Trial document




drksid header

  DRKS00016681

Trial Description

start of 1:1-Block title

Title

MySupport: Implementation and Evaluation of routinely assessed Patient-Centered Outcome Measures (PCOM) in oncological and palliative care settings

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

Trial Acronym

MySupport

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

[---]*

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

Brief Summary in Scientific Language

People with life-threatening or incurable diseases frequently experience complex and constantly changing problems including physical, psychological and social burdens with varying severity.
Provided that reported stresses and burdens are relevant to the treatment and that they are used and embedded in treatment and health care by professionals, several investigations have been able to show that routine assessment and recording of patient-centered outcome measures (PCOM = standardised, validated questionnaires for the assessment of the perception of health status and well-being from the patient's perspective) may positively impact health care processes as well as treatment outcomes. Recent developments within the section of new media may thereby open up further opportunities for the use of PCOMs in everyday clinical practice due to a more simplificated exchange of information and moreover, the use of automatic alerts.
The present project aims to implement structures and processes for a routinely used (web-based) assessment and clinical use of patient-centered outcome measures in varying palliative and oncological contexts. For this purpose, the Integrated Palliative Care Outcome Scale (IPOS) will be used to measure patient-side stresses and symptoms as well as their severity. Data acquisition is realized by either providing patients and professionals with paper forms of the IPOS or instructing them in the use of the web application Cankado which allows (1) patients to document physical, psychological and social burdens online via the use of a computer, tablet or smartphone and (2)professionals to view and access patients’ reported data at any time. During the implementation process, patients, professionals as well as study nurses evaluate the (a) feasibility and acceptance of the assessment of PCOMs and (b)their (potential) effects on communication, treatment processes and outcomes.
The implementation will be realized in four palliative care units, two outpatient palliative care services and an oncological day clinic.
A further aim of the present investigation consists in the validation of an algorithm for the screening of patients' needs for Early Palliative Care.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016681
  •   2019/04/24
  •   [---]*
  •   yes
  •   Approved
  •   84/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   C00-C97 -  Malignant neoplasms
  •   Z51.5 -  Palliative care
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients group 1: Patients who provide informed written consent to participate in the present implementation study:
    - Completion of the IPOS (Integrated Palliative Care Outcome Scale) questionnaire and a part of the Distress Thermometer (practical problems) at the beginning of treatment; then every 7 days and if the course of the disease/symptoms are significantly changing (if needed); last questionnaire should be completed before the end of hospital treatment or during/after the seventh week of treatment in outpatient settings; via paper questionnaire or by the use of the web application Cankado
    - Clinical use and clinical embedding of patient information deriving from the questionnaires in patient care and treatment by the professionals
    - Evaluation of the experiences and assessment of all patients at the end of hospital treatment or during/after the 7th week of treatment in outpatients
    - Documentation of sociodemographic, disease- and treatment-related information as well as data on media support needs and suggestions for future improvements
  •   Patients Group 2: Patients who do not provide informed written consent to participate in the present investigation, but provide informed written consent for the documentation of the following information:
    Sociodemographic and disease-related information as well as the reasons for their denial to participate in the present project
  •   Study nurses and professionals:
    - Implementation of center-specific steering groups that define and implement center-specific goals, processes and responsibilities in a Plan-Do-Check-Act process, documentation via checklists.
    - Implementation in 3 stages with Study Nurses (functioning as facilitators within the implementation process) initially taking over most responsibilities and increasingly handing them over to the professionals during the course of the project; online trainings for professionals
    - Evaluation of professionals' experiences by questionnaire surveys at the end of the implementation phases
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. Feasibility and acceptance from patients' and professionals' point of view regarding the integration into everyday's routine, acceptance and user-friendliness:
- Assessment of the frequency of questionnaires' use and the completeness of provided data
- Questioning of patients by the study nurses in order to evaluate patient’s previous experiences with new media and aditionally questioning of those patients who used the web application for PCOM recording after first or second recording in order to identify need of support and difficulties in use
- Written survey evaluation of all patients at the end of treatment (or during their 7th week of treatment) regarding their experiences with PCOM recordings during the course of the project and evaluation of the wish for further use/PCOM recordings

2. Effects of the (web-based) recording of PCOMs on the identification of patients' problems, health care processes, communication between professionals and patients, team communication, individual treatment success (e.g. with respect to quality of life, symptom control):
- At the beginning of treatment, professionals identify and mark previously unknown symptoms and burdens (and/or their severity)
- Evaluation of checklists
- Written survey evaluation of all study nurses and professionals

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

Secondary Outcome

Specificity and sensitivity, predictive value as well as area under the curve (AUC) in the ROC analysis as measures of the quality of the prediction of palliative treatment need based on the data on the IPOS and professionals' answering of the surprise question ("Would you be surprised if this patient died in the next year?")

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

Recruitment

  •   Actual
  •   2019/04/30
  •   300
  •   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

Patients with oncological diagnoses and / or palliative patients who
Group 1: give informed written consent to participate in the present project
Group 2: give informed written consent regarding the documentation of sociodemographic and disease-related information as well as the documentation of their reasons for not participating in the present project

Study Nurses and professionals who
- are directly or indirectly (e.g. during team meetings) involved in the assessment and clinical use of PCOMs during the project
- are willing to participate

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

Exclusion Criteria

Patients
- with unsufficient German language skills
- during the final phase/ the last days of life
- with cognitive and/or physical limitations that prevent them from providing answers to the questions on the IPOS themselves or to family members and professionals who may support them during the completion of the questionnaire

practicioners
- with less than one month of working experience in the corresponding institution/service during the implementation process
- who became involved in patients' treatment during their work as temporary worker or consultant or in the course of their work for an external service

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • 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
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Dr.  Isabell  Ofer 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • 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
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Dr.  Isabell  Ofer 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • 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
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Helga  Jäger 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • 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
    • MWK Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg
    • Postfach 103453
    • 70029  Stuttgart
    • 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 ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.