Chronic Conditions, Multiple, Family Research, Parent-Child Relations, Parenting, Patient Empowerment, Patient Engagement, Premature Infant Disease, Self Efficacy
Conditions
Keywords
neonatal intensive care unit, prematurity, family management, self-management, patient education
Brief summary
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.
Detailed description
Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.
Interventions
PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
usual care and welcome videos
Sponsors
Study design
Eligibility
Inclusion criteria
* English-speaking parents * Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA) * Parents who had a singleton or twin birth * Parents 18 years of age or older
Exclusion criteria
* Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent * Infants with imminent or probable death based on the healthcare team's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Self-Rating of Depression | Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. | Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. |
| Maternal Self-Rating of Anxiety | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. | Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. |
| Receipt of Exclusive Mother's Human Milk | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3). | Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds |
| Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age | Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth. | Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\] |
| NICU Length of Stay | Date of NICU discharge will be assessed until study completion, with maximum of 1 year | Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU) |
| Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | Thirty days after infant discharge from the NICU. | The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?, to ensure all rehospitalizations and ED visits were captured. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PREEMIE PROGRESS PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant.
PREEMIE PROGRESS: PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU). | 33 |
| Attention Control To maintain their attention, control parents will view Welcome Videos that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.
Attention Control: usual care and welcome videos | 31 |
| Total | 64 |
Baseline characteristics
| Characteristic | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 6.7 | 30.5 years STANDARD_DEVIATION 4.3 | 29.8 years STANDARD_DEVIATION 5.7 |
| Age, Customized Infant gestation at birth (wks) | 29.2 weeks STANDARD_DEVIATION 1.8 | 29.3 weeks STANDARD_DEVIATION 2.1 | 29.2 weeks STANDARD_DEVIATION 1.9 |
| Birth weight (g) | 1253.9 grams STANDARD_DEVIATION 392.4 | 1286.2 grams STANDARD_DEVIATION 359.2 | 1269 grams STANDARD_DEVIATION 374 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 29 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Income (in $10,000) | 47000 Annual income in $10,000 STANDARD_DEVIATION 39000 | 44000 Annual income in $10,000 STANDARD_DEVIATION 39000 | 45400 Annual income in $10,000 STANDARD_DEVIATION 39000 |
| PROMIS (Patient-Reported Outcomes Measurement Information System)8a Anxiety | 53.4 T-score STANDARD_DEVIATION 8.8 | 57.3 T-score STANDARD_DEVIATION 76.9 | 55.2 T-score STANDARD_DEVIATION 9.7 |
| PROMIS (Patient-Reported Outcomes Measurement Information System)8a Depression | 48.1 T-score STANDARD_DEVIATION 8.6 | 49.3 T-score STANDARD_DEVIATION 8 | 48.7 T-score STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 10 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 17 Participants | 35 Participants |
| Region of Enrollment United States | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 24 Participants |
| Sex: Female, Male Male | 17 Participants | 23 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 1 / 34 |
| other Total, other adverse events | 3 / 31 | 0 / 34 |
| serious Total, serious adverse events | 0 / 31 | 0 / 34 |
Outcome results
Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age
Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
Time frame: Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.
Population: Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PREEMIE PROGRESS | Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age | -0.8 Z-score |
| Attention Control | Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age | -0.72 Z-score |
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response
The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?, to ensure all rehospitalizations and ED visits were captured.
Time frame: Thirty days after infant discharge from the NICU.
Population: Coded as Yes/No and extracted from the infant's electronic health record. Mothers were also asked Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?, to ensure all rehospitalizations and ED visits were captured.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PREEMIE PROGRESS | Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | 2 Participants |
| Attention Control | Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | 4 Participants |
Maternal Self-Rating of Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.
Time frame: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.
Population: The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point \[14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)\], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline at each time point in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PREEMIE PROGRESS | Maternal Self-Rating of Anxiety | T2-Baseline | -3.08 T-score | Standard Error 1.74 |
| PREEMIE PROGRESS | Maternal Self-Rating of Anxiety | T3-Baseline | 2.87 T-score | Standard Error 1.77 |
| PREEMIE PROGRESS | Maternal Self-Rating of Anxiety | T4-Baseline | -4.67 T-score | Standard Error 1.59 |
| Attention Control | Maternal Self-Rating of Anxiety | T2-Baseline | -1.96 T-score | Standard Error 1.52 |
| Attention Control | Maternal Self-Rating of Anxiety | T3-Baseline | -3.91 T-score | Standard Error 1.53 |
| Attention Control | Maternal Self-Rating of Anxiety | T4-Baseline | -7.54 T-score | Standard Error 1.93 |
Maternal Self-Rating of Depression
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: T-score: standardized score mean of 50 and standard deviation (SD) of 10 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.
Time frame: Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.
Population: The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point \[14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)\], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline to 30 days after infant discharge from the NICU (T4).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PREEMIE PROGRESS | Maternal Self-Rating of Depression | T2 - Baseline | -3.75 T-score mean changes | Standard Error 1.7 |
| PREEMIE PROGRESS | Maternal Self-Rating of Depression | T3 - Baseline | -2.21 T-score mean changes | Standard Error 1.58 |
| PREEMIE PROGRESS | Maternal Self-Rating of Depression | T4 - Baseline | -4.08 T-score mean changes | Standard Error 1.42 |
| Attention Control | Maternal Self-Rating of Depression | T2 - Baseline | -4.08 T-score mean changes | Standard Error 1.42 |
| Attention Control | Maternal Self-Rating of Depression | T3 - Baseline | -2.50 T-score mean changes | Standard Error 1.35 |
| Attention Control | Maternal Self-Rating of Depression | T4 - Baseline | -3.75 T-score mean changes | Standard Error 1.7 |
NICU Length of Stay
Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
Time frame: Date of NICU discharge will be assessed until study completion, with maximum of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PREEMIE PROGRESS | NICU Length of Stay | 68.3 days | Standard Deviation 36.3 |
| Attention Control | NICU Length of Stay | 57.2 days | Standard Deviation 23.4 |
Receipt of Exclusive Mother's Human Milk
Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds
Time frame: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).
Population: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PREEMIE PROGRESS | Receipt of Exclusive Mother's Human Milk | T3 | 14 Participants |
| PREEMIE PROGRESS | Receipt of Exclusive Mother's Human Milk | Baseline | 17 Participants |
| PREEMIE PROGRESS | Receipt of Exclusive Mother's Human Milk | T2 | 13 Participants |
| Attention Control | Receipt of Exclusive Mother's Human Milk | T2 | 15 Participants |
| Attention Control | Receipt of Exclusive Mother's Human Milk | T3 | 10 Participants |
| Attention Control | Receipt of Exclusive Mother's Human Milk | Baseline | 18 Participants |