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CNU0010.1177/1474515116666781European Journal of Cardiovascular NursingBertelsen et al.
EUROPEAN
SOCIETY OF
Original Article CARDIOLOGY ®
Abstract
Aim: To investigate whether phase II cardiac rehabilitation (CR) conducted by a community model of shared care CR
(SC-CR) including health care centres and general practice was feasible and provided acceptable results and to compare
SC-CR to hospital-based CR (H-CR) in a randomised controlled trial.
Methods: Patients were randomised to H-CR or SC-CR after admission for acute coronary syndrome. In SC-CR, the
general practitioner took over the responsibility of the remaining rehabilitation, pharmacological treatment and risk
factor management after the initial visit to the hospital outpatient clinic. The Municipal Health Care Centres provided
courses on smoking cessation, nutrition, and exercise training and contributed to disease education and psychosocial
support. The main endpoint was adherence to the CR programme and compliance with lifestyle modifications.
Results: In total, 1364 patients were screened, 327 (24%) were eligible, and 212 (65%) accepted participation. Phase II
CR was completed by 192 (91%) of the participants. Full adherence to the CR programme was seen in 53% in SC-CR
versus 54% in H-CR (relative risk (RR): 0.98, 95% confidence interval: 0.73–1.32). In H-CR, patients had higher rates of
adherence to dietary advice and health education. In SC-CR, 12% of patients did not attend the risk factor evaluation and
clinical assessment with their general practitioner. No difference in risk factor improvement was found. Exercise training
was declined by 25% in both groups.
Conclusion: Adherence to phase II CR was high in both groups. SC-CR did not improve adherence and efficacy, but
had comparable effects on medication and risk factors. Thus, SC-CR was safe and effective.
Keywords
Ischaemic heart disease, secondary prevention, cardiac rehabilitation, acute coronary syndrome, shared care,
community-based, randomised controlled trial, health care organisation
Date received: 12 February 2016; revised: 11 May 2016; accepted: 9 August 2016
1Department of Cardiology, Aarhus University Hospital, 5Instituteof Public Health, Section for General Practice, Aarhus
Denmark University, Denmark
2Department of Cardiology, Viborg Regional Hospital, Denmark
3Department of Clinical Epidemiology, Aarhus University Hospital, Corresponding author:
Jannik B Bertelsen, Department of Cardiology, Aarhus University
Denmark
4Department of Medicine, Silkeborg Regional Hospital, Denmark Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.
Email: jannik.bertelsen@auh.rm.dk
Bertelsen et al. 335
Sample size
Using Danish Heart Association data, we hypothesised
that SC-CR would improve the rate of full attendance by
20% up to 55%.9 This was considered realistic because a
previous Danish study reported that 58.5% of all patients
participated fully or partially in the CR component of
health education at the hospital.5 The expected sample size
of 208 participants would enable us to identify such an
increase in the attendance rate with a power of 0.80 and a
two-sided p-value of <0.05. The proportion of patients
who dropped out or withdrew was expected to be 10%.
Randomisation
Computer randomisation was performed after consent was
obtained, stratified by hospital and municipality, ensuring
an equal distribution of H-CR and SC-CR in each hospital.
Blinding was not possible.
Municipality Initial and end of Physical exercise Health education Smoking Dietary advice Risk and clinical
course cessation evaluation
Aarhus Individually Group-based (10 Group-based (10 Individually Individually Individually
2 sessions, each 30 patients) patients) 2 sessions, 2 sessions, each 45 1 session, 15
minutes 30 sessions, each 60 7 sessions, each 45 each 15 minutes minutes
By physiotherapist minutes minutes minutes By nurse or By general
or nurse By physiotherapist By rehabilitation nurse By nurse dietician practitioner
Viborg Individually Group-based Group-based (10–12 Individually Group-based Individually
2 sessions, each 30 (10–12 patients) patients) 1 session, 15 (10–12 patients) 1 session, 15
minutes 12 sessions, 60 7 sessions, each 45 minutes 2 sessions, 60 minutes
By physiotherapist minutes and 12 minutes By nurse minutes and 2 By general
or nurse sessions, 90 minutes By rehabilitation nurse sessions, 150 practitioner
By physiotherapist minutes
By nurse or
dietician
Silkeborg Individually Group-based (10 Group-based (10 Individually Group-based (10 Individually
2 sessions, each 30 patients) patients) 2 sessions, patients) 1 session, 15
minutes 12 sessions, 60 8 sessions, each 60 each 15 2 sessions, 60 minutes
By physiotherapist minutes and 12 minutes minutes minutes and 2 By general
or nurse sessions, 90 minutes By nurse By nurse sessions, 150 practitioner
By physiotherapist minutes
and nurse By nurse or
dietician
Skive Individually Group-based (10 Group-based (5 Individually Group-based (10 Individually
2 sessions, each 30 patients) patients) 2 sessions, patients) 1 session, 15
minutes 16 sessions, each 60 7 sessions, each 60 each 15 2 sessions, 90 minutes
By physiotherapist minutes minutes minutes minutes By general
or nurse By physiotherapist, By rehabilitation By nurse By dietician practitioner
nurse and specialist, nurse and
ergonomist ergonomist
Favrskov Individually Group-based (10 Individually Individually Individually Individually
2 sessions, each 30 patients) 2 sessions, each 45 2 sessions, 2 sessions, each 30 1 session, 15
minutes 30 sessions, each 90 minutes each 15 minutes minutes
By physiotherapist minutes By rehabilitation nurse minutes By dietician By general
or nurse By physiotherapist By nurse practitioner
and nurse
Skanderborg Individually Group-based (10 Group-based (10 Individually Group-based (10 Individually
2 sessions, each 30 patients) patients) 2 sessions, patients) 1 session, 15
minutes 12 sessions, 60 7 sessions, each 45 each 15 2 sessions, 60 minutes
By physiotherapist minutes and 12 minutes minutes minutes and 2 By general
or nurse sessions, 90 minutes By rehabilitation nurse By nurse sessions, 150 practitioner
By physiotherapist minutes
and nurse By nurse or
dietician
Samsø Individually Group-based (5 Group-based (5 Individually Group-based (5 Individually
2 sessions, each 30 patients) patients) 2 sessions, patients) 1 session, 15
minutes 24 sessions, each 60 3 sessions, each 45 each 15 2 sessions, 45 minutes
By physiotherapist minutes minutes minutes minutes By general
or nurse By physiotherapist By nurse By nurse By nurse or practitioner
and nurse dietician
Table 3 shows patient baseline characteristics at the Adherence to phase II CR is shown in Table 4. No dif-
time of randomisation. Women constituted 25% of the ference was seen in terms of full adherence to the combined
patients, forming 21% in H-CR and 29% in SC-CR CR programme (SC-CR vs. H-CR, RR: 0.98, 95% CI:
(p = 0.09). The mean transportation time between the home 0.73–1.32). Adherence to the individual components of the
and the rehabilitation facility to the MHCC was 19 min- programmes varied. Adherence rates to dietary advice (RR:
utes (range: 4–150) and to the hospitals was 26 minutes 0.61, 95% CI: 0.46–0.80) and health education (RR: 0.63,
(range 5–120) (p = 0.54). 95% CI: 0.48–0.83) were significantly lower in the SC-CR
338 European Journal of Cardiovascular Nursing 16(4)
Hospital Initial rehabilitation Physical exercise Health Smoking cessation Dietary Risk and clinical
education advice evaluation at end
of rehabilitation
Aarhus Individually Group-based (12 Individually Individually Individually Individually
University By rehabilitation patients) 1–3 sessions, 1–3 sessions, each 30 2 sessions, 75 By nurse for
Hospital nurse for 60 minutes 24 sessions, each each 30 minutes minutes – included in minutes and 30 minutes and
and with cardiologist 75 minutes By rehabilitation health education 25 minutes cardiologist for
for 45 minutes By physiotherapist nurse By rehabilitation nurse By dietician 30 minutes
Viborg Individually Group-based (10 Group-based Individually Group-based Individually
Regional By rehabilitation patients) (20 patients) 3 sessions, each 15 (20 patients) By nurse for
Hospital nurse for 45 minutes 16 sessions, each 7 sessions, each minutes 1 session, 45 30 minutes and
and cardiologist for 60 minutes 45 minutes By nurse minutes cardiologist for
30 minutes By physiotherapist By rehabilitation By nurse 15 minutes
and nurse nurse
Silkeborg Individually Group-based (10 Group-based (8 Individually Group-based Individually
Regional By rehabilitation patients) patients) 3 sessions, each 30 (8 patients) By nurse for
Hospital nurse for 60 minutes 24 sessions, each 3 sessions, each minutes 1 session, 45 30 minutes and
Cardiologist available 60 minutes 90 minutes By nurse minutes cardiologist for
By physiotherapist By nurse By dietician 15 minutes
arm. In SC-CR, risk factor evaluation and clinical assess- end of CR. Adherence to dietary advice and health
ment at the end of CR were to be performed by the GP; education was better in H-CR. Several participants in
however, 12% did not attend, whereas all patients in H-CR both treatment arms chose not to take part in exercise
attended the evaluation and clinical assessment by the car- training.
