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Michael M. Evans, MSN, RN, CNS, CMSRN, is an Instructor of Nursing, The Pennsylvania State University Worthington Scranton Campus, Dunmore, PA.
Acknowledgment: I would like to thank Karen Paczkowski, MD, with Physicians Health Alliance, for her help and guid- ance in implementing this project, as well as Dr. Cindy Mailloux and Dr. Jean Steelman, nursing faculty with Misericordia University, for their sup- port and guidance in implementing the project.
Michael M. Evans
Evidence-Based Practice Protocol to Improve Glucose Control in
Individuals with Type 2 Diabetes Mellitus
Diabetes mellitus (DM) is a group of diseases that includes type 1 DM,type 2 DM, gestational DM, medication-induced DM, and pre-DM; all are characterized by high levels of blood glucose (American Diabetes Association [ADA], 2008). Currently, 24 million children and adults in the United States (8% of the population) have diabetes; unfortunately, nearly one-third of those individuals are unaware they have the disease. In addi- tion, 57 million Americans have pre-diabetes (ADA, 2007a). Type 2 DM accounts for 90%-95% of all cases of diabetes (Centers for Disease Control, 2003). In type 2 DM, the body does not use insulin properly due either to insulin resistance or relative insulin deficiency (ADA, 2007a).
In 2000, DM was the sixth leading cause of death in the United States, with heart disease leading the cause of diabetes-related deaths. About 65% of deaths occurring among people with DM are attributed to heart disease or stroke. DM is the leading cause of blindness among adults ages 20-74, and diabetic retinopathy is linked to 12,000-24,000 new cases of blindness each year. In 2000, nearly 130,000 people with DM underwent dialysis treatment or kidney transplantation. About 60%-70% of people with DM also have mild-to-severe forms of nervous system damage that impairs sensation in the feet or hands and slows digestion of food in the stomach. Also, more than 60% of non-traumatic lower-limb amputations in the United States occur among people with DM (ADA, 2007a).
To determine if a person has pre-diabetes or diabetes, health care providers conduct a fasting plasma glucose test (FPG) or an oral glucose tolerance test. Either test can be used to diagnose pre-diabetes or dia- betes; however, the ADA (2007b) recommends the FPG because it is easi- er, faster, and less expensive to perform. A fasting blood glucose level of 100-125 mg/dl signals pre-diabetes, while FPG greater than 125 mg/dl sig- nifies diabetes (ADA, 2007b). DM contributes to many complications which are very costly to patients and the U.S. health care system. Direct medical costs related to DM in 2007 were $116 billion, while indirect costs (e.g., disability, work loss, premature mortality) accounted for $58 billion. Total costs related to DM in the United States in 2007 were $174 billion (ADA, 2008). In Pennsylvania, where the APRN intervention occurred, direct medical costs related to DM in 2006 were estimated at nearly $5 bil- lion and indirect costs at a little over $2 billion (ADA, 2006).
Research has shown that keeping blood glucose results as close to normal as possible can prevent or delay many of the complications and costs associated with DM. The classic randomized clinical trial conducted by The Diabetes Control and Complications Trial Research Group (1993) found maintenance of blood glucose as close to normal as possible slows the onset and progression of diabetes-related eye, kidney, and nerve dis-
Type 2 diabetes mellitus is a major public health prob- lem in the United States. In adult patients with type 2 DM, what is the effect of adding a follow-up telephone intervention by an APRN on blood glucose control as com- pared to standard treatment alone? Findings from one sys- tematic review and five ran- domized control trials were used to support a protocol to elicit improvement in gly – cemic control.
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eases. The findings showed a reduction in eye disease by 76%, kidney disease by 50%, and nerve disease by 60%. The study also demonstrated any sustained low- ering of blood glucose has positive effects, even if the person has a history of poor glycemic control. The United Kingdom Prospective Diabetes Study (1998) also con- cluded intensive blood glucose control decreases the risk of microvascular complications and diabetes-related deaths.
To maintain tight glycemic control, the literature strongly sup- ports use of the ADA Standards of Medical Care in Diabetes (2007b). Standards currently do not recom- mend a follow-up telephone inter- vention, but they do encourage use of a complex treatment regime for persons with type 2 diabetes in order to maintain tight glycemic control and delay or minimize diabetes-related complications. Because many persons diagnosed with type 2 diabetes are older adults, complex treatments may be difficult to implement. Involve – ment of an advanced practice nurse (APN) may empower patients to care for their chronic illness and maintain their optimal level of wellness. The purpose of this article is to explore the effec- tiveness of an APN-led follow-up telephone intervention on gly – cemic control in individuals with type 2 DM. The effectiveness of the intervention was measured by the interpretation of daily fasting blood glucose results.
Focused Problem In adults with type 2 DM, what
is the effect of adding a follow-up telephone intervention by an APN on blood glucose control as com- pared to ADA-recommended stan- dard treatment alone? Target pop- ulation for the intervention was adults diagnosed with type 2 DM who could read, write, and under- stand English; were able to per- form self-blood glucose monitoring every day before eating; and were willing to call or fax the results to the collaborating physician’s office on a weekly basis. Excluded from the evidence-based practice proto- col (EBPP) were persons with a diagnosed psychotic disorder or
disabling sensory or cognitive impairment; who had a new diag- nosis of type 2 DM and had not attended standard outpatient DM education classes; were receiving drugs that can cause medication- induced hyperglycemia or hypo- glycemia (steroids, antibiotics) at the time of APN intervention implementation; and patients with an acute illness that may cause hyperglycemia. Individuals who were pregnant or planning to become pregnant, those without access to a telephone, those with- out a blood glucose monitor or without access to one, persons with hypoglycemia unawareness, and those with a life expectancy of less than 1 year were excluded from the EBPP.
Intended users of the EBPP included adult health clinical nurse specialists, family and adult nurse practitioners, and internal medicine and family physicians with whom an APN could collabo- rate to initiate the stated interven- tion. Other potential beneficiaries of the EBPP were all health care professionals who have direct con- tact with individuals with type 2 DM and can facilitate their appro- priate referrals and education.
The objective of the EBPP pro- tocol was to improve glucose con- trol in individuals with type 2 DM, as demonstrated through the trending of FBG results. The ADA (2007b) recommends self-monitor- ing of blood glucose (SMBG) as a component of effective therapy that allows patients to evaluate their individual responses to thera- py and assess whether glycemic targets are being reached. SMBG can be useful in preventing hypo- glycemia, adjusting medications, and identifying effects of physical activity. The optimal frequency and timing of SMBG for patients with type 2 DM is not known but should be sufficient to facilitate attainment of glucose goals. Use of hemoglobin A1c testing in combina- tion with SMBG allows better eval- uation of blood glucose manage- ment as well as verification of accuracy of self-reported blood glucose results. However, inclu- sion of this measure was not possi- ble in the current study.
Literature Review A literature review was per-
formed for the most current and rel- evant information related to the research question. Six computer- ized research data bases were accessed: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Source: Nursing/Academic Edition, MED- LINE, Educational Resource Information Center (ERIC), the Cochrane Library, and DiabetesPro (professional resources online). The keywords used to retrieve doc- uments were diabetes mellitus, type 2 diabetes mellitus, diabetes melli- tus and follow-up interventions, dia- betes mellitus and follow-up inter- ventions and advanced practice nursing, diabetes mellitus and fol- low-up interventions and clinical nurse specialists, diabetes mellitus and follow-up interventions and meta analysis, diabetes mellitus and follow-up interventions and system- atic reviews, diabetes mellitus and follow-up phone call interventions, diabetes mellitus and nursing educa- tion, diabetes mellitus and glucose control, diabetes mellitus and glu- cose control and advanced practice nursing, diabetes mellitus and glu- cose control and clinical nurse spe- cialists. After completion of the lit- erature review, 22 studies were reviewed for the EBPP; however, only six studies (1999-2007) met the selection criteria based for the proposed APN intervention. One study was a systematic review, and five studies were randomized con- trol trials.
The selected studies suggest- ed follow-up phone call interven- tions can help improve glycemic control in individuals with DM.
Conceptual Model The conceptual model used to
direct the EBPP was Dorthea Orem’s Self-Care Deficit Theory of Nursing. Within Orem’s conceptual model, three theories are expressed: theory of nursing sys- tems, theory of self-care deficit, and theory of self-care. The cur- rent study was based on Orem’s Mid-Range Theory of Self-Care, which identified self-care as “a human regulatory function that individuals must, with delibera- tion, perform themselves or have
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performed for them to maintain life, health, development, and well being” (Orem, 1995, p. 103). The theory of self-care was related to the EBPP because individuals with type 2 DM must adhere to treat- ment guidelines (self-care) in order to maintain life, health, develop- ment, and well-being, as evidenced by improved glycemic control and blood sugar stability. The APN intervention served as one method to facilitate self-care.
Major Recommendations Two guidelines were reviewed
using the Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument (2001) to for- mulate the APN algorithm (see Figure 1) and questions (see Figure 2) in the follow-up phone call inter- vention. The Standards of Medical Care in Diabetes (ADA, 2007b) guided the formulation of ques- tions and recommendations in – volving diabetes management. The intervention included questions and recommendations about appropriate medical evaluations, management plans, SMBG, diag- nostic testing, physical activity,
psychosocial assessment, immu- nizations, hypoglycemia/hyper- glycemia problems, sick day guide- lines, hypertension control, lipid management, aspirin therapy, smoking cessation, foot care, and nephropathy/retinopathy screen- ing, and treatment.
Based on the guidelines (ADA, 2007b), patient recommendations were made during the APN inter- vention, including SMBG for achievement of glycemic goals and hemoglobin A1c testing at appropri- ate intervals. Meal planning (car- bohydrate counting and limiting
Figure 1. Type 2 DM Follow-Up Phone Call Treatment Algorithm:
A Coaching/Collaboration Protocol
Adult with type 2 DM who has attended standard
ADA outpatient DM education classes.
Schedule initial visit with APN to discuss DM
During bi-weekly follow-up phone calls, discuss ADA
standards of care and record FBG results.
Effectiveness of EBPP measured through an
improvement in FBG results
Unwilling to participate in EBPP
Comparison Group: No further reminders regarding plan of care
Provide recommendations following ADA standards of care
based on patient responses.
Collaborate with physician as necessary to adapt plan of care.
Intervention Group: Begin proposed
treatment modality with follow-up phone call
Willing to participate in EBPP
Obtain PMH to ensure criteria are met for EBPP.
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fat intake) and physical activity of at least 150 minutes/week were discussed with all patients, and a brief psychosocial assessment was performed on all patients in the EBPP as a screening for any emo- tional problems. Also discussed was treatment of hypoglycemia with 15-20 grams of a rapid-acting carbohydrate. The importance of obtaining the pneumococcal vac- cine and the annual influenza vac- cine also was identified.
Other patient recommenda- tions included blood pressure screening to identify individuals with hypertension and further treatment involving medications, lifestyle, and behavioral therapy. Dyslipidemia screening was rec- ommended annually, or more fre- quently based on lipid values, in order to achieve goals and treat- ment with a HMG-CoA reductase
inhibitor medication (statin) for all patients trying to achieve a reduc- tion in low-density lipoprotein (LDL) of 30%-40% regardless of baseline LDL levels. Also, aspirin therapy was recommended as a primary prevention strategy for individuals with an increased risk of cardiovascular disease and as a secondary prevention strategy in persons with a history of cardio- vascular disease. All patients in the EBPP were advised not to smoke.
Patients also were advised to perform an annual test for the presence of microalbuminuria and receive appropriate pharma- cotherapy if indicated. Yearly dila- tion and comprehensive eye exam- inations by an ophthalmologist or optometrist were recommended to reduce the risk and progression of diabetic retinopathy. Finally, a
comprehensive foot exam was rec- ommended annually to patients in the EBPP to identify risk factors predictive of ulcers or amputa- tions, or identify any areas of skin breakdown.
Risks and Benefits of the Guideline
Risks of following the guide- lines included events such as severe hypoglycemia and weight gain, which is attributed to the improved glycemic control. Other risks involved liver dysfunction from statin therapy and fluid reten- tion for patients receiving oral thi- azolidinediones for hyperglyce – mia. Benefits of following the guidelines included the opportuni- ty for optimal management of dia- betes involving improved glycemic control as well as appropriate pre- vention and management of dia- betes complications (ADA, 2007b).
