Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330720
Status:
COMPLETED
Last Update Posted:
2006-05-29
First Post:
2006-05-26
Brief Title:
Impact of An Emergency Response System on Anxiety and Health-Care Use
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
31 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 Womens College Health Sciences Center is a tertiary university-affiliated teaching hospital with an annual Emergency Department census of 40000 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
32 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
321 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
322 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 ResidenceFollow-up impractical
33 Patient recruitment All eligible patients presenting during study hours 0800h-2200h 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
34 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 clients living arrangement
35 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 eg 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
36 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
37 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
371 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 228 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
372 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 373 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 374 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
38 Data Collection Demographic variables age gender home circumstance mini mental status and social support will be recorded from the patients 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
39 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
310 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 assessment33 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 15 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 34 and an alpha of 005 with 40 subjects per group the study would have over 95 power to detect a between-group reduction of 15 points from 60 to 45 in the mean HADS-A score
3101 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
311 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
31 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 Womens College Health Sciences Center is a tertiary university-affiliated teaching hospital with an annual Emergency Department census of 40000 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
32 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
321 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
322 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 ResidenceFollow-up impractical
33 Patient recruitment All eligible patients presenting during study hours 0800h-2200h 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
34 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 clients living arrangement
35 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 eg 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
36 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
37 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
371 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 228 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
372 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 373 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 374 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
38 Data Collection Demographic variables age gender home circumstance mini mental status and social support will be recorded from the patients 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
39 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
310 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 assessment33 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 15 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 34 and an alpha of 005 with 40 subjects per group the study would have over 95 power to detect a between-group reduction of 15 points from 60 to 45 in the mean HADS-A score
3101 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
311 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PSIF Grant 02-13 | None | None | None |