Stress, Psychological Clinical Trial
— CPIPEOfficial 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
Verified date | April 2024 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 6400 |
Est. completion date | January 2029 |
Est. primary completion date | January 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Ghana | Upper East and North East regions health facilities | Navrongo | |
Kenya | Migori and Homabay Counties health facilities | Migori |
Lead Sponsor | Collaborator |
---|---|
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 |
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* Note: There are 131 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 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. | Baseline and 6 months | |
Secondary | 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. | 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. | 6 months and 12 months | |
Secondary | 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. | 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. | Baseline and 12 months | |
Secondary | Change in unconscious bias knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 6 months | |
Secondary | 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. | 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 months and 12 months | |
Secondary | Change in unconscious bias knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 12 months | |
Secondary | Change in Perceived Stress Scale (PSS) score from baseline to 6 Months, among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 6 months | |
Secondary | 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. | 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. | 6 months and 12 months | |
Secondary | Change in Perceived Stress Scale (PSS) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 12 months | |
Secondary | Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout. | Baseline and 6 months | |
Secondary | 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. | The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout. | 6 months and 12 months | |
Secondary | Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout. | Baseline and 12 months | |
Secondary | Change in bias awareness and mitigation scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 6 months | |
Secondary | 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. | 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. | 6 months and 12 months | |
Secondary | Change in bias awareness and mitigation scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | 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. | Baseline and 12 months | |
Secondary | Change in explicit bias scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias. | Baseline and 6 months | |
Secondary | Change in explicit bias scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities. | The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias. | 6 months and 12 months | |
Secondary | Change in explicit bias scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias. | Baseline and 12 months | |
Secondary | Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment. | Baseline and 6 months | |
Secondary | Change in supportive environment score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities. | Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment. | 6 months and 12 months | |
Secondary | Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment. | Baseline and 12 months | |
Secondary | Change in self-reported PCMC provision scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities. | The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision. | Baseline and 6 months | |
Secondary | 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. | The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision. | 6 months and 12 months | |
Secondary | Change in self-reported PCMC provision scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities. | The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision. | Baseline and 12 months | |
Secondary | 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. | Survey questions on receipt and timing of postnatal care | Baseline and 6 months | |
Secondary | 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. | Survey questions on receipt and timing of postnatal care | 6 months and 12 months | |
Secondary | 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. | Survey questions on receipt and timing of postnatal care | Baseline and 12 months | |
Secondary | 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. | Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding | Baseline and 6 months | |
Secondary | 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. | Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding | 6 months and 12 months | |
Secondary | 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. | Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding | Baseline and 12 months | |
Secondary | 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. | 10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression | Baseline and 6 months | |
Secondary | 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. | 10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression | 6 months and 12 months | |
Secondary | 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. | 10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression | Baseline and 12 months |
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