Caring for Providers to Improve Patient Experience (CPIPE) Trial

University of California San Francisco (UCSF)

Status: Invitation-only

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06085105

23-38843

R01HD110370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,400 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,400 participants in 2 patient groups

CPIPE Intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Peer support groups

Behavioral: Leadership engagement

Behavioral: CPIPE Training

Behavioral: Mentorship

Behavioral: Embedded champions

CPIPE control arm

No Intervention group

Description:

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