Preterm Birth Clinical Trial
Official title:
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study
Verified date | November 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - self described race as Non-Hispanic Black - history of prior singleton preterm delivery (before 37 weeks gestation) - current singleton gestation Exclusion Criteria: - women with anomalous fetuses - age below 18] - non-English speaking |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | Enrollment target of 30% of eligible patients recruited. | study duration (approximately 14 months) | |
Primary | Acceptability as Measured by Number of Participants Who Completed the Study | Completion target of 80% participants retained in study protocol. | study duration (approximately 14 months) | |
Secondary | IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | approximately 1 year | ||
Secondary | Pregnancy Specific Anxiety (PSA) | Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety. | baseline, 28 weeks | |
Secondary | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive). | protocol completion (approximately 1 year) | |
Secondary | Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient). | protocol completion (approximately 1 year) | |
Secondary | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative). | protocol completion (approximately 1 year) | |
Secondary | Change in Maternal Social Support Scale (MSSS) | The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support. | baseline to protocol completion (approximately 1 year) | |
Secondary | Gestational Age at Delivery in Weeks | approximately 40 weeks | ||
Secondary | Birth Weight in Grams | approximately 40 weeks | ||
Secondary | Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | approximately 40 weeks | ||
Secondary | Length of Delivery Hospital Admission in Days | approximately 40 weeks |
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