Nationwide Implementation of Standardized Structured Reporting (IMPROVING)

Nationwide Implementation of Standardized Structured Reporting to Support Optimal Treatment Decisions

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

Study Overview

• Status: Unknown
• Conditions: Standardized Structured Reporting
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Julie Swillens, MSc; Phone Number: +31-615343689; Email: Julie.Swillens@radboudumc.nl
• Study Contact Backup: Name: Rosella Hermens, PhD; Phone Number: + 31 24 36 15305; Email: Rosella.Hermens@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Nijmegen Medical Center
      • Contact: Julie Swillens, MSc
      • Principal Investigator: Rosella Hermens, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dutch pathologists, MDT-members and residents, using SSR of urological, gynecological or gastro-intestinal cancers.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers and facilitators in implementation of SSR in MDT - focus groups and self-developed questionnaire	Barriers and facilitators in implementation of SSR among MDT members measured by focus groups and a self-developed questionnaire	9 months
Effectiveness of implementation tools - frequencies of use of SSR templates in pathology in the Netherlands	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determinants of barriers and facilitators in implementation of SSR - focus groups and a self-developed questionnaire	Determinants of barriers and facilitators in implementation of SSR among MDT members measured by focus groups and a self-developed questionnaire	1 month
Experiences with implementation tools - questionnaire	Experiences of pathologists and other MDT members with the implementation tools, measured by a questionnaire	6 months
Use of implementation tools - questionnaire	Use of implementation tools among pathologists and other MDT members, measured by a questionnaire	6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Dutch Cancer Society; PALGA foundation

Study record dates

Study Major Dates

• Study Start (Anticipated): August 21, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: standardized structured reporting; treatment decisions; multidisciplinary team; pathology; implementation tools
• Other Study ID Numbers: KWF-8281; 2018-4124 (Other Identifier: CMO - Radboudumc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No