ClinicalTrials.gg
CompletedNCT03498365Delphi-MCDAUpdated Mar 22, 2021

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

An interventional study of MCDA and Delphi in Behavioral Changes, 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

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

Read the 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.

02

Conditions studied

  • Behavioral Changes

Keywords

  • decision analysis
  • decision support
03

In context

Lead sponsor

ThinkWell is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Protocol lab online trialsl Delphi (PLOT-D) Participant

Exclusion criteria

Exclusion Criteria:

  • None if meets inclusion criteria
05

Study design

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

Study arms

  • Experimental
    Online MCDA

    Behavioral: MCDA

  • Active comparator
    Online Delphi

    Behavioral: Delphi

Interventions

  • BehavioralMCDA

    Experimental decision support

  • BehavioralDelphi

    Standard support

06

What researchers measure

Primary outcomes

  1. My Decision Quality (MDQ)

    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.

    Time frame: Up to 20 weeks or study completion

Other outcomes

  1. Time to consensus

    Aggregated group time to reach consensus

    Time frame: Up to 20 weeks or study completion

07

Study locations

1 site
  • University of Oxford
    Oxford, United Kingdom
08

References and documents

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. PubMed 29076631 ↗
  • 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 ↗
  • Dowie J, Kjer Kaltoft M, Salkeld G, Cunich M. Towards generic online multicriteria decision support in patient-centred health care. Health Expect. 2015 Oct;18(5):689-702. doi: 10.1111/hex.12111. Epub 2013 Aug 2. PubMed 23910715 ↗
  • Kaltoft MK, Dowie J, Turner R, et al. Decisional equipoise is not decisional conflict: avoiding the false clarity bias in the evaluation of decision aids and Shared Decision Making processes. F1000Research 2015;4. doi:10.7490/F1000RESEARCH.1110671.1
  • Kaltoft M, Cunich M, Salkeld G, Dowie J. Assessing decision quality in patient-centred care requires a preference-sensitive measure. J Health Serv Res Policy. 2014 Apr;19(2):110-7. doi: 10.1177/1355819613511076. Epub 2013 Dec 12. PubMed 24335587 ↗

Individual participant data

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

Supporting information: Study protocol, Informed consent form

Time frame: following publication

Access criteria: contact PI

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in May 2019, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2018
First posted
Apr 13, 2018
StartActual
Mar 15, 2019
Primary completionActual
May 30, 2019
CompletionActual
Oct 31, 2019
Last update
Mar 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03498365
Lead sponsor
ThinkWell
Responsible party
Amy Price (Principal Investigator, ThinkWell) — Principal investigator
First posted
Apr 13, 2018
Start date
Mar 15, 2019
Primary completion
May 30, 2019
Completion
Oct 31, 2019
Last update
Mar 22, 2021

Study contacts

Amy I Price, PhD
principal investigator · University of Oxford
Mike J Clarke, DPhil
principal investigator · Queen's University, Belfast
Mette Kjer Kaltoft, PhD
study director · Syddansk Universitet
Jack Dowie, PhD
study director · The London School of Hygiene & Tropical Medicine

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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