Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care
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| ClinicalTrials.gov Identifier: NCT03797898 |
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Recruitment Status :
Recruiting
First Posted : January 9, 2019
Last Update Posted : June 11, 2021
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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.
There are 2 major phases to this study. In Phase 1, the 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. In Phase 2, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preventive Health Services Health Promotion | Other: Parent Coach | Not Applicable |
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.
There are 2 major phases to this study. In Phase 1, the 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. In Phase 2, 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 940 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children |
| Actual Study Start Date : | March 5, 2019 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | September 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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).
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Other: 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. |
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No Intervention: Control
usual care well child care
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- Receipt of Preventive Care Services: Anticipatory Guidance topics received by parent report at well visits [ Time Frame: 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.
- Healthcare Utilization: Emergency Department Visits made in 12 month period by parent report [ Time Frame: 12 months post enrollment ]number of emergency department care visits in past 12 months (parent report)
- Clinician Time with Parent during the WCC visit, from Observations of Well Child Care Visit [ Time Frame: Baseline and 12 month post enrollment data collected by visit observations with timed data of visit ]Differences in time spent in parent-provider visit pre versus post intervention during the well child care visit
- Receipt of Preventive Care Services: Psychosocial Screening received by parent report at well visits [ Time Frame: 12 months post enrollment ]Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics (psychosocial screening received or not)
- Receipt of Preventive Care Services: Developmental Concerns addressed and Screening received by parent report at well visits. [ Time Frame: 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 during 12 month period by parent report [ Time Frame: 12 months post enrollment ]number of hospitalizations in past 12 months by parent report
- Healthcare Utilization: Well Child Care Visits Up to Date by Medical record review at 12 months post enrollment [ Time Frame: 12 months post enrollment ]up to date on well child care by clinic electronic medical record review
- Experiences of Care: Helpfulness of care assessment by parent report [ Time Frame: 12 months post enrollment ]parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey
- Experiences of Care: Family Centeredness of Care- whether it was received by parent report [ Time Frame: 12 months post enrollment ]receipt of family centeredness of care using items adapted from National Survey of Children's Health
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797898
| Contact: Lorena Porras-Javier, MPH | 3109027202 | lporras@mednet.ucla.edu | |
| Contact: Elizabeth K Wingfield, M.A. | 917 923 7329 | elizabeth.wingfield@seattlechildrens.org |
| United States, California | |
| University of California, Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Peter G Szilagyi, MD/MPH 310-206-6328 pszilagyi@mednet.ucla.edu | |
| United States, Washington | |
| Seattle Children's Research Institute | Recruiting |
| Seattle, Washington, United States, 98121 | |
| Contact: Tumaini R Coker, MD/MBA 310-663-6721 tumaini.coker@seattlechildrens.org | |
| Principal Investigator: | Tumaini R Coker, MD/MBA | Seattle Children's |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tumaini Coker, Associate Professor, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT03797898 |
| Other Study ID Numbers: |
STUDY00000413 5R01HD088586 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 9, 2019 Key Record Dates |
| Last Update Posted: | June 11, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |