NCT06085105

Caring for Providers to Improve Patient Experience (CPIPE) Trial

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,400 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stress, Psychological
• Maternal Health
• Healthcare Provider
• Adverse Outcomes
• Stress, Emotional
• Mental Health Issue
• Burnout
• Burnout, Psychological
• Discrimination, Social

Interventions

Type	Name	Description
BEHAVIORAL	CPIPE Training	A two day training covering the following topics: understanding stress \& burnout and developing positive coping mechanisms, bias awareness \& mitigation, person-centered maternity care mindfulness, dealing with difficult situations, emergency obstetric and neonatal care, teamwork and communication, mentorship and peer support.
BEHAVIORAL	Peer support groups	Groups for healthcare providers to meet with other healthcare providers of their cadre, and discuss issues they are facing, brainstorm solutions, and provide support to one another.
BEHAVIORAL	Mentorship	Mentor-mentee relationships that provide the opportunity to coach junior healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. Mentors develop their mentorship and leadership skills.
BEHAVIORAL	Leadership engagement	Engagement of County leadership at the onset of the project through a community advisory board, regular updates of the study and findings, and discussing systemic gaps that impact provider stress and bias.
BEHAVIORAL	Embedded champions	To facilitate ongoing engagement and sustainability at the facility level, we identified facility champions who lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2023-10-16
• Last updated: 2025-07-03

Locations

2 sites across 2 countries: Ghana, Kenya