Trial Outcomes & Findings for Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (NCT NCT04149002)

NCT ID: NCT04149002

Last Updated: 2022-11-02

Results Overview

Enrollment target of 30% of eligible patients recruited.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

study duration (approximately 14 months)

Results posted on

2022-11-02

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Arm: Weekly IP3 Text Messages
* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3 (Individualized Prematurity Prevention Plan). 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. * Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers. * Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information * Formal letter of encouragement from provider at 28 weeks gestation 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.
Control Arm: General Pregnancy Text Messages
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Overall Study
STARTED
14
16
Overall Study
COMPLETED
12
16
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Arm: Weekly IP3 Text Messages
* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3 (Individualized Prematurity Prevention Plan). 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. * Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers. * Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information * Formal letter of encouragement from provider at 28 weeks gestation 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.
Control Arm: General Pregnancy Text Messages
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Overall Study
Lost to Follow-up
1
0
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Arm: Weekly IP3 Text Messages
n=14 Participants
* 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. * Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers. * Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information * Formal letter of encouragement from provider at 28 weeks gestation 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.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
30.9 years
STANDARD_DEVIATION 5.3 • n=99 Participants
32.1 years
STANDARD_DEVIATION 7.0 • n=107 Participants
31.5 years
STANDARD_DEVIATION 6.2 • n=206 Participants
Sex: Female, Male
Female
14 Participants
n=99 Participants
16 Participants
n=107 Participants
30 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=99 Participants
16 Participants
n=107 Participants
30 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=99 Participants
16 Participants
n=107 Participants
30 Participants
n=206 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
14 Participants
n=99 Participants
16 Participants
n=107 Participants
30 Participants
n=206 Participants

PRIMARY outcome

Timeframe: study duration (approximately 14 months)

Enrollment target of 30% of eligible patients recruited.

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=54 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Feasibility as Measured by Number of Recruited Eligible Patients Enrolled
30 Participants

PRIMARY outcome

Timeframe: study duration (approximately 14 months)

Completion target of 80% participants retained in study protocol.

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Acceptability as Measured by Number of Participants Who Completed the Study
12 Participants
16 Participants

SECONDARY outcome

Timeframe: approximately 1 year

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance
1 Participants
3 Participants

SECONDARY outcome

Timeframe: baseline, 28 weeks

Population: Participants who completed the PSA questionnaire.

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.

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=11 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=15 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Pregnancy Specific Anxiety (PSA)
Baseline
2.6 score on a scale
Standard Deviation 1.0
2.4 score on a scale
Standard Deviation 0.9
Pregnancy Specific Anxiety (PSA)
28 Weeks
2.3 score on a scale
Standard Deviation 0.9
2.3 score on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: protocol completion (approximately 1 year)

Population: Participants who completed the IPC-18 questionnaire.

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).

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=11 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=15 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
Lack of clarity
1.6 score on a scale
Standard Deviation 0.6
1.6 score on a scale
Standard Deviation 1.1
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
Elicits concern
4.6 score on a scale
Standard Deviation 0.6
4.7 score on a scale
Standard Deviation 0.6
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
Explain results
4.5 score on a scale
Standard Deviation 0.6
4.6 score on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: protocol completion (approximately 1 year)

Population: Participants who completed the IPC-18 questionnaire.

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).

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=11 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=15 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain
4.4 score on a scale
Standard Deviation 1.1
4.8 score on a scale
Standard Deviation 0.4

SECONDARY outcome

Timeframe: protocol completion (approximately 1 year)

Population: Participants who completed the IPC-18 questionnaire.

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).

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=11 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=15 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
Emotional support
4.7 score on a scale
Standard Deviation 0.5
4.8 score on a scale
Standard Deviation 0.4
Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
Discrimination due to race/ethnicity
1.5 score on a scale
Standard Deviation 0.7
1.3 score on a scale
Standard Deviation 0.8
Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
Disrespectful to office staff
1.2 score on a scale
Standard Deviation 0.3
1.1 score on a scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: baseline to protocol completion (approximately 1 year)

Population: Participants who completed the MSSS questionnaire.

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.

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=11 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=15 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Change in Maternal Social Support Scale (MSSS)
0.1 score on a scale
Standard Deviation 1.5
-1.4 score on a scale
Standard Deviation 2.4

SECONDARY outcome

Timeframe: approximately 40 weeks

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Gestational Age at Delivery in Weeks
34.0 weeks
Standard Deviation 6.1
35.7 weeks
Standard Deviation 3.5

SECONDARY outcome

Timeframe: approximately 40 weeks

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Birth Weight in Grams
2442.5 grams
Standard Deviation 1255.9
2607.9 grams
Standard Deviation 750.6

SECONDARY outcome

Timeframe: approximately 40 weeks

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Neonates
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Neonates
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)
5 Neonates
4 Neonates

SECONDARY outcome

Timeframe: approximately 40 weeks

Outcome measures

Outcome measures
Measure
Eligible Patients Recruited
n=14 Participants
Patients who met all study inclusion criteria.
Control Arm: General Pregnancy Text Messages
n=16 Participants
* a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview 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.
Length of Delivery Hospital Admission in Days
2 days
Interval 2.0 to 3.0
3 days
Interval 2.0 to 3.0

Adverse Events

Intervention Arm: Weekly IP3 Text Messages

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Arm: General Pregnancy Text Messages

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarahn M. Wheeler, MD

Duke University

Phone: (919) 684-6327

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place