Background
During the last decades, mortality from ischaemic heart disease (IHD) and heart failure (HF) has decreased due to improved primary and secondary prevention [
1‐
3]. Thus, along with changed age composition, many people worldwide are living with these conditions which cause disability on several levels [
4,
5]. Health promotion and risk factor reduction are typically managed in cardiac rehabilitation (CR) and CR is known to improve clinical outcomes [
2]. Integrated patient education in CR programmes may also reduce fatal and/or non-fatal cardiovascular events and improve health related quality of life (HRQoL) [
3,
6]. Patient education is recommended to focus on the individual’s personal resources rather than only increasing knowledge on disease management [
7]. However, CR interventions have primarily been evaluated on clinical outcomes and less evaluated on the ability to promote level of function including return to work (RTW).
Work plays an important role for psychological and social wellbeing, and loss of productivity has economic costs for society [
4,
8]. Clinical guidelines across nations therefore intend to cover vocational counselling in CR however, RTW internationally still seems to remain suboptimal [
9,
10]. In Denmark it has been estimated that 21 and 25% of people with IHD and HF, respectively do not RTW 1 year after engaging in CR [
11,
12]. Moreover, some patients struggle to balance workplace demands with the individual resources and health status and therefore experience recurrent sick leave episodes after RTW [
13‐
15]. Problems in the work reintegration process has recently been emphasised since a study showed that detachment from employment was three-fold higher among post myocardial infarct patients 1 year after return to work compared with a matched population [
16].
Personal resources as coping and self-care are important aspects in a successful RTW process [
17]. CR-interventions aiming the ability to cope with and engage in everyday life evaluated on RTW have provided inconsistent results [
18,
19]. Thus, the evidence of the pedagogical approaches and methods to promote the RTW process is unknown.
Learning and coping strategies (LC) is a patient education method that aims to facilitate personal resources through inductive teaching with a high level of patient involvement and includes supplement of individual clarifying interviews. The health professionals and experienced patients jointly perform the group based CR sessions [
20]. The LC-REHAB trial was conducted in a hospital setting in Denmark, and aimed to assess the effect of LC strategies on various outcomes and have shown to promote patient adherence to CR [
20,
21]. In the present trial it was hypothesised that the LC strategies also promoted RTW compared with usual CR by enabling patients to use acquired LC skills in the RTW process. Furthermore, that those receiving LC strategies would reduce the number of sick leave relapses by the gained insight of health condition and how to cope with that.
The primary aim was to assess the effect of adding LC strategies in CR on RTW 1 year after inclusion of patients diagnosed with IHD or HF. Secondary to assess if addition of LC strategies in CR reduced sick leave relapses during one-year follow-up.
Discussion
The present trial showed that addition of LC strategies in hospital based phase II CR did not improve RTW status at one-year follow-up compared to standard CR. Nor did addition of LC strategies seem to reduce sick leave relapses during one-year follow-up.
Prior to this trial, comparable CR-interventions aiming at facilitating personal resources to improve RTW had consisted of patient-involving educational sessions, making an individual worksheet plan, including the role of the spouse, shared-decision making and a partnership-based approach [
18,
19]. The evidence for these approaches and methods is inconsistent and rely on a sparse basis [
18,
19]. In cancer rehabilitation no comparable educational interventions established effect regarding RTW neither [
28]. Comparing the effect of patient educational approaches across studies is however complicated by methodical differences as well as heterogeneity in patients, compared interventions and CR-delivery.
The trial benefitted from being able to measure the effect of a patient education method developed from a specific pedagogical approach in patient education. Despite the lacking effect of the intervention on RTW, the intervention provides knowledge for further research in CR patient education. According to the first guidance for evaluating complex interventions by the Medical Research Council (MRC), lack of effect may reflect implementation failure rather than genuine ineffectiveness of the intervention and has been identified as problems concerning development, implementation, and evaluation [
29].
