A structuralised sick-leave program compared to usual care sick leave management in patients after an acute myocardial infarction

In this study we aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute myocardial infarction.

Background

Coronary artery disease is a major health and economic burden in developed countries. The treatment of an acute myocardial infarction has radically changed during the last decade. The patients are usually re-vascularized and mobilized during the first few days after the event. The patients are often discharged after 4 days, which is in contrast to previous treatment of myocardial infarction, which was mainly based on observation and resting. Numerous research projects have been performed with the aim to improve the outcome of the acute coronary syndrome. Much less effort has been to do optimize the follow-up procedure after an acute life-threatening event such as myocardial infarction.

Short and long-term sickness absence after an acute myocardial infarction is associated with substantial costs for the society. We also know that a long sickness absence makes it more difficult for the patient to return to the work. There are no clear guidelines as regards the optimal duration and degree of sick leave with this condition and scientific data guiding doctors are extremely sparse. Furthermore, sick-listing practices for heart patients vary considerably among countries. This may be due to various factors, e.g. different sickness insurance systems, labour market conditions, and sick listing traditions among physicians. In Finland and Sweden, about half of the patient were available to the labour market two years after a myocardial infarction.

In this study, we aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute myocardial infarction. We also aim for identifying both medical and psychosocial factors associated with a good prognosis for returning to work after a myocardial infarction. 

Hypothesis/Problem statement

A structuralised sick-leave program after an acute myocardial infarction is cost-effective without a negative effect on quality of life compared to usual care sick leave management in this patient group.

Research methodology

Participants

One hundred and twenty consecutive patients admitted to Oslo university hospital due to an acute myocardial infarction.

Intervention

Patients who are to be discharged from the department of cardiology at Ullevål University hospital after an acute myocardial infarction and who are eligible according to inclusion and exclusion criteria of the study will be randomized, after giving informed consent, either to the structuralised sick-leave program or to the usual care sick-leave management.

Patients randomized to the structuralized program will get full-time sick-leave for 2 weeks after discharge. After that period, the patients are encouraged to return to work at full-time or part-time according to an individual adaptation. The GP of the patients are also instructed to help the patients to go back to work as soon as possible. Both the patients and the GP:s of the patients are given a telephone number to a cardiologist, available for support and questions during office time.  

Outcome measures

Sick-leave registration will be reported at each follow-up visit. All cardiovascular hospitalisations during the follow-up period are included and assigned a cost, based on the diagnosis-related group (DRG) category reference and length of stay.  

Quality of life

Quality-of-life measures are estimated at baseline and after 6 and 12 months, using the Standard Medical Outcomes Study Short Form-36 (SF-36) questionnaire and the Disease-specific Utility-Based Quality of life–Heart questionnaire (UBQ-H). The UBQ-H was developed specifically for use in coronary artery disease and has been validated in this clinical situation.

Statistical analysis

The SF-36 guides suggest that a difference of 10 points between groups per health domain indicates a clinically worthwhile difference. Sample size calculations revealed that about 50 patients per treatment arm would allow 80% power for detecting such a difference (assuming an 18-point standard deviation) in each of the SF-36 health domains with P = 0.05. A total of 100 patients would also offer greater than 80% power to detect a clinically worthwhile 0.1 ±0.2 SD difference in utility scores on the UBQ-H questionnaire. In this study, 120 patients will be included to cover for patients lost to follow-up.  

The results will be published in peer-reviewed scientific international journals.

  • Paper I - Health economy evaluation of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute myocardial infarction.
  • Paper II - Quality of life evaluation of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute myocardial infarction.
  • Paper III - Evaluation of medical and psychosocial factors associated with a good prognosis for returning to work after a myocardial infarction. 

Studentens work plan

All data are already available. The student needs to make the analyses and write the papers.

Some analyses are already performed. We have partners from Health Economy, who are prepared to help with these kind of analysis. The student will have the results in his/her hands at day 1. Then analyses, writing and the PhD courses have to be done.

About the Research environment

The research group has several other PhD students. Stefan Agewall is the head of a research group at Ullevål focusing on acute coronary heart disease. I am the tutor of 2 post doc students and 2 other PhD students. Previously I have assisted 8 students to their PhD.

Emneord: Klinisk/samfunnsmedisinsk prosjekt, Akuttmedisin, helseforskning, Helseøkonomi, Hjerte kar og lunger, Rehabilitering
Publisert 2. sep. 2021 12:02 - Sist endret 2. sep. 2021 12:02