Caring for Providers to Improve Patient Experience (CPIPE) Study: A Cluster Randomized-controlled Trial to Assess the Impact of the CPIPE Intervention on Person-centered Maternity Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,379
- 试验地点
- 2
- 主要终点
- Change in person-centered maternity care (PCMC) score from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
研究概览
简要总结
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.
详细描述
Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. The proposed R01 will test the effectiveness of an intervention that targets provider stress and bias to improve PCMC. The investigators will accomplish this through 3 aims. Aim 1: to assess the effectiveness of the CPIPE intervention on PCMC in Kenya and Ghana. The investigators hypothesize that CPIPE will improve PCMC for all women, and especially for low SES women. The primary outcome is PCMC measured with the PCMC scale through multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to intervention), midline (6 months post-baseline), and endline (12 months post-baseline) (N=2000 at each time point). A sub-aim 1 will assess the cost-effectiveness of CPIPE. Aim 2: to examine the mechanisms of impact of CPIPE on PCMC. The investigators will assess the effect of CPIPE on intermediate outcomes such as provider knowledge, self-efficacy, stress, burnout, and bias levels; and conduct mediation analysis to assess if changes in these outcomes account for the effect of CPIPE on PCMC. Aim 3: to assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health; and examine if changes in PCMC account for these effects.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women's survey
- •Eligibility criteria
- •Women receiving care at the study facilities.
- •Have given birth within the 12 weeks preceding the data collection.
- •Capable and willing to provide informed consent.
- •Age 15 or above, with individuals aged 15-17 meeting the criteria for emancipated minors as defined by Kenyan or Ghana law (pregnant or parenting, living apart from their parents or guardian; living separately with or without their parents or guardian's consent, regardless of duration; and, controlling their financial affairs regardless of the source of income).
排除标准
- •Women who are too ill to participate or do not live within a feasible location if interviews are scheduled to be conducted in the community.
- •Women who are younger than 15 years of age.
- •Provider's cohort
- •Eligibility criteria
- •Healthcare providers working in maternal health units for at least 6 months at the time of data collection.
- •Capable and willing to provide informed consent.
- •Able and committed to attending the intervention training and follow up activities.
- •Age 18 or above.
- •Exclusion criteria
- •1. Healthcare providers planning to no longer be working at the facilities in the next six months, at the time of enrollment.
研究组 & 干预措施
CPIPE control arm
The control group will not receive the CPIPE intervention during the 12-month data collection period but will maintain their usual facility level activities.
CPIPE Intervention arm
1. Training: A two-day training that addresses the following topics: Stress & positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
干预措施: CPIPE Training (Behavioral)
CPIPE Intervention arm
1. Training: A two-day training that addresses the following topics: Stress & positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
干预措施: Peer support groups (Behavioral)
CPIPE Intervention arm
1. Training: A two-day training that addresses the following topics: Stress & positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
干预措施: Mentorship (Behavioral)
CPIPE Intervention arm
1. Training: A two-day training that addresses the following topics: Stress & positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
干预措施: Leadership engagement (Behavioral)
CPIPE Intervention arm
1. Training: A two-day training that addresses the following topics: Stress & positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
干预措施: Embedded champions (Behavioral)
结局指标
主要结局
Change in person-centered maternity care (PCMC) score from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
时间窗: Baseline and 6 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Change in person-centered maternity care (PCMC) score from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
时间窗: 6 months and 12 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Change in person-centered maternity care (PCMC) score from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
时间窗: Baseline and 12 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
次要结局
- Change in unconscious bias knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in unconscious bias knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in stress and stress management knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in stress and stress management knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in Perceived Stress Scale (PSS) score from baseline to 6 Months, among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in Perceived Stress Scale (PSS) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in Shirom-Melamed Burnout Measure (SMBM) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in unconscious bias knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in Perceived Stress Scale (PSS) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in postnatal care utilization from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 12 months)
- Change in stress and stress management knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in self-reported PCMC provision scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in self-reported PCMC provision scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in post-partum depression rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(6 months and 12 months)
- Change in bias awareness and mitigation scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in bias awareness and mitigation scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in explicit bias scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in explicit bias scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in explicit bias scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in postnatal care utilization from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 6 months)
- Change in breastfeeding rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 6 months)
- Change in bias awareness and mitigation scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in breastfeeding rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 12 months)
- Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.(Baseline and 6 months)
- Change in supportive environment score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.(6 months and 12 months)
- Change in self-reported PCMC provision scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.(Baseline and 12 months)
- Change in postnatal care utilization from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(6 months and 12 months)
- Change in breastfeeding rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(6 months and 12 months)
- Change in post-partum depression rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 6 months)
- Change in post-partum depression rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.(Baseline and 12 months)