Protocol Lab for Online Trials-Delphi

Decisional Variability by Presentation Methods for Consensus Clinical Trial

— PLOT-D  

Official title:

Protocol Lab for Online Trials-Delphi (PLOT-D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498690
• Other study ID #: PLOT-D Ranking
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2021
• Source: ThinkWell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Protocol Lab for Online Trials-Delphi (PLOT-D) module will use an online three-round Delphi combined with Participatory action research to inform the development of a multi-use protocol template to use in writing protocols for self-recruited online trials of interventional self-management. The Delphi will include an embedded randomized controlled trial to test how and if stakeholders adapt their views based on the contributions of others inside or outside the groups with which they are familiar.

Description:

The research aims to provide support for citizens to work alongside researchers to build participatory health trials online (any randomized trial that uses the internet for a health or wellness intervention). Tools to develop methods to run quality online trials protocols are needed. Also, help for adapting guidance to include the public and patients as partners in research for online trials is limited. The purpose of this work is to facilitate improved practice within protocol writing for participatory online trials.

Public and patient involvement (PPI), is one method used to conduct participatory research. PPI actively engages communities or individuals and moves beyond educating, engaging or doing interviews with research participants and does the research with them as partners. There is growing consensus that PPI is of value to researchers, industry, regulators, and members of the public.

There is an active discussion that is without substantial evidence for when the optimal time in the research process is to start PPI and whether patients and the public should join the research team, act as advisors, or have everyone contribute perspectives and work with their roles or peer groups.

The embedded study within the Delphi explores how working with stakeholder feedback in different ways may influence decision ranking as well choice similarities and differences

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 30, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None if inclusion criteria are met

Related Conditions & MeSH terms

• Decisional Variability by Presentation Methods for Consensus

Intervention

Behavioral:
• Integrative
Stakeholder groups: a-b
• Role specific
Stakeholder groups: a or b
• Consecutive
Stakeholder groups: a=> b

Locations

Country	Name	City	State
United Kingdom	ThinkWell	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
ThinkWell

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The top five disparities and similarities in ranking between interventions	Prioritization of method preferences as decided by participants	Up to 20 weeks or study completion
Secondary	Differences and similarities between stakeholder groups	Ranking differences between stakeholders randomized to different forms of information presentation	Up to 20 weeks or study completion