Treatment of Dyslipidemia by FNPs

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Treatment of Dyslipidemia by FNPs Essay

Dyslipidemia refers to the abnormal lipid levels in the body which occurs in the blood. As a result, accumulation of these lipids occurs in blood vessels leading to vascular complication such as atherosclerosis and other cardiovascular complications such as cardiovascular disease (CVD). Pharmacologically, dyslipidemia is treated by use of lipid-lowering agents such as statins in conjunction with other medications which aid in controlling the ensuing hypertensive states. Treatment of Dyslipidemia by FNPs Essay. It has been noted that most cases fail to resolve due to a failure in medication compliance by patients leading to high mortality rates.

Family nurses practitioners (FNPs) are instrumental in the treatment process and management of patients with excess lipid levels. It is evident that FNPs are not involved in the prescription of drug regimens rather are involved majorly in the drug administration process, monitoring of lipid levels and the provision of health education in such patients (Miller, 2009). Combination therapies and a high number of hospital visits for monitoring can contribute to such failures in adherence (Mason, 2005). The aim of the visits would be for assessment of the efficacy of medication by the nurses. FNPs can achieve this by monitoring lipid levels of patients. Proper guidelines are followed which will enable them to monitor for the right lipid levels since different patients have different lipid goals (Miller, 2009). The care providers are also involved in dose titrations depending on the progress of the patients

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Health education offered to patients assists in transferring adequate knowledge and helps to motivate patient’s participation in the regimen. FNPs are involved in advising patients on the right nutrition and lifestyle practices such as constant body fitness and weight management which contributes to the remission of the disease (Mason, 2005). The programs are individualized depending on the needs of the patients. FNPs also offer counseling to patients who might not be confident about their regimens and progress thus maximizing the results. Motivation is critical in achieving the lipid goals. All these are the crucial roles that FNPs play in ensuring a full recovery.

Lowering plasma lipid levels in patients in the months following hospital discharge for a myocardial infarction (MI) is clearly beneficial if recurrent cardiac events and mortality are to be prevented; traditionally, however, there has been a large gap between guidelines and levels achieved in routine practice. Treatment of Dyslipidemia by FNPs Essay.

OBJECTIVES AND METHODS
A randomized, open-label clinical trial was conducted to assess the impact of nurse-centred surveillance and treatment in achieving nationally recognized lipid targets in post-MI patients. This program had the following features: systematic telephone follow-up of patients discharged from the University of Sherbrooke (Sherbrooke, Quebec) after an MI; systematic lipid testing three months after discharge; close liaison with, and guidance of, patients’ primary care physicians to intervene on results of this test if targets were not obtained; and continued monitoring of patients until lipid profiles consistent with consensus targets were achieved. The impact of this approach was tested and compared with that of a control group that continued to be followed by a primary care physician for up to 18 months.

RESULTS
A total of 127 patients were randomly assigned into an intervention group (n = 64) or a control group (n = 63). The intervention group was followed by telephone for an average (±SD) of 4.4 ± 2.0 months post-MI. At this point, when intervention was optimized, the mean low-density lipoprotein cholesterol (LDL-C) level was 2.19 ± 0.65 mmol/L in the intervention group, and 87.3% of patients had LDL-C levels of less than 2.5 mmol/L. Patients from both experimental groups returned at 12 months and 18 months post-MI for a new blood lipid assessment. In total, 12.5% of patients in each group were lost to follow-up. At 12 months and 18 months, the mean LDL-C level was not different between the two groups, nor was there a significant difference in the proportion of patients achieving LDL-C levels of less than 2.5 mmol/L (51.6% in the intervention group and 65% in the control group at 18 months; P > 0.05). Treatment of Dyslipidemia by FNPs Essay.When the combined end point of an LDL-C level of less than 2.5 mmol/L, a triglyceride level of less than 2.0 mmol/L and a total cholesterol to high-density lipoprotein cholesterol ratio of less than 4.0 was considered, the proportion of patients achieving this composite at 18 months was low and not different between the two groups (23.4% in the intervention group and 38.3% in the control group; P > 0.05). Over 95% of patients in both groups were on a lipid-lowering medication, and more than 90% had complied with their medication regimen at 18 months. Treatment of Dyslipidemia by FNPs Essay.

