EBP - Statin Adherence - A. Raley

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Evidence-Based Practice Presentation – Statin Adherence:

Evidence-Based Practice Presentation – Statin Adherence By: Ashley Raley Maryville University Adult II - NURS623

Introduction:

Introduction Statin Medications Prescribed to millions of patients to lower LDL and decrease cardiovascular risk Approximately 50% or more of patients discontinue statin therapy within the 1 st year of initiation and adherence decreases with time (NIH, 2013). Considered the most effective treatment of dyslipidemia, a major risk factor for coronary artery disease. Considered one of the safest hypolipidemic drugs. Statin Intolerance Adverse events are cited as the most common cause of statin discontinuation. Most common intolerances include hepatotoxicity, muscle related toxicity, and peripheral neuropathy. Non-adherence is particularly unsatisfactory due to most patients with dyslipidemia are asymptomatic (Maningat et al., 2013 )

Background information & Clinical significance:

Background information & Clinical significance Background Hyperlipidemia is highly associated with coronary heart disease (CHD) and peripheral vascular disease (PVD) Approximately 11.5 years are lost as a consequence of having CHD (Sikka et al., 2011 ) Statin therapy is effective in lower cholesterol, especially LDL (bad cholesterol) Discontinuation of statin therapy = dyslipidemia and its grave consequences including stroke and heart attack ( Sikka et al., 2011). Clinical Significance Non-adherence to statin treatment is recognized as a major public health concern Leads to morbidity, mortality, and increased healthcare costs. As a provider it is important to address patients’ concerns and assess risks vs benefits with continued statin therapy. Imperative that providers are aware of evidence based findings regarding types of interventions that may increase adherence According to the World Health Organization (WHO), adherence is defined as the degree to which the patient’s behavior corresponds with the agreed recommendations from a healthcare provider (as cited by Maningat et al., 2013). Goal - reduce patients risk for CHD  

Search history:

Search history An online search through Maryville University library was performed: The following data bases were searched: CINAHL, Medline, EBSCO, and the Cochrane Library Key search terms included the following: “ statin ”, “ adherence ”, “ intervention ”, “ hyperlipidemia ” “ telephonic ”, and “ provider ” Limits set included: Publication dates between 2009-2013 Checked options: “ peer reviewed ”, “ evidenced-based practice ”, “ research article ” 18 manuscripts retrieved from these key terms searched: 3 primary research articles used for this presentation were obtained from CINAHL, along with several supporting articles

PICO:

PICO In adults who are prescribed a statin medication  (P) , does implementation of a telephonic-outreach intervention  (I)   versus usual care or no intervention  (C)  improve patient adherence to statin therapy  (O) ?

Integration and Synthesis of the Evidence (yungsheng et al. 2010):

Integration and Synthesis of the Evidence (yungsheng et al. 2010) Overview of evidence: Randomized clinical trial conducted over 1 year Evaluated whether pharmacist–delivered telephone counseling versus normal clinical care was more effective in improving statin adherence, thereby reaching LDL goal. Participants in the intervention group received 5 pharmacist-delivered telephone counseling calls post-hospital discharge. Sample: Study population consisted of 689 patients recruited from a cardiac catheterization lab at a tertiary care hospital Patients were randomly assigned to one of the assigned groups. 338 to control group and 351 to intervention group. Inclusion – Participants- Between ages 30 to 85 years old and had CHD defined as the presence of at least one coronary lesion > 50% at the time of angiography Exclusion – U nwilling to give informed consent; history of intolerance to 2 or more statin medications, had a poor prognosis with life expectancy < 5 years, had psychiatric illness, and/or no telephone.

Results (Yungsheng et al., 2010):

Results (Yungsheng et al., 2010) Primary outcome evaluated at one year: Percentage of patients with a LDL < 100 and statin adherence Based on primary outcomes, 65% in the intervention group and 60% in the usual care group achieved an LDL < 100. There were not significant statistical differences of statin adherence rates and LDL goal attainment for both groups Future trials should consider evaluating interventions that link other healthcare team members including physician and specialty provider, i.e. cardiologist to further improve patient adherence.

Integration and synthesis of evidence (fischer et al., 2012):

Integration and synthesis of evidence ( fischer et al., 2012) Overview of evidence Prospective, randomized clinical trial conducted over 20 months. Purpose To determine whether a nurse-run, telephone-based outreach program improved statin adherence versus usual-care among diabetic adults. Nurses promoted behavioral changes and provided self-management techniques. Sample Study population consisted of 762 adult diabetic patients 381 patients were assigned to the intervention and usual care (control) group. Inclusion Criteria 17 years or older, diabetic, and actively seen at community center for primary care services Exclusion Criteria Pregnant or lactating women, ESRD patients, and/or comorbid illness with life expectancy less than 1 year.

Results (fischer et al., 2012):

Results (fischer et al., 2012) Primary outcome - patients achieving LDL < 100 LDL < 100 among patients increased from 52.0% to 58.5% for the intervention group and decreased from 55.6% to 46.7% in the control group. Nurse led telephonic program assisted in improving medication adherence, leading to LDL goal attainment. Key components : Motivational interviewing techniques and promotion of patient self-management measures Secondary outcomes: Telephonic intervention did not affect glycemic or blood pressure control. T elephonic based outreach program was associated with lower healthcare utilization, i.e. emergency room visits or hospitalization, resulting in reduced healthcare costs. A dditional research is recommended using a more targeted approach. No documentation was noted regarding how frequent telephone calls were made to patients and some nurses did not document all calls. The primary end point was attaining LDL < 100

Integration and synthesis of evidence (Eussen ET AL., 2010):

Integration and synthesis of evidence (Eussen ET AL., 2010) Overview of E vidence Open-label, prospective, randomized controlled trial Purpose Evaluate the effectiveness and feasibility of a community pharmacy based program versus usual care to improve patient adherence to statin treatment. Intervention group was pharmacist led and 5 counseling sessions via telephone were conducted over 1 year for new statin users Sample Participants were recruited from 26 community pharmacies; informed consent was received from participants. Total of 899 were included in the study – 460 randomly assigned to usual care group and 439 assigned to pharmacist group Inclusion New statin user – defined as those who were not prescribed a statin medication within past 6 months – verified by pharmacy, 18 years or older, and had available telephone service

Results (eussen ET AL., 2010):

Results ( eussen ET AL., 2010) Primary Outcomes The difference in discontinuation rate was more statistically significant at 6 months versus 12 months from start of treatment. Those in the intervention group were 34% less likely to discontinue treatment after 6 months from initiation. 11% of patients in the intervention group and 16% in the control group discontinued statin treatment within 6 months after initiation. After 1 year after initiation of therapy, 23% in the intervention group and 26% in the usual care group discontinued statin treatment. Secondary outcomes LDL level – Patients receiving intervention had significantly lower LDL levels due to increased rate of adherence to statin therapy. Average reduction in LDL for intervention group was 17.2mg/dL and 9.47mg/dL for control group. Overall, improvement in statin adherence was modest, however, implementation of this telephonic program was relatively inexpensive and did show positive results.

Critique of evidence:

Critique of evidence Strengths All are randomized controlled clinical trials were appropriate for each study Prospective studies allowed for obtaining first-hand information, increasing reliability and accuracy of findings. Statistical analyses were used to compare and interpret data. To ensure accurate results, variable measurement, i.e. lipid level was taken at baseline and every 3 to 6 months after initiation of the studies. Statin adherence measured by continuous multiple-interval (CMA) through pharmacy records – measured ratio of days supplied to total days between refills. In other words, CMA accounts for discontinuation and gaps between refills.

Critique of evidence:

Critique of evidence Limitations Does not identify the specific type or doses of statins prescribed Was not stated whether patients were able to switch statins if they did not tolerate a particular statin medication Different statin drugs may affect LDL level differently, affecting attainment of LDL goal No baseline LDL values for Yungsheng et al. (2010). Inclusion criteria for studies was not specific Several variable factors could affect outcomes, i.e. co-morbidities, age, gender, level of education, and patients not taking a lot of other medications. Limited information regarding participant characteristics. Exclusion criteria was not mentioned for Essen et al. (2010) research study Did not have data on cost and insurance coverage which are factors that would affect medication adherence Vague information regarding how often telephone calls were made to patient for study completed by Fischer et al. (2012) Yungsheng et al. (2010) - Bias existed by excluding those with memory impairment and including those who were more likely to be adherent Adherence to statin treatment may have been enhanced as subjects were aware of their behavior being monitored .

Themes across studies:

Themes across studies PICO – In adults who are prescribed a statin medication  (P) , does implementation of a telephonic-outreach intervention  (I)  versus usual care or no intervention  (C)  improve patient adherence to statin therapy  (O ) ? Overall, there was modest improvement in statin therapy adherence among those who received telephonic intervention versus usual care. Additional research is warranted to evaluate other interventions that may produce more significant statistical differences. Key interventions to improve adherence included increased provider-patient communication, frequent follow-up, patient education, and motivational techniques via telephonic programs. P romoting the use of telephonic programs will can help patients attain LDL goals and reduce their risks for heart attack and stroke. The costs for telephonic programs is fairly inexpensive and easy to implement. Patients’ primary care providers and cardiologists were not involved in studies. If they were involved this have may have lead to a greater improvement in statin adherence. Research findings from telephonic programs also revealed secondary outcomes including reduced healthcare costs, emergency room visits, and hospitalizations, thereby reducing overall healthcare costs.

Comparative Evaluation of the Evidence to Practice:

Comparative Evaluation of the Evidence to Practice Comparison of findings with your own practice Statin medications are frequently prescribed as first-line treatment to help lower LDL level Upon initiation of statin treatment, teaching is providing during this visit. Under normal circumstances, a follow-up assessment is almost always completed in clinic, The most common complaint and reason for patients discontinuing statin treatment is myalgia. Many patients are hesitant to begin statin treatment due to what they hear about possible adverse effects and being asymptomatic. Feasibility of changing practice Implementing telephonic program is feasible due to its low cost and simplicity to initiate. Increased accessibility - Patients will not have to leave home and can receive education and instruction over telephone. Out of pocket expense for participation in telephonic program would likely be more affordable for patients in comparison to driving expenses and in-office visit for consultation. Barriers to change Not enough time allotted to providers to make follow-up calls while in clinic seeing patients Need designated provider to make follow-up phone calls

New guidelines (American heart association, 2014):

New guidelines (American heart association, 2014) Risk assessment is now the start of the process for statin treatment Providers must shift thinking away from only looking at cholesterol levels New guidelines recommend first assessing risk factors such as age, gender, race, smoking status, blood pressure status, diabetes, family history, and cholesterol levels to determine cardiovascular risk and whether the patient needs a statin medication N o longer need to get LDL cholesterol levels down to a specific target number No evidence to prove that one target number is “best” Guidelines for statin therapy also recommended for the following groups: People without cardiovascular disease who are 40 to 75 years old and have a 7.5 percent or higher risk for having a heart attack or stroke within 10 years. People with a history of a cardiovascular event (heart attack, stroke, unstable or stable angina, peripheral artery disease, transient ischemic attack, or coronary or other arterial revascularization). People 21 and older who have a very high level of bad cholesterol (190 mg/dL or higher ). People with Type 1 or Type 2 diabetes who are 40 to 75 years old. Those who do not fall into one of the four groups may still benefit from statin treatment.

Summary Key Findings & Implications for Practice :

Summary Key Findings & Implications for Practice Improving statin adherence – Based on research findings from this literature review, the most promising intervention to improve adherence is telephonic intervention as this provides additional instruction, reinforcement, and reminders to patients. It has been shown that adherence interventions are most critical during the first few months after initiating statin therapy, as this is the most likely time patients will choose to stop treatment. Implementation of telephonic programs will require extended follow-up from designated healthcare team members including the primary physician, specialty provider (cardiologist), RN, case manager, and/or pharmacist. Clinical Setting: Providers must ensure adequate explanation about management of hyperlipidemia and benefits of statin treatment Providers must educate on potential adverse effects of statin medication. As stated by NIH (2013) “The most important breakthrough for increasing statin adherence may not be new at all: remembering to involve the patient and making patients an active part of shared decision making may in fact be the best way to achieve statin adherence.”

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