Caring for Providers to Improve Patient Experience (CPIPE) Trial

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06085105
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Kenya Medical Research Institute (Other), Navrongo Health Research Centre, Ghana (Other)
• Enrollment: 6,400
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 3200
• Patients Per Site Per Month: 53.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological; Maternal Health; Healthcare Provider; Adverse Outcomes; Stress, Emotional; Mental Health Issue; Burnout; Burnout, Psychological; Discrimination, Social	Behavioral: CPIPE Training; Behavioral: Peer support groups; Behavioral: Mentorship; Behavioral: Leadership engagement; Behavioral: Embedded champions	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 6400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: 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
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jan 1, 2028
• Anticipated Study Completion Date: Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Exclusion criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Upper East and North East regions health facilities	Navrongo		Ghana
2	Migori and Homabay Counties health facilities	Migori		Kenya

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Patience Afulani, PhD, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Project website

Publications

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• Afulani PA, Buback L, Kelly AM, Kirumbi L, Cohen CR, Lyndon A. Providers' perceptions of communication and women's autonomy during childbirth: a mixed methods study in Kenya. Reprod Health. 2020 Jun 3;17(1):85. doi: 10.1186/s12978-020-0909-0.
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• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT06085105
• Other Study ID Numbers: 23-38843; R01HD110370
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, San Francisco: quality of care; Kenya; providers; mental health; burnout; stress; person-centered care; discrimination; prejudice; unconscious bias
• Additional relevant MeSH terms: Burnout, Psychological; Stress, Psychological

Study Results

No Results Posted as of Oct 16, 2023