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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.
The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index.
The team will collect feedback on the intervention based on an intake questionnaire and an exit interview.
Information will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: Weekly IP3 text messages | Other |
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| Control Arm: General pregnancy text messages | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Arm Weekly IP3 text messages | Behavioral | Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | Enrollment target of 30% of eligible patients recruited. | study duration (approximately 14 months) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | approximately 1 year | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarahn Wheeler, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm: Weekly IP3 Text Messages |
Intervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. |
| FG001 | Control Arm: General Pregnancy Text Messages |
Active Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm: Weekly IP3 Text Messages |
Intervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | Enrollment target of 30% of eligible patients recruited. | Posted | Count of Participants | Participants | study duration (approximately 14 months) |
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Approximately 1 year
Adverse Events are for Mothers only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm: Weekly IP3 Text Messages |
Intervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarahn M. Wheeler, MD | Duke University | (919) 684-6327 | sarahn.wheeler@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Mar 30, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2020 | Nov 23, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Intervention Arm vs. Active Control Arm
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| Active Control Arm General pregnancy text messages | Other | Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. |
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| baseline, 28 weeks |
| 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) |
| 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) |
| 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) |
| 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) |
| Gestational Age at Delivery in Weeks | approximately 40 weeks |
| Birth Weight in Grams | approximately 40 weeks |
| Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | approximately 40 weeks |
| Length of Delivery Hospital Admission in Days | approximately 40 weeks |
| BG001 | Control Arm: General Pregnancy Text Messages |
Active Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Acceptability as Measured by Number of Participants Who Completed the Study | Completion target of 80% participants retained in study protocol. | Posted | Count of Participants | Participants | study duration (approximately 14 months) |
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| Secondary | IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | Posted | Count of Participants | Participants | approximately 1 year |
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| 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. | Participants who completed the PSA questionnaire. | Posted | Mean | Standard Deviation | score on a scale | baseline, 28 weeks |
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| 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). | Participants who completed the IPC-18 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | protocol completion (approximately 1 year) |
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| 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). | Participants who completed the IPC-18 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | protocol completion (approximately 1 year) |
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| 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). | Participants who completed the IPC-18 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | protocol completion (approximately 1 year) |
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| 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. | Participants who completed the MSSS questionnaire. | Posted | Mean | Standard Deviation | score on a scale | baseline to protocol completion (approximately 1 year) |
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| Secondary | Gestational Age at Delivery in Weeks | Posted | Mean | Standard Deviation | weeks | approximately 40 weeks |
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| Secondary | Birth Weight in Grams | Posted | Mean | Standard Deviation | grams | approximately 40 weeks |
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| Secondary | Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | Posted | Count of Units | Neonates | approximately 40 weeks | Neonates | Neonates |
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| Secondary | Length of Delivery Hospital Admission in Days | Posted | Median | Inter-Quartile Range | days | approximately 40 weeks |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Control Arm: General Pregnancy Text Messages |
Active Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D000091642 | Urogenital Diseases |
| Explain results |
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| Disrespectful to office staff |
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