A Randomized Clinical Trial To Asses The Impact of An Emergency Response System on Anxiety and Health-Care Use Among Older Emergency Patients After A Fall
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Anxiety measured with the Hospital Anxiety and Depression Scale, at 1 month
Study Overview
Brief Summary
What to do after an elderly patient falls but is not seriously injured can be a very challenging decisions for the patient and the Emergency Physician. Unfortunately, homecare support is often unavailable for weeks. The patient and physician must then choose between discharge home without support, or hospitalization. An emergency response service (ERS) allows the patient to summon assistance from anywhere in their home, and may provide another option.
Objectives: To see how an ERS affects patients' anxiety, fear of falling, and use of the health-care system after discharge. We will study patients over 70 years of age who have fallen but do not need to be hospitalized. Our belief is that the ERS will improve patient anxiety, and may prevent return visits to the Emergency or episodes of prolonged immobilization after a fall.
Methods: Patients agreeing to participate in the study will be assigned by chance to receive either current standard discharge care, or standard care plus the use of the emergency response system. Patients will be interviewed one month after discharge to compare the impact of the ERS. This study is a first step in deciding whether the ERS is a useful new technology.
Detailed Description
Research Design & Methods:
3.1. Study Design & Setting: A prospective, assessment blinded, randomized study design will be used. Patients randomized to the intervention group will be given an ERS communicator for a period of 30 days following their visit to the ED. Patients in the conventional care group will receive standard advice upon discharge. (See Control Group, below). Sunnybrook and Women's College Health Sciences Center is a tertiary, university-affiliated teaching hospital with an annual Emergency Department census of 40,000 patients. An audit of patients presenting to our Emergency Department for the month of December 2000 identified 87 patients over 70 years attending after a fall or fall-related injury who were discharged.
3.2. Study Population: The study will include elderly patients who present to the Emergency Department of our institution with a complaint of a fall, and who are being discharged home by the treating physician.
The proposed trial is designed to guide practical choices rather than merely to acquire scientific information. In the terms of Schwartz and Lellouch, it is 'pragmatic' rather than 'explanatory'. Patients who do not comply with their allocated treatment will be analyzed according to the "intention-to-treat" principle .
3.2.1. Inclusion Criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 70 years.
- •Primary complaint of a fall and discharged home directly from the Emergency Department -
Exclusion Criteria
- •Admitted to hospital
- •Not independently living
- •No Phone Line
- •Unable to give informed consent
- •Living outside geographic catchment area -
Outcomes
Primary Outcomes
Anxiety measured with the Hospital Anxiety and Depression Scale, at 1 month
Secondary Outcomes
- Fear of Falling, using Falls Efficacy Scale at 1 month
- Proportion who Returned to the Emergency Department by 2 months
- Proportion who are Hospitalized by 2 months
- Length of Stay by 2 months, in Days.