Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi (Delphi-MCDA)

March 18, 2021 updated by: Amy Price, ThinkWell
To examine the effects of using decision support tools during the online Delphi process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this exploratory work is to develop improved methods for building a protocol for a participatory randomized controlled trial. An online Delphi will be combined with an embedded trial testing the effectiveness of a decision support tool. This method provides for consensus building and collaborative problem-solving which is informed, and participatory. The online Delphi offers involvement and confidentiality thus sidestepping the complications of power imbalances and undue influence as respondents contribute anonymously.

The embedded trial was considered after the building of a database of existing online trials and conducting a descriptive analysis" Creating a database of Internet-based clinical trials to support a public-led research programme: A descriptive analysis, followed by the completion of a systematic overview of systematic overviews, "Patient and Public Involvement in Clinical Trials Design: An Overview of Systematic Reviews" and followed this with an analysis of "Self-Management Open Online Trials in Health"(In review). The results included a lack of standardization, insufficient guidance for implementation and significant research reporting weaknesses. Decision-making support tools may improve decision quality.

This embedded trial will be implemented in an online Delphi to come to the consensus about what declarations and methods to include when building a participatory online trials protocol.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 online trialsl Delphi (PLOT-D) Participant

Exclusion Criteria:

  • None if meets inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Online MCDA
Behavioral: MCDA
Experimental decision support
ACTIVE_COMPARATOR: Online Delphi
Behavioral: Delphi
Standard support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
My Decision Quality (MDQ)
Time Frame: Up to 20 weeks or study completion
MDQ is a patient reported outcome measure that combines a set of importance weights for multiple criteria (options, effect, importance, chance, trust, support ,control and commitment) with performance ratings for each option on these criteria and calculates the overall score as the expected value of these components.
Up to 20 weeks or study completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to consensus
Time Frame: Up to 20 weeks or study completion
Aggregated group time to reach consensus
Up to 20 weeks or study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThinkWell

Collaborators

London School of Hygiene and Tropical Medicine

Investigators

  • Principal Investigator: Amy I Price, PhD, University of Oxford
  • Principal Investigator: Mike J Clarke, DPhil, Queen's University, Belfast
  • Study Director: Mette Kjer Kaltoft, PhD, Syddansk Universitet
  • Study Director: Jack Dowie, PhD, The London School of Hygiene & Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2019

Primary Completion (ACTUAL)

May 30, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

April 1, 2018

First Submitted That Met QC Criteria

April 7, 2018

First Posted (ACTUAL)

April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLOT-D MCDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data is not available due to data protection rules. De-identified aggregated data may be available by contacting the Principal Investigator

IPD Sharing Time Frame

following publication

IPD Sharing Access Criteria

contact PI

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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