Same-day discharge of patients after elective percutaneous coronary intervention (PCI) in obstructive coronary artery disease (CAD) has been introduced to optimize healthcare resources.1,2 Accelerated PCI pathways are safe with no increase in adverse outcomes in psychosocially balanced patients undergoing uncomplicated invasive procedures.3–6 Patients with mental problems or lack of social support require more comprehensive healthcare to manage the transition between PCI and self-management of chronic CAD.3–6 The value of secondary prevention during recovery after PCI is well documented and involves adherence to medical therapy, follow-up activities, emotional well-being, and lifestyle modification.7,8 However, patients' self-management of long-term secondary CAD prevention is known to be suboptimal, thus impacting negatively on survival rate, prognosis, and readmission rate.9–12 Initiatives to improve patients' understanding of, and engagement in, secondary CAD prevention may preferably be initiated during PCI hospitalization.7,8 Time for nursing care, as well as discharge planning, is limited in accelerated PCI pathways, which challenges ability to acknowledge the seriousness of obstructive CAD and adapt to an adequate preventive behavior.4,5
Study investigators have documented that telephone follow-up optimizes self-management in patients with cardiac disease.13 However, the impact of telephone follow-up in secondary CAD prevention is inconclusive.13,14 Communication based on motivational interviewing is a documented instrument to enhance patients' ability to undertake preventive self-management.15 To the best of our knowledge, no study investigators have evaluated the influence of motivational telephone follow-up on CAD preventive self-management shortly after same-day discharge in patients undergoing elective PCI.14 Thus, the aim of this prospective, randomized, controlled study was to assess the 30-day impact of a nurse-led telephone follow-up performed 2 to 5 days after same-day discharge following PCI pathways.
Study Design and Patients
We conducted a single-center randomized controlled study at the Department of Cardiology, Aarhus University Hospital, Denmark. Patients referred to elective same-day PCI with symptoms of unstable or stable angina pectoris and a diagnosis of obstructive CAD were considered eligible for this study.16 Further inclusion criteria were age of 18 years and older and ability to speak and understand Danish. Exclusion criteria were scheduled coronary artery bypass grafting or cardiac valve surgery, cognitive deficit or neurological sequelae, and treatment of cancer or other life-threatening diseases that would interfere with optimal participation.
According to standards on elective PCI pathways,4 the patients in our department are discharged after 4 hours of in-hospital observation in successful and uncomplicated PCI procedures. The PCI procedures in our department were performed according to standards of care including selection of interventional strategy (eg, predilation or postdilation, choice of stent, and direct stenting). Arterial access site was femoral or radial.16
All eligible same-day discharged patients undergoing PCI were screened consecutively for study enrollment from September 15, 2014, to June 15, 2015. Eligible patients received written material about the study after the PCI procedure. Included patients agreed to participate (within 2 days) in the study and provided written informed consent.
We collected recent and updated clinical data before the PCI procedure from our hospital records on cardiovascular risk factors including family history of CAD, smoking, hypertension, hypercholesterolemia, diabetes mellitus, body mass index, known heart disease, and comorbidity. Family history of CAD was defined as disease debut at younger than 56 years and younger than 66 years in first-degree relatives for men and women, respectively. Smoking was defined as current smoking. Hypertension was defined as blood pressure of 140/90 mm Hg or greater and/or use of antihypertensive medical therapy. Hypercholesterolemia was defined by total cholesterol of greater than or equal to 5 mmol/L or low-density lipoprotein cholesterol of greater than or equal to 3 mmol/L and/or use of lipid-lowering medical therapy. Body mass index was calculated as weight (kg)/height2 (m2), and body mass index of 25 kg/m2 or greater was defined as overweight. Comorbidity was defined as kidney disease, cerebral events, lung disease, and/or other diagnosed severe diseases (eg, cancer).
In the hospital medical records, we identified all prescriptions of dual antiplatelet medical therapy at the time of discharge. The recommended antiplatelet medical therapy included aspirin 75 mg daily indefinitely and a P2Y12 inhibitor (clopidogrel or ticagrelor) for 12 months.