The intervention in the LC arm was developed to aim at promoting the individuals’ personal resources rather than targeting multiple factors affecting level of function [
30]. A more comprehensive approach has however been suggested with beneficial effects on RTW by both a review on CR and a Cochrane review on cancer rehabilitation [
10,
28]. LC strategies in this trial lacked of involvement of contextual factors in general and workplaces in particular. The relapsed patients had jobs in health-care, service jobs and manual labour. Job type and support from the employer is found important for CR patients and recently contextual factors at the workplace and organisational practices have been identified to constrain the margin of manoeuvre in work reintegration [
15,
31]. This may imply that the physical demanding jobs, that also are low level educational job types among relapsed patients are more difficult to reintegrate into after sick leave due to IHD or HF. Thus, the findings in this trial together with emerging evidence suggest development of interventions that foster accommodation and support from involvement of contextual factors like workplaces in integrated CR programmes [
31].
The implementation of the theoretical understanding in LC strategies may be questioned, since it was not described to what extent the illness perspective on work resumption was approached by the health professionals in the CR sessions. In the present study low household income, low educational level, no self support prior to CR and higher age at baseline were all statistically significant risk factors for not adhering to the CR exercise sessions (results not shown). These socioeconomic factors are in line with frequently reported predictors for not only poor adherence to CR but also detachment from employment [
16,
32]. It was likely to assume that the poorer adherence in high risk patients contributed to the absent effect of LC strategies. Implementation of future interventions to improve RTW should therefore ensure: adequate RTW-aimed interventions, include practical implications that in particular aim the process of RTW, and optimise adherence to CR for patients in high risk of detachment from employment.
Evaluation in this trial was done using an outcome that only accommodated a paid job or education and neglected possible enhanced participation in e.g. volunteer work or social relations. This standardised outcome may have conflicted with the individualised approach in LC strategies. Alternative evaluation of CR that measures more participation-related outcome might be relevant to reflect the aim of rehabilitation and furthermore to address the important well-known participation restrictions in patients with chronic IHD [
5,
33].
Study limitations and strengths
Information bias was considered minimal; DREAM has been validated against workplace-registered job attendance and long-term sick listing and found to have high sensitivity and specificity [
34]. Classification of RTW based on transfer payments from DREAM has elsewhere been defined based on various numbers of weeks (ranging from 1 week to 5 weeks) [
12,
13,
16]. The chosen definition of four consecutive weeks in this trial might have affected the frequencies of RTW but was not expected to be differentiated between arms. Selection bias was furthermore not considered as there was complete follow up; therefore, threats to the internal validity of the trial were not assumed.
The trial was carried out in western Denmark where the population in general is lower educated than the total population of Denmark and the trial enrolled patients with HF [
35]. Both level of education and living with HF are associated with increased risk of not returning to work and may have caused the overall lower RTW proportion (61-73%) in this trial compared to other studies [
11,
12,
16].
According to the power calculation, a 14% difference in RTW was expected between the two trial arms; however the trial detected a 4 percentage point difference. It was expected that lacking practical implications in the LC strategies for improving RTW rather than a low sample size was the reason of no difference.
The estimate may have been affected towards the null hypothesis as mutual interaction between the arms was plausible due to lack of blinding of the health professionals. Moreover, patient education was delivered in both arms and the effect of the patient education in the control arm may have contributed to even out the effect of LC strategies.
Approximately, 50% of the population with IHD and HF asked to participate declined to participate in the trial [
21]. However, no knowledge of the patients that declined was accessible and it was thus unknown if selection of the patients was present at enrolment. This caused limitation of the generalisability of the results and the trial was not able to provide answers about the effect on the total population of people with IHD or HF.
Temporal and contextual factors affect the ability to RTW and influence the external validity of the outcome measure. Also, this means that comparing results in an international context should be done carefully due to heterogeneity in RTW definitions and occupational systems.
Conclusion
Addition of LC strategies in CR showed no improvement of RTW compared to CR alone after 1 year. Implications for further development and research of patient education methods in CR to improve RTW are: involvement of contextual factors in development of the intervention, and implementation that ensures practical implications targeting RTW like workplace involvement and job type. Lastly, evaluation should address the interventions’ ability to improve participation among patients living with IHD and HF.
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