Protocol Lab for Online Trial Delphi and Question Effects

Study Overview
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Brief Summary
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This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.

Detailed Description
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A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented. The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.

Official Title
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Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study

Conditions
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Behavior, Adaptive, Decision Analysis

Intervention / Treatment
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* Behavioral: presentation order
* Behavioral: alternative presentation order


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Protocol lab for online trials Delphi (PLOT-D) participants Exclusion Criteria: None if inclusion criteria are met

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Method of presentation one<br> | Behavioral: presentation order<br>* section presentation one<br>|
| Active Comparator: Method of presentation two<br> | Behavioral: alternative presentation order<br>* section presentation two<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Context effects of question order | measure to what extent question section order changes context response between conditions | Up to 20 weeks or study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Question section presentation order | response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions | Up to 20 weeks or study completion | 
| Retention | difference in number of items retained at the end of the first Delphi round by randomized assignment to condition | Up to 20 weeks or study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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online trial, decision analysis