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

Trial Summary

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 data supports the effectiveness of the Adapted PARENT Model treatment?

Research shows that the PARENT model, which includes a parent coach and online tools, improves well-child care services and reduces emergency visits for young children in low-income areas. ^{1 2 3 4 5}

How is the Adapted PARENT Model treatment different from other treatments for well-child care?

The Adapted PARENT Model is unique because it uses a health educator, known as a 'parent coach', to provide most of the well-child care services, rather than relying solely on a doctor. It also includes a web-based tool for planning visits and automated text messages for reminders and education, making it more accessible and tailored to the needs of low-income families. ^{1 2 3 6 7}

What is the purpose of this trial?

Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role ("Parent's Coach") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by families in low-income communities, and decreases reliance on the clinician as the primary provider of WCC services. The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino, Medicaid-insured populations. The aims of this study are to (1) Adapt the PARENT intervention to meet the needs of a diverse, largely Black population of underserved families, (2) Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services, emergency department utilization, and parent experiences of care, (3) Determine whether the effectiveness of adapted PARENT differs by family-level factors, (4) Explore parents' experiences in receiving adapted PARENT, (5) Examine the economic impact of adapted PARENT from the parent stakeholder perspective, (6) Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective, and (7) Examine the economic impact of adapted PARENT on healthcare utilization, from the perspectives of parents and families. This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model.

Research Team

Tumaini Coker, MD, MBA

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Well-child care clinical practice redesign for serving low-income children. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. [2018]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Parent escalation of care for the deteriorating child in hospital: A health-care improvement study. [2023]

6. Canada 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Six Questions for Well-Child Care Redesign. [2019]