Trial document



drksid header

  DRKS00006780

Trial Description

start of 1:1-Block title

Title

Optimizing transition home from inpatient stroke rehabilitation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

OpTheraS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Transition from inpatient to outpatient care is not optimally organized according to judgments of clinicians, family physicians, physiotherapists and occupational therapists.
The purpose of this study is to investigate the current transition practice from inpatient to outpatient care after stroke and determine interventions to overcome problems in discharge home in the future.
A systematic literature search will be conducted and patients with stroke will be interviewed after discharged home. Clinicians, family physicians, occupational therapists, physical therapists, speech therapists and nurses will be asked about their experiences and attitudes to the current discharge practice.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In Saxony-Anhalt, the number of people suffering from stroke is much higher than the national average in Germany (371 versus 326 per 100 000 inhabitants per year). Transition from inpatient to outpatient care is not optimally organized according to judgments of clinicians, family physicians, physiotherapists and occupational therapists.
The study will 1) systematically identify barriers of the current transition practice from inpatient to outpatient care and 2) determine interventions to overcome these problems in the future. The study uses the UK Medical Research Council`s guideline on developing and evaluating complex interventions as framework.
First, a scoping review about interventions to improve discharge of stroke patients’ transition will be conducted. Second, a sample of 360 patients will be interviewed via phone six weeks after discharge. If the respondent is engaged in any therapy during the point of time, the therapist will be additionally asked about the specific prescribed therapy. Third, semi-structured interviews with clinicians and family physicians (n=8) will be conducted as well as group discussions with occupational therapists, physical therapists and speech therapists aimed to explore professionals’ attitudes to the current discharge practice and to identify challenges of transition from inpatient to outpatient care. A final inter-professional workshop will summarize the results and discuss the feasibility of potential interventions.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006780
  •   2014/09/18
  •   [---]*
  •   yes
  •   Approved
  •   2014-76, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients will be interviewed via phone six weeks after discharge from hospital or inpatient rehabilitation. They will asked about quality of life,stroke specific limitations, use of services and satisfaction with services.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Patient interviews will be conducted only once. Since this is not an interventional trial, it is not distinguished between primary and secondary outcomes. Patients will be asked about quality of life, stroke specific limitations, use of services and satisfaction with services.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Patient interviews will be conducted only once. Target criterias will not be differientated into primary and secondary outcomes.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/08/25
  •   360
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

diagnosis I63 or I61 ICD-10, discharge home, persistent need for therapy (recommendation to follow-up outpatient treatment in the discharge letter)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients, already taking part in a post hospital intervention study

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Martin-Luther-Universität Halle-WittenbergMedizinische FakultätProdekanat Forschung
    • Mr.  Prof. Dr. med. habil.  Dirk  Vordermark 
    • Magdeburger Str. 8
    • 06112 Halle/Saale  Halle
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Dr. rer. medic.  Susanne  Saal 
    • Magdeburger Str. 8
    • 06097   Halle/Saale
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Dipl. Soz.  Melanie  Müller 
    • Magdeburger Str. 8
    • 06097   Halle/Saale
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Martin-Luther-Universität Halle-WittenbergMedizinische FakultätProdekanat Forschung
    • Mr.  Prof. Dr. med. habil.  Dirk  Vordermark 
    • Magdeburger Straße 8
    • 06112  Halle/Saale
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/12/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Saal S., Kirchner-Heklau U., Müller T., Wohlfarth K., Hamzei F., Müller M., Strobel S., Clewing C.: Optimierung der Überleitung von der stationären zur ambulanten Gesundheitsversorgung nach Schlaganfall (OpTheraS) – Bestandsaufnahme der aktuellen Praxis und Analyse von Wirkmechanismen der Überleitung. Die Rehabilitation. DOI: 10.1055/s-0043-124347; EPub: 2018/01/30.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.