Implementation of the Guideline
Implementation of the EBPP occurred with oversight of a col- laborating preceptor, Dr. Karen Paczkowski, a practitioner with Physician Health Alliance. The process evolved over an 8-week period and began with an initial face-to-face meeting in which the patient was asked to join the EBPP and participate in follow-up tele- phone calls at mutually deter- mined times. The proposed algo- rithm allowed patient coaching for improved blood glucose control. In addition, collaboration with a physician permitted necessary medication adjustments and changes, diagnostic tests, and additional referrals when neces- sary to assist the patient to improve blood glucose control and self-care by eliminating the knowl- edge deficit. Initial face-to-face office visits with the APN followed by bi-weekly telephone contact also helped to guide patients in assumption of self-care and improved adherence to the treat- ment regime. The intervention environment supported personal development by allowing patients to discuss areas of concern or interest and by APN coaching.
Fasting blood glucose (FBG) results were used as the outcome
The following will be covered in the 15-20 minute bi-weekly phone call: 1. Do you have a follow-up appointment with your primary care provider? 2. Are you self-monitoring your blood glucose levels at home? 3. If yes, how often? 4. Are you satisfied with your blood glucose monitor? 5. What were your blood glucose values over the last 48 hours? 6. Are you going to have a HgbA1c drawn within next 3-4 months? 7. If previously done, what was the value? 8. Are you taking medication for your DM? 9. If yes, what medications? 10. If yes, are you having any problems with it? 11. Any hyperglycemia or hypoglycemia problems? 12. What was your blood pressure at your last screening? 13. If it was greater than130/80, are you being treated with lifestyle and behavioral
changes (exercise, diet modifications)? 14. If it was greater than 140/90, are you being treated with medication as well as
lifestyle and behavioral changes? (preferably ACE inhibitors or ARBs as they have been shown to delay the progression of macroalbuminuria and nephropathy)
15. What was your last cholesterol level? 16. Are you taking a statin (shown to delay onset of CVD)? 17. Do you take an aspirin daily (75-162 mg/day)? 18. Have you been tested for the presence of microalbuminuria? 19. If present, are you currently taking an ACE inhibitor or an ARB? 20. Have you had a dilated and comprehensive eye examination by an
ophthalmologist or optometrist since diagnosis? 21. Have you had a foot examination since diagnosis? 22. Provide smoking cessation counseling. 23. Have you had the flu shot this year? 24. Is your pneumonia vaccine up to date? 25. Discuss sick day guidelines. 26. Are you getting exercise of moderate intensity at least three times a week for
30 minutes at a time? 27. Discuss meal planning. 28. How are you feeling emotionally? 29. Is there anything that we have not discussed that you would like to discuss
concerning your treatment plan?
Figure 2. Content of Follow-Up Telephone Intervention
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measure and recorded with each telephone intervention so trends could be tracked and medication changes or adjustments, diagnos- tic testing, and appropriate refer- rals made by the collaborating physician when necessary. As shown in Figure 3, a downward trend of FBG occurred in the inter- vention group. Also, participants in the intervention group received advanced coaching on the latest ADA standards of care by an APN. The comparison group received the ADA standards of care and called or faxed in their FBG results bi-weekly to the collaborating physician’s office but received no APN intervention.
Discussion As displayed in Figure 3, the
EBPP showed a significant reduc- tion in FBG results of 72 mg/dL, correlating to 2% decrease in hemoglobin A1c (ADA, 2007b). However, bias might have influ- enced the results in a nonhomoge- neous sample because of conven- ience sampling and time con- straints. The sample of the inter- vention group was all female, ages 69-79, whereas the comparison group had male and female partici- pants ages 39-87. Baseline hemo- globin A1c was 5.9%-9.5% for the intervention group and 6.9%-8.2% for the comparison group. Also, participant contamination may have occurred during the APN intervention. As shown in Figure 4, participants in the comparison group benefitted from the collabo- rative efforts of the APN and physi- cian regarding elevated FBG results. They did not receive the bi-weekly follow-up telephone intervention but may have received a medication adjustment or change in treatment regime in order to improve glycemic control. However, the intervention group maintained better glycemic con- trol as compared to the compari- son group (see Figure 5).
Limitations Limitations of the EBPP includ-
ed time constraints, which did not allow for hemoglobin A1c testing, self-reported FBG data, failure to limit extraneous variables (includ-
Figure 5. Differences Between Intervention and Comparison Groups
Figure 3. Comparison of Intervention Group Before and
After APN Intervention
300 250 200 150 100 50 0
A B C D E F
Figure 4. Differences of Comparison Group Before and
After APN Intervention
G H I J K L
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ing glucometer malfunction), and a small sample size (six participants in each groups). In addition, one individual in the intervention group required surgery and anoth- er required corticosteroid treat- ment during the EBPP, interven- tions that may have altered FBS results.
