Health Behavior Clinical Trial
Official title:
A Randomized Controlled Trial of Peer Support Workers in the Emergency Department for People Experiencing Homelessness in the Niagara Region of Ontario, Canada
NCT number | NCT04012697 |
Other study ID # | 7048 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | March 19, 2020 |
Verified date | February 2023 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peer support workers with lived experience of homelessness will provide advocacy, supportive counselling, assistance with navigating the system, and role-modeling for people experiencing homelessness in emergency departments in the Niagara region of Ontario, Canada. Previous research has demonstrated that people experiencing homelessness experience barriers to care and poor health outcomes, including increased risk of dying, and are frequent users of the emergency department for physical and mental health needs. The benefits of peer support have been studied in hospital psychiatric units and with people experiencing homelessness, but no studies have yet explored the potential impact of peer support workers on homelessness in the emergency department. The investigators plan to do a 12-month randomized study of peer support workers compared to usual care in the emergency department, and evaluate outcomes such as physical health, mental health, addictions, and behaviours, as well as cost-effectiveness and changes in how people experiencing homelessness seek health care. The investigators hope that the findings of this study will provide additional knowledge and evidence for future efforts to improve care for people experiencing homelessness.
Status | Terminated |
Enrollment | 19 |
Est. completion date | March 19, 2020 |
Est. primary completion date | March 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Canadian citizen or permanent resident - Resident of Ontario in the past 12 months - Age 18 or over - Absolute homeless (e.g., living outside, including but not limited to abandoned buildings, vehicles, transit stations; residing in shelters; residing in hotel/motel rooms) - Hidden homeless (e.g., living with others, residing in transitional housing) Exclusion Criteria: - Not a Canadian citizen or permanent resident of Canada - Not a resident of Ontario for the majority of the past 12 months - Under the age of 18 - Does not meet criteria for absolute or hidden homelessness (see: Inclusion Criteria) - Refusal to disclose housing, citizenship, or residential status |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Niagara Community Foundation, Niagara Poverty Reduction Network, Quest Community Health Centre, United Way Niagara |
Canada,
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* Note: There are 47 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-effectiveness analysis of peer support worker intervention as compared to usual care at 12 months | The total mean costs for the usual care group will be subtracted from the total mean costs for the intervention group to provide the incremental cost (IC). The mean quality-adjusted life years (QALYs) associated with the intervention and usual care groups will be calculated using the health state and associated health utility score from the Time 12 administration of the EQ-5D-5L, multiplied against the value of '1' representing a 12-month treatment effect/duration of peer support (or usual care). The mean QALY of the usual care group will be subtracted from the mean QALY of the intervention group to provide the incremental effectiveness (IE). The incremental cost-effectiveness ratio (ICER), representing the average cost per additional QALY gained, will be calculated by dividing IC by IE (Neumann, Sanders, Russell, Siegel, & Ganiats, 2017). | 12 months | |
Other | Survival analysis of health service use/outcomes using administrative health data | We will examine time to first emergency department readmit, time to second emergency department readmit, and time to admission to an inpatient service. A failure is considered to have occurred if the participant visits the emergency department after the enrollment presentation or is admitted to hospital through the emergency department. | From the date of assignment until the date of first emergency department readmit, second emergency department readmit, and admission to an inpatient service, assessed up to 12 months | |
Other | Non-parametric survival analysis using administrative health and peer support questionnaire data to evaluate changes in health care provision between contacts with the peer support worker | We will examine the amount of procedures, tests and time spent within an emergency department as a crude measurement of health needs. At first presentation, an increase in these values in the intervention group relative to the usual care group is suggestive that the peer support worker is providing information to the medical team that improves care. At subsequent visits though, if our intervention is effective at improving un-met health needs, the opposite relationship should occur. We will augment these administrative measures with aspects of an 11-item peer support worker survey which will further document interactions with the medical team. | From the date of assignment until the date of each subsequent visit, assessed up to 12 months | |
Other | Survival analysis of mental health and physical health on the SF-12 | Survival analysis will be also conducted on the SF-12 to evaluate how quickly mental and physical health degrades in our sample after the initial intervention. We will count an occurrence of one and two standard deviations below mean as a failure in our sample and will perform this analysis on both physical and mental well-being summary scores separately. | From the date of assignment until the date of scoring one standard deviation below mean and two standard deviations below mean for each of physical health score and mental health score, respectively, assessed up to 12 months | |
