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Completed

NCT Number: NCT04149002

Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan

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.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility as Measured by Number of Recruited Eligible Patients Enrolled

    Time frame: study duration (approximately 14 months)

    Enrollment target of 30% of eligible patients recruited.

  2. Acceptability as Measured by Number of Participants Who Completed the Study

    Time frame: study duration (approximately 14 months)

    Completion target of 80% participants retained in study protocol.

Secondary outcomes

  1. IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance

    Time frame: approximately 1 year

  2. Pregnancy Specific Anxiety (PSA)

    Time frame: baseline, 28 weeks

    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.

  3. Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain

    Time frame: protocol completion (approximately 1 year)

    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).

  4. Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain

    Time frame: protocol completion (approximately 1 year)

    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).

  5. Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain

    Time frame: protocol completion (approximately 1 year)

    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).

  6. Change in Maternal Social Support Scale (MSSS)

    Time frame: baseline to protocol completion (approximately 1 year)

    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.

  7. Gestational Age at Delivery in Weeks

    Time frame: approximately 40 weeks

  8. Birth Weight in Grams

    Time frame: approximately 40 weeks

  9. Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)

    Time frame: approximately 40 weeks

  10. Length of Delivery Hospital Admission in Days

    Time frame: approximately 40 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2019
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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