Nationwide Implementation of Standardized Structured Reporting (IMPROVING)

August 27, 2018 updated by: Rosella Hermens, Radboud University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboud University Nijmegen Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
9 months
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)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 month
Experiences with implementation tools - questionnaire
Time Frame: 6 months
Experiences of pathologists and other MDT members with the implementation tools, measured by a questionnaire
6 months
Use of implementation tools - questionnaire
Time Frame: 6 months
Use of implementation tools among pathologists and other MDT members, measured by a questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dutch Cancer Society
PALGA foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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