher ZM, Suleiman AB. How public and private reforms dramatically improved access to dialysis therapy in Malaysia. Health Aff (Millwood). 2010 Dec;29(12):2214-22. doi: 10.1377/hlthaff.2009.0135.

  PMID: 21134922 BACKGROUND

• EBPG (European Expert Group on Renal Transplantation); European Renal Association (ERA-EDTA); European Society for Organ Transplantation (ESOT). European Best Practice Guidelines for Renal Transplantation (part 1). Nephrol Dial Transplant. 2000;15 Suppl 7:1-85. No abstract available.

  PMID: 11286185 BACKGROUND

• Sennfalt K, Magnusson M, Carlsson P. Comparison of hemodialysis and peritoneal dialysis--a cost-utility analysis. Perit Dial Int. 2002 Jan-Feb;22(1):39-47.

  PMID: 11929142 BACKGROUND

• Meier-Kriesche HU, Schold JD, Srinivas TR, Reed A, Kaplan B. Kidney transplantation halts cardiovascular disease progression in patients with end-stage renal disease. Am J Transplant. 2004 Oct;4(10):1662-8. doi: 10.1111/j.1600-6143.2004.00573.x.

  PMID: 15367222 BACKGROUND

• Winkelmayer WC, Glynn RJ, Mittleman MA, Levin R, Pliskin JS, Avorn J. Comparing mortality of elderly patients on hemodialysis versus peritoneal dialysis: a propensity score approach. J Am Soc Nephrol. 2002 Sep;13(9):2353-62. doi: 10.1097/01.asn.0000025785.41314.76.

  PMID: 12191980 BACKGROUND

• Hooi LS, Lim TO, Goh A, Wong HS, Tan CC, Ahmad G, Morad Z. Economic evaluation of centre haemodialysis and continuous ambulatory peritoneal dialysis in Ministry of Health hospitals, Malaysia. Nephrology (Carlton). 2005 Feb;10(1):25-32. doi: 10.1111/j.1440-1797.2005.00360.x.

  PMID: 15705178 BACKGROUND

• Yusof FA, Goh A, Azmi S. Estimating an EQ-5D value set for Malaysia using time trade-off and visual analogue scale methods. Value Health. 2012 Jan-Feb;15(1 Suppl):S85-90. doi: 10.1016/j.jval.2011.11.024.

  PMID: 22265073 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

• Abdul Halim Abdul Gafor, MBBS, MMED

  Nephrology unit, Department of Medicine, National University of Malaysia

  PRINCIPAL INVESTIGATOR

• Mohd Rizal Abdul Manaf, MBBS, PhD

  Department of Community Health, National University of Malaysia

  PRINCIPAL INVESTIGATOR

• Naren Kumar Surendra

  Department of Community Health, National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

MY (5)