Even with these limitations, the author still finds the results clinically significant. The APN intervention may have been more successful than interventions in reviewed literature (Aubert et al., 1998; Maljanian, Grey, Staff, & Conroy, 2005; Oh, Kim, Yoon, & Choi, 2003; Piette et al., 2000; Wong, Mok, Chan, & Tsang, 2005) due to the educational knowledge and training of APNs.
Conclusion According to Bourbonniere
and Evans (2002), “An APRN demonstrates a high level of expertise in assessing, diagnosing, and treating complex health responses of individuals, groups, and communities. Through the lens of their expert skills, interventions are based on greater depth and breadth of knowledge and a finely honed ability to synthesize physio- logical, psychological, social, and environmental data” (p. 2062). The EBPP’s impact may have been due in part to the APN’s holistic view of the patient, who received care con- sistent with ADA (2007b) recom-
mendations with the addition of the APRN intervention.
References American Diabetes Association (ADA).
(2006). The estimated prevalence and cost of diabetes in Pennsylvania. Retrieved from http://www.diabetes arch ive.net /advocacy-and- lega l resources/cost-of-diabetes-results. jsp?state=Pennsylvania&distr ict= 0&DistName=Pennsylvania+%28Entire +State%29
American Diabetes Association (ADA). (2007a). Diabetes statistics. Retrieved from http://www.diabetes.org/diabetes- basics/diabetes-statistics/
American Diabetes Association (ADA). (2007b). Standards of medical care in diabetes-2007. Retrieved from http:// care.diabetesjournals.org/content/30/ suppl_1/S4.full
American Diabetes Association (ADA). (2008). Economic costs of diabetes in the U.S in 2007. Retrieved from http:// care.diabetesjournals.org/content/ 31/3/596.full.pdf+html
Aubert, R.E., Herman, W.H., Waters, J., Morre, W., Sutton, D., Peterson, B.L., … Koplan, J.P. (1998). Nurse case man- agement to improve glycemic control in diabetic patients in a health mainte- nance organization. Annals of Internal Medicine, 129(8), 605-612.
Bourbonniere, M., & Evans, L. (2002). Advanced practice nursing in the care of frail older adults. Journal of American Geriatric Society, 50(12), 2062-2076.
Centers for Disease Control. (2003). 2003 National diabetes fact sheet. Retrieved from http://www.cdc.gov/diabetes/pubs/ general.htm#what
Maljanian, R., Grey, N., Staff, I., & Conroy, L. (2005). Intensive telephone follow-up to a hospital-based disease management model for patients with diabetes melli- tus. Disease Management, 8(1), 15-25.
Oh, J.A., Kim, H.S., Yoon, K.H., & Choi, E.S (2003). A telephone-delivered interven- tion to improve glycemic control in type 2 diabetic patients. Yonsei Medical Journal, 44(1), 1-8
Orem, D.E. (1995). Nursing: Concepts of practice (5th ed.). St. Louis: Mosby.
Piette, J.D., Weinberger, M., McPhee, S.J., Mah, C.A., Kraemer, F.B., & Crapo, L.M. (2000). Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes. The American Journal of Medicine, 108(1), 20-27.
The AGREE Collaboration. (2001). The appraisal of guidelines for research and evaluation (AGREE) instrument. Re – trieved from http://www.agreecollabora tion.org/pdf/agreeinstrumentfinal.pdf
The Diabetes Control and Complications Trial Research Group. (1993). The effect of intensive treatment of diabetes on the development and progression of long- term complication in insulin-dependent diabetes mellitus. The New England Journal of Medicine, 329(14), 977-986.
UK Prospective Diabetes Study (UKPDS) Group. (1998). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. The Lancet, 352(9131), 837-851.
Wong, F.K., Mok, M.P., Chan, T., & Tsang, M.W. (2005). Nurse follow-up of patients with diabetes: Randomized controlled trial. Journal of Advanced Nursing, 50(4), 391-402.
Additional Reading Sparacino, P. (2005). The clinical nurse spe-
cialist. In A.B. Hamric, J.A. Spross, & C.M. Hanson (Eds.), Advanced practice nursing: An integrative approach (3rd ed.) (pp. 416-435). St. Louis: Elsevier Saunders.
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