Other | Non-parametric survival analysis using data on address of residence to evaluate changes in discharge planning between contacts with the peer support worker | We will assess discharge planning as a cause for improved health care system use. One reflection of improved discharge planning may be stability in the participant's address. Our strategy for data collection will include a question on the participant's address, and any other changes in their contact information. We will employ non-parametric survival analysis to see if our intervention is 1) Associated with reduced stays at shelters, and 2) Associated with the same address as previous contact. An outcome is considered a failure if the person is staying at a shelter or has changed addresses from previous contact. | From the date of assignment until the date of address change designating a stay at a shelter or address change from previous contact, assessed up to 12 months | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hospitalizations, measured using administrative health data | The primary outcome of the study includes the number of hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of days spent in hospital, measured using administrative health data | The primary outcome of the study includes the number of days spent in hospital. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of emergency department visits, measured using administrative health data | The primary outcome of the study includes the number of emergency department visits. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hours spent in the emergency department at each visit, measured using administrative health data | The primary outcome of the study includes the number of hours spent in the emergency department at each visit. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of procedures performed in the emergency department, measured using administrative health data | The primary outcome of the study includes the number of procedures performed in the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in procedures performed during hospitalizations, measured using administrative health data | The primary outcome of the study includes the number of procedures performed during hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in proportions from the pre-intervention 12-month baseline to the post-intervention 12-month period in diagnoses at the time of discharge from the emergency department, measured using administrative health data | The primary outcome of the study includes the diagnosis at time of discharge from the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in mortality, measured using administrative health data | The primary outcome of the study includes mortality. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in overdose presentations, measured using administrative health data | The primary outcome of the study includes overdose presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in psychiatric presentations, measured using administrative health data | The primary outcome of the study includes psychiatric presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Primary | Change in proportion from pre-intervention 12-month baseline to post-intervention 12-month period in composition of presenting complaints to the emergency department, measured using administrative health dat | The primary outcome of the study includes the composition of presenting complaints to the emergency department and potential differences over time in the proportions of different presentations (e.g., physical health vs. mental health, Canadian Triage and Acuity Scale (CTAS) levels). This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment. | 12 months pre-study enrollment and 12-months post-study enrollment | |
Secondary | Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 6 months | The CSI is a 14-item self-report measure of psychiatric symptoms (Boothroyd & Chen, 2008). Respondents report the frequency of various psychiatric symptoms as experienced over the past month on a 5-point Likert scale. Scores range from 0 to 56, with higher scores indicating report of more frequent psychiatric symptoms. The CSI has been psychometrically validated with a sample of people who were experiencing homelessness, living precariously, at risk for homelessness, or had prior history of homelessness (Conrad et al., 2001). The CSI was found to have excellent internal consistency with a Cronbach's alpha of 0.90 and a test/retest intraclass correlation coefficient of 0.79 with this population. The CSI is intended to evaluate change in persons with moderate and high severity psychological symptoms or emotional distress, and is sensitive to change in symptomatology over time. Administration of the questionnaire requires approximately 5 minutes. | 6 months | |
Secondary | Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 12 months | The CSI is a 14-item self-report measure of psychiatric symptoms (Boothroyd & Chen, 2008). Respondents report the frequency of various psychiatric symptoms as experienced over the past month on a 5-point Likert scale. Scores range from 0 to 56, with higher scores indicating report of more frequent psychiatric symptoms. The CSI has been psychometrically validated with a sample of people who were experiencing homelessness, living precariously, at risk for homelessness, or had prior history of homelessness (Conrad et al., 2001). The CSI was found to have excellent internal consistency with a Cronbach's alpha of 0.90 and a test/retest intraclass correlation coefficient of 0.79 with this population. The CSI is intended to evaluate change in persons with moderate and high severity psychological symptoms or emotional distress, and is sensitive to change in symptomatology over time. Administration of the questionnaire requires approximately 5 minutes. | 12 months | |
Secondary | Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 6 months | The GAIN-SS is a 24-item self-report measure which assesses psychopathology and crime/violence across various dimensions and screens for people who are likely to have diagnoses or require clinical services (Dennis, Chan, & Funk, 2006). The total score contributes to a Total Disorder Screener (TDScr), with four, 5- to 7-item subset screeners including the Internalizing Disorder Screener (IDScr), Externalizing Disorder Screener (EDScr), Substance Disorder Screener (SDScr), and Crime/Violence Screener (CVScr). The GAIN-SS is internally consistent with a Cronbach's alpha of 0.89 and good discriminant validity for each of the sub-screeners. The Total Disorder Screener has over 90% sensitivity and specificity with a ROC of 0.97 with a cut point of 3 or more. For the sub-screeners, scores can be divided into three groupings of 0 (low), 1-2 (moderate), and 3-5 (high), with the lower cut point of 1+ featuring 90% sensitivity and the upper cut point of 3+ featuring 90% specificity. | 6 months | |
Secondary | Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 12 months | The GAIN-SS is a 24-item self-report measure which assesses psychopathology and crime/violence across various dimensions and screens for people who are likely to have diagnoses or require clinical services (Dennis, Chan, & Funk, 2006). The total score contributes to a Total Disorder Screener (TDScr), with four, 5- to 7-item subset screeners including the Internalizing Disorder Screener (IDScr), Externalizing Disorder Screener (EDScr), Substance Disorder Screener (SDScr), and Crime/Violence Screener (CVScr). The GAIN-SS is internally consistent with a Cronbach's alpha of 0.89 and good discriminant validity for each of the sub-screeners. The Total Disorder Screener has over 90% sensitivity and specificity with a ROC of 0.97 with a cut point of 3 or more. For the sub-screeners, scores can be divided into three groupings of 0 (low), 1-2 (moderate), and 3-5 (high), with the lower cut point of 1+ featuring 90% sensitivity and the upper cut point of 3+ featuring 90% specificity. | 12 months | |
Secondary | Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 6 months | The EQ-5D is a 5-item generic measure of health status that provides a descriptive profile for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. Health is defined across five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which encompass a broad range of different disease areas, specialties, and types of care. Each dimension offers the following five levels: No problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. The EQ-5D-5L offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions). | 6 months | |
Secondary | Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 6 months | The Visual Analogue Scale is a 20-cm scale for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. This instrument offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions). | 6 months | |
Secondary | Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 12 months | The EQ-5D is a 5-item generic measure of health status that provides a descriptive profile for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. Health is defined across five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which encompass a broad range of different disease areas, specialties, and types of care. Each dimension offers the following five levels: No problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. The EQ-5D-5L offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions). | 12 months | |
Secondary | Mean change from baseline in health status on the Visual Analogue Scale (VAS) at 12 months | The Visual Analogue Scale is a 20-cm scale for respondents to provide a self-rating of their health and produce a utility score for cost-effectiveness analysis. This instrument offers a total of 3125 health states with a value set for Canada demonstrating a range of health utilities from -0.148 for the worst health state (55555, that is, extreme problems with mobility, self-care, etc.) to 0.949 for the best health state (11111, that is, no problems with any of the dimensions). | 12 months | |
Secondary | Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 6 months | The SF-12 is a 12-item questionnaire that has been investigated and utilized for measuring health status among people experiencing homelessness (Larson, 2002). It features categorical questions that assess limitations in role functioning as a result of physical and emotional health, as well as numerous Likert scale responses including a 3-point scale to assess limitations in physical activity and physical role functioning, a 5-point scale for pain and another for overall health, and a 6-point scale to assess mental health, vitality, and social functioning. The SF-12 produces a summary score each for mental health and physical health, which are able to differentiate between diagnostic groups and levels of severity of illness. Internal consistency in a sample of people experiencing homelessness demonstrated a Cronbach's alpha of 0.82 for physical health and 0.79 for mental health. | 6 months | |
Secondary | Mean change from baseline in mental health and physical health on the 12-item Short Form Survey (SF-12) at 12 months | The SF-12 is a 12-item questionnaire that has been investigated and utilized for measuring health status among people experiencing homelessness (Larson, 2002). It features categorical questions that assess limitations in role functioning as a result of physical and emotional health, as well as numerous Likert scale responses including a 3-point scale to assess limitations in physical activity and physical role functioning, a 5-point scale for pain and another for overall health, and a 6-point scale to assess mental health, vitality, and social functioning. The SF-12 produces a summary score each for mental health and physical health, which are able to differentiate between diagnostic groups and levels of severity of illness. Internal consistency in a sample of people experiencing homelessness demonstrated a Cronbach's alpha of 0.82 for physical health and 0.79 for mental health. | 12 months |
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