Case-management Rehabilitation Intervention in Facilitating Return to Work After Myocardial Infarction

NCT04934735 | Completed DMC

• 1 other identifier: 2006038
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Case Manager; Myocardial Infarction; Sick Leave; Return to Work

Keywords

Rehabilitation, return to work, maintenance of employment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 24 months from hospital discharge

Secondary Outcomes (2)

• Occupational status of employed patients (full-time vs. part-time)

  Up to 24 months from hospital discharge

• Occupational status of employed patients (Same vs. different job)

  Up to 24 months from hospital discharge

Study Arms (2)

The intervention group: received a complex case-management rehabilitation program

ACTIVE COMPARATOR

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 the standard care

NO INTERVENTION

The control group received regular care.

Interventions

Rehabilitation program group PROCEDURE

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

The intervention group: received a complex case-management rehabilitation program

Eligibility Criteria

• Age: Up to 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sex/Gender: Both males and females
• Age limits: Minimum Age: 25 years old; Maximum age: 57 years old
• Clinical diagnosis: Patients after acute myocardial infarction
• Occupational status: Patients that have been working before the myocardial infarction
• HMO membership: Members in Maccabi Healthcare Service (HMO in Israel)
• Sampling Method: A consecutive participant sampling took place. Each patient who fulfilled the study terms was invited to participate in the study

You may not qualify if:

• Age over 57 years old or less than 25 years old
• Clinical diagnosis: Patients who had not sustained acute myocardial infarction
• Occupational status: Not working 6 months prior to the acute myocardial infarction
• HMO membership: Non-members of Maccabi Healthcare Service (HMO in Israel).
• Consent to participate: Patients who have not agreed to participate in the study

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

‪Shlomo Moshe‬

Rishon LeZiyyon, 7526601, Israel

Location

Related Publications (1)

• Zack O, Melamed S, Silber H, Cinamon T, Levy D, Moshe S. The Effectiveness of Case-management Rehabilitation Intervention in Facilitating Return to Work and Maintenance of Employment After Myocardial Infarction: Results of a Randomized Controlled Trial. Clin Rehabil. 2022 Jun;36(6):753-766. doi: 10.1177/02692155221076826. Epub 2022 Feb 22.

  PMID: 35191331 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Melamed Shmuel, Ass. Prof.

  Tal Aviv University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The intervention group received a complex case-management rehabilitation program (described below) and the control group received the standard care.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Occupational Department

Model Details: This prospective randomized controlled trial was conducted among patients who underwent an uncomplicated acute MI. Two weeks after hospitalization patients were referred to an examination by a cardiologist (to obtain a standardized clinical examination for all participants). Following this examination, the patients were assigned to an intervention group and a control group using simple randomization based on a computer-generated random sequence of numbers. The main outcomes are the rate of return to work in each phase of the study (meaning after 6,12,18, and 24 months)

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 22, 2021
• Study Start: June 1, 2007
• Primary Completion: June 30, 2008
• Study Completion: August 31, 2011
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)