Physician assistants in the Phoenix Veterans Administration Health Care System (PVAHCS) undertook a process improvement project addressing the need for over-the-counter (OTC) medication counseling for diabetic patients. Within the framework of the Kidneys-in-a-Box (KIB) program, published by the National Academy of Nephrology PAs, participants examined current practices for the six modifiable factors outlined in the National Kidney Disease Education Program (NKDEP) of the National Institutes of Health (NIH).

Chart review by PVAHCS found a significant lack in OTC medication education, with less than 10% of reviewed patients having been counseled on medications that may affect kidney function. OTC medication counseling and distribution of a brochure developed for the project were implemented over a three-month time frame in the daily practices of the participating PAs and the PVAHCS Nephrology Clinic. Post project chart review of 110 patient records found a statistically significant increase in patient education (50.9%). While the change in PA behavior is significant, the goal of the project moving forward is to show impact on incidence of acute kidney injury (AKI) in the diabetic veteran population.


In July 2016, PAs in the Phoenix Veterans Administration Health Care System (PVAHCS) chose to participate in a Practice Improvement Continuing Education Program (PI-CME) called Kidneys in a Box (KIB). 1 KIB is designed for non-nephrology PAs to help decrease the progression of chronic kidney disease (CKD) in the diabetic population. The project utilizes the process improvement methodology to assess practice habits incorporating modifiable factors identified by NKDEP (National Kidney Disease Education Program; see Table 1).

PI methodology involves examining current practices, identifying areas of needed improvement, implementing modifications to practices based on evidenced-based medicine, and examining the results for efficacy of change. This twelve-week project requires both pre- and post-chart reviews, development and implementation of an interventional improvement strategy (strategies), and analysis of results after project completion.

Hypertension, diabetes, and advancing age are risk factors for developing CKD, and 1 in 3 Americans will develop CKD during their lifetimes.2 A 2004 study by Miller et al. reviewed the number of diabetic patients receiving care in the VA nationwide and found that the prevalence of diabetes in the veteran population was near 20% in 2000. The number is expected to increase 2% annually.3 A subsequent study by Maxwell et al found that nearly 500,000 veterans receive VA care for diabetes.4 The Veterans Health Association (VHA) emphasizes the care of the diabetic patient beginning at the primary care (PCP) level and throughout the organization’s specialty care clinics.

The VA/DOD Clinical Practice Guidelines for the Management of Diabetes Mellitus (v. 4.0) outlines diagnosis, management and screening for all patients with an active problem list diagnosis of diabetes type 1 or 2. 5 VHA prioritizes 10 diabetic- related complications requiring special attention (see Table 2) and recognizes the need for a patient-centered plan of care as there is no one-size-fits-all approach for this group of patients.

As the VHA already highlighted 5 of the 6 modifiable risk factors for diabetics that KIB/NKDEP suggested, the sixth area (over the counter medications-OTC) was chosen as an intervention. The goal of our PI-CME project was to analyze, identify, and implement active patient education for diabetic patients relating to medications which can contribute to progression of CKD in all populations.


KIB was identified as a national PI-CME project providing necessary continuing education credits while enhancing patient care and education. KIB was selected from available PI-CME programs based on four factors: cost effectiveness, adaptability to diverse practice environments, potential impact on VHA patients, and ease of implementation in the current VHA system.

Participants were identified within the PVAHCS through open invitation to all PAs during monthly administrative meetings and via email. Of the 42 PAs practicing at the PVAHCS, 14 elected to participate in the KIB project. The participating PAs practice in a variety of clinical settings, including: gastroenterology, ENT/surgery, mental health, palliative care, primary care, hospital internal medicine, allergy/immunology, and compensation and pension.

A needs assessment was performed through a chart review of 140 charts across the 14 providers’ patient panels. Chart reviews were performed with each participating PA identifying 10 patients with an active problem list diagnosis of diabetes type-2. Charts were reviewed for the 6 modifiable factors outline in the KIB project guidelines (see Table 1). Initial chart review data identified a lack of OTC medication education.

An investigating team was formed which consisted of 6 PAs representing a variety of specialty fields, 2 clinical pharmacy specialists, and a nephrologist. Current VHA practices, documentation and educational brochures were identified through inter-professional outreach and literature search. The workgroup identified a lack of patient-centered OTC medication materials and the need to improve documentation of counseling.

The group identified additional primary literature sources to expand and provide a more comprehensive list of OTC products that should be avoided in diabetic patients with an emphasis on preventing AKI in this population. The list of products was reviewed and a local brochure was developed through consensus (see Appendix 1). Per VA policy, the brochure was approved by local patient education specialists and produced for distribution in color format as a trifold brochure by the medical media department at the PVAHCS.

Additionally, standardized documentation of the intervention was developed by the workgroup. The documentation was added to patient visit notes by all participating PAs through the course of their usual practice when patients were identified as diabetic and when education was provided. At each patient encounter, with a patient identified as diabetic and a brochure provided, the PAs documented patient education and added the following to their encounter note: “Patient provided a copy of the OTC Medication in Diabetes and Chronic Kidney Disease pamphlet as part of the on-going KIB process improvement project.” Development of a standardized documentation phrase allowed for broad querying of the Computerized Patient Record System (CPRS) health record using the acronym KIB.

The patient education brochure and documentation were launched in July 2016. Continued implementation was encouraged through regular work group meetings and reminder emails. At the end of the three-month intervention, the participating PAs conducted a review of 10 charts. Charts were selected from the individual PAs patient panel in a similar manner as charts selected for pre-implementation. Data from pre-and post-implementation chart reviews were them compiled for comparison.


As part of the KIB PI-CME project, the six modifiable factors for patients with diabetes were analyzed in patients in the PVAJCS medical center.

Pre-implementation review of 140 patient charts is highlighted in Table 3 and in Chart 1. Of the 140 charts reviewed, 84 veterans were currently prescribed a statin medication, 120 had their HbA1C checked and 80 had a urine albumin-to-creatinine ratio (UACR) within the prescribed time frame of 6 months and 1 year respectively. Documentation of tobacco use counseling or active smoking cessation was noted in 70 patients, although this metric is difficult to assess in the CPRS chart as there is no single standardized location for documentation.

The pre-implementation chart review showed two areas of weakness: documentation of CKD staging, which was noted in only 26 of 140 charts (18%), and counseling with respect to OTC medications to avoid, which was found in only 13 (9.3%) charts reviewed. While all aspects of kidney education could be addressed in the VA system, as a group, it was felt that the significantly low percentage of documented OTC medication counseling was an area in dire need of improvement and was the modifiable factor most likely to have the greatest impact system-wide.

An OTC medication brochure was developed in collaboration with our pharmacy team. This was then handed out by project participants to all patients with an active problem list diagnosis of diabetes. During project development, a secondary goal of providing patient education for use in the nephrology clinic was identified and added to the project end points. Thus, the brochure developed for the KIB program was also given to every veteran seen by the PVAHCS nephrology clinic, a secondary but important intervention.

Post-implementation chart review was conducted after 3 months of brochure distribution. Of the 14 PAs who initiated the project, 11 completed the post-implementation chart review within the prescribed time-frame upon completion of the 3-month implementation phase. Data returned by this chart review showed a documented increase in the number of patients with OTC medication counseling from the initial 9.3% to 50.9% which is considered highly statistically significant. A total of 110 patient charts were reviewed showing counseling in 56 patients as documented with the KIB statement inserted in to the patient chart. Data for post-implementation is outlined in Table 4 and Chart 2.


The bench mark of OTC medication counseling was identified through a needs assessment process and an OTC medication brochure for patient education was developed by an inter-professional group. Distribution of the brochure was then implemented over a 3-month time frame with a post analysis to determine effectiveness. Patients identified as diabetic with an active problem list diagnosis in CPRS were targeted for education along with all patients currently in treatment in the PVAHCS nephrology clinic.

Similar to previously published data,1 implementation of the KIB PI project appears to have modified provider behavior. Results show that OTC medication counseling increased from less than 10% to 46%. However, the significance of these results over an extended period of time and in the setting of modifying patient outcomes will be analyzed at a later time.

Given the potential for long-term patient impact, the investigating team plans to continue the project with the goal of expansion of the patient education portion to the entirety of the PVAHCS and possibly on a regional and/or national level. In the short-term, there are plans to address implementation of the brochure in the endocrinology clinic and the diabetic education office, with continued expansion within the nephrology clinic. With expansion of the patient education component, systemic tracking through the CPRS system will be necessary to standardize documentation. The ultimate goal is to examine the effects of this education program on diagnosed cases of acute kidney injury (AKI) occurring in diabetic patients system-wide; for both AKI and CKD, or AKI alone.

Limitations of the study include the chart review process as a point of potential bias in the sampling. Several of the specialty areas do not see many diabetic patients. Additionally, several of the participants practice in the setting of long term inpatient care, which may skew the number of patients in both the pre- and post-chart reviews rather than providing a more representative cross section of the veteran population in the system. Moving forward the project working group plans to develop a standardized chart review process across the specialties and implementation of OTC medication counseling system wide.


1. Thomsen, K., Zuber, K., Davis, J. and Thomas, G. 2016. Improving treatment for patients with chronic kidney disease. JAAPA. Nov;29(11):46-53.

2. National Kidney Foundation. 2015. https://www.kidney.org/news/americans-are-kidney-clueless, retrieved 11/30/16.

3. Miller, D.R., Safford, M.M., Pogach, L.M. 2004. Who has diabetes? Best estimates of diabetes prevalence in the Department of Veterans Affairs based on computerized patient data. Diabetes Care 27 (Suppl. 2):B10-B21.

4. Maxwell, L.G., McFarland, M.S., Baker, J.W., Cassidy, R.F. 2016. Evaluation of the impact of a pharmacist-led telehealth clinic on diabetes-related goals of therapy in a veteran population. Pharmacotherapy, v 36:3, 348-356.

5. Veterans Health Administration. 2013. VHA DIRECTIVE 1063 Utilization of physician assistants (PAs).

6. Veterans Administration. 2010. VA/DoD Clinical practice guidelines for the management of diabetes mellitus, version 4.0.

7. Bicalho, M.D., Soares, D.B., Botoni, F.A., Reis, A.M., Martins, M.A. 2015. Drug-induced nephrotoxicity and dose adjustment among four drug information sources. International Journal of Environmental Research and Public Health, v 12, 11227-11240.

8. Gabardi, S., Munz, K., Ulbricht, C. 2007. A review of dietary supplement-induced renal dysfunction. Clinical Journal of America Society of Nephrology, v2, 757-765.

9. Kidney Disease: Improving Global Outcomes (KDIGO) Lipid Work Group. 2013. KDIGO Clinical Practice Guideline for Lipid Management in Chronic Kidney Disease. Journal of the International Society of Nephrology, Kidney International, Suppl. 3, 259–305.

10. Naughton, C.A. 2008. Drug-induced nephrotoxicity. American Academy of Family Physicians, v78, 743-750.

11. Paige, N.M., Nagami, G.T. 2009. The top 10 things nephrologists wish every primary care physician knew. Mayo Clinical Proceedings, 84:2, 180-186.

12. Cronin, R.M., VanHouten, J.P., Siew, E.D., Eden, S.K., Fihn, T.S., Nielson, C.D., Peterson, J.F., Baker, C.R., Ikizler, T.A, Speroff, T., Matheny, M.E. 2015. National veterans health administration inpatient risk stratification models for hospital-acquired acute kidney injury. Journal of American Medical Informatics Associated. 0:1-18. Doi 10.1093.

13. National Kidney Foundation. 2015. Diabetes – A Major Risk Factor for Kidney Disease. https://www.kidney.org/atoz/content/diabetes, retrieved 6/30/2016