A Clinical Care Pathway for Obese Pregnant Women: A Pilot Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Feasibility (Rates)
研究概览
简要总结
Clinics will be randomized to the use of the care pathway for obese pregnant women or standard care. Women who are (1) up to 20 weeks + 6 days gestation into their pregnancy, (2) are carrying one baby (not twins) that is healthy (no life threatening anomalies) and (3) have a Body Mass Index ≥ 30 kg/m², will be included. Data will be obtained from the Ministry of Health's Antenatal Records, charts, and for those in the intervention group, the care path (filled out by the practitioners - the participants' obstetrician, midwife, or family doctor). At the end of the study, practitioners will complete a survey, participate in structured interviews to understand barriers, facilitators, and motivators of using the care path.
Primary Objective:
To evaluate the feasibility of implementing and testing a clinical care pathway for obese pregnant women in a pilot cluster randomized controlled trial (RCT)
Secondary Objectives:
To obtain pilot data on A) process outcomes (steps of the pathway, e.g. what % of obese women receive a screen for diabetes) B) clinical outcomes (e.g. what % of obese women receive a diagnosis of diabetes), C) provider outcomes (e.g. Is the intervention acceptable, feasible & efficient? Barriers & facilitators to use, effectiveness? [Structured interviews])
详细描述
STUDY DESIGN:
Investigators propose a pilot cluster RCT with a 1:1 allocation ratio of clinics randomized to the clinical care pathway for obese pregnant women (intervention group) versus standard care (control group).
Investigators have followed the SPIRIT statement (Standard Protocol Items: Recommendations for Interventional Trials)
RANDOMIZATION:
The unit of randomization will be the clinic providing pregnancy care. All pregnant women who meet inclusion criteria at a clinic randomized to the intervention will receive the intervention, while all pregnant women who meet the inclusion criteria at a clinic randomized to usual care will receive usual care. Investigators used a 1:1 allocation between the intervention and the control groups, with paired randomization by type of clinic (obstetrician-lead versus midwife-lead, since they likely differ regarding patient characteristics and health care, and pairing will aid in providing a reasonable balance of characteristics with a small sample size.) Investigators generated the randomization sequence using www.randomization.com. The randomization seed for obstetrical clinics was "21262" and the randomization seed for midwifery clinics was "23340".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for clinics:
- •location in southwestern Ontario (for proximity to the research team),
- •availability of a clinician willing to serve as the local site lead, and
- •lack of any type of existing clinical care pathway for obese pregnant women
- •Inclusion criteria for participants:
- •women with a pre-pregnancy (or in the event of inability to recall, then first measured) BMI >30 kg/m2
- •with viable singleton pregnancies up to 20 weeks + 6 days gestational age upon first visit to randomized clinic
排除标准
- •Women with:
- •a miscarriage or termination of pregnancy after enrollment,
- •twins or higher order multiples or
- •a fetus with a known lethal anomaly.
研究组 & 干预措施
Clinical care pathway
The intervention is the clinical care pathway designed by investigators, informed by the national guideline co-authored by one of the team, and supplemented by the review of the literature
干预措施: Clinical Care Pathway (Other)
Usual Care
The control group will receive the usual prenatal care.
结局指标
主要结局
Feasibility (Rates)
时间窗: 10 months
1. the feasibility of the intervention (defined as \>80%: A. compliance with each step in care path and B. clinicians recommend it.) 2. the feasibility of a cluster RCT (defined as \>80%: A. randomization (of approached clinics), B. uptake (of eligible women), C. completeness of follow-up.
次要结局
- Process outcome - Rates of offer(10 months)
- Exploratory clinical outcomes - Rates of detection(10 months)
- Provider outcomes - Questionnaire --Rates of(10 months)
研究者
Sarah McDonald
Principal Investigator
McMaster University