Abstract
Review question/objective: : The objective of this review is to assess the evidence on the effectiveness of implementation of a pay-for-performance program on clinical outcomes in the adult chronic kidney disease (CKD) patient receiving hemodialysis.
The review question is: What is the effectiveness of implementation of a pay-for-performance program on clinical outcomes in the adult CKD patient receiving hemodialysis, as compared to the period immediately before implementation of the program?
More specifically, the objectives are to identify:
* The effectiveness of a pay-for-performance program on management of anemia in the adult chronic hemodialysis patient, with hemoglobin reported as grams per deciliter (g/dL).
* The effectiveness of a pay-for-performance program on adequacy of hemodialysis, as measured by a single-pool Kt/V, where "K" equals the dialyzer clearance of urea, "t" equals the time on dialysis and "V" equals the volume of distribution of urea,1 or a urea reduction ratio (URR), where the URR = 100 x (1 - post-dialysis blood urea nitrogen [BUN]/pre-dialysis BUN).2
Article Content
Background
Chronic kidney disease (CKD) is a global health concern that burdens healthcare resources. In 1990, CKD was ranked 36th in the list of causes of lives lost globally and increased to 19th in 2013.3 Chronic kidney disease causes a progressive decline in kidney function, with renal replacement therapy ultimately required to replace the function of the kidneys. There are five stages of CKD based on the glomerular filtration rate. The glomerular filtration rate is a marker of the glomerular filtrate that forms in the nephron within one minute.4 The glomerular filtration rate may vary depending on body surface area, age and gender, with normal values ranging from 120 to 130 mL/min/1.73 m2.4 The rate of decline in kidney function varies, and the start of renal replacement therapy depends on the presence of symptoms related to kidney failure.5 A decline in the glomerular filtration rate to less than 30 mL/min/1.73 m2 is associated with severely decreased kidney function, described as stage four CKD, and preparation for renal replacement therapy is recommended.6-9
The modalities of renal replacement therapy include hemodialysis, peritoneal dialysis and transplantation, with 85% of chronic dialysis patients in 53 countries receiving hemodialysis.3Hemodialysis began as an experimental therapy in 1943,10 and the first CKD patient was treated with repeated hemodialysis in the United States in 1963.11 In 1972, the United States Congress amended the Social Security Act and enacted a Medicare entitlement program for kidney disease to extend coverage to individuals less than 65 years of age with CKD requiring hemodialysis or transplantation.12,13
Countries that provide public reimbursement for hemodialysis are challenged when trying to balance the burden of disease against the costs of treatment. In the United States, the CKD population requiring renal replacement therapy represents less than 1% of all Medicare beneficiaries and approximately 6% of total spending.14 Economic and quality concerns led the United States and Germany to implement quality benchmarking programs that impose penalties on dialysis providers for failure to meet established standards.15-19 These pay-for-performance models are designed to assure a threshold of quality is achieved while managing the cost of the dialysis treatment. Anemia is a consequence of CKD and adequacy of hemodialysis is a measure of treatment effectiveness or quality. A deficiency in erythropoietin commonly occurs in CKD, resulting in anemia.20 Adequacy of hemodialysis is the delivered dose of hemodialysis required to adequately reduce urea in an individual with kidney failure.2 Management of anemia often requires the use of erythropoietin-stimulating agents to maintain hemoglobin, and hemodialysis adequacy may require the expense of a larger artificial kidney, increased frequency of treatment and an extended treatment time. The clinical indicators associated with management of anemia and hemodialysis adequacy represent costly components of the hemodialysis treatment. Evidence-based guidelines for management of anemia in CKD have been published by multiple organizations.2,5,9,20-24
Germany instituted weekly capitated payments for hemodialysis in 2002 and pay-for-performance with clinical indicators for hemodialysis adequacy and management of anemia consistent with established evidence-based guidelines in 2007.16-18 In 2011, the United States introduced a bundled, capitated prospective payment system for hemodialysis, followed by pay-for-performance as a quality incentive program with clinical indicators for hemodialysis adequacy and management of anemia that reflected evidence-based guidelines in 2012.25 The quality incentive program in the United States imposes a reimbursement penalty to dialysis providers that do not achieve a total minimum score on quality.26 The quality assurance program in Germany imposes a review process for dialysis providers with more than 15% of patients not meeting quality standards, with reimbursement decreased depending on the outcome of the review.16,27
