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Nationwide Implementation of Standardized Structured Reporting (IMPROVING)

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ClinicalTrials.gov Identifier: NCT03649126
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Dutch Cancer Society
PALGA foundation
Information provided by (Responsible Party):
Rosella Hermens, Radboud University

Brief Summary:
The first objective is to explore factors that impede or facilitate implementation of SSR in pathology (and other disciplines) among the MDT members receiving SSRs. The second objective is to select, develop and evaluate (process and effect outcomes) implementation tools supporting optimal implementation of SSR in pathology. The third objective is to offer implementation tools to all pathology laboratories in the Netherlands and to share the SSR-kit for successful implementation with other medical disciplines

Condition or disease Intervention/treatment
Standardized Structured Reporting Behavioral: Implementation tools

Detailed Description:
By implementing SSR in various disciplines, we contribute to improving communication, efficiency and quality of multidisciplinary team (MDT) meetings and facilitate optimal treatment decision making. Optimal discussion of each patient at MDT meetings can be achieved by a clear communication of all diagnostic results among MDT members. However, the adoption of innovations, such as SSR, is laborious, especially when the innovation requires changing daily habits. Offering implementation tools supports the adoption of innovations among medical professionals. Implementation tools are most effective when they are developed on the basis of factors that impede or facilitate the innovation. Besides the importance of investigating these factors for SSR among pathologists, we will also involve MDT members receiving pathology SSRs in our study. After all, because MDT members will greatly benefit from SSR, they could play a key role in stimulating the use of SSR among pathologists. Therefore, we will also explore which tools MDT members need to stimulate the diagnostic disciplines in using SSR. Subsequently, we will develop and evaluate implementation tools to support the use of SSR by pathologists. The kit for successful implementation of SSR will be offered to other medical disciplines like radiology, endoscopy, and surgery who face similar challenges with implementation of SSR. The SSR-kit consists of our multidisciplinary approach for the whole process of developing implementation tools for SSR, examples of tools for SSR, and other results of this project.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Nationwide Implementation of Standardized Structured Reporting to Support Optimal Treatment Decisions
Estimated Study Start Date : August 21, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Dutch pathologists hospital I

Pathologists in hospital I using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology

Dutch pathologists hospital II

Pathologists in hospital II using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology

Dutch pathologists hospital III

Pathologists in hospital III using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology

Dutch pathologists hospital IV

Pathologists in hospital IV using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology

Dutch pathologists hospital V

Pathologists in hospital V using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology

Dutch pathologists hospital VI

Pathologists in hospital VI using protocols of:

Urological cancer Gynaecological cancer Gastro intestinal cancer

Behavioral: Implementation tools
Implementation tools developed by experts in order to increase the use of SSR in pathology




Primary Outcome Measures :
  1. Barriers and facilitators in implementation of SSR in MDT - focus groups and self-developed questionnaire [ Time Frame: 9 months ]
    Barriers and facilitators in implementation of SSR among MDT members measured by focus groups and a self-developed questionnaire

  2. Effectiveness of implementation tools - frequencies of use of SSR templates in pathology in the Netherlands [ Time Frame: 6 months ]
    The improvement in use of SSR templates in the Netherlands (=effectiveness of implementation tools) measured by frequencies of use of SSR templates in pathology (=all laboratories in the Netherlands)


Secondary Outcome Measures :
  1. Determinants of barriers and facilitators in implementation of SSR - focus groups and a self-developed questionnaire [ Time Frame: 1 month ]
    Determinants of barriers and facilitators in implementation of SSR among MDT members measured by focus groups and a self-developed questionnaire

  2. Experiences with implementation tools - questionnaire [ Time Frame: 6 months ]
    Experiences of pathologists and other MDT members with the implementation tools, measured by a questionnaire

  3. Use of implementation tools - questionnaire [ Time Frame: 6 months ]
    Use of implementation tools among pathologists and other MDT members, measured by a questionnaire



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dutch pathologists, MDT-members and residents, using SSR of urological, gynecological or gastro-intestinal cancers.
Criteria

Inclusion Criteria:

  • Pathologists of urological, gynecological or gastro-intestinal cancers
  • Other MDT-members of urological, gynecological or gastro-intestinal cancers (medical oncologists, radiologists, radiotherapists, urologists, gynecologists, intestinal surgeons, nuclear medicine physicians, nurse practitioners).
  • Dutch
  • Residents

Exclusion Criteria:

  • Retirees

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649126


Contacts
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Contact: Julie Swillens, MSc +31-615343689 Julie.Swillens@radboudumc.nl
Contact: Rosella Hermens, PhD + 31 24 36 15305 Rosella.Hermens@radboudumc.nl

Locations
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Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Julie Swillens, MSc         
Principal Investigator: Rosella Hermens, dr.         
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
PALGA foundation

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Responsible Party: Rosella Hermens, dr., Radboud University
ClinicalTrials.gov Identifier: NCT03649126    
Other Study ID Numbers: KWF-8281
2018-4124 ( Other Identifier: CMO - Radboudumc )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosella Hermens, Radboud University:
standardized structured reporting
treatment decisions
multidisciplinary team
pathology
implementation tools