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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085105
Acronym
CPIPE
Enrollment
6379
Registered
2023-10-16
Start date
2024-03-01
Completion date
2026-05-06
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

quality of care, Kenya, providers, mental health, burnout, stress, person-centered care, discrimination, prejudice, unconscious bias

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.

Interventions

BEHAVIORALCPIPE 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.

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.

BEHAVIORALMentorship

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.

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.

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Kenya Medical Research Institute
CollaboratorOTHER
Navrongo Health Research Centre, Ghana
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women's survey Eligibility criteria 1. Women receiving care at the study facilities. 2. Have given birth within the 12 weeks preceding the data collection. 3. Capable and willing to provide informed consent. 4. 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).

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.

Design outcomes

Primary

MeasureTime frameDescription
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 monthsThe 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 monthsThe 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 monthsThe 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

MeasureTime frameDescription
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 monthsThe 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 monthsThe 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 baseline to 12 months among providers in intervention facilities compared to those in control facilities.Baseline and 12 monthsThe 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 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 monthsThe 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 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.6 months and 12 monthsThe 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 monthsThe 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 baseline to 6 Months, among providers in intervention facilities compared to those in control facilities.Baseline and 6 monthsPerceived 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 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.6 months and 12 monthsPerceived 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 monthsPerceived 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 monthsThe 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 monthsThe 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 baseline to 12 months among providers in intervention facilities compared to those in control facilities.Baseline and 12 monthsThe Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
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 monthsThe 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 monthsThe 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 baseline to 12 months among providers in intervention facilities compared to those in control facilities.Baseline and 12 monthsThe 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 monthsThe 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 monthsThe 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 monthsThe explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.Baseline and 6 monthsSurvey 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 monthsSurvey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.Baseline and 12 monthsSurvey 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 6 months among providers in intervention facilities compared to those in control facilities.Baseline and 6 monthsThe 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 monthsThe 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 baseline to 12 months among providers in intervention facilities compared to those in control facilities.Baseline and 12 monthsThe 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
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 monthsSurvey questions on receipt and timing of postnatal care
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 monthsSurvey questions on receipt and timing of postnatal care
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 monthsSurvey 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 monthsSurvey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
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 monthsSurvey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
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 monthsSurvey 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 months10-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 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 months10-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 months10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression

Countries

Ghana, Kenya

Contacts

PRINCIPAL_INVESTIGATORPatience Afulani, PhD, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026