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

Organizational Data

DRKS-ID:
DRKS00016681
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2019-04-24
Last update in DRKS:
2024-01-23
Registration type:
Prospective

Acronym/abbreviation of the study

MySupport

URL of the study

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Brief summary in lay language

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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 and two outpatient palliative care services. A further aim of the present investigation consists in the validation of an algorithm for the screening of patients' needs for Early Palliative Care. Furthermore, data will be collected in a radiooncological outpatient clinic, exclusively pursuing the secondary outcome with a simplified study design. (Amendments 06.09.2019, 12.03.2020)

Health condition or problem studied

ICD10:
C00-C97 - Malignant neoplasms
ICD10:
Z51.5 - Palliative care
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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 - Documentation of sociodemographic, disease- and treatment-related information as well as data on media support needs and suggestions for future improvements - 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
Arm 2:
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 During study implementation, there was insufficient willingness to agree to pure data use without participating in the study (n=5); the corresponding evaluations cannot be meaningfully performed, therefore the 5 participants are listed as "non-participants".
Arm 3:
Patients Group 3, simplified study design: - One-time data collection of the IPOS (Integrated Palliative Care Outcome Scale) and Distress Thermometer questionnaires and documentation of sociodemographic data - Documentation of disease- and treatment-related information - Assessment of need for specialized palliative care involvement by attending physician
Arm 4:
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 - Evaluation by in-depth interviews (all study nurses as well as two to five professionals from different professional groups per ward or care service)

Endpoints

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 as well as in-depth guideline oriented interviews with the study nurses and two to five professionals per ward or care service
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?")

Study Design

Purpose:
Supportive care
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
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Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Anästhesiologie, Zentrum für Schmerztherapie und Palliativmedizin Heidelberg
  • University medical center III. Medizinische Klinik, Hämatologie und Internistische Onkologie Mannheim
  • University medical center Klinik für Innere Medizin III Ulm
  • University medical center Klinik für Palliativmedizin Freiburg im Breisgau
  • Medical center Radio-Onkologie, Ortenau Klinikum, Betriebsstelle Offenburg Josefsklinik Offenburg

Recruitment period and number of participants

Planned study start date:
2019-04-26
Actual study start date:
2019-04-30
Planned study completion date:
No Entry
Actual Study Completion Date:
2020-07-15
Target Sample Size:
300
Final Sample Size:
386

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients with oncological diagnoses and / or palliative patients who Group 1 + 3: 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

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

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Klinik für Palliativmedizin
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
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Fax:
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Contact per E-Mail
URL:
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Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg, Klinik für Palliativmedizin
Bettina Couné
Robert-Koch-Straße 3
79106 Freiburg
Germany
Telephone:
0761 270-95910
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/palliativmedizin.html

Contact for Public Queries

Universitätsklinikum Freiburg, Klinik für Palliativmedizin
Bettina Couné
Robert-Koch-Straße 3
79106 Freiburg
Germany
Telephone:
0761 270-95910
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/palliativmedizin.html

Principal Investigator

Universitätsklinikum Freiburg, Klinik für Palliativmedizin
Bettina Couné
Robert-Koch-Straße 3
79106 Freiburg
Germany
Telephone:
0761 270-95910
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/palliativmedizin.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

MWK Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg
Postfach 103453
70029 Stuttgart
Germany
Telephone:
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Fax:
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Contact per E-Mail
URL:
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Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
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Vote of leading Ethics Committee

Date of ethics committee application:
2019-02-13
Ethics committee number:
84/19
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-04-15

Further identification numbers

Other primary registry ID:
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EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Only cooperation partners receive the anonymized tabular questionnaire data for subgroup analysis. The questionnaires will be made available after request of the partners and after anonymization.

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
Elster L, Müller E, Couné B, Jäger H, Gencer D, Keßler J, Mayer-Steinacker R, Keser M, Marquardt S, Rauser J, Becker G. Informationsgewinn durch Selbstassessment von Belastungen in der stationären Palliativversorgung. Zeitschrift für Palliativmedizin 2020;21(05):30.
Müller, E., Mayer-Steinacker, R., Gencer, D. et al. Feasibility, use and benefits of patient-reported outcome measures in palliative care units: a multicentre observational study. BMC Palliat Care 22,6 (2023).
Date of first publication of study results:
2020-08-31
DRKS entry published for the first time with results:
2022-03-04

Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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