10 Strategic Points Document for a Quality Improvement Project Grand Canyon

Theoretical Foundation

Literature Synthesis

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Practice Change Recommendation

·         End-stage renal disease adults require kidney transplants or hemodialysis to help them stay alive.

·         The primary role of maintenance hemodialysis (HD) is the extracellular fluid volume (ECV) balance, which makes sodium balance possible between interdialytic sodium intake and sodium removal during HD sessions (Wong M. et al., 2017). The problem addressed in the project is the relationship between adherence to fluid and diet restrictions and interdialytic weight gain among ESRD patients undergoing hemodialysis. Previous studies have shown that a positive dialysate-to-plasma sodium gradient is associated with increased thirst and interdialytic weight gain among ESRD patients (Jalalzadeh et al., 2021). However, there is a need for further studies on the effect of patient education on fluid and diet restrictions on patient adherence to the set restrictions.

o   Significance of the problem:  ESRD patients at the practice site do not adhere to fluid and diet restrictions resulting in fluid overload and interdialytic weight gain. Interdialytic weight gain can lead to several adverse health outcomes for ESRD patients. Fluid overload can increase the workload on the heart and lead to heart failure, while weight gain can exacerbate other underlying health conditions such as hypertension and diabetes (Weiner et al., 2017; Han et al., 2020). Additionally, maintaining an appropriate weight through adherence to fluid and diet restrictions can improve the overall quality of life for ESRD patients.

o   Moreover, the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines on nutrition recommendations for each stage of chronic kidney disease which is significant to be followed, as adherence to these guidelines could potentially have a significant impact on the weight and overall health outcomes of ESRD patients undergoing hemodialysis (Sakai et al., 2017)

ii.            Theoretical foundations:

·         Henderson’s Nursing Need Theory: Henderson’s Nursing Need theory emphasizes the importance of providing nursing care that addresses the physical, psychological, and social needs of patients (Henderson, 1997). The concepts of addressing the physical, psychological, and social needs align with the problem of interdialytic weight gain among ESRD patients in that it highlights the importance of addressing the physical needs of patients through appropriate fluid and diet management.

·         Cognitive Dissonance theory: Cognitive Dissonance theory suggests that individuals may experience psychological discomfort or dissonance when confronted with conflicting attitudes or behaviors (Festinger, 1957). This theory aligns with the problem of interdialytic weight gain among ESRD patients. It helps to understand how patients may struggle with the restrictions imposed by fluid and diet management and how they might change their attitudes or behaviors to resolve the discomfort.

·         The Health Belief Model: The Health Belief Model posits that individuals’ perceived susceptibility to a health problem, perceived seriousness of the problem, perceived benefits of acting, perceived barriers to acting, and cues to action all play a role in determining whether an individual will engage in health-promoting behaviors (Rosenstock, 1974). This theory aligns with the problem of interdialytic weight gain among ESRD patients.  It helps to understand how patients’ perception of the problem and their perceived benefit of taking action influence their adherence to fluid and diet restrictions.

Explanation: These theories were chosen as the theoretical foundations for the project because they provide a framework for understanding how patients may struggle with the restrictions imposed by fluid and diet management and how they might change their attitudes or behaviors to resolve the discomfort, and how patient’s perception of the problem and their perceived benefit of taking action influence their adherence to fluid and diet restrictions. By understanding these underlying psychological and social factors, the project aims to develop effective strategies for improving adherence to fluid and diet restrictions among ESRD patients, which could ultimately lead to better weight outcomes and improved overall health for these patients.

    iii.            Review of literature topics

·         About End Stage Renal Disease (ESRD) and chronic kidney disease (CKD)

·         What is diet and fluid restriction?

·         Strategies for diet and fluid management

·         What is intradialytic weight?

