NCT04471103

Brief Summary

A two-group parallel randomised trial of Delphi survey methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

July 2, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

DelphiReal-Time DelphiMulti-Round DelphiRandomised TrialTwo-Group ParallelSurvey

Outcome Measures

Primary Outcomes (1)

  • Comparison of outcomes prioritised within each survey arm

    Comparison of outcomes prioritised by respondents at the end of (i) the Real-time and (ii) multi-round Delphi processes. An outcome is judged 'prioritised' based on the proportion of respondents rating the outcome a 7-9 (inclusive) on a 9-point Likert scale (higher scores = higher importance for inclusion in the COS)

    End of both surveys (i.e. when the Multi-Round Delphi round 3 has finished and when the Real-Time Delphi has finished at the end of week 5).

Secondary Outcomes (4)

  • Feedback Effect

    Through study completion, an average of 14 weeks.

  • Initial Condition Effect

    During the Real-Time Delphi intervention (5 weeks).

  • Iteration Effect

    Through study completion, an average of 14 weeks.

  • Comparison of outcomes prioritised within each survey arm with the final Core Outcome Set

    Through study completion, an average of 1 year.

Other Outcomes (3)

  • Attrition rates

    Attrition rates will be recorded at the end of round 1 (week 3) and round 2 (week 9) in the Multi-Round Delphi and at weeks 2 and 4 in the Real-Time Delphi arm.

  • Frequency of re-visiting the Real-Time Delphi arm

    This will be measured when a participant visits the Real-Time Delphi survey and rates the outcomes fully for a second time (between the start of week 1 and the end of week 5).

  • Usefulness, Satisfaction and Ease of Use of each survey arm

    End of both surveys (i.e. when the Multi-Round Delphi round 3 (week 14) has finished and when the Real-Time Delphi has finished at the end of week 5)

Study Arms (2)

Real-Time Delphi Method

EXPERIMENTAL

The Real-Time Delphi Method involves a single-round Delphi survey rating the importance of outcomes for neonatal encephalopathy. Feedback on each outcome (participant's own rating score, rating of the outcome by stakeholder group and overall consensus results for that outcome) will be provided to the participant once they have rated an outcome. They can then modify how they rated the outcome based on this feedback if they wish. Participants can also re-visit and re-rate outcomes as many times as they wish when the survey is live. Duration will span approximately 5 weeks.

Other: Participation in a Delphi survey

Multi-round Delphi Method

ACTIVE COMPARATOR

The Multi-Round Delphi Method involves a three-round Delphi survey rating the importance of outcomes for neonatal encephalopathy. Feedback on each outcome (participant's own rating score, rating of the outcome by stakeholder group and overall consensus results for that outcome) will be provided to the participant at the end of Round 1 and the end of Round 2. Participants can then modify how they rated the outcome based on feedback, in Rounds 2 and 3, if they wish. Each survey Round will run for 3 weeks approximately. In between survey Rounds, there will be a downtime of approximately 10 days before providing feedback and a further 7 days before starting the next round. Duration will span approximately 14 weeks.

Other: Participation in a Delphi survey

Interventions

Participants will be asked to participate in an online Delphi survey (using one of two randomly allocated methods) to rate the importance of outcomes that should be measured to determine the effect of treatment for neonatal encephalopathy. Outcomes will be prioritised on their importance in a consensus-driven manner.

Multi-round Delphi MethodReal-Time Delphi Method

Eligibility Criteria

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

You may qualify if:

  • parents or caregivers of infants that have been diagnosed with and received treatment for neonatal encephalopathy
  • healthcare providers including:
  • neonatal nurse practitioners
  • midwives
  • obstetricians
  • neonatologists/paediatricians
  • neonatal/paediatric neurologists
  • general practitioners who provide long-term care for children with neonatal encephalopathy
  • policymakers
  • researchers/ academics with expertise in neonatal encephalopathy treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HRB-TMRN

Galway, H91 W6P8, Ireland

RECRUITING

Related Publications (2)

  • Quirke FA, Battin MR, Bernard C, Biesty L, Bloomfield FH, Daly M, Finucane E, Haas DM, Healy P, Hurley T, Koskei S, Meher S, Molloy EJ, Niaz M, Bhraonain EN, Okaronon CO, Tabassum F, Walker K, Webbe JRH, Parkes MJ, Kirkham JJ, Devane D. Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial. Trials. 2023 Jul 19;24(1):461. doi: 10.1186/s13063-023-07388-9.

  • Quirke FA, Healy P, Bhraonain EN, Daly M, Biesty L, Hurley T, Walker K, Meher S, Haas DM, Bloomfield FH, Kirkham JJ, Molloy EJ, Devane D. Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial. Trials. 2021 Feb 15;22(1):142. doi: 10.1186/s13063-021-05074-2.

Study Officials

  • Declan Devane, PhD

    Health Research Board - Trials Methodology Research Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A two-group parallel randomised trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 15, 2020

Study Start

August 13, 2021

Primary Completion

February 7, 2022

Study Completion

February 7, 2022

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations