Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001346662
Ethics application status
Approved
Date submitted
1/12/2023
Date registered
20/12/2023
Date last updated
20/12/2023
Date data sharing statement initially provided
20/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can we train maternity staff in Healthy Conversation Skills to support them to provide care for pregnancy weight gain?
Scientific title
Assessing the implementation of a Healthy Conversation Skills Intervention in maternity services to address antenatal care provider's barriers to providing gestational weight gain care
Secondary ID [1] 310013 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of study ACTRN12621000054819

Health condition
Health condition(s) or problem(s) studied:
Gestational Weight Gain 332228 0
Nutrition in pregnancy 332229 0
Physical Activity in Pregnancy 332230 0
Condition category
Condition code
Public Health 328946 328946 0 0
Health service research
Public Health 328947 328947 0 0
Health promotion/education
Reproductive Health and Childbirth 328948 328948 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2-month multi-component intervention will be implemented across maternity services in three health sectors. The Healthy Conversation Skills intervention will include organisational and clinician-focused implementation strategies to support antenatal care providers to use Healthy Conversation Skills to provide antenatal care for gestational weight gain.

Leadership: Existing clinical networks and antenatal clinic leaders will be engaged prior to and during the intervention period to provide authorisation and endorsement of Healthy Conversation Skills. This will include the presence of clinical leaders at training and endorsement through usual communication channels.

Service champion: Clinical Midwife Educators and Population Health staff (who are trained to deliver Healthy Conversation Skills training) will train, monitor performance and provide feedback to antenatal care providers in maternity services over the 2-month intervention period.

Community of practice meetings: Healthy Conversation Skills Trainers will be supported by community of practice meetings (face-to-face or online) to plan and implement the Healthy Conversation Skills intervention in each maternity service.

Clinician training: In pairs, Healthy Conversation Skills Trainers will deliver the group-based (6-16 participants) training to antenatal care providers in their services. Training sessions will be rostered into routine educational sessions, with the delivery of training sessions (e.g. timing; mode (face to face or online); amount of training (6 hours of full training or 3 hours of ‘lite’ training)) decided by each maternity service as per local need. Healthy Conversation Skills training aims to upskill health care workers in an empowering, person-centred approach to support patient health behaviour change by using open discovery questions (i.e. starting with ‘what’ and ‘how’) to help patients to explore the context of their behaviour, identify their own solutions, and plan their first steps to change. Antenatal care providers who participate in the training can use the skills when providing care for gestational weight gain during existing timing in antenatal appointments. Healthy Conversation Skills training was developed by a multidisciplinary research team at the University of Southampton, United Kingdom. It is based on Social Cognitive Theory and the training is underpinned by the Taxonomy of Behaviour Change Techniques. The training uses an interactive, participatory approach to learning built on the pedagogy of active learning, with the trainer modelling the philosophy and skills throughout. The nature of the training means that it is tailored to the context, beliefs and experiences of participants attending the training. The training provides opportunities for participants to reflect on discrepancies between their current and desired communication style, demonstrates an exemplar conversation, supports participants to practise the skills, and sets graded tasks (of increasing difficulty) to progressively increase skill level. The use of group work to provide social support and feedback, sharing of experiences and practising with each other is fundamental to this approach. There is no use of technology, and participants are discouraged from taking notes and encouraged to fully engage with the experiential training.

Educational materials: Healthy Conversation Skills Trainers will be provided with a training implementation toolkit (training manual, session guides and resource pack) and printed resources for antenatal care providers to practice and reflect on their communication skills.
Prompts and reminders: Physical point of care prompts, including posters, will be provided to each antenatal care provider at the end of training and displayed in each antenatal clinic rooms to remind antenatal care providers to use the skills learnt from the training.

All implementation strategies have been co-developed and approved to be implemented in all participating maternity services by the project executive leadership group. The 2-month intervention will be delivered sequentially in each of the three health sectors across a six-month period. Launch of the implementation strategies will commence on day 1 of the intervention period for each health sector, starting with the first training session and with all implementation strategies provided across the 2-month period.

This study will be conducted as a single-arm, pre-post study. Study outcome data from antenatal care providers will be collected over nine months, from the first day of the intervention (at the start of training) until 3 months post-intervention in each health sector. Adherence to the implementation strategies (i.e. log of delivery of each implementation strategy, including training completion and resource logs) will also be recorded during the intervention period.
Intervention code [1] 327532 0
Prevention
Intervention code [2] 327533 0
Behaviour
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336739 0
An assessment of antenatal care providers barriers and facilitators (using the Theoretical Domains Framework) to having behaviour change conversations will be undertaken through clinician surveys with staff who attend Healthy Conversation Skills training at each maternity services to determine the theoretical mediators of intervention effect. The surveys were designed specifically for this study, using a validated Theoretical Domains Framework survey.
Timepoint [1] 336739 0
Data collection pre- and post-training (immediately after training completion), and post intervention period (at 2-3 months post intervention) at each maternity service.
Primary outcome [2] 336744 0
An assessment of antenatal care providers’ competence in using Healthy Conversation Skills will be undertaken through clinician surveys with staff who attend Healthy Conversation Skills training at each maternity services. These evaluation tools and competence coding matrix have been previously used (Healthy Conversation Skills competence questionnaire) and reported to evaluate Healthy Conversation Skills in prior studies.
Timepoint [2] 336744 0
Data collection pre- and post-training (immediately after training completion), and post intervention period (at 2-3 months post intervention) at each maternity service.
Primary outcome [3] 336845 0
An assessment of antenatal care providers’ confidence in having behaviour change conversations will be undertaken through clinician surveys with staff who attend Healthy Conversation Skills training at each maternity services. These evaluation tools have been previously used (Healthy Conversation Skills confidence questionnaire) and reported to evaluate Healthy Conversation Skills in prior studies.
Timepoint [3] 336845 0
Data collection pre- and post-training (immediately after training completion), and post intervention period (at 2-3 months post intervention) at each maternity service.
Secondary outcome [1] 429526 0
The acceptability of Healthy Conversation Skills training will be assessed via clinician surveys with staff who attend training at each maternity service. These process measures will use a validated instrument (Acceptability of Intervention Measure (AIM)).
Timepoint [1] 429526 0
Data collection during the post intervention period (at 2-3 months post intervention) at each maternity service.
Secondary outcome [2] 429531 0
The appropriateness of Healthy Conversation Skills training will be assessed via clinician surveys with staff who attend training at each maternity service. These process measures will use a validated instrument (Intervention Appropriateness Measure (IAM)).
Timepoint [2] 429531 0
Data collection during the post intervention period (at 2-3 months post intervention) at each maternity service.
Secondary outcome [3] 429532 0
Fidelity of intervention delivery (including the number and duration of training and community of practice meetings) as a process evaluation measure will be assessed during the intervention period using training logs, surveys and project records designed specifically for this study.
Timepoint [3] 429532 0
Data collection will occur continuously throughout the 2-month intervention period at each maternity service.
Secondary outcome [4] 429836 0
Antenatal care provider exposure to the implementation strategies (i.e., reach) as a process evaluation measure will be assessed during the intervention period and post-intervention period using training logs, surveys and project records designed specifically for this study.
Timepoint [4] 429836 0
Data collection will occur continuously throughout the 2-month intervention period and during the post intervention period (at 2-3 months post intervention) at each maternity service.
Secondary outcome [5] 429839 0
A cost analysis will measure and value resources used in the development and delivery of the intervention from the perspective of the antenatal service provider. The analysis will adhere to cost and economic analysis guidelines. Delivery of the intervention strategies and data regarding resources expended on materials, labour and other expenses incurred in developing and executing the intervention will be recorded in project management logs. Labour costs for training, quality assurance processes, managerial oversight and activities undertaken by the Trainers will be recorded prospectively. Research and data collection and analysis costs will be excluded.
Timepoint [5] 429839 0
Data will be entered into project management logs on a fortnightly basis throughout the intervention period (for 2 months) at each maternity site.

Eligibility
Key inclusion criteria
Antenatal care providers (including registered midwives, medical practitioners, Aboriginal Health Practitioners and Aboriginal Health Workers) who provide antenatal care in the participating public maternity services.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health care providers who do not provide antenatal care in the participating public maternity services.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in antenatal care provider’s competence, confidence, and adoption data will be analysed by the McNemar’s Test. For the acceptability and appropriateness items, mean (SD) summary scores for each construct will be generated. Process measures for fidelity and reach will be reported using descriptive statistics.

Mean values will be calculated for Theoretical Domains Framework domains by summing the scores for each item within the domain and dividing by the total number of items. Differences in scores between various time points for Theoretical Domains Framework barriers will be analysed by mixed effects linear regression.

The cost analysis results will be incorporated into an economic model to project the expected costs that would be associated with broader scale-up of the Healthy Conversation Skills intervention in antenatal services across NSW.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/07/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
80
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314190 0
Government body
Name [1] 314190 0
Hunter New England Local Health District – Clinical and Health Services Research Fellowship Scheme
Country [1] 314190 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 316109 0
None
Name [1] 316109 0
Address [1] 316109 0
Country [1] 316109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313317 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 313317 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305
Ethics committee country [1] 313317 0
Australia
Date submitted for ethics approval [1] 313317 0
07/04/2021
Approval date [1] 313317 0
09/04/2021
Ethics approval number [1] 313317 0
2019/ETH13158

Summary
Brief summary
This study aims to determine if we can train maternity staff in Healthy Conversation Skills to support them to provide pregnancy weight gain care to pregnant women. We hypothesise that after receiving the Healthy Conversation Skills intervention, antenatal care providers will have higher competence and confidence, and report less barriers, to having behaviour change conversations about weight gain with pregnant women. This study will be conducted as a single-arm, pre-post study with staggered implementation of the 2-month Healthy Conversation Skills intervention in three health sectors within the Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidenced-based strategies including leadership support, service champions, community of practice meetings, clinician training, educational materials and prompts and reminders. Study outcomes include changes in antenatal care provider’s competence, confidence and barriers to having behaviour change conversations with patients, and adoption of Healthy Conversation Skills. Implementation processes of fidelity, reach, acceptability and appropriateness of the intervention will also be measured. A cost analysis will be undertaken to assess the cost of the Healthy Conversation Skills intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127714 0
Dr Jenna Hollis
Address 127714 0
Hunter New England Population Health, Locked bag 10, Wallsend, NSW, 2287
Country 127714 0
Australia
Phone 127714 0
+61 2 49246655
Fax 127714 0
Email 127714 0
[email protected]
Contact person for public queries
Name 127715 0
Dr Jenna Hollis
Address 127715 0
Hunter New England Population Health, Locked bag 10, Wallsend, NSW, 2287
Country 127715 0
Australia
Phone 127715 0
+61 2 49246655
Fax 127715 0
Email 127715 0
[email protected]
Contact person for scientific queries
Name 127716 0
Dr Jenna Hollis
Address 127716 0
Hunter New England Population Health, Locked bag 10, Wallsend, NSW, 2287
Country 127716 0
Australia
Phone 127716 0
+61 2 49246655
Fax 127716 0
Email 127716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no ethical approval to share individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21105Informed consent form    386164-(Uploaded-01-12-2023-16-56-31)-Study-related document.pdf
21106Ethical approval    386164-(Uploaded-01-12-2023-16-55-45)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.