Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study
Phase: NA
Conditions: Preterm Birth
Sponsor: Duke University

 
 
 
 
 
 
 
 
Improving the clinical encounter to enhance an Individualized Prematurity Prevention Plan (IP3) 
The IMPaCT-IP3 Study 
 
Document Date: July 1, 2020 
 
NCT04149002 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The study objective is to determine the feasibility and acceptability of a patient-centered, culturally-
sensitive intervention addressing barriers to IP3 adherence identified by Non-Hispanic Black women. We 
hypothesize that the intervention is both feasible (ie. target enollment reached and 95% of all 
intervention components delivered) and acceptable (over 80% of participants give the intervention top 
rating in their exit interview). 
 
Background & Significance 
 
Preterm birth (PTB), delivery prior to 37 weeks gestation, is the leading cause of neonatal mortality and 
morbidity resulting in life-long medical complications such as blindness, chronic lung disease and 
intellectual disabilities. In 2019, the US PTB rate increased for the fourth consecutive year reaching 10 
percent. Additionally, dramatic racial disparities persist such that the PTB rate is 49% higher in non- 1 
Hispanic black (NHB) women. Preterm birth (PTB) stems from multiple etiologies including medically 
indicated PTB and spontaneous PTB.  Patients with a history of preterm birth seen in the Duke 
Prematurity Prevention Program are provided an Individualized Prematurity Prevention Plan (IP3).  The 
IP3 is a targeted care plan that incorporates components tailored to a patient’s individual risk factors for 
preterm birth such as life-style modifications (i.e. weight gain, nutrition recommendation, stress 
management), supplemental progesterone, serial cervix length screening, cerclage or low dose aspirin. 
 
Adherence is a key component of success of the IP3.  Given both the increasing PTB rate and persistent 
racial disparities, it is imperative to develop patient-oriented, culturally-sensitive interventions that 
improve the clinical encounter and increase IP3 adherence in NHB women. The current intervention was 
developed by a group of stakeholders and is grounded in qualitative data from NHB women about 
barriers and facilitators to supplemental progesterone for preterm birth prevention. The current 
proposal will test the intervention via a pilot randomized controlled trial comparing our intervention to 
an active control. 
 
Design & Procedures 
 
Once consented, patients will complete an intake via a red-cap data base.  The intake will include 
confirmation of basic demographics gleaned from the HER (e.g. age, self-described race, obstetrical 
history) and review of the participant’s IP3.  We will use redcap to randomize participants to the 
intervention or an active control. 
 
The intervention arm includes: 
 
1. A narrated powerpoint presentation describing the logistical details and medical rationale for 
components of the IP3.  Participants will view the chapters of the presentation that are relevant to their 
specific IP3.  There are a total of 4 possible chapters (lifestyle modifications, cervix length 
screening/cerclage, progesterone therapy, low dose aspirin).  Each chapter of the presentation is ~ 10 – 
15 min in length.  Each chapter also includes a 4- 5 questions pre-test and the same questions are 
delivered as a post-test after the presentation.  

 
2. Print materials including a letter explaining the importance of prenatal care for preterm birth 
prevention to employers.  The letter will be given to the research participant and NOT directly to the 
employer.  She will decided if and when the letter is provided. The letter, as with all aspects of the 
project, is optional for her to use.  We will record which patients say they would like to use it and ask if 
patients actually used it and found it helpful during the exit interview. 
 
3. Text messages sent week to encourage the patient to continue with their IP3 and provide basic 
pregnancy information 
 
4. Formal letter of encouragement from provider at 28 weeks gestation 
 
The active control arm includes: 
 
1. A narrated powerpoint with general information about the Duke Prematurity Prevention Program 
 
2. Text messages sent approximately weekly with general pregnancy information (e.g. Tylenol is most 
often safe in pregnancy) 
 
For the subset of patients that have low dose aspirin or vaginal progesterone as part of their IP3 
(whether they are in the control or the intervention arm), they will get an additional weekly text to 
gauge medication compliance. 
 
Measures: 
 
1. Demographic data – Via EHR review and intake interview we will collect basic demographic data (e.g. 
e.g. age, self-described race, obstetrical history) and review the participant’s IP3 
 
2. IP3 Knowledge:  We will assess the participant’s knowledge about the medical and logistical details of 
the components of their IP3.  In the intervention group, knowledge will be assessed via a brief pre-
test/post-test prior to each chapter of the narrated powerpoint.  In the active control group knowledge 
will be assess via the same questions that correspond to the pretest of the chapters that correspond to 
their IP3, however the will be a single assessment rather than a pre and post-test. 
 
3. Pregnancy-Specific Anxiety (PSA):  The PSA is a validated 13-item tool used to assess anxiety specific 
to pregnancy this tool has been correlated with preterm birth outcome. We will administer the PSA at 
intake and 28 weeks. 
 
4. Interpersonal Processes of Care (IPC):  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).    
 

5. Maternal Social Support Scale (MSSS):  The MSSS is a six-question scale that quantifies a pregnant 
women’s social support as low, medium or adequate.  We will administer the MSSS at intake, 28 weeks 
gestation and postpartum 
 
6. IP3 Adherence Data:  We will gather data on adherence to the IP3 based on both participant report 
and EHR chart review. 
 
7. Delivery outcomes:  We will gather delivery outcome data (e.g. gestational age at delivery, birth 
weight, NICU admission, length of hospital stay) based on based on patient report and EHR chart review 
 
Selection of Subjects 
  
We will recruit up to 60 pregnant women from the Duke Perinatal Clinics with the following inclusion 
criteria: self-described non-Hispanic Black race, history of prior preterm delivery (before 37 weeks 
gestation), current singleton gestation, with an IP3 documented. We will exclude women with 
anomalous fetuses, age below 18 or are non-English speaking. 
 
The study staff will approach the subject and provide information regarding the study.  If the patient is 
interested in participating, then study staff will obtain informed consent at that time.  The patient can 
take as much time to decide about participation and the study team will come up with a plan with the 
patient to follow up on a decision to participate.  Voluntariness will be emphasized.  Patients will also be 
told that they were identified as being eligible because their medical chart indicated they have a history 
of a prior preterm birth. 
  
For those patients who choose to ‘opt out,’ to prevent unwelcome emails, phone calls, or other contacts 
from those other than a patient’s clinician, researchers/study teams must check the opt out status for 
each patient who may be eligible for their study and exclude those not wishing to be contacted. 
 
Data Analysis & Statistical Considerations 
 
The proposed study is a feasibility and acceptability pilot study.  We will measure: 
  
Feasibility by: 
-target enollment reached 
-95% of all intervention components delivered 
  
Acceptability will be measured by an exit interview which includes: 
-quantative assessment of the adherence to intervention components 
-qualitative feedback about how the intervention should be changed 
-participants overall rating of the intervention over 80% of participants give the intervention top rating 
in their exit interview.