·         Best practices for engaging patients within fluid and diet restrictions

·         Diet and fluid restriction reduces inter-dialytic weight gain in ESRD patients

Annotated Bibliography

Han, B. G., Lee, J. Y., Kim, M. R., Shin, H., Kim, J. S., Yang, J. W., & Kim, J. Y. (2020). Fluid overload is a determinant for cardiac structural and functional impairments in type 2 diabetes mellitus and chronic kidney disease stage 5 not undergoing dialysis. PloS one, 15(7), e0235640. https://doi.org/10.1371/journal.pone.0235640

In this scholarly article, Han et al. (2020) evaluate the impact of fluid overload on cardiac alterations in patients with diabetes and non-dialysis-dependent chronic kidney disease (CKD). Chronic fluid overload in patients with end-stage renal disease (ESRD) is a profound risk factor for death. Therefore, this study involved 135 eligible patients for analysis. The researchers conducted all laboratory studies before the first dialysis application. These studies included measuring high-sensitivity C-reactive protein (hs-CRP) levels using a Cobas 8000 modular analyzer (Roche Diagnostics GmbH, Mannheim, Germany). Han et al. (2020) conclude that strict volume controls are the cornerstone of effective treatment and prevention of cardiac impairments in patients with diabetes and non-dialysis-dependent CKD stage 5 (DMCKD5-ND).

Jalalzadeh, M., Mousavinasab, S., Villavicencio, C., Aameish, M., Chaudhari, S., & Baumstein, D. (2021). Consequences of Interdialytic Weight Gain Among Hemodialysis Patients. Cureus, 13(5), e15013. https://doi.org/10.7759/cureus.15013

In this scientific study, the researchers aimed to identify the association of interdialytic weight gain/dry weight × 100 (IDWG%) on blood pressure (BP) and the nutritional status of hemodialysis (HD) patients. According to Jalalzadeh et al. (2021), sodium and water overload at all stages of chronic kidney disease (CKD) may result in plasma volume expansion, left ventricular (LV) dilatation, and LV hypertrophy. To achieve the study’s objective, the researchers conducted this study on 300 hemodialysis (HD) patients from four HD centers in Zanjan and Tehran, Iran. The study’s primary finding was that higher IDWG% resulted in lower dry weight and longer time on HD therapy. The researchers conclude that age and body weight is essential for IDWG and IDWG%. Therefore, it is possible to personalize interventions and advice on fluid and sodium restriction.

Perez, L. M., Fang, H. Y., Ashrafi, S. A., Burrows, B. T., King, A. C., Larsen, R. J., … & Wilund, K. R. (2021). A pilot study to reduce interdialytic weight gain by providing low‐sodium, home‐delivered meals to hemodialysis patients. Hemodialysis International, 25(2), 265–274. https://doi.org/10.1111/hdi.12902

This pilot study aimed to determine whether four weeks of low-sodium, home-delivered meals in hemodialysis (HD) reduces interdialytic weight gain (IDWG). Other study outcomes include changes in dietary sodium intake, thirst, xerostomia, blood pressure, muscle sodium concentration, and volume overload. The study involved 20 hemodialysis (HD patients) in achieving the objective. The participants followed a predetermined (control) diet for the first four weeks and four weeks of three low-sodium, home-delivered daily meals. The study revealed that the low-sodium meal intervention significantly reduced IDWG than the control period. Therefore, the researchers concluded that low-sodium, home-meal delivery could effectively improve volume control and blood pressure in HD patients.

Ramaswamy, K., Brahmbhatt, Y., Xia, J., Song, Y., & Zhang, J. (2020). Individualized dialysate sodium prescriptions using sodium gradients for high‐risk hemodialysis patients lowered interdialytic weight gain and achieved target weights. Hemodialysis International, 24(3), 406–413. https://doi.org/10.1111/hdi.12830

In this scholarly article, Ramaswamy et al. (2020) conducted an open-label, non-randomized study to explore the effects of individualized dialysate sodium (DNa) prescription using Na gradients at high risk for large interdialytic weight gain (IDWG). According to the researchers, large interdialytic weight gain (IDWG) increases morbidity and mortality in chronic hemodialysis patients. The study revealed that patients with individualized DNa concentration had 3.6 times greater odds of having lower IDWG than those with standard dialysate sodium concentration. Therefore, it is valid to conclude that individualized DNa prescriptions are well-tolerated and may be effective in optimal fluid management in high-risk hemodialysis (HD) patients.

Sakai, A., Hamada, H., Hara, K., Mori, K., Uchida, T., Mizuguchi, T., Minaguchi, J., Shima, K., Kawashima, S., Hamada, Y., & Nikawa, T. (2017). Nutritional counseling regulates interdialytic weight gain and blood pressure in outpatients receiving maintenance hemodialysis. The journal of medical investigation: JMI, 64(1.2), 129–135. https://doi.org/10.2152/jmi.64.129

Hemodialysis (HD) patients in outpatient settings must maintain salt and water intake to avert adverse consequences, including high blood pressure. In this scholarly article, Sakai et al. (2017) investigated whether long-term nutritional counseling by a nationally registered dietitian could improve IDWG and blood pressure in hemodialysis (HD) patients. The study involved 48 patients in the outpatient settings at Kawashima hospital. Upon measuring the patients’ pre-and post-dialysis systolic and diastolic blood pressure, the researchers revealed a significant decrease in blood pressure after study initiation (149±19 to 134 ±18 mmHg). Also, it was evident that long-term nutritional counseling by a nationally registered dietitian may improve the IDWG ratio and blood pressure in HD patients. Therefore, it is essential to individualize nutritional counseling interventions to decrease salt and water intake and reduce blood pressure.

Weiner, D. E., Brunelli, S. M., Hunt, A., Schiller, B., Glassock, R., Maddux, F. W., … & Nissenson, A. (2014). We are improving clinical outcomes among hemodialysis patients: a proposal for a “volume first” approach from the chief medical officers of US dialysis providers. American journal of kidney diseases, 64(5), 685-695. https://doi.org/10.1053/j.ajkd.2014.07.003

The absence of sufficient trial data to guide various aspects of hemodialysis therapy, high mortality, and mortality rates prompt improved care interventions. This article reports the consensus opinions realized at the March 2013 symposium of the Chief Medical Officers of the 14 largest dialysis providers in the United States. These dialysis providers recommended extracellular fluid status, gradual fluid removal, the avoidance of interdialytic sodium by incorporating dialysate sodium concentrations, and dietary counseling to emphasize sodium avoidance. These steps are profound components of dialysis treatment and essential strategies for preventing adverse effects associated with increased sodium intake and volume overload in hemodialysis (HD) patients.

Wong, M. M., McCullough, K. P., Bieber, B. A., Bommer, J., Hecking, M., Levin, N. W., McClellan, W. M., Pisoni, R. L., Saran, R., Tentori, F., Tomo, T., Port, F. K., & Robinson, B. M. (2016). Interdialytic Weight Gain: Trends, Predictors, and Associated Outcomes in the International Dialysis Outcomes and Practice Patterns Study (DOPPS). American journal of kidney diseases: the official journal of the National Kidney Foundation, 69(3), 367–379. https://doi.org/10.1053/j.ajkd.2016.08.030

In this article, the researchers aimed to identify facility- and patient-level predictors of IDWG, their temporal trends, and the association between IDWG and mortality and hospitalization risk. To realize these objectives, Wong et al. (2016) used two study designs; a sequential cross-section design to identify facility-and patient-level predictors of IDWG and a prospective cohort study to explore associations between IDWG, mortality, and hospitalization risk. The study involved 21,919 participants in HD therapy. The study revealed that the predictors of mortality and cause-specific hospitalization in HD patients were modifiable facility mean dialysate sodium concentrations. Therefore, reductions in dialysate sodium concentration can reduce IDWG and improve other health outcomes in HD patients.

