Caring for Providers to Improve Patient Experience (CPIPE) Trial

NCT ID: NCT06085105

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 6400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-01-01

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CPIPE Training

Intervention Type: BEHAVIORAL

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.

Peer support groups

Intervention Type: BEHAVIORAL

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.

Mentorship

Intervention Type: BEHAVIORAL

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.

Leadership engagement

Intervention Type: BEHAVIORAL

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.

Embedded champions

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

1. 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.

2. Women who are younger than 15 years of age.

Provider's cohort

Eligibility criteria

1. Healthcare providers working in maternal health units for at least 6 months at the time of data collection.

2. Capable and willing to provide informed consent.

3. Able and committed to attending the intervention training and follow up activities.

4. Age 18 or above.

1. Healthcare providers planning to no longer be working at the facilities in the next six months, at the time of enrollment.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Navrongo Health Research Centre, Ghana

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patience Afulani, PhD, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Upper East and North East regions health facilities

Navrongo, , Ghana

Migori and Homabay Counties health facilities

Migori, , Kenya

Countries

Ghana; Kenya

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Related Links

https://personcenteredequitylab.ucsf.edu/projects#cpipe

Project website

Other Identifiers

R01HD110370

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-38843

Identifier Type: -

Identifier Source: org_study_id