Clinical trial NCT03498365: Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi
Official title: Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Changes
Keywords: decision analysis
decision support
Lead sponsor: ThinkWell
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2018-04-13
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility criteria: Inclusion Criteria:

Protocol lab online trialsl Delphi (PLOT-D) Participant

Exclusion Criteria:

* None if meets inclusion criteria

Primary outcomes:
measure: My Decision Quality (MDQ)
timeFrame: Up to 20 weeks or study completion
Secondary outcomes:
Other outcomes:
measure: Time to consensus
timeFrame: Up to 20 weeks or study completion
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Amy I Price, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, Belfast
name: Mike J Clarke, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Syddansk Universitet
name: Mette Kjer Kaltoft, PhD
role: STUDY_DIRECTOR
affiliation: The London School of Hygiene & Tropical Medicine
name: Jack Dowie, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.
citation: 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
citation: 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.