NCT03498365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

April 1, 2018

Last Update Submit

March 18, 2021

Conditions

Keywords

decision analysisdecision support

Outcome Measures

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.

    Up to 20 weeks or study completion

Other Outcomes (1)

  • Time to consensus

    Up to 20 weeks or study completion

Study Arms (2)

Online MCDA

EXPERIMENTAL
Behavioral: MCDA

Online Delphi

ACTIVE COMPARATOR
Behavioral: Delphi

Interventions

MCDABEHAVIORAL

Experimental decision support

Online MCDA
DelphiBEHAVIORAL

Standard support

Online Delphi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Protocol lab online trialsl Delphi (PLOT-D) Participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 29076631BACKGROUND
  • 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.

    PMID: 29942546BACKGROUND
  • 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.

    PMID: 23910715BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24335587BACKGROUND

Study Officials

  • Amy I Price, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Mike J Clarke, DPhil

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR
  • Mette Kjer Kaltoft, PhD

    Syddansk Universitet

    STUDY DIRECTOR
  • Jack Dowie, PhD

    The London School of Hygiene & Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 13, 2018

Study Start

March 15, 2019

Primary Completion

May 30, 2019

Study Completion

October 31, 2019

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
following publication
Access Criteria
contact PI

Locations