diologist at the hospital. Exercise training was declined by CR adherence was similar to the adherence rates
approximately 25% of the patients in both groups. reported in other trials.3,6,10 One of the main differences in
Table 5 shows the percentages of patients achieving the the two CR models was the location of the rehabilitation
recommended treatment targets and the prescribed cardio- facilities. However, the median difference in transporta-
vascular medicine at discharge, at the end of phase II CR, tion time between the hospital and the MHCC turned out
and at 12 months after ACS. No differences were found to be too small for evaluating a superior effect of transpor-
regarding total cholesterol, low-density lipoprotein choles- tation time on adherence.
terol, daily exercise, blood pressure, smoking status, waist Achievement of lifestyle targets seemed difficult to
circumference, or BMI. Overall, the percentage of patients obtain, which corresponds to the findings from the
achieving the target blood pressure seemed to decline from EUROASPIRE IV survey.11 Chow et al. found that a ben-
baseline to follow-up, but while an increasing percentage efit from adherence to behavioural advice (smoking, diet,
of patients in SC-CR achieved the recommended blood and exercise) was seen after 6 months.2 The finding of
pressure target, the percentage was decreasing in H-CR. In smoking cessation in approximately 50% is similar to
general, all patients were treated with statins and aspirin, that which has been found in other studies; however, the
and most were also given a second platelet inhibitor. percentage fulfilling the recommendation of 30 minutes
Approximately 80% received a beta-blocker. Close to a of exercise on ⩾5 days a week declined in both groups
third had a renin–angiotensin–aldosterone system (RAAS) during the phase II CR period. Similar effects have been
inhibitor prescribed. At the end of phase II, CR RAAS reported previously.12 Recently, a dose–response rela-
inhibition increased in both groups to approximately 40%. tionship between the number of CR sessions attended and
At 12 months after ACS, adherence to statins was signifi- mortality was reported, and long-term survival benefits
cantly higher in H-CR, but otherwise only small differ- in patients joining a comprehensive CR programme has
ences were observed. also made the effort of increasing adherence to CR even
more advantageous, and hence a relevant measure of
exercise in particular.10,13 However, the shared care model
Discussion did increase adherence to exercise training.
The shared care model did not improve the adherence to Adherence to the recommended medication was high,
and efficacy of the SC-CR programme compared with being almost complete to dual antiplatelet therapy and
H-CR, which was our primary outcome, but we found no statins and at approximately 80% to beta-blockers.
indication that SC-CR was not safe. In the H-CR arm, However, only 40% received RAAS inhibition medica-
significantly more patients had risk factor evaluation, tion. Approximately 80% in a Dutch study and 65% in a
dietary advice, and clinical assessment performed at the French study received this type of medication.12,14
Bertelsen et al. 339
Figure 2. Flowchart of the Danish randomised controlled trial ‘Shared care rehabilitation after acute coronary syndrome’
conducted in the Danish Central Region, 2011–2014. Three of the 99 in the hospital-based cardiac rehabilitation group did not
complete the questionnaires at the 4-month follow-up. CAG: Coronary Angiography; CABG: Coronary Artery Bypass Grafting.
Approximately 75% of our patients were normoten- for this, but according to the PEACE study, the useful-
sive at the first clinical examination. Strangely, the per- ness of angiotensin-converting enzyme inhibitors in
centage of patients achieving the recommended blood patients with ACS and normal blood pressure is not nec-
pressure values decreased from baseline to follow-up in essarily very high.16
H-CR and increased in H-CR. An Austrian study found Participation in the trial was rejected by 35% of poten-
that 91% achieved the target blood pressure after CR, but tial candidates. The patients declining to participate had,
this study included heart failure patients.15 Potentially, on average, a higher mean age and more frequently were
the percentage achieving the target blood pressure may more women, and the main reason they provided was a
have been higher if RAAS inhibitors had been prescribed lack of surplus energy due to uncertainty related to the ran-
more aggressively. There is no very obvious explanation domisation and the possibility of facing a new model of
340 European Journal of Cardiovascular Nursing 16(4)
Table 3. Baseline data from the randomised controlled trial ‘Shared care rehabilitation after acute coronary syndrome’, conducted
in the Danish Central Region, 2011–2014.
STEMI: ST-elevation myocardial infarction; NSTEMI: non-ST-elevation myocardial infarction; UAP: unstable angina pectoris.
Table 4. Participation in the different elements of phase II cardiac rehabilitation at the 4-month follow-up in percentages.
The physician at the end of cardiac rehabilitation was a general practitioner in the shared care arm and a cardiologist in the hospital arm. Full adher-
ence was found in all components of the combined cardiac rehabilitation programme.
RR: relative risk for participation in ⩾50% of a component of shared care compared to hospital care; CI: confidence interval. * Statistical significant.
Table 5. Percentages of patients achieving the recommended treatment goals at baseline and after phase II cardiac rehabilitation and at the 12-month follow-up.
Bertelsen et al.
Treatment goal Achieving treatment goal Achieving treatment Shared care vs. Achieving treatment goal Shared care vs. hospital
at baseline (%) goal after phase II (%) hospital after phase II after 12 months (%) after 12 months
Hospital Shared care Hospital Shared care RR 95% CI Hospital Shared care RR 95% CI
(n = 100) (n = 100) (n = 99) (n = 93) (n = 97) (n = 93)
Total cholesterol <4 mmol/L 13 22 64 63 1.00 0.74–1.35 75 57 0.67 0.51–0.89*
LDL cholesterol <1.8 mmol/L 6 14 48 41 0.86 0.63–1.16 47 36 0.80 0.58–1.09
Exercise daily minimum 30 minutes/5 54 49 49 45 0.93 0.69–1.24 58 55 0.93 0.68–1.25
days/week
Daily smokers 44 39 20 17 0.98 0.60–1.59 – – – –
Smoke reduction ⩾50% at follow-up – – 75 63 0.73 0.36–1.51 – – – –
BP ⩽130/80 mmHg 65 54 57 53 0.92 0.69–1.24 44 41 0.93 0.68–1.27
BP <135/85 mmHg 83 69 73 73 1.00 0.71–1.39 64 72 1.21 0.86–1.71
Waist circumference
Males <94 cm, Females <80 cm 21 21 27 26 0.97 0.69–1.36 28 28 0.99 0.72–1.37
Males 94–102 cm 36 24 33 25 0.80 0.56–1.14 33 24 0.77 0.54–1.11
Females 80–88 cm
Males >102 cm 43 55 39 49 1.22 0.91–1.63 39 48 1.12 0.84–1.48
Females >88 cm
BMI
<25 kg/m2 36 33 29 24 0.87 0.61–1.24 29 24 0.87 0.61–1.24
25–30 kg/m2 48 41 51 42 0.81 0.60–1.10 51 42 0.81 0.60–1.10
>30 kg/m2 15 26 20 34 1.45 1.08–1.93 20 34 1.45 1.08–1.93*
HbA1c <6.5% 16 18 9 13 1.26 0.85–1.87 9 13 1.26 0.85–1.87
Acetyl salicylic acid 100 99 98 96 0.72 0.40–1.29 96 95 0.88 0.48–1.60
Clopidogrel/ticagrelor 93 93 94 91 0.84 0.52–1.35 61 66 1.11 0.82–1.52
Statins 99 98 96 95 0.87 0.47–1.58 99 92 0.54 0.40–0.73*
Beta-blockade 81 77 77 84 1.28 0.84–1.96 70 75 1.15 0.81–1.62
RAAS inhibitor 34 33 40 41 1.01 0.75–1.36 40 46 1.13 0.85–1.51
Diuretics 12 22 13 17 1.17 0.81–1.68 12 15 1.12 0.76–1.65
Other antihypertensives 21 16 19 23 1.11 0.79–1.56 24 27 1.09 0.79–1.50
Target treatment goals are carefully communicated to the general practitioner at discharge in cases of shared care rehabilitation at the 4-month follow-up.
* Statistically significant. LDL: low-density lipoprotein; BP: daytime average ambulatory blood pressure; RAAS: renin–angiotensin–aldosterone system; RR: relative risk reported as shared care versus
hospital-based cardiac rehabilitation; CI: confidence interval.
341
342 European Journal of Cardiovascular Nursing 16(4)
CR. Due to the rejection rate and a sample size of 212, Trial registration: clinicaltrials.gov identifier: NTC
caution must be exerted when generalising our findings. 01522001.
The data did not allow for subgroup analysis of transporta-
tion time or comorbidity. Acknowledgement
The objective of this trial was to evaluate adherence to The staff of the Municipal Health Care Centres of Aarhus,
CR in a new setting with primary care in charge. The trial Viborg, Skive, Silkeborg, Favrskov, Skanderborg, and Samsø
results could be extrapolated to other hospitals and munici- and the cardiac rehabilitation staff of the Department of
palities in Denmark, since the model is based on exploiting Cardiology, Aarhus University Hospital and Viborg and
existing resources that are now present in all Danish Silkeborg Regional Hospitals are thanked.
municipalities, but high attention to inter-sectoral coordi-
nation in the CR course is important. A model with nurses Conflict of interest
coordinating the course between sectors has been described The authors declare that there is no conflict of interest.
as a useful measure.17
The Organisation for Economic Co-operation and Funding
Development report on Danish Health quality from The trial is funded by the Central Region Denmark as a part of
2013 emphasises the need for specific quality initiatives the chronic care programme.
focused on coordination between primary and secondary
care.18 This can be accomplished with the SC-CR model. References
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