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| Name | Class |
|---|---|
| Jewish General Hospital | OTHER |
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An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec.
The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures.
The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults aged 60 or older |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Mobilization | Other | The EM program consists of a progression of functional activities from level of function (LOF) 0 (lowest mobility) to 5 (highest mobility). Each LOF has 3 primary activities designed to promote the patient to the next level. The nurse will begin with mobility activities based on the LOF that matches the patient's current status. The nurse and clinical partner will attempt and/or complete each LOF activity once per shift. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization | The mean improvement change in the Level of Function scale score in patients undergoing early mobilization. The Level of Function scale measures mobility and ranges from 0 (bed immobile) to 5 (walking more than 20 meters), with higher scores indicating better mobility. | Duration of Cardiac Intensive Care Unit stay (average 4 days) and 1 and 12 months post-hosptialization |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of physical function | Recovery of physical function at 1 month and 12 months as measured by the Short Form (SF)-36 physical component summary score (measures 8 subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health). The score range is from 0 to 100 and scores are calibrated so that 50 is the average score. Higher scores mean less disability. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the CICU in the early mobilization program aged 60 or older.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Goldfarb, MD | Lady Davis Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital / Lady Davis Institute | Montreal | Quebec | H3T 1E2 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2018 | Nov 21, 2018 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2018 | Nov 21, 2018 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 1 month and 12 months. |
| Recovery of functional ability | The recovery of functional ability at 1 month and 12 months as measured by the Level of Function scale score. The Level of Function scale measures mobility and ranges from 0 (bed immobile) to 5 (walking more than 20 meters), with higher scores indicating better mobility. | 1 month and 12 months |
| D013812 |
| Therapeutics |