Caring for Providers to Improve Patient Experience (CPIPE) Trial

NCT06085105 | Enrolling By Invitation

• 2 other identifiers: 23-38843R01HD110370
• Study Type: interventional
• Target: 6,400
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Baseline and 6 months

• 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.

  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.

  6 months and 12 months

• 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.

  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.

  Baseline and 12 months

Secondary Outcomes (33)

• 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 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 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 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

Study Arms (2)

CPIPE Intervention arm

EXPERIMENTAL

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.

Behavioral: CPIPE Training; Behavioral: Peer support groups; Behavioral: Mentorship; Behavioral: Leadership engagement; Behavioral: Embedded champions

CPIPE control arm

NO INTERVENTION

The control group will not receive the CPIPE intervention during the 12-month data collection period but will maintain their usual facility level activities.

Interventions

CPIPE Training 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.

CPIPE Intervention arm

Peer support groups 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.

CPIPE Intervention arm

Mentorship 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.

CPIPE Intervention arm

Leadership engagement 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.

CPIPE Intervention arm

Embedded champions 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 Intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Kenya Medical Research Institute: collaborator
• Navrongo Health Research Centre, Ghana: collaborator

Study Sites (2)

Upper East and North East regions health facilities

Navrongo, Ghana

Location

Migori and Homabay Counties health facilities

Migori, Kenya

Location

Related Publications (132)

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  RESULT

• Afulani PA, Getahun M, Ongeri L, Aborigo R, Kinyua J, Ogolla BA, Okiring J, Moro A, Oluoch I, Dalaba M, Odiase O, Ouner JJ, Mendes WB, Walker D, Neilands TB. A cluster randomized controlled trial to assess the impact of the 'Caring for Providers to Improve Patient Experience' (CPIPE) intervention in Kenya and Ghana: study protocol. BMC Public Health. 2024 Sep 16;24(1):2509. doi: 10.1186/s12889-024-20023-9.

  PMID: 39285405 DERIVED

Related Links

• Project website

MeSH Terms

Conditions

Stress, Psychological; Burnout, Psychological; Social Discrimination; Psychological Well-Being; Prejudice; Bias, Implicit

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior; Personal Satisfaction

Study Officials

• Patience Afulani, PhD, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 16, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1); KE (1)