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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498365
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Amy Price, ThinkWell

Brief Summary:
To examine the effects of using decision support tools during the online Delphi process.

Condition or disease Intervention/treatment Phase
Behavioral Changes Behavioral: MCDA Behavioral: Delphi Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Online MCDA Behavioral: MCDA
Experimental decision support

Active Comparator: Online Delphi Behavioral: Delphi
Standard support




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Time to consensus [ Time Frame: Up to 20 weeks or study completion ]
    Aggregated group time to reach consensus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Protocol lab online trialsl Delphi (PLOT-D) Participant

Exclusion Criteria:

  • None if meets inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498365


Locations
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United Kingdom
University of Oxford
Oxford, United Kingdom
Sponsors and Collaborators
ThinkWell
London School of Hygiene and Tropical Medicine
Investigators
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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:
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Responsible Party: Amy Price, Principal Investigator, ThinkWell
ClinicalTrials.gov Identifier: NCT03498365    
Other Study ID Numbers: PLOT-D MCDA
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: following publication
Access Criteria: contact PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Price, ThinkWell:
decision analysis
decision support
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms