Standardized Structured ReportingIMPROVINGNCT03649126
Nationwide Implementation of Standardized Structured Reporting
An observational study of Standardized Structured Reporting, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Standardized Structured Reporting
- What is being tested?
- Implementation tools
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Aug 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dutch pathologists, MDT-members and residents, using SSR of urological, gynecological or gastro-intestinal cancers.
Who may be able to join
- 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
Who cannot join
- Retirees
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525GA
Julie Swillens, MSc
Rosella Hermens, dr.
About this study
Official title: 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
Read the 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.
- Conditions
- Standardized Structured Reporting
- Being tested
- Implementation tools
- Keywords
- standardized structured reporting, treatment decisions, multidisciplinary team, pathology, implementation tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation toolsBehavioural
Implementation tools developed by experts in order to increase the use of SSR in pathology
| Study group | Role | What they receive |
|---|---|---|
| Dutch pathologists hospital I | Pathologists in hospital I using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools | |
| Dutch pathologists hospital II | Pathologists in hospital II using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools | |
| Dutch pathologists hospital III | Pathologists in hospital III using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools | |
| Dutch pathologists hospital IV | Pathologists in hospital IV using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools | |
| Dutch pathologists hospital V | Pathologists in hospital V using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools | |
| Dutch pathologists hospital VI | Pathologists in hospital VI using protocols of:
Urological cancer Gynaecological cancer Gastro intestinal cancer Receives: Behavioral: Implementation tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 6 months
Secondary outcomes (3)
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
Measured: 1 month
Experiences with implementation tools - questionnaire
Experiences of pathologists and other MDT members with the implementation tools, measured by a questionnaire
Measured: 6 months
Use of implementation tools - questionnaire
Use of implementation tools among pathologists and other MDT members, measured by a questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start21 Aug 2018 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standardized Structured ReportingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, PALGA foundation
- Responsible party
- Principal investigator, Rosella Hermens, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649126
- Sponsor's protocol ID
- KWF-8281
- Other IDs
- 2018-4124
- Acronym
- IMPROVING
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Implementation of Standardized Structured Reporting to Support Optimal Treatment Decisions
- ClinicalTrials.gov ID
- NCT03649126
- Acronym / sponsor ID
- IMPROVING / KWF-8281
- Conditions
- Standardized Structured Reporting
- Keywords
- standardized structured reporting, treatment decisions, multidisciplinary team, pathology, implementation tools
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, PALGA foundation
- Study start
- 21 Aug 2018 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dutch pathologists hospital I | – | Behavioral: Implementation toolsPathologists in hospital I using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
| Dutch pathologists hospital II | – | Behavioral: Implementation toolsPathologists in hospital II using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
| Dutch pathologists hospital III | – | Behavioral: Implementation toolsPathologists in hospital III using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
| Dutch pathologists hospital IV | – | Behavioral: Implementation toolsPathologists in hospital IV using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
| Dutch pathologists hospital V | – | Behavioral: Implementation toolsPathologists in hospital V using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
| Dutch pathologists hospital VI | – | Behavioral: Implementation toolsPathologists in hospital VI using protocols of: Urological cancer Gynaecological cancer Gastro intestinal cancer |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dutch pathologists, MDT-members and residents, using SSR of urological, gynecological or gastro-intestinal cancers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Retirees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation toolsImplementation tools developed by experts in order to increase the use of SSR in pathology | Behavioural | Dutch pathologists hospital I, Dutch pathologists hospital II, Dutch pathologists hospital III, Dutch pathologists hospital IV, Dutch pathologists hospital V, Dutch pathologists hospital VI |
Primary outcome
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
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)
3 secondary outcomes
Determinants of barriers and facilitators in implementation of SSR - focus groups and a self-developed questionnaire
Time frame: 1 month
Experiences with implementation tools - questionnaire
Time frame: 6 months
Use of implementation tools - questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Standardized Structured Reporting, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Swillens, MSc (+31-615343689, Julie.Swillens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators in implementation of SSR in MDT - focus groups and self-developed questionnaire (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.