Several systematic reviews have been published regarding the effectiveness of design elements of pay-for-performance programs in health care in developing and developed countries.28,29 However, there are no published systematic reviews available on the effectiveness of pay-for-performance on clinical outcomes for hemodialysis. Van Herck et al.28 conducted a systematic review to assess the evidence on the impact of pay-for-performance on primary care physician practice and hospital care in countries with pay-for-performance and found capitation reimbursement is associated with underutilization of services, and fee for service models with overutilization of services. Eijkenaar et al.29 performed an umbrella review of 22 systematic reviews that assessed the effects of pay-for-performance in health care and found a 5% overall improvement in the incentivized performance of physicians to improve quality without increasing cost. According to Eijkenaar et al.,29 the evidence suggests the effects of pay-for-performance may increase with certain design elements such as ease of tracking outcome measures, measures with room for improvement, payment that is sufficient to provide an incentive and based on absolute performance, focus on small groups and developed in collaboration with providers. It was the conclusion of Eijkenaar et al.29 that additional research is needed on the benefits of pay-for-performance to determine its value and effect on health. These findings support the need for a systematic review on the effectiveness of pay-for-performance for hemodialysis. A literature search was performed, and studies are available on the effectiveness of pay-for-performance on hemodialysis outcomes.17,30,31 The review will include studies that compare the clinical indicators associated with management of anemia and adequacy of hemodialysis in the period before implementation of a pay-for-performance program, to the period after implementation.
Preliminary searches of the JBI Database of Systematic Reviews and Implementation Reports, the Cochrane Library, PubMed and CINAHL have confirmed that no systematic review has been published or is in progress on this topic. The objective of this review is to identify and synthesize the best available evidence on the effectiveness of pay-for-performance programs on clinical outcomes in the CKD patient receiving hemodialysis.
Inclusion criteria
Types of participants
The review will consider studies that include adult participants 18 years and older, diagnosed with CKD who received hemodialysis in an outpatient dialysis in countries with a pay-for-performance program for hemodialysis. Individuals under 18 years receiving hemodialysis will not be included.
Types of interventions
The review will consider studies that evaluate the effectiveness of implementation of a pay-for-performance program for hemodialysis. The pay-for-performance programs considered will include a penalty for failure to meet predetermined thresholds for anemia or adequacy of hemodialysis. The review will consider studies that evaluate the following:
* Adequacy of hemodialysis before implementation of a pay-for-performance program compared to adequacy of hemodialysis after implementation of the pay-for-performance program.
* Anemia in hemodialysis before implementation of a pay-for-performance compared to anemia in hemodialysis after implementation of the pay-for-performance program.
It is well known that a pay-for-performance program for hemodialysis was first implemented by Germany in 2007,17,18 and the United States in 2012.25 If other countries are identified as having a pay-for-performance program for hemodialysis, they will be considered for inclusion in this review.
Outcomes
The review will consider reports that include any of the following outcome measures:
* Anemia as measured by hemoglobin reported as grams per deciliter (g/dL).
* Adequacy of hemodialysis as measured by a single-pool Kt/V, where "K" equals the dialyzer clearance of urea, "t" equals the time on dialysis and "V" equals the volume of distribution of urea,1 or a urea reduction ratio (URR), where the URR = 100 x (1 - post-dialysis blood urea nitrogen [BUN]/pre-dialysis BUN).2
Types of studies
The review will consider experimental and observational study designs, including quasi-experimental studies, before-and-after studies, prospective and retrospective cohort studies and analytical cross-sectional studies for inclusion. Studies will first be assessed to determine the geographic location where the study was done and the period in which the study was conducted to confirm implementation of a pay-for-performance program occurred during the period described in the study.
