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CompletedNCT03498677Updated Mar 22, 2021

Protocol Lab for Online Trial Delphi and Question Effects

An interventional study of presentation order and alternative presentation order in Behavior, Adaptive and Decision Analysis, sponsored by ThinkWell. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by ThinkWell · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
385
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Behavior, Adaptive
  • Decision Analysis

Keywords

  • online trial
  • decision analysis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Protocol lab for online trials Delphi (PLOT-D) participants

Exclusion criteria

Exclusion Criteria:

  • None if inclusion criteria are met
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
385 participants (actual)

Study arms

  • Active comparator
    Method of presentation one

    Behavioral: presentation order

  • Active comparator
    Method of presentation two

    Behavioral: alternative presentation order

Interventions

  • Behavioralpresentation order

    section presentation one

  • Behavioralalternative presentation order

    section presentation two

05

What researchers measure

Primary outcomes

  1. Context effects of question order

    measure to what extent question section order changes context response between conditions

    Time frame: Up to 20 weeks or study completion

Secondary outcomes

  1. Question section presentation order

    response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions

    Time frame: Up to 20 weeks or study completion

  2. Retention

    difference in number of items retained at the end of the first Delphi round by randomized assignment to condition

    Time frame: Up to 20 weeks or study completion

06

Study locations

1 site
  • ThinkWell
    Oxford, Oxfordshire OX4 4DN, United Kingdom
07

References and documents

Publications

  • Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6. PubMed 29370827 ↗
  • Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM. Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463. doi: 10.1186/s13063-016-1591-y. PubMed 27664072 ↗
  • Snow R, Crocker JC, Crowe S. Missed opportunities for impact in patient and carer involvement: a mixed methods case study of research priority setting. Res Involv Engagem. 2015 Aug 4;1:7. doi: 10.1186/s40900-015-0007-6. eCollection 2015. PubMed 29062496 ↗
  • Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393. PubMed 21283604 ↗
  • Fletcher AJ, Marchildon GP. Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18
  • Brice A, Price A, Burls A. Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec. PubMed 29942546 ↗
  • Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress. Res Involv Engagem. 2016 Apr 27;2:15. doi: 10.1186/s40900-016-0029-8. eCollection 2016. PubMed 29062516 ↗
  • Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018 Feb;24(1):240-253. doi: 10.1111/jep.12805. Epub 2017 Oct 27. PubMed 29076631 ↗
  • Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991

Individual participant data

Plan to share: Yes — Aggregated de-identified data will be available on reasonable request

Supporting information: Study protocol, Icf

08

Registry details

Key details

Study ID
NCT03498677
Lead sponsor
ThinkWell
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
May 29, 2018
Primary completion
Apr 30, 2019
Completion
Oct 30, 2019
Last update
Mar 22, 2021

Study contacts

Amy Price, PhD
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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