None listed
Conditions
Brief summary
This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended smoking cessation care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which smoking cessation care is consistent with guideline recommendations: assessment using CO monitors (predicted 7.2% increase); brief advice (predicted 17.6% increase); referral (predicted 21.8% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, prompts and reminders, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for smoking will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Acceptability of the intervention to women will also be measured.
Interventions
A 4-month multi-component clinical practice change intervention will be implemented across Maternity Services in three health sectors. The practice change intervention will involve two components: 1. Best practice care pathway: Implementation support strategies will be used to support the routine implementation of the following best practice care pathway for smoking cessation during existing antenatal appointments for all pregnant women. Care will be delivered by the attending antenatal care provider (doctor, midwife or Aboriginal health worker) within existing time scheduled for antenatal appointments, with no additional time added, and the time taken on additional components will be monitored. The intervention will support the delivery of recommended antenatal care through the usual mode of providing antenatal care at each maternity service, and can include face-to-face, telephone and/or video conference consultations. The best practice pathway is consistent with clinical guidelines (1) and is based on models of assessment, brief intervention and referral that have been shown to increase smoking cessation during pregnancy. (2) i. Assess smoking status using a Carbon Monoxide (CO) breath monitor for all women at the first/booking in appointment, and for all women who smoke at follow-up appointments; ii. for women who smoke, Advise to quit and discuss risks of smoking and benefits of quitting; iii. and, for women who have quit in the last 6 months, Advise on relapse prevention iv. for women who smoke, and recent quitters, Arrange assistance, including; a. referral to telephone-based Quitline, or culturally appropriate local service provider for Aboriginal women if available for behavioural counselling and b. if clinically appropriate, Nicotine Replacement Therapy (oral formulation as first line pharmacotherapy, patch as second line) It is estimated that for women who have recently quit or currently smoke, providing the full care pathway will take 5-10 minutes. For all other women it will take <1 minute. 2. Implementation support strategies: The following organisational and clinician-focused strategies will support clinician implementation of the above care pathway. Leadership: Existing clinical networks and antenatal clinical leaders will be engaged prior to and during the intervention period to facilitate ongoing authorisation and endorsement of the initiative. This will include the presence of clinical leaders at staff training sessions and through their involvement in communication of performance and feedback. A clinical expert group will provide clinical guidance across all components of the intervention. Aboriginal Health staff will provide oversight on cultural appropriateness of the intervention. Prompts and reminders: Physical point of care prompts will be designed specifically for the study and provided to clinicians to support care delivery, including stickers in the antenatal care record, and a clinic room flip chart, to prompt recommended care delivery. Local guidelines and procedures: Will be developed to outline the care pathway elements, including guidelines for NRT provision, local service referral options and procedures for each maternity service site. Service champion: A dedicated Clinical Midwife Educator (CME) will be allocated to each of the three health sectors for the four month intervention phase to facilitate the implementation of the practice change intervention in each service. They will train and advise staff, monitor performance and provide feedback to antenatal clinicians and service managers. Clinician training and resources: Multi-mode (online and face-to-face) training will be provided to clinicians in each maternity service, facilitated by the CMEs. The initial focus will be on encouraging staff to complete the online training during the first 3 weeks of the intervention period. The online Smoking Cessation training module is estimated to take 40 minutes to complete. Following this staff will participate in at least 60 minutes of face-to-face training during the 4 month intervention period. Face-to-face training sessions will be rostered into the routine educational sessions, with the delivery of the training sessions (e.g. timing and number of repeat training sessions) decided by each maternity service as per local need. The training will focus on addressing identified barriers to care delivery and use evidence-based training elements including interactive components and case studies. Printed resources to support clinician delivery of recommended care will be designed specifically for the study and provided to each maternity service. Care delivery monitoring and feedback (including academic detailing): Data on patient-reported receipt of care from telephone surveys and data from electronic medical records will be used to compile monthly reports of guideline recommended care delivery. Antenatal clinic managers will be supported to access, interpret and monitor performance measures. Services will be supported to set care delivery goals, monitor progress and develop action plans in response to feedback. Performance measures will be built into maternity services’ existing monitoring accountability frameworks, including operational plans and monthly accountability meetings. The implementation support strategies will delivered to participating maternity services at the same time as they will commence delivering the ‘best practice care pathway’ - at the commencement of the 4 months intervention period in each maternity service. All implementation support strategies have been co-developed and approved to be implemented at all participating maternity services by the executive leadership group. All strategies will be implemented in each maternity service, however the concentration of time and effort on individual strategies will be dependent on the results of formative staff surveys which will asked staff to rank their key barriers to providing recommended care. These key barriers will be mapped to Behaviour Change Techniques and implementation strategies to identify the priority strategies to support practice change at that site. Launch of the implementation support strategies will commence on day 1 of the 4-month intervention period, starting with training sessions and a memo from operational management with staff encouraged to uptake the new best practice care pathway from that point onwards, with all implementation strategies provided across the 4 month intervention period. All strategies other than the dedicated Clinical Midwife Educator and specific academic detailing have the potential to continue on an ongoing basis to support care delivery. 1. Australian Government, Department of Health. Clinical Practice Guidelines: Pregnancy Care - 2020 Edition. Canberra, ACT, Australia.2020. 2. Bar-Zeev Y, Bonevski B, Lim LL, Twyman L, Skelton E, Gruppetta M, Palazzi K, Oldmeadow C, Gould GS. Improving health providers smoking cessation care in pregnancy: A systematic review and meta-analysis. Addict Behav. 2019 Jun;93:29-38. doi: 10.1016/j.addbeh.2019.01.002. Epub 2019 Jan 10. PMID: 30684819.
Sponsors
Study design
Eligibility
Inclusion criteria
The best practice care pathways will be implemented as routine care for all women attending antenatal clinics within the participating sectors. All health professionals providing antenatal care will participate in the implementation intervention as part of routine service improvement and all will be offered to opportunity to participate in clinician surveys pre and post intervention. All pregnant women who have had attended at least one face-to-face antenatal appointment with an obstetrics focus for a first/booking in appointment, 28 week appointment, or 36 week appointment within three health sectors of the Hunter New England Local Health District (HNELHD) of New South Wales, Australia who meet the following inclusion criteria will be eligible for participation in study surveys: - Had an antenatal care appointment with an HNELHD maternity service in Greater Newcastle, Peel or Lower Mid North Coast Sector. - Aged 18 years or older. - More than 12 weeks and less than 37 weeks’ gestation at time of the appointment. - English proficient to complete a survey. - Mentally and physically capable of completing a survey. - Attended the appointment of interest in the previous week.
Exclusion criteria
Pregnant women will be excluded if they are determined by clinical discretion to be inappropriate to contact for the telephone/online survey (e.g. medical or social issues).