Adapted PARENT Model for Well Child Checkups

Recruiting at 1 trial location

Overseen By Tumaini Coker, MD, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new model for providing well-child care to families in low-income communities. Instead of relying solely on doctors, a community health worker, or "coach," will guide families through important preventive care for their young children. The study compares this community-driven approach, known as the Adapted PARENT Model, to traditional doctor-led care, focusing on its impact on health services and family experiences. This trial suits families with children aged 9 to 15 months who have visited the participating practices and are insured through certain health plans. As an unphased study, it offers families the chance to contribute to innovative healthcare solutions that could improve community health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Adapted PARENT Model is safe for well-child checkups?

Research shows that the Adapted PARENT Model aims to enhance regular child healthcare by employing a community health worker, known as a "Parent's Coach," to assist families. This method was primarily tested with Latino families on Medicaid. Studies found that families felt comfortable with this model, and no major safety concerns arose.

The PARENT model offers families comprehensive support and resources without over-relying on doctors. Previous studies have not identified any significant safety issues, indicating that this model is safe for families to incorporate into their child's regular care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adapted PARENT Model because it innovates well-child checkups by incorporating a community health worker, or "coach," into the care team. Unlike traditional well-child care, which relies solely on the primary care clinician, this model offers a team-based approach that provides family-centered preventive services. The coach helps families by independently conducting anticipatory guidance, social needs screenings, and developmental screenings, and connects them to community resources. This approach aims to address broader family needs and lessen the burden on clinicians, potentially enhancing the quality and comprehensiveness of preventive care for young children.

What evidence suggests that the adapted PARENT model is effective for well-child care?

Research has shown that the Adapted PARENT Model, which participants in this trial may receive, improves healthcare for children in low-income communities. Studies have found that a Parent Coach, who serves as a community health worker, facilitates the delivery of preventive care services. In past trials, this approach resulted in improved child development checks, assessments of social needs, and connections to community resources. Parents reported better experiences with their child's care, and emergency room visits decreased. Overall, the Adapted PARENT Model has proven highly beneficial in providing comprehensive care to families in need. ^{1 2 4 6 7}

Who Is on the Research Team?

Tumaini Coker, MD, MBA

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for Black families with children aged between 9 and 15 months who have visited the practice in the last 9 months and are insured by Partners for Kids, an ACO. It's designed to help improve well-child care.

Inclusion Criteria

are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN

have ≥1 visit at the practice in previous 9 months

I am between 9 and 15 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the adapted PARENT model for all well-visits, newborn through 15 months of age, with a 9-month implementation exposure period

9 months

Regular well-child care visits

Follow-up

Participants are monitored for receipt of preventive care services, healthcare utilization, and parent experiences of care

Every 9 months, up to 5 years

Evaluation

Evaluation of the intervention's effectiveness and patient-centered economic outcomes

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adapted PARENT Model

Trial Overview The study tests the adapted PARENT model, which uses a community health worker as a 'Parent's Coach' to provide Well-Child Care services, aiming to enhance preventive care and reduce emergency visits compared to traditional care.

How Is the Trial Designed?

Group I: Adapted PARENT Model Experimental Treatment 1 Intervention

PARENT is a team-based approach to care that utilizes a community health worker (called a "coach") as part of the WCC team to provide comprehensive and family-centered preventive care services, address concerns related to family social needs, and decrease reliance on the clinician as the sole provider of preventive care services. The coach independently meets with the family at every early childhood well-child care visit to provide anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. Practices will implement the adapted PARENT model for all well-visits, newborn through 15 months of age, and have a 9-month implementation exposure period to ensure that children ≤15 months of age at the practice have received the intervention; thereafter the practices maintain the intervention.

Group II: Traditional Well-Child Care Active Control 1 Intervention

Our comparator is traditional well-child care, which follows national preventive care guidelines including structured and standardized developmental and social needs screening, and is in widespread use. These are well-child care visits led by the primary care clinician without a community health worker. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention.

Adapted PARENT Model is already approved in United States for the following indications:

Approved in United States as PARENT for:

• Preventive care services for children and families in low-income communities

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) model significantly improved the quality of well-child care for low-income families, as parents reported better preventive care and overall experiences with healthcare services.

Children in the PARENT intervention group had 52% fewer emergency department visits compared to the control group, suggesting that this model may lead to cost savings and better health outcomes for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Coker, TR., Chacon, S., Elliott, MN., et al.[2018]

The PARENT intervention, which utilizes a Parent Coach to provide well-child care services, is being evaluated in a large cluster randomized controlled trial involving 916 families with children under 12 months, aiming to improve the quality of care in low-income communities.

The study will assess key outcomes such as the receipt of anticipatory guidance and emergency department use, with the goal of establishing PARENT as an effective and sustainable model for delivering preventive care services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. Hurst, R., Liljenquist, K., Lowry, SJ., et al.[2022]

A new model of well-child care (WCC) for children aged 0 to 3 years was developed through collaboration with community health centers and independent practices, emphasizing the role of health educators in providing anticipatory guidance and developmental screening.

The model includes innovative communication methods, such as secure web-based tools and non-face-to-face communication, to enhance family-centered care and improve the delivery of recommended services, making it adaptable for other small practices and clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Well-child care clinical practice redesign for serving low-income children. Coker, TR., Moreno, C., Shekelle, PG., et al.[2021]

The 'Calling for Help' (C4H) intervention increased parent awareness to 35% in a pediatric hospital setting, indicating a positive response from both parents and nurses regarding its implementation.

Despite the positive feedback, only 12% of clinical deterioration events had documented parent concerns, highlighting the need for further strategies to boost parent confidence in using C4H and improve communication between parents and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent escalation of care for the deteriorating child in hospital: A health-care improvement study. Gill, FJ., Leslie, GD., Marshall, AP.[2023]

The PARENT model, which includes a parent coach and tools like the Well-Visit Planner, was found to be highly acceptable and feasible among parents in low-income communities, with 97-99% of participants recommending the coach-led well visits.

Parents reported that the intervention improved the efficiency and comprehensiveness of well-child care visits, with 87% using the Well-Visit Planner and 62% finding the text message service helpful for reinforcing information discussed during visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Mimila, NA., Chung, PJ., Elliott, MN., et al.[2022]

The current well-child care system in the U.S. is struggling to meet the comprehensive preventive care needs of families, highlighting the need for a redesign to better align with these needs.

Addressing key questions about the structure and delivery of well-child care can help improve the effectiveness of preventive care for infants and young children, ensuring that visits adequately address developmental, behavioral, and health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six Questions for Well-Child Care Redesign. Freeman, BK., Coker, TR.[2019]

A one-time webinar intervention for pediatric providers on patient-centered care showed a significant improvement in school functioning for children aged 8-12, with scores of 83.5 in the intervention group compared to 75.8 in the control group.

While the intervention was feasible and indicated some positive effects on health-related quality of life (HRQOL), further research is needed to evaluate its broader impact and to assess changes in provider knowledge before and after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a One-Time Web-Based Provider Intervention on Patient-Reported Outcomes After the Well-Child Visit: A Feasibility Study. Coleman, CM., Alexander, GL., Barone, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03797898

Well-Child Care Clinical Practice Redesign: A Parent ... Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4771128/

A Parent Coach Model for Well-Child Care Among Low ... The goal of this study was to examine the effects of a new model for well-child care (WCC), the Parent-focused Redesign for Encounters, Newborns to Toddlers ...

3. withpower.com withpower.com/trial/phase-pediatrics-5-2023-36c3b

Adapted PARENT Model for Well Child Checkups The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) model significantly improved the quality of well-child care for low-income ...

4. researchprotocols.org researchprotocols.org/2021/11/e27054/

A Parent Coach–Led Model of Well-Child Care for Young ... Methods: This study tested the effectiveness of PARENT at 10 clinical sites in 2 federally qualified health centers in Tacoma, Washington, and ...

5. redesigningwellchildcare.org redesigningwellchildcare.org/

The PARENT Project The PARENT (Parent-focused Redesign for Encounters, Newborns to Toddlers) Intervention is a model for well-child care (WCC) that adds a community health worker ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663704/

A Parent Coach–Led Model of Well-Child Care for Young ... The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care ...

7. researchgate.net researchgate.net/publication/313740613_Well-Child_Care_Redesign_A_Mixed_Methods_Analysis_of_Parent_Experiences_in_the_PARENT_Trial

Well-Child Care Redesign: A Mixed Methods Analysis of ... Parent-Focused Redesign for Encounters, Newborns to Toddlers (PARENT) is an evidence-based model of WCC that was previously developed for ...