Sufficient fluid volume management in hemodialytic persons is essential for patient outcomes and experience (Iseki, 2022). Volume overload may result in breathlessness and peripheral edema (Dasgupta et al., 2019). The long-term effects include left ventricular hypertrophy, hypertension, and heart failure, which are associated with higher mortality rates. Current practices, including low dialysate sodium concentration (DNa), have not been effective: excessive fluid removal may result in abdominal pain, dizziness, cramps, and vomiting (Dasgupta et al., 2019). According to the KDOQI guidelines, sodium intake is limited to less than 2.3g daily (100mmol daily) sodium or less than 5.8g salt to improve volume control and reduce blood pressure in Chronic Kidney Disease (CKD) 3 to 5, post-transplantation, or CKD5D patients (Iseki, 2022).

ii.            Understanding the relationships and impacts of Kidney Disease Outcome Quality Initiative Nutrition Guideline for intradialytic sodium and fluid overload on the weights of renal disease adults in hemodialysis facilities in Florida is essential.

Setting

Location

Inclusion and Exclusion Criteria

i.          Dialysis Facilities

ii.          Rural city in Florida

iii.          Inclusion Criteria

·            Has been diagnosed with End-stage renal disease

·            Aged 18 years and above.

·            Is a current patient.

·            Sober state of mind and capable of giving consent legally

v.      Who cannot participate?

·         Is below 18 years old.

·         Is not a current patient.

·         Has not been diagnosed with End stage renal disease

ii.            Dependent variable: Level of engagement with fluid and dietary restriction knowledge. Data will be collected using the modified end-stage renal disease adherence questionnaire in similar studies. The questionnaire includes items on diets, fluids, and adherence behaviors.

1. Dependent variable: Inter-dialytic weight gain. The Hemodialysis/Inter-dialytic weight flow sheet will be used to collect data. The flow sheet captures data such as treatment time, dialysis solution, pre-dialytic weight, post-dialytic weight, and laboratory results

i.            According to the Centers for Medicare & Medicaid Services (CMS), quality is defined by the National Academy of Medicine as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Quality improvement is the framework used to improve care systematically. Quality improvement seeks to standardize processes and structures to reduce variation, achieve predictable results, and improve outcomes for patients, healthcare systems, and organizations (CMS.gov).

ii.            The federal government defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (HHS.gov). Research yields valid results through the strict implementation of a fixed protocol, and the focus of research is on long-term gains in learning.

iii.            There are many similarities and differences between research and QI:

·         Similarities

o   Both involve a systematic investigation designed to achieve reliable and valid results. Both involve the analysis of data.

o   Both may involve the implementation of a new intervention.

o   Both may result in a presentation or publication.

·         Differences

o   QI projects are often flexible and incremental in design, employing strategies such as a plan-do-study-act cycle.

o   QI uses data analysis to determine whether the workforce follows best practices and professional guidelines.

o   It implements a new practice or process to improve (for example) workflow, patient safety, staff expertise, cost-effectiveness, etc.

o   QI interventions are often proven successful elsewhere and widely accepted in the profession/discipline. It evaluates the best strategies to implement these interventions locally.

o   QI projects can help characterize the population to serve their needs better or improve their care. Its projects aim to directly benefit existing patients by implementing immediate local improvements.

o   QI does not increase patient risk beyond the risks involved in the care they are already receiving.

o   QI tools apply primarily to the unique characteristics of our local setting.

o   The results of QI projects typically are evaluated by an internal committee or executives who decide whether to adopt the new practice permanently.

ii.            Permission will be needed to allow the patient from hemodialysis facilities to participate in the study. Approximately 60 participants will be asked to take part in the survey. As illustrated, the data will be collected through questionnaires and weight sheets, and they will then be stored in electric format. Participants will have informed consent, and their privacy will be maintained.

ii.            Descriptive statistics on SPSS will be used to analyze the data. Patient demographics will be summarized into standard deviations, means, medians, percentages, and interquartile ranges for the categorical and continuous data. Chi-squares and three-way contingency tables will be used to test associations between the identified variables, helping to categorize the patient adherence to fluid restrictions, medications, dietary recommendations, and hemodialysis schedules into aggregated scores.

iii.            Notably, t-tests will be employed to help determine the relationships concerning weight pre-dialysis and post-dialysis and compare the weight loss across the sample based on age. A binomial logistic regression analysis will then be conducted to identify the correlation between diet and fluid restriction education, patient adherence level, and inter-dialytic weight gain.

