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Trial registered on ANZCTR


Registration number
ACTRN12616000623493
Ethics application status
Approved
Date submitted
6/05/2016
Date registered
13/05/2016
Date last updated
26/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parenting help study: Evaluating the use of Teachback delivered by nurses in a parenting helpline.
Scientific title
Randomised controlled trial of the Teachback method to improve service delivery and health communication for the government funded telephone parenting service (Pregnancy, Birth & Baby Helpline, Healthdirect Australia).
Secondary ID [1] 288451 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health literacy. 297479 0
Pregnancy health advice. 298685 0
Baby health advice 298686 0
Young child health advice 298690 0
Condition category
Condition code
Public Health 297666 297666 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is to test the effectiveness of a communication technique Teachback - which is for checking and ensuring understanding in a non-shaming way and involves asking a person to explain in their own words what they need to know. Teachback will be used by nurses staffing the Pregnancy, Birth & Baby Helpline (PBB) – a government funded telephone parenting service (Healthdirect Australia). Implementation of this method is to improve service delivery and health communication for the PBB Helpline.

This is a stepped wedge cluster randomised trial in which all nurses will be invited to participate in the study and will cross over to the intervention according to a training schedule. The duration of the study period is 6 weeks, with nurses randomised to receive the training at 2 weeks or 4 weeks.

Each group of nurses will attend a single two-hour face-to-face training session according to the study schedule. This will take place on site at the call centre and will be delivered by an experienced trainer who has led a previous study on Teachback and has expertise in running Teachback training sessions. Sessions will be co-facilitated by a researcher closely involved with study design, and will be attended by the manager, supervisor, and clinical trainer of the telephone service.
The training schedule will include:
- Background evidence for Teachback.
- How to do Teachback and examples of phrases.
- Videos with Teachback in different contexts.
- Interactive activities that include role plays and scenarios.

In addition, flyers about the study will be placed around the call centre to promote the study and training sessions to nurses. Reminder emails about the use of Teachback and helpful strategies will be sent to participating nurses intermittently.

Both nurses and callers to the PBB Helpline are participants and the intervention will be evaluated by both interviewing callers and feedback from the nurses. Callers to the PBB Helpline will be interviewed one week after their initial call by an independent organisation. Nurses will be asked to reflect on their communication during their calls by completing a short survey during their shift.
Intervention code [1] 293777 0
Other interventions
Comparator / control treatment
This is a 6-week stepped wedge cluster randomised trial in which all nurses will act as their own controls. Initially all nurses will be providing usual care. After two weeks half of the nurses (Group 1) will receive training in Teachback. Two weeks after that the remaining nurses (Group 2) will cross to the intervention arm, so that all are providing the intervention.
Control group
Active

Outcomes
Primary outcome [1] 297202 0
Subscale “having sufficient information” of the Health Literacy Questionnaire* (a validated measure of health literacy). We will use a modified version that replaces references to “health” with terminology suited to pregnancy and parenting issues.
We will ask callers to rate the sufficiency of information they received during their call using a 4-point Likert-type scale.
*Osborne RH, Batterham RW, Elsworth GR, Hwakins M, and Buchbinder R, 2013. The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ). BMC public health, 13(1), p.1.
Timepoint [1] 297202 0
1 week following the call to the PBB Helpline.
Secondary outcome [1] 320335 0
Caller satisfaction with the service and information provision. We will ask callers to rate their satisfaction with their experience of the PBB Helpline and information they received using 5-point scale. Open ended question will be used to probe. Questions were created for a previous customer satisfaction survey by the PBB Helpline and from The OPAL Study*.
*Spilby et al (2007): Labouring to better effect: studies of services for women in early labour The OPAL study (OPtions for Assessment in early Labour). UK government report 1-182
Timepoint [1] 320335 0
1 week following the call to the PBB Helpline.
Secondary outcome [2] 321004 0
Confidence. We will ask callers to rate their confidence in managing the issue they phoned the PBB Helpline about using a 5-point scale. Callers are asked how confident they are in recommending this service using a 5-point scale. This is modified from a validated questionnaire*.
*Devilly et al (2000) Psychometric properties of the credibility/expectancy questionnaire. Journal of Behavior Therapy and Experimental Psychiatry 31
Timepoint [2] 321004 0
1 week following the call to the PBB Helpline.
Secondary outcome [3] 321005 0
Links to other services. We will ask the callers about details and experiences of any referrals to other services. Questions were created for a previous customer satisfaction survey for the PBB Helpline and adapted for this study.

Timepoint [3] 321005 0
1 week following the call to the PBB Helpline.
Secondary outcome [4] 323413 0
Expectations. Callers will be asked about their expectations before calling the helpline. Expectation questions are adapted from the OPAL study*.
*Spilby et al (2007): Labouring to better effect: studies of services for women in early labour The OPAL study (OPtions for Assessment in early Labour). UK government report 1-182
Timepoint [4] 323413 0
1 week following the call to the PBB Helpline
Secondary outcome [5] 323414 0
Experiences. Callers will be asked about their experiences during the call. Experience questions are adapted from a previous PBB customer satisfaction survey.
Timepoint [5] 323414 0
1 week following the call to the PBB Helpline
Secondary outcome [6] 323448 0
Actionability of advice. Callers will be asked if they acted upon the advice they were given. This will be measured with items developed specifically for this study.
Timepoint [6] 323448 0
1 week following the call to the PBB Helpline
Secondary outcome [7] 323449 0
Feeling listened to. Callers will be asked how much effort was made to listen to and understand their issues. These are CollaboRATE* questions using 5-point scale.
*Elwyn et al (2013) Developing CollaboRATE: A fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Education and Counseling 93 102–107
Timepoint [7] 323449 0
1 week following the call to the PBB Helpline.
Secondary outcome [8] 323450 0
Repeat callers. Callers will be asked if they have phoned the PBB Helpline since the initial call and their reasons for doing this. This will be measured with items developed specifically for this study.
Timepoint [8] 323450 0
1 week following the call to the PBB Helpline.
Secondary outcome [9] 323595 0
Nurses self-reflection survey. Nurses will be asked to reflect on their communication during their calls. Additional questions about their experiences of Teach-back will be added for the intervention condition. This will be measured with items developed specifically for this study.
Timepoint [9] 323595 0
At the end of each call and at the end of the nurse's shift.

Eligibility
Key inclusion criteria
People will be eligible to participate in the study if they at least 16 years of age and are fluent in English. Participants may be from a range of socioeconomic and educational backgrounds.
Nurses staffing the PBB Helpline will be invited to participate in the study. Nurses who are unable to complete training in teachback will be excluded.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they are unable to speak adequate English as we do not have access to interpreting services for the study.
Individuals whose call requires transfer to nurse triage for an emergency, a counsellor for psychological support or translator will not be invited to participate. Callers on sensitive topics (e.g. termination, miscarriage) are excluded and calls that are less than 4 minutes duration.

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)
Nurses will be aware of their allocation to either Group 1 or Group 2.
Pairs of nurses will be matched and stratified according to average weekly hours worked. Nurses will be allocated to a group by The University of Sydney researchers by an electronic generation of a random number sequence.

An independent organisation will be interviewing the participant callers and they will not be aware of the group allocation, nature of the intervention or the study design.

Initially participant callers in both the intervention and control groups will be informed that they are participating in an evaluation of the PBB Helpline. A written debrief statement will be emailed to participants after the study is complete explaining that the PBB Helpline want to improve their service and that a trial of Teachback was conducted to see if it was effective.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation technique using Excel RAND function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The analysis will be to test for differences between Teachback and usual care on a range of measures, including knowledge perception and confidence. Participant’s health literacy level will be assessed with a single-item screener, so we can assess separately if there is a difference between the two conditions for participants with low health literacy.

Specific details of the sample size calculations include:
- The standardized effect size is 0.5
- Power: 80%
- Significance Level: 0.05 (5%)

N = 16 clusters (nurses)

There is the assumption that each cluster handles a minimum of 5 calls in each arm.
Sample size calculations suggested the number of participants needed is 400 (callers) however to be able to detect effects in the secondary outcomes it’s is worthwhile recruiting more participants. A larger sample size will allow for dropouts or non-participation. So the number of participants needed for our study is 600 and oversampling participants allows for fewer nurses participating and in the event that nurses don’t provide the minimum number of calls. We cannot predict ahead of time what will happen with the nurses.

Additionally, our primary outcome is an adapted measure and we don’t have data for this population, so it is reasonable to oversample.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292931 0
Government body
Name [1] 292931 0
Healthdirect Australia
Address [1] 292931 0
Level 19, 133 Castlereagh Street
Sydney NSW 2000
Country [1] 292931 0
Australia
Primary sponsor type
University
Name
School of Public Health, The University of Sydney
Address
Edward Ford Building A27
The University of Sydney NSW 2006

Country
Australia
Secondary sponsor category [1] 291695 0
Other
Name [1] 291695 0
Royal District Nursing Service
Address [1] 291695 0
31 Alma Road
St Kilda VIC 3182
Country [1] 291695 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294289 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294289 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 294289 0
Australia
Date submitted for ethics approval [1] 294289 0
18/01/2016
Approval date [1] 294289 0
05/03/2016
Ethics approval number [1] 294289 0
2016/083
Ethics committee name [2] 294926 0
Royal District Nursing Service Human Research Ethics Committee
Ethics committee address [2] 294926 0
Human Research Ethics Committee
Royal District Nursing Service
31 Alma Rd
ST KILDA VIC 3182
Ethics committee country [2] 294926 0
Australia
Date submitted for ethics approval [2] 294926 0
29/03/2016
Approval date [2] 294926 0
12/04/2016
Ethics approval number [2] 294926 0
150013

Summary
Brief summary
This study is trialing the Teachback method to improve service delivery and health communication for the government funded telephone parenting service (Pregnancy, Birth & Baby Helpline, Healthdirect Australia). The primary outcome is assessing the effectiveness of Teachback compared with the usual care delivered through the PBB Helpline on a range of topics, testing chiefly if knowledge, understanding and satisfaction has increased by the Teachback intervention.

This is a stepped wedge cluster randomised trial in which all nurses will be invited to participate in the study and will cross over to the intervention according to a training schedule.

Both nurses and callers to the PBB Helpline are participants and Teachback will be evaluated by both interviewing callers and feedback from the nurses. Callers to the PBB Helpline will be interviewed one week after their initial call by an independent organisation. Nurses will be asked to reflect on their communication during their calls by completing a short survey throughout their shift. Nurses will also be invited to provide further feedback about the study through qualitative interviews/focus groups.
Trial website
Trial related presentations / publications
Public notes
The intervention was first delivered 12th May (first group of nurses trained evening of 11 May).

Contacts
Principal investigator
Name 63202 0
Prof Kirsten McCaffery
Address 63202 0
Room 301F, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63202 0
Australia
Phone 63202 0
+61 (02) 9351 7220
Fax 63202 0
Email 63202 0
kirsten.mccaffery@sydney.edu.au
Contact person for public queries
Name 63203 0
Dr Suzanne Morony
Address 63203 0
Room 126a, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63203 0
Australia
Phone 63203 0
+61 (02) 9351 5102
Fax 63203 0
Email 63203 0
suzanne.morony@sydney.edu.au
Contact person for scientific queries
Name 63204 0
Dr Suzanne Morony
Address 63204 0
Room 126a, Edward Ford Building A27
The University of Sydney NSW 2006
Country 63204 0
Australia
Phone 63204 0
+61 (02) 9351 5102
Fax 63204 0
Email 63204 0
suzanne.morony@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary