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

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

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.

Study Overview

• Status: Completed
• Conditions: Decisional Variability by Presentation Methods for Consensus
• Intervention / Treatment: Behavioral: Integrative; Behavioral: Role specific; Behavioral: Consecutive

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX4 4DN
      • ThinkWell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None if inclusion criteria are met

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Integrative	Behavioral: Integrative; Stakeholder groups: a-b
ACTIVE_COMPARATOR: Role Specific	Behavioral: Role specific; Stakeholder groups: a or b
ACTIVE_COMPARATOR: Consecutive	Behavioral: Consecutive; Stakeholder groups: a=> b

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences and similarities between stakeholder groups	Ranking differences between stakeholders randomized to different forms of information presentation	Up to 20 weeks or study completion

Collaborators and Investigators

• Sponsor: ThinkWell
• Investigators: Principal Investigator: Amy I Price, PhD, University of Oxford; Principal Investigator: Mike J Clarke, DPhil, Queen's University, Belfast

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2019
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): October 30, 2019

Study Registration Dates

• First Submitted: April 1, 2018
• First Submitted That Met QC Criteria: April 7, 2018
• First Posted (ACTUAL): April 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: decision analysis; online trial
• Other Study ID Numbers: PLOT-D Ranking

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregated de-identified data will be available on request to principal investigator Amy Price dr.amyprice@gmail.com
• IPD Sharing Time Frame: following publication and for 5 years
• IPD Sharing Access Criteria: email investigator dr.amyprice@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No