Anxiety Clinical Trial
Official title:
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
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.
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:
1. Age Greater than or equal to 70 years.
2. Primary complaint of a fall and discharged home directly from the Emergency Department.
3.2.2. Exclusion Criteria: Definition and Rationale: Exclusion Criteria: Definition
/Rationale
1. Admitted to hospital Will not benefit from intervention
2. Not independently living Not living in own domicile, or Seniors residence if subject
responsible for own activities of daily life /Dependant individuals not likely to
benefit from intervention
3. No Phone Line Required to install ERS Line
4. Unable to give informed consent Communication barrier, dementia (MMS < 23)
5. Living outside catchment area Postal code of Residence/Follow-up impractical
3.3. Patient recruitment: All eligible patients presenting during study hours
(08.00h-22.00h, 7 days a week) will be introduced to the study by a Research Nurse. Patients
expressing an interest in study participation will be asked to provide formal written
consent and will be randomized to either control or intervention groups (see “Intervention”,
below) prior to discharge from the Emergency Department. To maximize follow-up, contact
information will be verified prior to discharge, including information on next of kin and
family physician.
3.4. Control Group Current standard care of the elderly who have fallen at our institution
involves referral to an Emergency Geriatric Nurse Clinician, who is available between 9 and
5, seven days a week. Patients referred after hours currently receive a telephone follow-up
the next day. Based on the face-to face or telephone interview, the Geriatric Nurse
Clinician arranges follow-up with the Regional Geriatric Assessment program, suggests
gait-aids such as a cane or walker, or may recommend a change in the client’s living
arrangement.
3.5. Intervention Patients randomized to the intervention group will receive standard care
as outlined above. In addition, they will be given an emergency response system (ERS) for a
trial period of 30 days following their visit to the ED. The ERS consists of a battery
operated personal alarm system, kept within reach of the patient at all times. The ERS is
monitored 24 hours per day by a response team, with access to an updated summary of the
medical history and social circumstances of the client. Patients are instructed to activate
the ERS for falls or other events requiring assistance. Once the system is activated, an
automated log of the event is generated. The response team can communicate with the
individual via a 2-way speaker, and determine what resources are required (e.g. dispatching
an ambulance, mobilization of home care, private health care, or family support). The
proposed benefits of this system are to provide timely access to assistance by a team with
specific knowledge of the patient for clients with restricted mobility, impaired visual or
auditory acuity, or cognitive impairments that might interfere with their ability to access
or choose an appropriate level of response from the health care system using existing
methods such as 911 or Telehealth.
3.6. Length of Follow-up All patients will be contacted by telephone after one week to
arrange a follow-up home visit interview between 30-37 days after discharge from the ED.
Previous studies have shown that the highest return rates occur during the first month of
discharge, , and that visits during this first month are more likely to be for the same
problem than latter visits 31.
3.7. Primary Outcome: Hospital Anxiety Scale The primary goal of the current pilot study
will be to determine the impact of the ERS on patient quality of life after discharge from
the Emergency Department, as measured by the Hospital Anxiety Scale 1. The HAD-A scale has
been used widely in the assessment of anxiety for many different patient groups, including
the elderly 21, , both as a screening tool and as an outcome measure, and has been shown to
have satisfactory levels of psychometric validity 42. The scale consists of seven Likert
scales, scored between 0 and 3, for a theoretical range of 0 to 21.
3.7.1. Secondary Outcomes: Fear of Falling Efficacy Scale: The falls efficacy scale is
previously validated scale designed to measure elders self-confidence in their ability to
avoid falling in daily living activities 2,28. Elders rate their confidence to avoid a fall
a 0 to 10 scale during ten activities (see Appendix A.). In addition, we will measure
patients’ confidence that, were they to fall, they would be able to get up on their own.
3.7.2. Health Care Utilization: Health care utilization will be measured by patient reports
of utilization of the following health care resources in the month following presentation:
to the ED
1. Total return visits to an emergency department;
2. Total family physician visits;
3. Total contacts with Tele-health;
4. Total admissions to hospital and length of stay; 3.7.3. Patient and caregiver
perceptions of the ERS It is important to document the behavioural and social processes
attendant upon the introduction of any new technology, or any innovative application of
an existing technology. In this instance we shall, through a short series of
semi-structured questions, ask patients who are in receipt of Lifeline to reflect on
their day to day experiences in relation to the possession and use of the equipment,
during the month following their visit to the emergency department, and the perceived
impacts of the scheme on family and friends. This component of the study derives from a
phenomenological paradigm , and will specifically adopt an ethnographic methodology in
order elicit patient-centered accounts of the technology 3.7.4. Patient Morbidity
We will compare the following measures of patient morbidity:
1. Self-reported falls
2. Self-reported injuries
3. Length of immobilization or “Down time”. The ERS has the potential to reduce patient
morbidity by preventing the terrifying experience of prolonged periods of immobility or
incapacitation after falling. In the literature, “downtime” has generally been
estimated by patient self-report . When the patient is unable to estimate, the last
witnessed time that the patient was ambulatory or in contact with another individual
will be used as a proxy.
3.8. Data Collection Demographic variables (age, gender, home circumstance, mini mental
status, and social support) will be recorded from the patient’s ED chart relating to the
presenting event. A questionnaire (see Appendix A) will be administered during face-to-face
interviews with patients in both the treatment and the conventional care groups. Baseline
interviews will be conducted prior to randomization to ensure blinding. The questionnaire
includes both the HAD-A scale and the Fear-Efficacy scale 2. In addition to these core
items, people in the intervention group will be asked to describe their experiences and
views of the ERS. Their responses will be recorded verbatim.
3.9. Data Analysis Plan Numerical data will be entered directly into a SAS (v10) database
for statistical analysis, following the general principles of Pocock in relation to a simple
one-way trial, and will be by ‘intention to treat’. The narrative (or “qualitative”) data
will be analyzed using the framework method .
3.10. The sample size calculation was based on the ability to detect a difference in
anxiety, our primary outcome, measured by the HADS-A. There is no definition in the
literature for the minimal clinically important difference (MCID) for the HADS-A. Two
previous large studies of community dwelling elders found that a 3 point change in HADS-A
represented two-standard deviations from their baseline assessment.33 Using 3 points as the
MCID yielded a sample size requirement of only 11 subjects per group. Such a small sample
size would not permit analysis of secondary endpoints, and might be judged to lack face
validity. Thus, a more conservative definition of the MCID for HADS-A of 1.5 points was
chosen. Because of uncertainty regarding the distribution of HADS-A scores in our target
population, we used the Wilcoxon rank sum test to estimate the required sample size. Given a
standard deviation of 3.4, and an alpha of 0.05, with 40 subjects per group, the study would
have over 95% power to detect a between-group reduction of 1.5 points from 6.0 to 4.5 in the
mean HADS-A score.
3.10.1. Recruitment rate A pilot study at our institution demonstrated that during a one
month period, 87 patients over 70 years of age were discharged from the emergency
department. Assuming that 45% of attendees were recruited, we estimate that approximately 39
people per month will be available for recruitment. Assuming a further 10% loss to
follow-up, we estimate that a five-month period will be required to recruit 160 subjects.
3.11. Ethical Considerations Ethical approval is being sought from our institutional
research ethics board of SWCHSC. The Research Nurse will obtain full written informed
consent.
Patient confidentiality will be strictly maintained. Data will be made anonymous before
analysis, and results will be published such that it is impossible to identify any
participant. Documents with patient identification will be kept in a, separate, locking
filing cabinets. The data will be archived for five years following completion of the study,
and then destroyed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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