CONCLUSIONS
This trial did not support the role of nurse-managers and a system of telephone-based contacts to ensure the continuity of care and aggressive intervention when considering cardiovascular risk factors in post-MI patients. This trial also re-emphasized the important remaining treatment gap in secondary prevention of coronary artery disease, particularly if composite lipid end points are to be targeted.

Keywords: Case management, Disease management, Dyslipidemia, Myocardial infarction, Nursing, Patient care team, Randomized controlled trials, Specialties
There is currently little dispute that plasma lipid levels should be lowered aggressively in patients who have had a myocardial infarction (MI) (1,2). However, although aggressive lipid lowering is now a very well-established treatment, and has been proven to be cost-effective (3), it is generally believed that large gaps exists between what is recommended in consensus guidelines (4,5) and what is actually achieved in routine clinical practice (6–8). Much effort has been invested during the past decade in demonstrating that large and comprehensive cardiac rehabilitation centres improve risk factor management and outcomes (9–12). However, only a relatively small proportion of patients with established coronary artery disease (CAD) has access to these facilities (13,14), and the overall cost of these centres, while not prohibitive, is nonetheless an obstacle to their wider adoption.

In attempt to address these matters, our group has also been working on a unique, nurse-centred surveillance and treatment program aimed at closing the large gap between nationally recognized guidelines for lipid lowering and current actual practice in the secondary prevention of CAD. This program has previously been described elsewhere (15) and has the following features: systematic follow-up (by telephone or in person) of every patient discharged from the University of Sherbrooke (Sherbrooke, Quebec) after the diagnosis of MI; systematic lipid testing three months after discharge from the hospital in a stable condition; close link (through telephone and letter communication) with patients’ primary care physicians, making them aware of test results and targets to be achieved; supervision of primary care physicians in their interventions in these high-risk patients; and close re-evaluation of the patient until treatment results in a lipid profile consistent with consensus targets. Treatment of Dyslipidemia by FNPs Essay.Using this integrated approach, we had previously published (15) that more than 90% of our post-MI patients could be followed systematically, and that lipid profiles at discharge from this nurse-managed program could be brought to what was considered minimal coronary risk at the time of the initiation of this project. Although the initial results were encouraging, our approach had never been studied in the setting of a controlled environment.

The goal of the current project, therefore, was to test, in a randomized, controlled trial, whether a nurse-managed approach was more effective than conventional care for patient adherence to treatment and for control of the lipid profile up to 18 months post-MI. More specifically, we were interested in using stricter lipid targets than those used in the past and in evaluating the proportion of patients who would be able to maintain these goals on a longer-term basis.

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PATIENTS AND METHODS
Patient population
One hundred twenty-seven patients admitted to the Centre hospitalier universitaire de Sherbrooke (Sherbrooke, Quebec) (‘the Centre’) for an MI between January 1, 2001, and September 1, 2002, were randomly assigned to the present trial. The Centre is the major acute care hospital in the Eastern Townships area and has approximately 600 inpatient beds in two separate hospitals (Fleurimont and Bowen) 4 km apart; it serves a regional population of approximately 300,000. The patient population is relatively confined to this well-defined region and, as a result, relies heavily on a network of local primary care physicians for follow-up. Only patients younger than 70 years of age were included in the present study, because at the time of inception of the program, only limited data were available on the benefits of aggressive lipid-lowering interventions in older patients. Over the entire period of recruitment to the present project, a total 334 patients were discharged from the Centre with a primary diagnosis of MI based on information provided in their discharge summary. Therefore, the present nonconsecutive study sample represents 38% of the entire population that was available. Reasons for not being enrolled in the present trial included age older than 70 years (17%), uncertain diagnosis of MI based on laboratory and electrocardiogram results (9.2%), coronary artery bypass grafting (6.9%) and associated severe concomitant complications preventing comparable follow-up (8.7%), refusal by the patient (12%) and hospitalization over a weekend or a holiday (8.2%). Treatment of Dyslipidemia by FNPs Essay.

Study design
The present study was a randomized, open-label trial in which patients intensively followed using a nurse-managed approach were compared with a group of patients followed by their regular physician (control group). The study was approved by the local Institutional Review Board and all patients signed an informed consent form. To ensure the appropriateness of the trial, the consent forms used for the two experimental groups were different. In the intensive group, patients were given detailed instructions on how they would be followed in this nurse-managed project; in the control group, details of the approach used in the intensive group were not revealed. Volunteers in the control group were asked only for permission to call their pharmacists and to return to the hospital at 12 months and 18 months post-MI for some blood tests, without specifically referring to lipid assessments.

The research nurse or dietician at the Centre met all the research volunteers before discharge from the hospital. Random assignment took place before meeting the potential volunteers because the informed consent form to be signed would depend on the group allocation. Even if the timing of the random assignment was slightly different from what is generally seen, we know a posteriori, from the number of patients that did not provide consent, that group allocation was not affected. On first contact with the patient, the relevant consent form was signed, and several demographic and medical variables were collected from the patient’s medical record. In the Centre, a complete lipid profile is routinely obtained within 24 h of admission for an MI, and the approach is intended not to obstruct the management of a patient in the acute period following MI – any decision to treat dyslipidemia in patients from both treatment groups during hospitalization was left to the cardiology team.

In the intervention group, and as previously described (15), each patient received a letter a few weeks after hospital discharge and was followed up with a telephone call, during which the coordinator reaffirmed the importance of obtaining a complete fasting lipid profile three months after the index MI. The call was also used to impart key educational messages on the importance of cholesterol management in the prevention of CAD, and the need for the long-term follow-up and treatment of this risk factor. Patients were able to attend either the Centre or one of the networks of regional hospitals or general practitioners to have their lipid profile determined. Treatment of Dyslipidemia by FNPs Essay. If a patient elected to attend a site other than the Centre, the results of the profile were forwarded by the hospital or the general practitioner to the Centre’s research team. This approach had previously been validated (15) in the Eastern Township area. The lipid goals to be obtained in patients randomly assigned to the intervention group were as follows: a low-density lipoprotein cholesterol (LDL-C) level of less than 2.5 mmol/L; a triglyceride (TG) level of less than 2.0 mmol/L; and a total cholesterol (TC) to high-density lipoprotein cholesterol (HDL-C) ratio of less than 4.0, as recommended in the Canadian guidelines (16) extant at the time of inception of the present protocol. If the three-month lipid profile showed values above these targets, the Centre’s research nurse-manager informed the patient and contacted the patient’s physician to recommend an appropriate intervention, namely, a dietary consultation (involving a dietician), and/or the prescription of a lipid-lowering medication or the adjustment of the patient’s existing medication. If the physician did not feel proficient enough to implement the intervention recommended, the patient was invited to attend the clinic at the Centre. In all other instances, the nurse-manager ensured that treatment had been proposed and initiated by contacting the patient two weeks after the physician was notified of the need for intervention.

Once the targets were reached, the volunteer was temporarily discharged from the intensive approach, but was recontacted at 12 months and 18 months after the index MI for a compliance assessment through the pharmacist, and a complete lipid profile was undertaken at the Centre.

In contrast to the measures adopted for the intervention group, no specific, short-term follow-up was performed in the control group. Decisions to measure and/or treat the lipid parameters were left entirely to the patients’ family physicians. Treatment of Dyslipidemia by FNPs Essay.

Primary end point
Efficacy assessment
The primary end point of the present study was the proportion of patients in each experimental group who registered the target LDL-C level of less than 2.5 mmol/L at 12 months and 18 months after hospital discharge. The TG and HDL-C level targets were examined as secondary outcomes in the context of an aggregate end point of simultaneously achieving an LDL-C level of less than 2.5 mmol/L, a TG level of less than 2.0 mmol/L and a TC:HDL-C ratio of less than 4.0, as recommended in the Canadian consensus guidelines at that time (16). With 56 completers per group (an attrition of approximately 12%), the study had 85% power to detect an absolute 25% difference on a theoretical baseline proportion of 60% of patients in the control group who would achieve an LDL-C level of less than 2.5 mmol/L (17). An absolute difference of 25% was considered clinically relevant and was determined prospectively. The sample size calculation was based on an alpha error of 0.05 in a two-sided test.

Other end points
Time spent with the nurse-manager
Time spent during each intervention by the nurse-manager over the phone or in person was recorded and used to evaluate the degree of intervention in both experimental groups. It is reported in total number of minutes over the 18-month follow-up.

Quality of life
The quality of life was examined in the two experimental groups at baseline (before the MI hospitalization discharge), and after 12 months and 18 months using the standard version of the Medical Outcomes Study 36-item Short Form health survey (SF-36) (18). Norm-based scores were used to assign all scales originally scored from 0 to 100 a mean of 50 and an SD of 10 in the general 1998 United States population. Treatment of Dyslipidemia by FNPs Essay. The hypothesis to be tested was that the intervention would have either a neutral or beneficial effect on the quality of life because patients would be better informed and less prone to anxiety. A scoring algorithm (QualityMetric Incorporated, USA) was used to produce scores on multi-item and summary scales, as well as to adjust scores for respondents in each experimental group who did not answer every survey item.

Persistence in the use of a lipid-lowering drug
Drug compliance was estimated in patients who were prescribed a lipid-lowering medication during the follow-up period. Compliance was measured using information gathered from the patient’s pharmacist, under informed consent, at 12 months and 18 months, and by obtaining a detailed history of each pharmacy visit made by the patient. A medication compliance index was then calculated, taking into account the number of tablets issued at a given visit, the date of the next visit to the pharmacy, as well as the number of days between the two visits. The compliance index, expressed in percentages and integrated over the entire period of follow-up, represented the proportion of days when a lipid-lowering medication was taken on schedule. This approach was previously validated by our group (15). Doses of lipid-lowering agents prescribed in both experimental groups were also calculated on these follow-up time points. Because many different agents were used in these patients, doses of lipid-lowering agents were expressed as a percentage of the maximum total daily dose recommended for a given agent. The following maximum daily doses were used for this calculation (in alphabetical order): atorvastatin (80 mg), bezafibrate (400 mg), cholestyramine (8 g), micronized fenofibrate (200 mg), gemfibrozil (1200 mg), pravastatin (40 mg), rosuvastatin (40 mg) and simvastatin (80 mg). For a fair comparison of the means of the two experimental groups, patients who were not on any lipid-lowering agent at 12 months and 18 months of follow-up were assigned a 0% value for this adjusted-dose end point. Treatment of Dyslipidemia by FNPs Essay.

Statistical analyses
Data are reported as means ± SDs. Comparisons between each group were performed using the Student’s t test for continuous variables. For nominal variables (eg, the proportion of patients reaching an LDL-C level of less than 2.5 mmol/L), the χ2 test was used. In some instances, when more than 20% of expected frequencies were less than five, a Fisher’s exact test was performed. A two-factor analysis of variance with interaction was also used to compare scores from the SF-36 across time and between treatment groups. P < 0.05 was considered statistically significant.

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RESULTS
Patient baseline characteristics
Table 1 depicts the baseline characteristics of 127 patients randomly assigned to the intervention or the control groups in the present trial. The majority of subjects were male (approximately 80% to 85%), but there was no statistically significant difference between groups (P < 0.05). The mean age in each group was approximately 57 years. The proportions of smokers, and of patients with diabetes or at least one clinical CAD episode before their index events, were similar between the two experimental groups. As a whole, these patients were followed by 95 different general practitioners in the area. There is evidence that only 10 of these physicians (10.5%) followed a maximum of one or two patients in each experimental group over a period of up to 3.5 years.

TABLE 1
Patient baseline characteristics

Intervention group (n = 64) Control group (n = 63) P
Age, years (mean ± SD) 57.8 ± 9.6 56.9 ± 8.8 NS*
Male sex, % 89.1 77.8 NS†
Currently smoking, % 45.8 33.9 NS†
Diabetes, % 17.2 15.9 NS†
Prior history of CAD, % 41.3 28.6 NS†
*Nonpaired Student’s t test;
†χ2 test. CAD Coronary artery disease; NS Not significant
Lipid profiles during the acute phase of the index MI
A complete lipid profile was obtained during the first 24 h following an index MI in 89.1% of patients in the intervention group and 88.9% of patients in the control group, and the difference between these two proportions was not statistically different (P > 0.05).Treatment of Dyslipidemia by FNPs Essay.

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Mean baseline values for each lipid parameter are shown in Table 2; there were no significant intergroup differences in any of these indexes. Reported use of lipid-lowering medications at the index hospitalization was also the same in the two groups (approximately 23%). Table 3 provides relevant information on the duration of hospitalization and the procedures performed during the index MI hospitalization in both groups. The similar proportions of all these variables in both groups provides assurance that the random assignment resulted in a homogeneous distribution of patients between the two experimental groups. Treatment of Dyslipidemia by FNPs Essay.