Skip to main content

Hospital-based versus community-based shared care cardiac rehabilitation after acute coronary syndrome: protocol for a randomized clinical trial

Jannik Buus Bertelsen1, Jens Refsgaard2, Helle Kanstrup1, Søren Paaske Johnsen3, Ina Qvist4, Bo Christensen5 & Kent Lodberg Christensen1

1. sep. 2013
15 min.

Faktaboks

Fakta

Low attendance in cardiac rehabilitation (CR) is a worldwide problem despite the documented benefits of CR in relation to both morbidity and mortality [1]. Studies have shown that only 15-59% of the relevant patients participate in CR [2-4]. Among participants, 50-79% complete the programme [2]. Furthermore, three months after first-time acute myocardial infarction (MI), almost one in three patients displays anxiety, depressive disorders or both, but only one third of these patients receive psychosocial support, whereas approximately 80% adhere to their cardioprotective drugs [5]. Safety concerns and the presumed need for specialization at all levels (physicians, nurses, physiotherapists and dieticians) have so far blocked the introduction of CR at the hospitals in most health care systems. CR is offered to patients with acute coronary syndrome (ACS) (MI and unstable angina pectoris), patients with heart failure and after bypass or valvular surgery. During the past years, hospitals have been merged into larger units causing inconvenience and extended transportation time for numerous patients. Various countries have tried to respond to this by improving local healthcare in different ways. In Denmark, the responsibility for disease, prevention and rehabilitation has been shifted to the local authorities.

The intention is to promote out-hospital treatment of chronic diseases by utilizing the general practitioner`s (GP) profound knowledge of the patient. Cardiovascular disease affects a large part of the population with chronic diseases. Age at first-time MI is increasing [6] and 90% of cardiac patients older than 65 years have at least one additional chronic disease [7]. To meet the challenges of the growing population with chronic diseases and to support the GP, most municipalities have established municipal healthcare centres (MHCCs). The MHCCs provide health education and encourage lifestyle modification through elements of smoking cessation, exercise, nutrition and psychosocial support to patients with chronic diseases such as heart disease, chronic pulmonary disease and diabetes.

Our aim is to compare two models of CR: A shared care model of phase II CR (SC-CR) versus hospital-based CR (H-CR) in ACS in terms of adherence and efficacy.

MATERIAL AND METHODS

Study design

This randomized controlled trial will compare H-CR with SC-CR. SC-CR is based on a model of shared care in which the first visit takes place at the hospital after which responsibility for the subsequent rehabilitation is transferred to the GP. During SC-CR, the MHCC provides courses on smoking cessation, nutrition, exercise training, contributes to disease education and provides psychosocial support. The GP handles pharmacological treatment and general risk factor management. The GP is thus involved earlier and to a greater extent than in the H-CR model.

ACS is confirmed by coronary stenotic or thrombotic lesions. Table 1 outlines the criteria for study inclusion and exclusion, and Figure 1 summarizes the design.

Randomization

Written informed consent is obtained during admission followed by a subsequent computer randomization which is stratified by hospital to ensure equal distribution of H-CR and SC-CR in each hospital. Patients refusing participation are offered H-CR.

Study course

Project controls

During admission, questionnaires dealing with background information and lifestyle issues (smoking, diet, physical exercise and alcohol) and for male patients also erectile dysfunction issues using the validated 5-item International Index of Erectile Function [8] are completed. A Global Registry of Acute Coronary Events (GRACE) score is obtained at discharge [9]. The questionnaires on lifestyle and background have previously been used as part of a population-based questionnaire survey for mapping health and prevalence of chronic diseases in the Central Danish Region [10].

The initial project visit in the hospital is 1-2 weeks after discharge. Visit two is after four months of follow-up (at five months, if bypass surgery is performed due to delay on rehabilitation), and visit three is after 12 months of follow-up. The questionnaires used for assessing quality of life (QoL) are validated for cardiac patients. The following are used: The Short Form Health Survey (SF-12) [11], HeartQoL [12] and the EQ-5D, which can estimate quality-adjusted life years [13]. The Patient Assessment of Chronic Illness Care (PACIC) instrument is used to assess the chronic care [14]. The Hospital Anxiety and Depression Scale (HADS), which is a validated score system on anxiety and depression, is obtained six weeks after discharge and at visit two and three[15]. The information obtained is listed in Table 2.

Initial in-hospital rehabilitation visit (all patients)

All patients visit the rehabilitation nurse who outlines the course plan and assesses the patient’s mental status. A clinical assessment by a cardiologist is done immediately after an ergometer bicycle test. If the patient performs without having angina or an adverse event, training outside the hospital is acceptable. If the patient is randomized to SC-CR, a standardized letter is sent to the GP and to the MHCC conveying information on the shared care model, prescribed medicine, optimal individualized treatment goals and a standard plan for the GP follow-up visits. The course of H-CR is outlined in Appendix 1 and the course of SC-CR is outlined in Appendix 2.

Study outcomes

The primary outcome is adherence to the CR programme measured as a composite of the participation in the various elements of CR, a modified version of Wurgler [16]:

– Smoking cessation course, if smoker

– Dietary advice

– Exercise training

– Clinical assessment by a doctor

– Patient education

– Individual talks with health staff (nurse, physiotherapist, dietician)

Participation in one element is defined as 50% attendance or more.

Full participation is participation in all elements, i.e. six of six if smoker and five of five if non-smoker. Most participation is equivalent to one element missing. Partial participation is two elements missing, whereas limited rehabilitation is defined as three elements or more missing. Secondary outcomes include measured changes in bike exercise test, 24-h ambulatory blood pressure measurement (ABPM), weight, abdominal circumference, cholesterol levels, fasting blood glucose and haemoglobin A1C. Secondary outcomes also include reported changes in: lifestyle, health-related QoL (HeartQoL, SF-12, EQ-5D), anxiety and depression level, readmission and major adverse cardiovascular events (death, MI, stroke) and assessment of support in chronic illness care with PACIC.

Ethical considerations

The study is conducted in accordance with good clinical practice and the ethical standards described in the Helsinki Declaration.

The Central Denmark Region Committees on Biomedical Research Ethics and the Danish Data Protection Agency have approved the study protocol. Clinical Trials ID: NTC 01522001.

Safety aspects

The risk of adverse events (AE) in supervised exercise training is low in patients with ACS. Danish guidelines state that team size should allow the physiotherapists to observe each participant.

Furthermore, staff involved in physical exercise should be trained in basic heart lung rescue and the physiotherapist should be trained in cardiac symptoms. All AEs are registered.

Assessment methods

Information on primary outcome will be registered from patient records and attendance lists. Information on MI and readmissions will be obtained through interviews and checked against hospital records. Secondary outcome measures are obtained by the project nurse. Data are collected as part of standard procedures, including interview, questionnaire, clinical examination, blood tests, bike exercise tests and 24-h ABPM. Patients who drop out are contacted twice by phone and, if possible, an interview is conducted in cases where further attendance is refused.

Sample size

We aim to include 208 patients within a maximum inclusion period of 20 months. Patients will be randomized for H-CR and SC-CR. The included patients are expected to be equally distributed between the two participating hospital units. Based on how CR is conducted, four subgroups with around 50 participants each can be established; the participating centres will include H-CR Aarhus, H-CR Viborg/Silkeborg, SC-CR Aarhus and SC-CR Viborg/Silkeborg.

Power calculations

Based on information from the Danish Heart Association, 35% of the candidates for rehabilitation are expected to participate in most of the rehabilitation in the Central Denmark Region [16]. We hypothesize that SC-CR will improve the attendance rate by 20 percent point to 55%. The expected sample size will enable us to identify such an increase in the attendance rate with a power of 0.80 and a two-sided p-value < 0.05. The share of patients who drop-out /withdraw is expected to be 10%. A participation rate of 55% is considered realistic as a previous Danish study has reported that 58.5% of all patients participated fully or partially in CR at the hospital [5].

Statistical analysis

Data analysis will be performed according to the intention-to-treat principles. If a patient is rejected from the SC-CR model for medical reasons at the first rehabilitation visit, he or she will be recorded as having been excluded. If a patient regrets participation before the baseline rehabilitation control visit, he or she will be recorded as having withdrawn. Patients lost to follow-up will be recorded as dropouts. Difference between the SC-CR and H-CR groups in terms of primary endpoint attendance will be analyzed using the χ2 test.

