Clinical trial NCT02649595: Bridge Copenhagen - Respite Care for Homeless People
Official title: Bridge Copenhagen - Respite Care for Homeless People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Homelessness
Respite Care
Keywords: Homeless
Homelessness
Respite care
EQ-5D
Quality of life questionnaire
Economic evaluation
Cost-utility analysis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Red Cross Copenhagen
name: Region Capital Denmark
name: Copenhagen Municipality, Denmark
First posted: 2016-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to determine the effect of a two week respite program (Red Cross) for homeless people just discharged from hospitals in the capital region of Denmark.

The study is a randomized controlled trial and an economic evaluation. The intervention is a 2 week stay at a Red Cross respite care center. The intervention is intended for homeless people or functional homeless, who has been admitted to hospital and received standard medical care and treatment at the hospital. Under normal circumstances the homeless patients would be discharged to live on the street and receive care from programs in the municipalities. The respite center offers standard nursing care, rest with a place to sleep, food and help dealing with social problems such as economy and housing. The respite care center is led by a nurse who is represented during daytime from Monday to Friday and besides that, volunteers are used as staff.

The control group is receiving usual care and is discharged to the street and the usual communal programs.

The study examines whether a 2 week stay is cost effective and whether it can improve the health related quality of live (HRQoL). The hypothesis is that a respite care stay will result in a 25 % reduction in health care costs and increase the HRQoL.

Detailed description: The study is a randomized controlled trial with an economic evaluation of a Red Cross respite care stay for homeless people, who have just been discharged from hospital in the capitol region of Denmark.

The effect of a respite care stay for homeless people has never been investigated in Denmark.

Intervention:

The intervention consists of a 2 week stay at a Red Cross respite center. The intervention is intended for homeless or the functional homeless who is not ill enough to stay in the hospital, but to sick or frail to live on the streets. The homeless patients have received the standard medical care and treatment at the hospital and would under normal circumstances be discharged to live on the street and receive care from programs in the municipalities. The respite care center offers a free stay with a place to sleep, food three times a day, help with nursing tasks and help dealing with social problems such as economy and housing. The place is led by a nurse who is working during daytime from Monday to Friday and besides that, volunteers are used as staff.

The control group is discharged from hospital to the street and the usual programs in the municipalities.

Outcome:

The primary outcome is the difference in health economic costs measured in DKK over a period of 3 months. The secondary outcomes are difference in Quality adjusted life-years (QALY) over a period of 3 month, health economic costs over a period of 6 months, difference in elective health care costs, difference in acute health care costs and difference in social costs.

Quality adjusted life-years can be calculated by using the EQ-5D-5l questionnaire that measures health related quality of life (HRQoL). The answers from the questionnaire can be converted to an index value and is used to calculate QALY's. Quality Adjusted Life-Years is also used as the outcome measure of the cost-utility analysis (CUA).

Data collection:

Data about health economic costs for the CUA is going to be extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, communal databases and from the operational costs of the respite center.

HRQoL is measured by using the questionnaire EQ-5D-5L. All participants answer the questionnaire at baseline at the hospital before randomization, then 2 weeks later and again 3 month from baseline. The answers from the questionnaire can be converted to an index value and is used to calculate Quality Adjusted Life-years (QALY). In this way it can be investigated whether there has been an increase or decrease in QALY's and clarify if there is any difference between the two groups.

Variables:

There will be collected information on following variables, demographics, mental illness (reported from latest hospital admission by the social nurses), physical health by Charlson score, self-reported substance abuse and duration of homelessness. Moreover records from the Red Cross respite center will be reviewed and information about what the individuals received help with is registered.

Analyses:

Regarding the primary outcome, an analysis of variance is performed to determine the difference between the costs of the intervention and control group. Furthermore analysis of variance is performed to compare the development in QALY's in both groups. Both the analysis for the primary and secondary outcome is performed as an intention to treat analysis.

The economic evaluation is performed like a CUA. Results from the CUA will be presented as an incremental cost-effectiveness ratio (ICER).

In case of a skew distribution between intervention and control group in possible confounders like the variables mentioned above, the analysis will also be adjusted for these.

Sample size:

With a power of 80 %, p- values=0,05, an estimated health economic costs in the control group on 100.000 DKK and a standard deviation of 39.243 DKK. To detect a difference between the groups of minimum 25.000 DKK, a total of 96 participants are needed in the study. That includes 20 % drop-out for data regarding the questionnaires.

Eligibility criteria: Inclusion Criteria:

* Homeless or functional homeless who is self-reliant and not ill enough to stay in the hospital but to sick or frail to live on the streets.

Exclusion Criteria:

* People who has cognitive problems understanding the information about the study.
* People who does not speak and understands at least one of the following languages: Danish, english, polish, romanian, german and french.
* People who have planned to leave Denmark within 6 month of inclusion in the study.

Primary outcomes:
measure: Health economic costs
timeFrame: 3 months
Secondary outcomes:
measure: Health Related Quality of Life (EQ-5D-5L)
timeFrame: 3 months
measure: Health economic costs
timeFrame: 6 months
measure: Elective health care costs
timeFrame: 3 and 6 months
measure: Acute health care costs
timeFrame: 3 and 6 months
measure: Social costs
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Clinical research Centre, Amager Hvidovre hospital
Study officials:
affiliation: Clinical Research Centre, University Hospital of Copenhagen, Hvidovre
name: Ove Andersen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bring C, Kruse M, Ankarfeldt MZ, Brunes N, Pedersen M, Petersen J, Andersen O. Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis. BMC Health Serv Res. 2020 Jun 5;20(1):508. doi: 10.1186/s12913-020-05358-4.