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临床试验/NCT06896292
NCT06896292进行中(未招募)不适用

Efficacy, Feasibility, and Acceptability of a Hybrid Patient Care Model in Improving Access to Guideline Recommended Antenatal Preventive Care

Hunter and New England Health2 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
372
试验地点
2
主要终点
Receipt of preventive care (Assessment of health risks)

研究概览

简要总结

The delivery of preventive care for modifiable health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) is a critical part of antenatal care. Clinical guidelines recommend that preventive care is delivered using three elements: Ask, Advise, and Help (AAH). Unfortunately, the AAH model for modifiable risk factors is not routinely delivered to all pregnant people in face-to-face antenatal visits. The investigators will test if adding a digital support tool to usual antenatal care increases the provision of guideline-recommended preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain, compared to usual antenatal care at two maternity services based at Maitland Hospital and Manning Base Hospital in New South Wales, Australia. The digital support tool will provide the opportunity for pregnant people to self-assess smoking, nutrition, alcohol, physical activity and gestational weight gain risk prior to their antenatal visits, while also being provided with tailored guideline-based information and the opportunity to self-refer to support services. Use of the digital support tool may also prompt pregnant people and/or their antenatal clinicians to have discussions around smoking, nutrition, alcohol, physical activity and gestational weight gain risks at antenatal appointments. As well as assessing impact on receipt of care for smoking, nutrition, alcohol, physical activity and gestational weight gain, the investigators will also explore the feasibility, acceptability, barriers/enablers to use and content and functional preferences of the digital support tool for pregnant people.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Data collection staff that are involved in undertaking telephone interviews with control and intervention group participants will not be aware of their group allocation when collecting data for primary outcome measures.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Any pregnant person (aged 18 years and over) with a scheduled first antenatal appointment at one of the two participating maternity services
  • •Sufficient level of English language proficiency to access and use the digital support tool and complete follow-up surveys.

排除标准

  • •Any pregnant person who has had an adverse pregnancy outcome. As per previous studies undertaken by the research team, this criterion will be assessed by review of relevant medical record fields and anyone who meets this criterion will be flagged to exclude from invitation to the study or from being included in any trial related data collection or contacts.
  • •No registered mobile phone number

研究组 & 干预措施

Hybrid care model

Experimental

The Hybrid care model will involve guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services + use of a digital support tool. The digital tool will allow patients to undertake self-assessment of smoking, nutrition, alcohol, physical activity and gestational weight gain risks, receive information and make self-referrals to support services at a time and in a way that suits them. Self-assessment results and information on self-referrals will be provided to antenatal clinicians prior to appointments to support clinician follow-up. The provision of preventive care via the digital support tool will facilitate more streamlined appointments by addressing priority issues and freeing up appointment time to address issues most relevant to the participant.

干预措施: Hybrid care model (Behavioral)

Usual care model

Active Comparator

Usual guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services

干预措施: Usual Care (Other)

结局指标

主要结局

Receipt of preventive care (Assessment of health risks)

时间窗: Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.

The percentage of pregnant people (N=840) receiving assessment of all health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) via the digital support tool or their antenatal provider.

Receipt of preventive care (Advice about health risks)

时间窗: Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.

The percentage of pregnant people (N=840) receiving advice on all relevant health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) via the digital support tool or their antenatal provider.

Receipt of preventive care (Help to address health risks)

时间窗: Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.

The percentage of pregnant people (N=840) who are referred to at least one preventive health service for an identified health risk (clinician referral or self-referral) via the digital support tool or their antenatal provider.

次要结局

未报告次要终点

研究者

发起方
Hunter and New England Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Melanie Kingsland

Program Manager

Hunter and New England Health

研究点 (2)

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