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Nudging in clinical trial registration

Last registered on June 06, 2023
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Pre-Trial

Trial Information

General Information

Title
Nudging in clinical trial registration
RCT ID
AEARCTR-0011161
Initial registration date
May 25, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 06, 2023, 9:15 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Germany
Region

Primary Investigator

Name
Lisa Bieselt
Affiliation
BfArM Federal Institute for Drugs and Medical Device
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2023-06-05
End date
2023-08-17
Keywords
Governance, Health
Additional Keywords
JEL code(s)
C 93, D91
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The aim of this field experiment is to test whether study registrants in the German Clinical Trials Register can be nudged to complete their registration.
The greatest effort for the study registrant, but also for the registry staff, arises during the initial application for registration. Afterwards, usually only a few queries have to be processed in order to complete the registration in the registry.
In this experiment, these entries are identified and randomised into 3 groups. 2 groups receive emails with a selected nudges. 1 group serves as a control.
The primary objective is whether the study will be registered within 6 weeks of the nudge.
Secondary objectives are
- Feedback from the study managers
- Changes to the study entry
- Deletion of the study entry
External Link(s)

Registration Citation

Citation
Bieselt, Lisa. 2023. "Nudging in clinical trial registration." AEA RCT Registry. June 06. https://doi.org/10.1257/rct.11161-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
E-Mails with selected Nudges
Intervention Start Date
2023-06-05
Intervention End Date
2023-07-17

Primary Outcomes

Primary Outcomes (end points)
Number of study entries registered by end of intervention
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
- feedback from the study managers
- Changes to the study entry
- Deletion of the study entry
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Study entries will be randomly assigned to one of three groups. The study managers of the entries in the first 2 groups will receive an e-mail with a selected nudge. 1 group serves as a control.
Experimental Design Details
Randomization Method
Stratified randomization: Three groups are formed, depending on the last change (6 to 12 month, 12 to 18 month, more than 18 month ) to the entry. Within the groups block randomization done in office via excel
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
750
Sample size: planned number of observations
750
Sample size (or number of clusters) by treatment arms
250 Nudge A Mail
250 Nudge B Mail
250 Controlgroup (no Mail)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials