Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001210460
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
1/09/2016
Date last updated
1/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial comparing semi-structured interviews and online questionnaires administered to health professionals and consumers in identifying the barriers and enablers to implementation of an Antenatal Corticosteroid Clinical Practice Guideline.
Scientific title
A randomised trial comparing semi-structured interviews and online questionnaires administered to health professionals and consumers in identifying the barriers and enablers to implementation of an Antenatal Corticosteroid Clinical Practice Guideline.
Secondary ID [1] 290000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 300010 0
Appropriate administration of antenatal Corticosteroids 300078 0
Use of a new bi-national antenatal corticosteroid clinical practice guideline 300079 0
Condition category
Condition code
Reproductive Health and Childbirth 299905 299905 0 0
Antenatal care
Public Health 299964 299964 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Completion of a semi-structured interview (SSI):
A Face to face interview was conducted by a single researcher (EM) to maintain consistency. Interviews were conducted at a time and location convenient to the participant. The majority of interviews were conducted at the hospital site. No explicit time restraints were applied
Intervention code [1] 295706 0
Behaviour
Comparator / control treatment
Completion of an (online) questionnaire:
The questionnaire was developed on the web based Survey Monkey (Registered Trademark and was emailed to the participants preferred email to be completed at a time convenient to them. Reminder emails were sent out to non-responders two weeks after the initial questionnaire followed by a telephone reminder one week later if there had been no response. On rare occasions participants were provided with a paper copy of the questionnaire if they were unable to access the online version.
Control group
Active

Outcomes
Primary outcome [1] 299387 0
1. Composite-Overarching barriers and enablers identified by each of the two assessment methods.
Assessed by: Theoretical Domains Framework (TDF) was used to classify responses by all participants by two researchers. Specific statements were used to reflect the beliefs coded within each domain. It was then decided it these beliefs would represent a barrier or enabler to implementation.
Overarching barriers were defined by: the presence of conflicting beliefs within a domain that would signal variation in provider attitudes and beliefs, the frequency of specific beliefs across transcripts and the likely impact of the belief on the behaviour. Overarching enablers were identified by: the presence of beliefs within a domain that were likely to facilitate implementation of the antenatal corticosteroid clinical practice guideline, the frequency of those beliefs across transcripts and the likely impact of the belief on the behaviour.Differences in the barriers and enablers identified between the two assessment groups were compared.
Timepoint [1] 299387 0
Duration of trial: April-November 2014
Primary outcome [2] 299388 0
2. Composite outcome-Effectiveness of one assessment method compared to the other
(effectiveness defined as: time taken for participant to complete assessment method; response rate to the pre-specified questions; level of agreement; influence of the assessment method on any differences identified; and the level of response defined by a scale were 1=not applicable and 4 indicated a comprehensive answer)

Assessed by: Time taken was assessed using the online log for the online questionnaire group and the recorded time on the audiorecorder for SSI participants. A second coding framework was developed to reflect responses from SSI and Questionnaire participants. To assess validity a second reviewer independently reviewed 10% of coded transripts that were selected at random. Responses to individual questions were compared by study group only if the questions asked were the same. The level of agreement between the two assessment methods (SSI and Questionnaire) was assessed using Fisher’s exact test for each question. In questions where a statistical difference was demonstrated between the two assessment methods; proportions or relative risks were used to identify the differences between the two assessment methods and the direction of the effect.
A third coding framework was developed to assess the leve of detail of response. The coding framework categorised responses from one to four. Where one represented the participant indicating the question was not applicable to them and four representing a detailed response. The difference in the level of response between the two assessment methods (SSI and Questionnaires) was assessed using Fisher’s exact test for each question.
Timepoint [2] 299388 0
Duration of the trial: April to November 2014
Secondary outcome [1] 327020 0
1. Level of agreement between the two assessment methods within each individual theoretical domain.

Assessed: Questions used in both the SSI and questionnaires were grouped according to the individual behavioural domain that the question corresponded to within the Theoretical Domains Framework. Similarities in responses within the 14 behavioural domains were compared between the two assessment methods.
Timepoint [1] 327020 0
Duration of trial: April to November 2014
Secondary outcome [2] 327021 0
2. Issues identified by the different assessment methods within each domain

Assessed: Questions used in both the SSI and questionnaires were grouped according to the individual behavioural domain that the question corresponded to within the Theoretical Domains Framework. Differences in responses within the 14 behavioural domains were compared between the two assessment methods.
Timepoint [2] 327021 0
Duration of the trial: April to November 2014

Eligibility
Key inclusion criteria
Health professionals working within three district health boards in four maternity hospitals in Auckland, New Zealand consented to participate. Consumers were recruited postnatally from 4 neonatal units across three district health boards (DHBs) in Auckland, New Zealand. Women were eligible to participate if they had received a dose(s) of ACS prior to preterm birth at or less than 34 weeks’ gestation
Participants completed a semi-structured interview or questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed, opaque envelopes were used to conceal study group allocation and were held by an independent researcher. Once eligibility of participants was confirmed including provision of informed consent, participants were randomised to either a SSI or questionnaire. The independent researcher responsible for randomisation was contacted by telephone and the next envelope in the relevant strata was opened to reveal the study group allocation either: “SSI Group” or the “Questionnaire Group”. Following study group allocation of participants, the lead investigator (EM) contacted the participant to explain how to proceed. Due to the nature of the study it was not possible for the researcher to be blinded to group allocation during analysis of the results.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was prepared by a statistician using a computer generated random number table. Participants were randomised to either a SSI or questionnaire. Participants were stratified by health professional (obstetrician, midwife, neonatologist/paediatrician) or consumer group and hospital site (Auckland District Health Board, Waitemata District Health Board and Counties Manukau District Health Board).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline demographics of all randomised participants were descriptively summarised within their respective study groups (SSI Group and Questionnaire Group). The Theoretical Domains framework (TDF) (Michie 2005, Cane 2012) was used to classify all participant responses into one or more of the 14 behavioural domains within the TDF framework. Two researchers independently coded responses and any differences wer resolved through discussion. The two reviewers decided whether these statements would represent a barrier or an enabler to implementation of the antenatal corticosteroid clinical practice guideline. Differences in the overarching barriers and enablers identified between the two groups were compared.
A second coding framework was developed following data collection to reflect the responses received from the SSI and questionnaire participants. Responses to individual questions were compared by study group if the questions asked were the same. For continuous variables differences of means with 95% confidence intervals (CI) were used to compare outcomes. When the data was skewed, differences of medians with Interquartile ranges (IQR) were used. For categorical variables Fishers exact tests were used.
A template of 43 questions was used in both the SSI and Questionnaire Groups. A number of the questions had multiple items and were analysed separately. The number and proportion of questions answered were reported for each individual question and overall.
The level of agreement between the two assessment methods (SSI and Questionnaire) was assessed using Fisher’s exact test for each question.
A third coding framework was developed to assess the level of detail of response by the participants for each individual question. The coding framework categorised responses from one to four. Where one represented the participant indicating the question was not applicable to them and four representing a detailed response. The difference in the level of response between the two assessment methods (SSI and Questionnaires) was assessed using Fisher’s exact test for each question. The influence of the type of question [open, closed or mixed (closed with a textbox)] was explored. All analyses were undertaken using SPSS version 20.0. The threshold of significance was set at p=0.05.
No formal sample size calculation was performed. A pragmatic approach was adopted to reflect the number of participants required to acheive data saturation and to reflect the number of participants that could be recruited with each health professional group across the hospital sites.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/04/2014
Date of last participant enrolment
Anticipated
Actual
24/11/2014
Date of last data collection
Anticipated
31/10/2014
Actual
24/11/2014
Sample size
Target
96
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 8121 0
New Zealand
State/province [1] 8121 0
Auckland

Funding & Sponsors
Funding source category [1] 294372 0
Charities/Societies/Foundations
Name [1] 294372 0
National Centre for Growth and Development (GRAVIDA)
Country [1] 294372 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293214 0
None
Name [1] 293214 0
Nil
Address [1] 293214 0
N/A
Country [1] 293214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295789 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 295789 0
Ethics committee country [1] 295789 0
New Zealand
Date submitted for ethics approval [1] 295789 0
28/01/2014
Approval date [1] 295789 0
28/02/2014
Ethics approval number [1] 295789 0
011193
Ethics committee name [2] 295790 0
ADHB Research review Committee
Ethics committee address [2] 295790 0
Ethics committee country [2] 295790 0
New Zealand
Date submitted for ethics approval [2] 295790 0
06/03/2014
Approval date [2] 295790 0
04/04/2014
Ethics approval number [2] 295790 0
A+6217
Ethics committee name [3] 295791 0
Awhina Maternity Clinical Governance Group
Ethics committee address [3] 295791 0
Ethics committee country [3] 295791 0
New Zealand
Date submitted for ethics approval [3] 295791 0
28/04/2014
Approval date [3] 295791 0
20/05/2014
Ethics approval number [3] 295791 0
RM 0980712728
Ethics committee name [4] 295792 0
CMDHB Research Committee
Ethics committee address [4] 295792 0
Ethics committee country [4] 295792 0
Date submitted for ethics approval [4] 295792 0
23/04/2014
Approval date [4] 295792 0
05/06/2014
Ethics approval number [4] 295792 0
1741/UAHPEC011193

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68490 0
Dr Emma Louise McGoldrick
Address 68490 0
Liggins Institute
The University of Auckland, Building 505,
Level 2, 85 Park Road, Auckland P Private Bag 92019, Auckland 1142, NZ

Country 68490 0
New Zealand
Phone 68490 0
+64 9 923 8346 Ext 86872
Fax 68490 0
Email 68490 0
[email protected]
Contact person for public queries
Name 68491 0
Emma Louise McGoldrick
Address 68491 0
Liggins Institute
The University of Auckland, Building 505,
Level 2, 85 Park Road, Auckland P Private Bag 92019, Auckland 1142, NZ
Country 68491 0
New Zealand
Phone 68491 0
+64 9 923 8346 Ext 86872
Fax 68491 0
Email 68491 0
[email protected]
Contact person for scientific queries
Name 68492 0
Emma Louise McGoldrick
Address 68492 0
Liggins Institute
The University of Auckland, Building 505,
Level 2, 85 Park Road, Auckland P Private Bag 92019, Auckland 1142, NZ
Country 68492 0
New Zealand
Phone 68492 0
+64 9 923 8346 Ext 86872
Fax 68492 0
Email 68492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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