The last two columns of Table 2 show the distribution and expected analysis of the data. Parametric data will be analyzed by student’s paired t-test and non-parametric data by the Wilcoxon signed rank test. Between the four subgroups, H-CR Aarhus, H-CR Viborg/Silkeborg, SC-CR Aarhus and SC-CR Central, two-way and one-way ANOVA analysis for paired and unpaired parametric data will be used. Non-parametric data will be analyzed by Friedman’s test for paired data and Kruskal-Wallis’ test for unpaired data. Non-normally distributed data will be transformed prior to the statistical analysis.

Trial registration: Clinical Trials ID: NTC 01522001

DISCUSSION

Increasing attendance in CR is a challenge. We aim to investigate whether phase II CR can be conducted in primary care (GP and MHCC) by comparing the results obtained here to what is achieved in-hospital. Depending on the patient, leaving the hospital environment earlier than normally could have a positive effect. Our study may help elucidate this and may guide the strategic decisions.

CR is recommended for all patients with ACS in Denmark. Healthcare is shifting towards earlier hospital discharge and more follow-up in primary care. More chronic diseases and cancer tasks are shifted to the GP and the MHCC. These strategic changes have already been implemented in some Danish regions even though it is unknown whether this is feasible and advantageous.

A review examining factors influencing attendance in CR programmes after referral concluded that attendance is highly influenced by social factors. Greater involvement of the patients and their families and a focus on social mechanisms might increase CR attendance and thus the rate of success [17]. A high CR attendance may have long-term benefits. An Australian study with 14 years of follow-up including 281 CR attenders showed a mortality risk of more than a factor two for “< 25% attenders” compared to” > 75% attenders” (odds ratio (OR) = 2.57, 95% confidence interval 1.04 to 6.38) [18].

Limitations

It is not technically possible to perform complete study nurse blinding, but the study nurses are instructed not to intervene. Should any problem occur, patients are referred to their CR staff.

Numerous trials studying adherence to CR suffer from selection bias, because those who are socially vulnerable (unemployed persons, less educated persons and singles), the elderly and women are less likely to attend [19]. The uncertainty of the new SC-CR model might result in rejection from potential participants.

We chose to include patients with ACS and an ejection fraction of at least 40% not to conflict with the hospital heart failure clinic set-up. Heart failure patients would probably benefit the most from CR, but in this context we have chosen a low-risk group with potentially lower rehabilitation benefits.

Finally, CR is performed slightly differently in the hospitals and in the MHCC with both individual and group-based CR. However in all cases CR includes exercise training, health education, psychosocial support, dietary advice, smoking cessation and clinical assessment.

Perspective

Primary care in which the GP is assisted by the MHCC and where they together perform most of CR can potentially strengthen the focus on the social and contextual factors – and may possibly serve as the cornerstone in the support of the increasing population of chronic patients as these shift towards a healthier lifestyle and may hence allow for an improved prognosis in the recovery from ACS.

APPENDICES

Appendix 1

Continued hospital-based cardiac rehabilitation (H-CR)

In all three hospitals, exercise training is given as two weekly one-hour group sessions during 12 weeks. Apart from this, there are some differences between the three hospitals.

H-CR is tailored individually in Silkeborg and Aarhus. This implies individual one-to-one sessions with a clinical dietician and a rehabilitation nurse regarding psychosocial support and education on disease prevention.

In Viborg, patients are offered two individual sessions with a rehabilitation nurse for psychosocial support. The remaining educational sessions including dietary advice are group based and given two hours once weekly for eight weeks.

HADS is obtained six weeks after discharge by the rehabilitation nurse. The cardiologist explores the cause if the score is eight or above in either anxiety or depression. The phase II H-CR is concluded by the cardiologist with a clinical examination, a status on cardiovascular risk factors, a check-up on the prescribed medicine and advice on future control at the GP.

Appendix 2

Continued shared care rehabilitation (SC-CR)

SC-CR is primarily group-based, but in the beginning of the course individual sessions are given by a nurse, a physical therapist or a clinical dietician to establish a personal relationship and to introduce the patient to the healthcare centre. In Aarhus, a five-week course with weekly two-hour lessons on cardiovascular health issues, cardiovascular disease and risk factors is given by a nurse. The clinical dietician then continues with a five-week course with two-hour sessions containing both theoretical and practical cooking instructions. Physical exercise supervised by a physiotherapist is given either twice weekly for ten weeks or once weekly for twenty weeks. The MHCC course is concluded with an individual evaluation.

In the other MHCC, the course is group-based and includes patients with different diagnoses (heart disease, chronic obstructive pulmonary disease or diabetes). Two-hour sessions are given weekly for eight weeks. Six of these lessons cover health and disease issues. The remaining two lessons cover dietary advice. Exercise training is one hour twice weekly for 12 weeks.

HADS is obtained six weeks after discharge at the MHCC. If the score for either anxiety or depression rises above eight the patient is instructed to turn to the GP and the GP is alerted directly from the MHCC.

The phase II SC-CR is concluded at the GP with a clinical examination, a status on cardiovascular risk factors, a check-up on the prescribed medicine and a plan for future control.

Correspondence: Jannik Buus Bertelsen, Department of Cardiology, Aarhus University Hospital, 8000 Aarhus C. Denmark. E-mail: jannbert@rm.dk

Accepted: 10 July 2013

Conflicts of interest:Disclosure forms provided by the authors are available with the full text of this article at www.danmedj.dk

Referencer

  1. Suaya JA, Shepard DS, Normand SL et al. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation 2007;116:1653-62.

  2. Zwisler AD, Soja AM, Rasmussen S et al. Hospital-based comprehensive cardiac rehabilitation versus usual care among patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease: 12-month results of a randomized clinical trial. Am Heart J 2008;155:1106-13.

  3. Brown TM, Hernandez AF, Bittner V et al. Predictors of cardiac rehabilitation referral in coronary artery disease patients: findings from the American Heart Association’s Get With The Guidelines Program. J Am Coll Cardiol 2009;54:515-21.

  4. Alter DA, Habot J, Grace SL et al. Ambulatory surveillance of patients referred for cardiac rehabilitation following cardiac hospitalization: a feasibility study. Can J Cardiol 2012;28:497-501.

  5. Larsen KK, Vestergaard M, Sondergaard J et al. Rehabilitation status three months after first-time myocardial infarction. Scand J Prim Health Care 2011;29:210-5.

  6. Schmidt M, Jacobsen JB, Lash TL et al. 25 year trends in first time hospitalisation for acute myocardial infarction, subsequent short and long term mortality, and the prognostic impact of sex and comorbidity: a Danish nationwide cohort study. BMJ 2012;344:e356.

  7. Wolff JL, Starfield B, Anderson G. Prevalence, expenditures, and complications of multiple chronic conditions in the elderly. Arch Intern Med 2002;162:2269-76.

  8. Foroutan SK, Rajabi M. Erectile dysfunction in men with angiographically documented coronary artery disease. Urol J 2007;4:28-32.

  9. Eagle KA, Lim MJ, Dabbous OH et al. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA 2004;291:2727-33.

  10. Breinholt Larsen F. Hvordan har du det? 2010: sundhedsprofil for region og kommuner i Region Midtjylland, voksne. Denmark, Aarhus: Center for Folkesundhed, Region Midtjylland;,2011.

  11. Mols F, Pelle AJ, Kupper N. Normative data of the SF-12 health survey with validation using postmyocardial infarction patients in the Dutch population. Qual Life Res 2009;18:403-14.

  12. Oldridge N, Hofer S, McGee H et al. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol 2013, 25 April (Epub ahead of print).

  13. Ellis JJ, Eagle KA, Kline-Rogers EM et al. Validation of the EQ-5D in patients with a history of acute coronary syndrome. Curr Med Res Opin 2005;21:1209-16.

  14. Glasgow RE, Wagner EH, Schaefer J et al. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care 2005;43:436-44.

  15. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70.

  16. Wurgler MW, Sonne LT, Kilsmark J et al. Danish heart patients’ participation in and experience with rehabilitation. Scand J Public Health 2012;40:126-32.

  17. Clark AM, King-Shier KM, Thompson DR et al. A qualitative systematic review of influences on attendance at cardiac rehabilitation programs after referral. Am Heart J 2012;164:835,845.e2.

  18. Beauchamp A, Worcester M, Ng A et al. Attendance at cardiac rehabilitation is associated with lower all-cause mortality after 14 years of follow-up. Heart 2013;99:593-5.

  19. Meillier LK, Nielsen KM, Larsen FB et al. Socially differentiated cardiac rehabilitation: can we improve referral, attendance and adherence among patients with first myocardial infarction? Scand J Public Health 2012;40:286-93.