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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03498365
Other study ID # PLOT-D MCDA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2019
Est. completion date October 31, 2019

Study information

Verified date March 2021
Source ThinkWell
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 385
Est. completion date October 31, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Protocol lab online trialsl Delphi (PLOT-D) Participant Exclusion Criteria: - None if meets inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MCDA
Experimental decision support
Delphi
Standard support

Locations

Country Name City State
United Kingdom University of Oxford Oxford

Sponsors (2)

Lead Sponsor Collaborator
ThinkWell London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Time to consensus Aggregated group time to reach consensus Up to 20 weeks or study completion
Primary 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. Up to 20 weeks or study completion
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