An interventional study of Rehabilitation program group in Case Manager, Myocardial Infarction and Sick Leave, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Open to participants aged Up to 57 Years. Per ClinicalTrials.gov, last updated 2021-06-25.
Sponsored by Assuta Hospital Systems · Not applicable, Interventional, and Health services research
Abstract Purpose: To study the long-term effectiveness of case-management rehabilitation intervention among patients after myocardial infarction (MI) compared with the current standard of care.
Methods: Participants were 151 patients who underwent uncomplicated MI and of which nearly all enrolled in a cardiac rehabilitation program. Patients were randomized into an intervention or control group and provided two years of follow-up data. The intervention, conducted within an occupational medicine clinic, started during hospitalization or immediately thereafter and continued for 2 years. It included: early referral to an occupational physician, charting an occupational intervention program, coordinating between the patient and relevant parties, psychosocial intervention, intensive follow-up sessions during the first 1.5 months, and more spaced interventions during the follow-up period. Outcome variables were: return to work within 6 months of hospitalization and maintenance of employment at one and two years of follow-up.
The program was conducted by a clinical social worker within the OM clinic and included several components:
Intervention during follow-up
The study received ethical approval from the institutional review board, serial number 2006038.
Statistical analysis Results are presented as mean + standard deviation (SD) for continuous variables and as frequencies for categorical variables. Data were analyzed using the SPSS statistical package (Version 26, SPSS Inc., Chicago, IL). Student's t-test was used to test for a difference between the means of two groups on a continuous dependent variable. Chi-square test of homogeneity was used to test for a difference between two proportions. For small groups, it was replaced by Fisher's exact test.
A multiple logistic regression model was used to investigate the relationship between employment status (employed/unemployed) at one year and two years of follow-up and CM program participation. Adjustments were made for factors that were found in previous studies to be associated with vocational re-integration and that could have confounded the findings of this study. A list of the possible confounders is presented in Table 4. Significance was determined by p\<0.05.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 151 is close to the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention group was followed at 6, 12, 18, 24 months after entering the study. The follow-up was conducted by the case manager for patients in the intervention group, and by a research assistant for patients in the control group. Medical data were retrieved from the computerized medical records in the relevant hospitals.
Procedure: Rehabilitation program group
The control group received regular care.
The case-management rehabilitation program was conducted by a clinical social worker within the occupational medicine clinic and included several components: 1. Intake by a case manager 2. Referral to an occupational physician was within one week of the intake. 3. Charting an occupational rehabilitation program and timing the RTW date 4. Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis. 5. Provision of a guidance booklet for employers on the RTW of cardiac patients. 6. The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests. 7. Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned.
Also known as: complex case-management rehabilitation program
Participants' return-to-work rates within 6 months from hospital discharge
This outcome measures the percentage of participants in either study or control groups, who have returned to work within 6 months of hospital discharge. This time window represents the optimal return to work period for most cardiac patients and assesses the effectiveness of the intervention in supporting the return to work process.
Time frame: Up to 6 months from hospital discharge
Percentage of participants that maintained their employment at 12, 18, and 24 months of follow-up
This outcome measures the percentage of participants in either study or control groups that have maintained their employment over time after having returned to work. Since some participants may not be capable of maintaining their employment status despite having returned to work, this outcome represents the effectiveness and quality of the return to work process and assesses the contribution of the case manager in supporting the participants' overall return to work.
Time frame: Up to 24 months from hospital discharge
Occupational status of employed patients (full-time vs. part-time)
This outcome measures the degree of employment (full vs. part-time) of participants that have returned to work after their myocardial event. Some participants are able to return to full-time work, others need their work hours accommodated - this measure provides more information on the employment status amongst those that have managed to return to work and the effectiveness of the case manager in supporting the return to full-time work.
Time frame: Up to 24 months from hospital discharge
Occupational status of employed patients (Same vs. different job)
This outcome measures whether participants that return to work, will do so to their previous jobs/occupation or whether to a different job/occupation. Some participants are able to maintain the same job/occupation, others require accommodations and/or restrictions - this measure provides more information on the employment status amongst those that have managed to return to work and the effect the case manager will have in supporting the return to the same job/occupation.
Time frame: Up to 24 months from hospital discharge
Plan to share: No — Owing to data privacy regulations, the raw data for this study cannot be shared.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assuta Hospital Systems