Caring for Providers to Improve Patient Experience (CPIPE) Trial

Not Applicable

Active, not recruiting

• Conditions: Stress, Psychological; Maternal Health; Stress, Emotional; Burnout; Adverse Outcomes; Mental Health Issue; Discrimination, Social; Healthcare Provider; Burnout, Psychological
• Interventions: Behavioral: CPIPE Training; Behavioral: Peer support groups; Behavioral: Mentorship; Behavioral: Leadership engagement; Behavioral: Embedded champions

• Registration Number: NCT06085105
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-16
• Study Start: 2024-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2028-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPIPE Intervention arm	Peer support groups	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.
CPIPE Intervention arm	CPIPE Training	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.
CPIPE Intervention arm	Mentorship	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.
CPIPE Intervention arm	Leadership engagement	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.
CPIPE Intervention arm	Embedded champions	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.

Primary Outcome Measures

Name	Time	Method
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.	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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
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	The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
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	The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
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	The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
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	The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
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	Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
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	Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
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	The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
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	The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
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	The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
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	Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
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	The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
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	Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
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	Survey questions on receipt and timing of postnatal care
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	The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
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	The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
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	The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
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	10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression
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	The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
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	The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
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	The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
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	The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
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	The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
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	Survey questions on receipt and timing of postnatal care
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	Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
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	The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
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	Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
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	Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
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	Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
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	The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
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	Survey questions on receipt and timing of postnatal care
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	Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
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	10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression
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	10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression

Trial Locations

Locations (2)

Upper East and North East regions health facilities; 🇬🇭 Navrongo, Ghana

Migori and Homabay Counties health facilities; 🇰🇪 Migori, Kenya