Behavioral ChangesDelphi-MCDANCT03498365
Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi
A study testing MCDA and Delphi in people with Behavioral Changes, run by ThinkWell at 1 site in United Kingdom.
Trial summary
To examine the effects of using decision support tools during the online Delphi process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavioral Changes
- What is being tested?
- MCDA and Delphi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2019to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Protocol lab online trialsl Delphi (PLOT-D) Participant
Who cannot join
- None if meets inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Behavioral Changes
- Being tested
- MCDA, Delphi
- Keywords
- decision analysis, decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCDABehavioural
Experimental decision support
DelphiBehavioural
Standard support
| Study group | Role | What they receive |
|---|---|---|
| Online MCDA | Experimental | Not described Receives: Behavioral: MCDA |
| Online Delphi | Active comparator | Not described Receives: Behavioral: Delphi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 weeks or study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start15 Mar 2019
- Primary completion30 May 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Behavioral ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Amy Price, ThinkWell
- Investigators
- Amy I Price, PhD, Principal investigator, University of OxfordMike J Clarke, DPhil, Principal investigator, Queen's University, BelfastMette Kjer Kaltoft, PhD, Study director, Syddansk UniversitetJack Dowie, PhD, Study director, The London School of Hygiene & Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498365
- Sponsor's protocol ID
- PLOT-D MCDA
- Acronym
- Delphi-MCDA
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data is not available due to data protection rules. De-identified aggregated data may be available by contacting the Principal Investigator
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 29076631Brice 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 29942546Dowie 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 23910715Kaltoft 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi
- ClinicalTrials.gov ID
- NCT03498365
- Acronym / sponsor ID
- Delphi-MCDA / PLOT-D MCDA
- Conditions
- Behavioral Changes
- Keywords
- decision analysis, decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online MCDA | Experimental | Behavioral: MCDA |
| Online Delphi | Active comparator | Behavioral: Delphi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Protocol lab online trialsl Delphi (PLOT-D) Participant
Key exclusion criteria (1 listed)
- None if meets inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCDAExperimental decision support | Behavioural | Online MCDA |
| DelphiStandard support | Behavioural | Online Delphi |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 29076631Price 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.
- Background: PubMed 29942546Brice 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.
- Background: PubMed 23910715Dowie 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.
- BackgroundKaltoft 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: PubMed 24335587Kaltoft 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.
- Individual participant dataSharing planned: Yes. Individual participant data is not available due to data protection rules. De-identified aggregated data may be available by contacting the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCDA and Delphi in people with Behavioral Changes, run by ThinkWell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
My Decision Quality (MDQ) (time frame: Up to 20 weeks or study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.