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| Name | Class |
|---|---|
| Canadian Association of Emergency Physicians | INDUSTRY |
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A randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.
Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. The investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with ADHF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Standard Care) | Active Comparator | The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital. |
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| Intervention Group | Experimental | The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Behavioral | For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death, hospital readmission, or ED revisit | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of return visits to any ER for any medical issue | Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period. | 30 days |
| Rate of admission to hospital at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Afilalo, FRCPC | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CODIM-MBM-17-052 | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004630 | Emergencies |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group (Standard Care) | Other | For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study |
|
Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.
| 90 days |
| Incidence of adverse effects from medication | Number of patients who experience unexpected side effects from their heart failure medications | 90 days |
| Self-Care Index | Change in the Self-Care Heart Failure Index from enrollment to follow-up | 90 days |
| Heart Failure Symptom Scale | Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up | 90 days |
| Frailty Index | Change in the Frailty Index from enrollment to follow-up | 90 days |
| Recruitment rate | The number of eligible of patients recruited into the study over a 3 month trial period | 90 days |
| Attrition rate | The number of patients enrolled the study who choose to leave the study before completing the follow-up | 90 days |
| Informed consent validation (qualitative) | Qualitative feedback from participants regarding the informed consent process | 90 days |
| All-cause death, hospital readmission, or ED revisit | 1 year |
Pilot study protocol |
| CODIM-MBM-17-052 | Informed Consent Form | View IPD | Patient consent Caregiver consent French and English available |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |