Health Promotion, Preventive Health Services
Conditions
Brief summary
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
Detailed description
Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families. A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities. To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics. In preparation for the trial, investigators will use a Community Engagement & Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.
Interventions
OTHERParent Coach
The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit. * Parent is English or Spanish proficient * For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.
Exclusion criteria
* More than one child attending Well-Child Care * Legal guardian of child is under 18 years of age * Parents who are employed by one of the federally-qualified health centers (FQHCs) * Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | 12 months post enrollment | Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better |
| Healthcare Utilization: Emergency Department Utilization | 12 months post enrollment | any emergency department care visit for the index child in past 12 months (parent report) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | 12 months post enrollment | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items |
| Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | 12 months post enrollment | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. |
| Healthcare Utilization: Hospitalizations | 12 months post enrollment | any hospitalizations for index child in past 12 months by parent report |
| Experiences of Care: Helpfulness of Care Assessment by Parent Report | 12 months post enrollment | parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better |
| Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report | 12 months post enrollment | receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better |
| Healthcare Utilization: Well Child Care Visits Up to Date | 12 months post enrollment | up to date on well child care by clinic electronic medical record review at 12 months post enrollment |
| Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit | Data not collected due to COVID Pandemic restrictions on in clinic observations. | time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two multi-site federally qualified health centers (FQHCs) in California and Washington State, with 6 and 4 participating practices each. The first participant was enrolled March 5, 2019 and the last participant was enrolled July 1, 2021. \*\*PLEASE NOTE that there were not multiple phases to the trial. this study was a cluster RCT that did not have multiple phases to the trial.
Pre-assignment details
Of 937 enrolled participants, 914 remained enrolled and were eligible to complete 12-month follow-up. Participants are unique parent/child dyads. The parents were enrolled and each parent had an index child that they provided data on. This was the child for who they were coming to the clinic for a well child visit, and the child had to be 12 months of age or younger.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. | 438 |
| Control usual care well child care | 476 |
| Total | 914 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible | 5 | 2 |
| Overall Study | Lost to Follow-up | 60 | 69 |
| Overall Study | Withdrawal by Subject | 9 | 7 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Continuous | 4.4 months STANDARD_DEVIATION 4 | 4.7 months STANDARD_DEVIATION 4 | 4.0 months STANDARD_DEVIATION 4 |
| Child chronic medical problems Chronic medical problems | 16 Participants | 6 Participants | 10 Participants |
| Child chronic medical problems No chronic medical problems | 896 Participants | 470 Participants | 426 Participants |
| Child health insurance Medicaid (Medi-Cal/Apple Health) | 855 Participants | 450 Participants | 405 Participants |
| Child health insurance Military | 1 Participants | 0 Participants | 1 Participants |
| Child health insurance More than one | 7 Participants | 3 Participants | 4 Participants |
| Child health insurance Private Insurance Plan | 14 Participants | 7 Participants | 7 Participants |
| Child health insurance Uninsured | 32 Participants | 15 Participants | 17 Participants |
| Child health insurance Unknown | 3 Participants | 1 Participants | 2 Participants |
| Child's current overall health Excellent | 618 Participants | 325 Participants | 293 Participants |
| Child's current overall health Fair/poor | 9 Participants | 1 Participants | 8 Participants |
| Child's current overall health Good | 87 Participants | 44 Participants | 43 Participants |
| Child's current overall health Very good | 194 Participants | 105 Participants | 89 Participants |
| Highest level of education completed 2-Year college or some college | 279 Participants | 152 Participants | 127 Participants |
| Highest level of education completed 4-Year college degree or greater | 77 Participants | 38 Participants | 39 Participants |
| Highest level of education completed High school graduate or GED | 325 Participants | 166 Participants | 159 Participants |
| Highest level of education completed Less than high school | 231 Participants | 120 Participants | 111 Participants |
| Household Annual Income < $29,999 per year | 482 Participants | 236 Participants | 246 Participants |
| Household Annual Income $30,000 to $49,999 per year | 194 Participants | 111 Participants | 83 Participants |
| Household Annual Income $50,000 to $69,999 per year | 54 Participants | 29 Participants | 25 Participants |
| Household Annual Income $70,000 or more | 38 Participants | 22 Participants | 16 Participants |
| Number of adults in the home 1 adult | 44 Participants | 23 Participants | 21 Participants |
| Number of adults in the home 2 adults | 489 Participants | 257 Participants | 232 Participants |
| Number of adults in the home 3 adults | 149 Participants | 82 Participants | 67 Participants |
| Number of adults in the home 4 or more adults | 231 Participants | 114 Participants | 117 Participants |
| Number of children that parent has 1 child | 313 Participants | 169 Participants | 144 Participants |
| Number of children that parent has 2 children | 256 Participants | 126 Participants | 130 Participants |
| Number of children that parent has 3 children | 187 Participants | 105 Participants | 82 Participants |
| Number of children that parent has 4 or more children | 157 Participants | 76 Participants | 81 Participants |
| Primary language spoken at home English | 455 Participants | 243 Participants | 212 Participants |
| Primary language spoken at home Other | 62 Participants | 34 Participants | 28 Participants |