Baseline data also included the patients' psychosocial condition obtained by a structured written questionnaire at discharge. Social variables included level of education, employment, and cohabiting status.17 Degree of education was categorized as low (no education, semiskilled worker, or basic year education), medium (basic education or short-term education < 4 years), or high (higher education ≥ 4 years). Degree of employment was categorized as low (retired or unemployed) or high (full- or part-time employed). Degree of cohabiting status was categorized as low (no cohabiting or unmarried) or high (married or cohabiting).17 To describe psychological conditions, we used the validated Hospital Anxiety and Depression Scale (HADS)18 and the General Self-efficacy Scale.19 The HADS consists of a 14-item self-administered scale designed to screen in-hospital patients for depression and anxiety, with 7 items related to anxiety and depression, respectively. The summarized score indicates a sign of depression or anxiety. The HADS-depression, as well as HADS-anxiety, is defined as a score of 8 or greater.18 The General Self-efficacy is a 10-item psychometric scale designed to assess self-belief in management with a variety of stressful or challenging demands. Each item is scored from 0 to 4; thus, the summarized General Self-efficacy score ranges between 10 and 40 points. Increased General Self-efficacy score is positively associated with degree of self-efficacy.19
Randomization and Follow-up
At discharge planning, included patients were randomized (nonblinded) by a study nurse to either the intervention group (telephone consultation and usual discharge procedure) or the control group (usual discharge procedure) in a 1:1 ratio stratified by gender (REDCap). Before discharge, the study nurse informed patients about the randomization result, and all patients filled in a structured written questionnaire about present psychosocial conditions, smoking status, physical activity, and dietary habits.17–19
Patients in the control group were managed according to guidelines for usual care and discharge planning in same-day post-PCI.8,16,20 Patients received counseling regarding antiplatelet and cardiovascular medical therapy, self-care according to symptoms of angina pectoris or other PCI-related complications, psychological reactions, recommended outpatient cardiac rehabilitation programs 30 days post-PCI at local hospitals, and recommended lifestyle modifications. All patients were referred to an outpatient clinic consultation by a cardiologist 3 months post-PCI.8,16,20
The intervention group received a nurse-led 15-minute telephone consultation within 2 to 5 days post-PCI (performed by M.H.). Overall, the intervention was designed to encourage self-management and behavior change. Thus, to standardize and to make the communication encourage appropriate behavior, we used European cardiovascular guidelines8,16,20 and a motivational counseling approach.15 The nurse who performed the intervention was specialized in secondary CAD prevention and trained in motivational communication.15 The consultation included counseling on use of antiplatelet and cardiovascular medical therapy regarding dosage, timing, benefits, and possible side effects; symptoms of angina pectoris and/or other PCI-related complications and self-care; emotional imbalance and need for psychological support; motivation for cardiac rehabilitation and encouraging participation; and current lifestyle behavior concerning smoking, physical activity, and healthy diet (Figure 1).8,16,20
Follow-up was 30 days post-PCI by a study nurse. Patients in both groups received a telephone interview and filled in a supplementary written follow-up questionnaire. The structured telephone survey included questions regarding adherence to antiplatelet medical therapy,21 follow-up activity, and emotional well-being. Patients were asked to return the structured written follow-up questionnaire on self-belief and lifestyle modification within 7 days.17–19
The primary outcome was adherence to P2Y12 inhibitors (clopidogrel or ticagrelor) at 30-day follow-up.21 Secondary outcomes were responses on adherence to aspirin, follow-up activities, emotional well-being, and lifestyle behavior. Adherence to antiplatelet medical therapy (P2Y12 inhibitors and aspirin) was identified by asking patients 4 systematic questions21: (a) “Did you every day use clopidogrel/ticagrelor/aspirin as recommended?”; (b) “Did you sometimes use clopidogrel/ticagrelor/aspirin as recommended?”; (c) “Did you not feel need for medical therapy (clopidogrel/ticagrelor/aspirin)?”; and (d) “Did you not use medical therapy (clopidogrel/ticagrelor/aspirin) because of side effects?”. Adherence was categorized as “yes” in question (a). Moreover, we designed the question: “Did you have questions about the treatment with antiplatelet medical therapy?” (“yes” or “no”). Follow-up activities (in-hospital readmissions, self-initiated contacts to general practice or hospitals) were identified by self-constructed questions asking patients: “Did you have any readmissions, self-initiated contacts with general practitioner, self-initiated contacts with discharging hospital and/or local hospitals?” (“yes” or “no”). According to emotional well-being within follow-up, we also used self-constructed questions, and the patients were asked about various aspects: “Did you feel well-informed?” and “Did you have any symptoms of angina pectoris, and do you know how to manage symptoms of angina pectoris?” (“yes” or “no”). Moreover, the questionnaire17 contributed with knowledge about smoking (smoking cessation), physical activity (hours daily/weekly spent on physical activity), and questions regarding dietary habits (daily amount of vegetables, daily amount of fruit, weekly consumption of fish, choice of low-fat diary and meat products).17 Response categories were as follows: more than once a day, every day, 5 to 7 times weekly, 3 to 4 times weekly, 1 to 2 times weekly, and rarely or never.17 Healthy diet was defined as a minimum of 2 to 3 daily servings of fruit and vegetables, fish at least twice a week, and the use of lean meat and low-fat dairy products.20,22 Healthy physical activity was categorized as moderate physical activity for more than 30 minutes minimum for 6 days a week.20 In the questionnaire, moderate physical activity was described as exercise, bicycling, brisk walking, or heavy gardening.17
The study was quantified as a development project. Thus, according to Danish law, it does not need approval from Central Denmark Region Committees on Biomedical and Research Ethics. We obtained informed consent from patients. The study followed the principles in the Declaration of Helsinki and was registered at the Danish Data Protection Agency (2014-41-3121).
