Early Mobilization in Older Adults With Acute Cardiovascular Disease

Study Overview
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Brief Summary
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The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.

Detailed Description
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The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic EM program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. Nested cohort studies will explore (1) the relationship between EM, sedentary time, and posthospitalization outcomes and (2) the impact of EM on muscle mass loss and inflammation in older adults with acute CV disease.

Official Title
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Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial

Conditions
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Nursing, Early Mobilization, Older Adults, Acute Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Early Mobilization
* Behavioral: Usual Mobility Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 60 years no planned cardiac surgery during admission Exclusion Criteria: projected cardiac ICU stays less than 24 hours patients unable to complete follow-up

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The nature of the intervention requires randomization of entire units to the intervention with associated mobility culture change and this precludes a standard randomized controlled trial design (i.e., randomization of some patients to the intervention but not others). The stepped-wedge design allows each site to function as its own control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Mobilization Intervention<br>The bedside nurse determines the prehospital Level of Function based on patient and family report and current Level of Function based on nursing mobility assessment. Each Level of Function has 3 primary activities designed to promote the patient to the next level. The nurse leads mobility activities based on the patient's current Level of Function once per shift, twice daily (AM+PM). If a patient is able to complete each of the 3 activities, the nurse on the subsequent shift will assess whether the Level of Function can be advanced. Physiotherapy consultation is available if required, although not obligatory. Patients are encouraged to spend as much time in the chair and ambulatory as possible. | Behavioral: Early Mobilization<br>* Nurse-driven early mobilization activities twice daily<br>|
| Active Comparator: Usual Mobility Care<br>Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice. | Behavioral: Usual Mobility Care<br>* Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization | Health-related quality of life | 1 month post-hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Physical Component Scale score | Health-related quality of life | 12 months post-hospitalization | 
| SF-36 Mental Component Summary score | Health-related quality of life | 1 month post-hospitalization | 
| SF-36 Mental Component Summary score | Health-related quality of life | 12 months post-hospitalization | 
| Level of Function Mobility Score | Functional status | 1 month post-hospitalization | 
| Level of Function Mobility Score | Functional status | 12 months post-hospitalization | 
| Hospital readmission | Resource use outcome | 1 month post-hospitalization | 
| Hospital readmission | Resource use outcome | 12 months post-hospitalization |