| Primary language spoken at home Spanish | 396 Participants | 199 Participants | 197 Participants |
| PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health | 54.3 T-Score STANDARD_DEVIATION 8.3 | 53.9 T-Score STANDARD_DEVIATION 8.2 | 54.7 T-Score STANDARD_DEVIATION 8.5 |
| PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health | 50.9 T-Score STANDARD_DEVIATION 8.2 | 50.6 T-Score STANDARD_DEVIATION 7.9 | 51.1 T-Score STANDARD_DEVIATION 8.4 |
| PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score | 57.4 T-Score STANDARD_DEVIATION 7.3 | 57.2 T-Score STANDARD_DEVIATION 7.6 | 57.6 T-Score STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized Latino | 664 participants | 343 participants | 321 participants |
| Race/Ethnicity, Customized Non-Latino Asian | 27 participants | 13 participants | 14 participants |
| Race/Ethnicity, Customized Non-Latino Black | 46 participants | 22 participants | 24 participants |
| Race/Ethnicity, Customized Non-Latino Multi-Racial | 31 participants | 15 participants | 16 participants |
| Race/Ethnicity, Customized Non-Latino Other | 35 participants | 25 participants | 10 participants |
| Race/Ethnicity, Customized Non-Latino White | 108 participants | 56 participants | 52 participants |
| Respondent country of birth Country other than U.S. | 445 Participants | 227 Participants | 218 Participants |
| Respondent country of birth United States | 467 Participants | 249 Participants | 218 Participants |
| Respondent marital status Divorced | 14 Participants | 8 Participants | 6 Participants |
| Respondent marital status Living with a partner | 354 Participants | 189 Participants | 165 Participants |
| Respondent marital status Married | 345 Participants | 181 Participants | 164 Participants |
| Respondent marital status Separated | 25 Participants | 12 Participants | 13 Participants |
| Respondent marital status Single (never married & currently not living with a partner) | 175 Participants | 86 Participants | 89 Participants |
| Sex/Gender, Customized Father | 42 Participants | 22 Participants | 20 Participants |
| Sex/Gender, Customized Grandmother | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Mother | 868 Participants | 454 Participants | 414 Participants |
| Trouble paying for any household expenses No trouble paying for any household expenses in past 12 months | 380 Participants | 186 Participants | 194 Participants |
| Trouble paying for any household expenses Trouble paying for any household expenses in past 12 months | 527 Participants | 289 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 452 | 1 / 485 |
| other Total, other adverse events | 0 / 452 | 0 / 485 |
| serious Total, serious adverse events | 0 / 452 | 1 / 485 |
Outcome results
Primary
Healthcare Utilization: Emergency Department Utilization
any emergency department care visit for the index child in past 12 months (parent report)
Time frame: 12 months post enrollment
Population: all participants completing 12 month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Healthcare Utilization: Emergency Department Utilization | 140 Participants |
| Control | Healthcare Utilization: Emergency Department Utilization | 147 Participants |
Primary
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits
Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better
Time frame: 12 months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | 73.9 score on a scale | Standard Deviation 23.4 |
| Control | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | 63.3 score on a scale | Standard Deviation 27.8 |
Secondary
Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit
time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.
Time frame: Data not collected due to COVID Pandemic restrictions on in clinic observations.
Population: Data were not collected due to COVID 19 pandemic restrictions on in clinic observations
Secondary
Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better
Time frame: 12 months post enrollment
Population: all participants completing 12 month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report | 89.0 score on a scale | Standard Deviation 22.5 |
| Control | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report | 85.5 score on a scale | Standard Deviation 27.1 |
Secondary
Experiences of Care: Helpfulness of Care Assessment by Parent Report
parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better
Time frame: 12 months post enrollment
Population: all participants completing 12 month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Experiences of Care: Helpfulness of Care Assessment by Parent Report | 77.8 score on a scale | Standard Deviation 25.2 |
| Control | Experiences of Care: Helpfulness of Care Assessment by Parent Report | 69.8 score on a scale | Standard Deviation 30.7 |
Secondary
Healthcare Utilization: Hospitalizations
any hospitalizations for index child in past 12 months by parent report
Time frame: 12 months post enrollment
Population: all participants completing 12 month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Healthcare Utilization: Hospitalizations | 12 Participants |
| Control | Healthcare Utilization: Hospitalizations | 9 Participants |
Secondary
Healthcare Utilization: Well Child Care Visits Up to Date
up to date on well child care by clinic electronic medical record review at 12 months post enrollment
Time frame: 12 months post enrollment
Population: all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Healthcare Utilization: Well Child Care Visits Up to Date | 309 Participants |
| Control | Healthcare Utilization: Well Child Care Visits Up to Date | 295 Participants |
Secondary
Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.
Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.
Time frame: 12 months post enrollment
Population: Number analyzed differs from overall because of missing data (participant did not respond to item in question)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Behavioral Concerns Elicited & Addressed | 305 Participants |
| Intervention | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Developmental Screening | 310 Participants |
| Control | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Behavioral Concerns Elicited & Addressed | 292 Participants |
| Control | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Developmental Screening | 332 Participants |
Secondary
Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits
Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items
Time frame: 12 months post enrollment
Population: all participants completing 12 month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | 253 Participants |
| Control | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | 203 Participants |