Festinger, L. (1957). A theory of cognitive dissonance. Stanford University Press.

Han, B. G., Lee, J. Y., Kim, M. R., Shin, H., Kim, J. S., Yang, J. W., & Kim, J. Y. (2020). Fluid overload is a determinant for cardiac structural and functional impairments in type 2 diabetes mellitus and chronic kidney disease stage 5 not undergoing dialysis. PloS one, 15(7), e0235640. https://doi.org/10.1371/journal.pone.0235640

Henderson, V. (1997). Basic principles of nursing care. International Council of Nurses.

Iseki, K. (2022). Nutrition and quality of life in chronic kidney disease patients: A practical approach for salt restriction. Kidney Research and Clinical Practice. https://doi.org/10.23876/j.krcp.21.203

Jalalzadeh, M., Mousavinasab, S., Villavicencio, C., Aameish, M., Chaudhari, S., & Baumstein, D. (2021). Consequences of Interdialytic Weight Gain Among Hemodialysis Patients. Cureus, 13(5), e15013. https://doi.org/10.7759/cureus.15013

Landrum, B., & Garza, G. (2015). Mending fences: Defining the domains and approaches of quantitative and qualitative research. Qualitative Psychology, 2(2), 199–209. https://doi.org/10.1037/qup0000030

Perez, L. M., Fang, H. Y., Ashrafi, S. A., Burrows, B. T., King, A. C., Larsen, R. J., … & Wilund, K. R. (2021). A pilot study to reduce interdialytic weight gain by providing low‐sodium, home‐delivered meals to hemodialysis patients. Hemodialysis International, 25(2), 265–274. https://doi.org/10.1111/hdi.12902

Ramaswamy, K., Brahmbhatt, Y., Xia, J., Song, Y., & Zhang, J. (2020). Individualized dialysate sodium prescriptions using sodium gradients for high‐risk hemodialysis patients lowered interdialytic weight gain and achieved target weights. Hemodialysis International, 24(3), 406–413. https://doi.org/10.1111/hdi.12830

Rosenstock, I. M. (1974). The health belief model and preventive health behavior. Health Education Monographs, 2(4), 354–386. https://doi.org/10.1177/109019817400200405

Sakai, A., Hamada, H., Hara, K., Mori, K., Uchida, T., Mizuguchi, T., Minaguchi, J., Shima, K., Kawashima, S., Hamada, Y., & Nikawa, T. (2017). Nutritional counseling regulates interdialytic weight gain and blood pressure in outpatients receiving maintenance hemodialysis. The journal of medical investigation: JMI, 64(1.2), 129–135. https://doi.org/10.2152/jmi.64.129

Weiner, D. E., Brunelli, S. M., Hunt, A., Schiller, B., Glassock, R., Maddux, F. W., … & Nissenson, A. (2017). We are improving clinical outcomes among hemodialysis patients: a proposal for a “volume first” approach from the chief medical officers of US dialysis providers. American journal of kidney diseases, 64(5), 685-695. https://doi.org/10.1053/j.ajkd.2014.07.003

What is Human Subjects Research? | HHS.gov.https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/lesson-2-what-is-human-subjects-research/index.html

Wong, M. M., McCullough, K. P., Bieber, B. A., Bommer, J., Hecking, M., Levin, N. W., McClellan, W. M., Pisoni, R. L., Saran, R., Tentori, F., Tomo, T., Port, F. K., & Robinson, B. M. (2017). Interdialytic Weight Gain: Trends, Predictors, and Associated Outcomes in the International Dialysis Outcomes and Practice Patterns Study (DOPPS). American journal of kidney diseases: the official journal of the National Kidney Foundation, 69(3), 367–379. https://doi.org/10.1053/j.ajkd.2016.08.030