Acute Cardiovascular Disease, Early Mobilization, Nursing, Older Adults
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALEarly Mobilization
Nurse-driven early mobilization activities twice daily
BEHAVIORALUsual Mobility Care
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.
Sponsors
Lady Davis Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization | 1 month post-hospitalization | Health-related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Physical Component Scale score | 12 months post-hospitalization | Health-related quality of life |
| SF-36 Mental Component Summary score | 1 month post-hospitalization | Health-related quality of life |
| Level of Function Mobility Score | 1 month post-hospitalization | Functional status |
| Hospital readmission | 1 month post-hospitalization | Resource use outcome |
Outcome results
None listed