The primary study outcome was adherence to P2Y12 inhibitors (clopidogrel or ticagrelor) at follow-up. Adherence in the control group was estimated to be 65%.23 The minimum sample size required to detect an absolute difference in the proportion of patients with high adherence of 20% between the 2 groups, with 90% power (2-sided significance level of 5% and 1:1 randomization) and loss to follow-up of 40% (follow-up questionnaire), was 300 patients.
Categorical data were expressed as number (%), and continuous data were expressed as mean (SD). Fisher's exact test, Pearson's χ2 test, and Student's t test were used for analysis. In sensitivity analyses, we analyzed baseline characteristics between the intervention group and the control group in those patients who returned the written follow-up questionnaire.
We analyzed data according to the intention-to-treat principle. A P ≤ .05 was considered statistically significant, and all tests were 2-tailed. Analyses were performed with STATA/IC 11 (StataCorp LP, College Station, Texas).
In total, 398 consecutive patients referred to elective same-day PCI with symptoms of unstable or stable angina pectoris and a diagnosis of obstructive CAD were screened for inclusion (Figure 2). A total of 355 patients met the inclusion criteria. Of these, 58 (16%) declined participation and 304 patients were randomized. After randomization, 7 patients (2%) withdrew consent and 3 patients (1 patient in the intervention group and 2 patients in the control group) were lost to telephone survey follow-up. Thus, 294 patients (97%) had telephone interview at 30-day follow-up. The baseline characteristics of these patients were well balanced, as shown in Table 1. The written follow-up questionnaire was completed by 254 patients (84%) (Figure 2). Baseline characteristics in the group of patients who completed the questionnaire revealed no differences between groups (see Table 1, Supplemental Digital Content, http://links.lww.com/JCN/A73).
Table 2 reports data on adherence to dual antiplatelet medical therapy in patients followed by telephone survey. P2Y12 inhibitors (clopidogrel or ticagrelor), as well as aspirin, were prescribed in all 294 patients 30 days post-PCI. There were no differences in the proportion of patients with adherence to P2Y12 inhibitors (95% vs 93%, P = .627) and aspirin (95% vs 93%, P = .627) between the intervention group and the control group. Approximately 1 of 4 patients had questions related to the use of antiplatelet medications.
Self-management according to follow-up activities and emotional well-being post-PCI is shown in Table 3. The proportion of patients readmitted (8% vs 16%, P = .048), as well as self-initiated contacts to general practitioners (29% vs 42%, P = .020), was lower in the intervention group compared with the control group. The proportion of patients with self-initiated contacts with discharging hospitals and/or local hospitals tended to be lowest in the intervention group (10% vs 18%, P = .064). We found no significant differences according to enrollment in cardiac rehabilitation. Overall, 53% of the patients had symptoms of angina pectoris post-PCI; however, there were no differences between groups. A higher proportion of patients in the intervention group compared with the control group knew how to manage symptoms of angina pectoris (90% vs 80%, P = .015) (see Table 2, Supplemental Digital Content, http://links.lww.com/JCN/A74, and Table 3, Supplemental Digital Content, http://links.lww.com/JCN/A75).
An analysis on lifestyle behavior in patients with available written questionnaire data (Table 4) illustrated that a higher proportion of patients in the intervention group reported a healthy physical activity level post-PCI (53% vs 41%, P = .043). We observed no difference in healthy diet or smoking cessation between groups.
In this prospective randomized study including patients undergoing same-day PCI, a nurse-led CAD preventive and motivational telephone consultation performed 2 to 5 days after discharge had no effect on the primary end point concerning patient-reported adherence to P2Y12 inhibitors (clopidogrel or ticagrelor) and aspirin. We observed, however, significant differences in the secondary end points. First, readmittance to hospital was halved, from 16% to 8%, in the motivational telephone consultation group as compared with the standard care group. Second, the proportion of patients initiating contacts with their general practitioners was also significantly reduced in the intervention group. Finally, a higher proportion of patients in the intervention group knew how to manage symptoms of angina pectoris and commenced healthy physical activity. These results thus suggest that a simple nurse-led intervention may have advisable clinical impact in the first month after same-day PCI.
We found no difference regarding the primary end point, primarily because of a much higher than anticipated patient-reported adherence to P2Y12 inhibitor treatment. Suboptimal adherence to antiplatelet medical post-PCI therapy has been reported to be common and to be associated with stent thrombosis, myocardial infarction, or death.24 Authors of a randomized study documented a “near-optimal” adherence to antiplatelet medical therapy 1 year post-PCI, with an intervention of 4 telephone follow-up calls focusing on maintaining adherence,25 whereas we found that adherence to antiplatelet medical therapy was reported by patients as “near ideal” in both our intervention as well as our control group 30 days post-PCI. Our standard clinical care, represented by the control group, seems to be associated with a high compliance rate at 30-day follow-up. Authors of a recent study describe how patients undergoing first-time PCI experience multiple and interacting challenges in trying to adhere to the medication regimen.26 It is also documented that adherence to antiplatelet medical therapy begins to decline after 3 to 6 months.11,27 Overall, this suggests that further studies (including translation of a validated adherence scale to Danish28 and registry-based data on adherence29) on potential long-term influence of nurse-led telephone counseling post-PCI are needed.30
Authors of another randomized study demonstrated a trend toward decreased readmission rates within 3 months in hospitalized medical patients contacted by telephone 1 week and 1 month after discharge.31 A similar trend was documented in a review focusing on nurse-led telephone interventions in patients with cardiac disease.13 The authors of this study, focusing on same-day–discharge PCI patients with a very limited time to inform patients, showed that a single nurse-led telephone contact favorably affected readmission rates in this specific cohort. Moreover, our study intervention indicated the same decreasing trend for self-initiated contacts to general practitioners or hospitals. We have not identified other studies that have investigated the influence of telephone follow-up after same-day PCI on patients' self-initiated contacts to their general practitioners or discharging and/or local hospitals. It is known that hospital readmission post-PCI is costly32,33 and readmission within 30 days is more often related to recurrent symptoms of angina than to PCI complications.12 The occurrence of chest pain in the days after accelerated PCI pathways may be an expression of emotional stress and uncertainty.5 Consequently, it might be reasonable to assume that supporting the patients' self-management ability by a nurse-led consultation regarding post-PCI symptoms of angina pectoris could reduce readmissions as well as contacts to general practitioners and hospitals. This coincides well with the findings in our study where patients contacted by telephone, based on a motivational communicative approach, were more likely to know how to manage angina pectoris symptoms, although more than half of the patients in both groups had experienced symptoms of angina pectoris.
No authors of previous studies have investigated nurse-led telephone follow-up post-PCI and the effect on self-management according to lifestyle.13,14 In our study, motivational telephone contact shortly after discharge had a significant positive influence on the patients' physical activity level and a small nonsignificant trend in the direction of healthier diet and reduced smoking. The EUROASPIRE IV survey on lifestyle, risk factors, and therapeutic management of coronary patients documented that a large group of patients do not comply with preventive recommendations and emphasized that, to achieve healthy lifestyle behavior, patients require comprehensive cardiac rehabilitation programs.34 The brief intervention in this study, although based on motivational interviewing, is likely too simplified if appropriate adaption to healthy lifestyle within 30 days should be achieved.
Future large-scale clinical trials are needed to elucidate details on the specific effect of the individual components of the intervention in this study.
Strengths and Limitations
The study was randomized with a control group receiving standard care and discharge planning. The intervention was standardized in accordance with European guidelines, and the communication was optimized by a motivational interviewing approach.8,16,20 The participation rate was acceptable, and in our study, we included consecutive patients undergoing PCI with same-day discharge in a real-world setting. The consequence of withdrawal was probably minor because the lost was random between groups. We did not record data on patients who refused to participate and therefore lacked the possibility of a sensitivity analysis. Risk factors were measured rather than self-reported, thus reducing potential information bias. With the observed near-ideal compliance rates, our study was statistically underpowered to show any effect on adherence to antiplatelet therapy in the group analysis of patients responding to the written questionnaire. We reduced the risk of information bias in our structured questionnaire and interview guide by implementing previously validated methods to the extent possible.17,19,21 However, the reliance of tested survey questions or self-constructed questions may carry inherent threats to the validity of the study results.
Nurse-led motivational telephone follow-up did not influence adherence to dual antiplatelet medical therapy after PCI. However, the intervention positively influenced self-management of angina pectoris and reduced hospital readmissions and self-initiated contacts to general practitioners and hospitals. Future research in this area is needed.
The authors would like to acknowledge the contribution of Annette Kongsgaard and all nurses at the Department of Cardiology, Aarhus University Hospital, Denmark, for their assistance with recruitment and data collection.
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adherence to medical therapy; percutaneous coronary intervention; self-management; telephone follow-up
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