Search strategy
The search strategy will be designed to identify both published and unpublished studies. A three-phase search strategy will be utilized in this review. In the first phase, a list of keywords will be identified based on the reviewer's knowledge of the topic of this review and applied in an initial search of PubMed and CINAHL. Following the initial search, a list of keywords, terms and concepts included in the title and abstract of identified studies will be compiled with the index terms used in the databases to develop a comprehensive search strategy. In phase two, an advanced search of all refined keywords and terms in each of the included databases will be conducted, and a comprehensive list of studies will be developed. The refined keywords and index terms will be joined with Boolean logic operators to narrow the search results, based on the topic of this review and the sensitivity and specificity of each included database. In the third phase, the identified studies will be sorted based on inclusion criteria and relevancy to the topic of this review. The reference lists of all identified reports and studies will be searched to assure no pertinent study was inadvertently missed, and full-text of any study that appears relevant will be sought.
A PRISMA flow diagram will be used for transparency and clarification of the search process and will include the number of records in the identification, screening, determination of eligibility and inclusion phase.32 Endnote (Philadelphia, PA, USA)33 bibliographic software will be used to manage database searches and import references. To avoid excluding relevant studies for countries other than Germany and the United States, there will be no date limitations, and studies published in English only will be considered for inclusion in this review.
The databases to be searched include the following:
* PubMed
* CINAHL (Cumulative Index to Nursing and Allied Health Literature)
* Embase (Excerpta Medica Database)
* EBSCO (Elton B. Stephens Co.) Global Health
The search for unpublished studies will include the following:
* ProQuest Dissertations and Theses
* MedNar
* DOPPS (Dialysis Outcomes and Practice Patterns Study Program)
* Arbor Research Collaborative for Health (http://http://www.arborresearch.org/)
* The Federal Joint Committee (G-BA) (http://http://www.english.g-ba.de/)
* Centers for Medicare & Medicaid Services (https://http://www.cms.gov/).
Initial keywords to be used will be: chronic, dialysis, kidney, renal, disorder, disease, CKD, end-stage, ESRD, kidney failure, replacement therapy, RRT, incentive, reimbursement, pay-for-performance, P4P, value-based purchasing, VBP, quality, anemia, hemoglobin, adequacy, Kt/V, URR, urea reduction
Assessment of methodological quality
Quantitative studies selected for retrieval will be assessed by two independent reviewers for methodological validity before inclusion in the review using standardized appraisal instruments34-36 from the Joanna Briggs Institute System for the United Management, Assessment and Review of Information37 (JBI-SUMARI), or parallel instruments if updated JBI instruments are available at the point of completing the review. Any disagreements that arise between the primary and secondary reviewer will be resolved through discussion or consultation with a third reviewer and decided by a majority.
Data extraction
Quantitative data will be extracted from studies included in the review using standardized data extraction tools38 from JBI-SUMARI,37 or parallel tools if updated JBI tools are available at the point of completing the review. The data extracted will include specific details about the sample characteristics, study design, interventions and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for clarification of missing information or unclear data.
Data synthesis
Quantitative studies, whenever possible, will be pooled in a statistical meta-analysis using JBI-SUMARI37 to provide a statistical summary of the effectiveness of pay-for-performance programs compared to the period immediately before implementation of a pay-for-performance program. All results will be double entered into JBI-SUMARI.37 Effect sizes will be expressed as weighted mean differences (for continuous data), and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square, and if possible, a subgroup analysis will be performed on different quantitative study designs included in this review. If statistical pooling is not possible, the findings will be presented in a narrative form, including tables and figures to aid in data presentation whenever appropriate.
Acknowledgements
The reviewers would like to acknowledge Alysha Sapp, The Center for Translational Research, for her contribution and assistance as a research librarian to the development of this protocol. This systematic review is conducted as a partial fulfillment of a Doctor of Nursing Practice (DNP) degree for JAAO through Loyola University New Orleans, New Orleans, Louisiana, USA.
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