Clinical trial NCT06085105: Caring for Providers to Improve Patient Experience (CPIPE) Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Kenya Medical Research Institute
name: Navrongo Health Research Centre, Ghana
First posted: 2023-10-16
Enrollment: 6400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: 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.
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: 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.
timeFrame: Baseline and 12 months
measure: Change in unconscious bias knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: Change in unconscious bias knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in Perceived Stress Scale (PSS) score from baseline to 6 Months, among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: Change in Perceived Stress Scale (PSS) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in bias awareness and mitigation scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: Change in bias awareness and mitigation scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in explicit bias scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: Change in explicit bias scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: 6 months and 12 months
measure: Change in explicit bias scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: Change in supportive environment score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: 6 months and 12 months
measure: Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: Change in self-reported PCMC provision scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: Change in self-reported PCMC provision scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
timeFrame: Baseline and 12 months
measure: 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.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: 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.
timeFrame: Baseline and 12 months
measure: 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.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: 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.
timeFrame: Baseline and 12 months
measure: 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.
timeFrame: Baseline and 6 months
measure: 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.
timeFrame: 6 months and 12 months
measure: 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.
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Navrongo
country: Ghana
facility: Upper East and North East regions health facilities
city: Migori
country: Kenya
facility: Migori and Homabay Counties health facilities
Study officials:
affiliation: University of California, San Francisco
name: Patience Afulani, PhD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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