Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol

Introduction International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme ‘isPO’ is aiming to ensure a provision of care in inpatient and outpatient settings accord...

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Main Authors: Christina Samel, Holger Pfaff, Stephanie Stock, Nadine Scholten, Martin Hellmich, Imke Jenniches, Clarissa Lemmen, Jan Christopher Cwik, Michael Kusch, Hildegard Labouvie, Alexander Gerlach, Anna Hagemeier, Peter Haas, Michael Hallek, Antje Dresen
Format: Article
Language:English
Published: BMJ Publishing Group 2020-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/3/e034141.full
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author Christina Samel
Holger Pfaff
Stephanie Stock
Nadine Scholten
Martin Hellmich
Imke Jenniches
Clarissa Lemmen
Jan Christopher Cwik
Michael Kusch
Hildegard Labouvie
Alexander Gerlach
Anna Hagemeier
Peter Haas
Michael Hallek
Antje Dresen
author_facet Christina Samel
Holger Pfaff
Stephanie Stock
Nadine Scholten
Martin Hellmich
Imke Jenniches
Clarissa Lemmen
Jan Christopher Cwik
Michael Kusch
Hildegard Labouvie
Alexander Gerlach
Anna Hagemeier
Peter Haas
Michael Hallek
Antje Dresen
author_sort Christina Samel
collection DOAJ
description Introduction International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme ‘isPO’ is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost–consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare.Methods and analysis The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study.Ethics and dissemination The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations.Trial registration number DRKS00015326; Pre-results.
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spelling doaj-art-20fef446e1684f66a7bdfe0e00d474dd2024-12-06T19:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-034141Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocolChristina Samel0Holger Pfaff1Stephanie Stock2Nadine Scholten3Martin Hellmich4Imke Jenniches5Clarissa Lemmen6Jan Christopher Cwik7Michael Kusch8Hildegard Labouvie9Alexander Gerlach10Anna Hagemeier11Peter Haas12Michael Hallek13Antje Dresen14Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, GermanyUniversity of Cologne, Faculty of Human Sciences, Institute of Medical Sociology, Health Services Research and Rehabilitation Science, Chair of Quality Development and Evaluation in Rehabilitation, Cologne, GermanyInstitute for Health Economics and Clinical Epidemiology, University of Cologne, Cologne, GermanyUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Medical Sociology, Health Services Research and Rehabilitation Science, Chair of Health Services Research, Cologne, GermanyInstitute of Medical Statistics and Computational Biology, University of Cologne, Cologne, GermanyIMVR - Institute of Medical Sociology, Health Services Research and Rehabilitation Science (IMVR), University of Cologne, Cologne, GermanyInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne, Cologne, GermanyClinical Psychology and Psychotherapy, Universität zu Köln, Köln, GermanyDepartment of Internal Medicine, University Hospital Cologne, Cologne, GermanyDepartment of Internal Medicine, University Hospital Cologne, Cologne, GermanyDepartment of Psychology, University of Cologne, Cologne, GermanyInstitute of Medical Statistics and Computational Biology, University of Cologne, Cologne, GermanyBIKER-Registry, Sankt Augustin, GermanyCentre for Integrated Oncology Aachen-Bonn-Cologne-Duesseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, GermanyIMVR - Institute of Medical Sociology, Health Services Research and Rehabilitation Science (IMVR), University of Cologne, Cologne, GermanyIntroduction International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme ‘isPO’ is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost–consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare.Methods and analysis The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study.Ethics and dissemination The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations.Trial registration number DRKS00015326; Pre-results.https://bmjopen.bmj.com/content/10/3/e034141.full
spellingShingle Christina Samel
Holger Pfaff
Stephanie Stock
Nadine Scholten
Martin Hellmich
Imke Jenniches
Clarissa Lemmen
Jan Christopher Cwik
Michael Kusch
Hildegard Labouvie
Alexander Gerlach
Anna Hagemeier
Peter Haas
Michael Hallek
Antje Dresen
Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
BMJ Open
title Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
title_full Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
title_fullStr Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
title_full_unstemmed Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
title_short Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol
title_sort evaluation of a complex integrated cross sectoral psycho oncological care program ispo a mixed methods study protocol
url https://bmjopen.bmj.com/content/10/3/e034141.full
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