1181 Participants Needed

HealthySteps for Social Determinants of Health

(WBWF Trial)

Recruiting at 1 trial location
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Naval Health Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

BACKGROUND: The Defense Health Agency (DHA) and the Office of Military Community and Family Policy (MC\&FP) requested assistance in evaluating the effectiveness of a military pilot implementation of a civilian program designed to assist families with infants called HealthySteps (HS; HealthySteps National Office, 2018). HS is a unique pediatric primary care-based program that helps families identify and manage parenting challenges. The program interweaves the medical support of the pediatrician's office with the resources and services of a HS Specialist trained to help parents understand their infants' needs (e.g., feeding, behavior, sleep) and their role as caregivers. HS Specialists provide enhanced educational support and facilitate targeted referrals to other relevant DoD and civilian support resources. OBJECTIVE: The HS program has not been widely implemented or evaluated previously in a military context. However, a small 2-site pilot was initiated in 2017 by MC\&FP to assess the feasibility of offering the HS program in military treatment facilities (MTF). The Defense Health Agency (DHA) further determined that this pilot program could be expanded to fulfill a 2019 National Defense Authorization Act (NDAA) requirement for the implementation and evaluation of a pilot program to reduce risk factors for child abuse and neglect within the U.S. military community. APPROACH: This outcome evaluation study entailed a review of medical records for families enrolled in the HS pilot as well as the collection of prospective survey data. Survey data collected from primary caregivers enrolled in HS at seven implementation locations throughout the U.S. is being compared with survey data collected from caregivers of newborns seeking care at control locations offering pediatric treatment as usual. VALUE: The HS program is expected to improve parental engagement in well-baby care, increase targeted screenings and referrals, improve parental efficacy and knowledge, as well as facilitate integration and utilization of existing family services available across disparate military support settings. It also is expected to increase military service satisfaction and perceived support among military parents. Summary reports of study results will be provided to MC\&FP, DHA, and Congress. RESEARCH COLLABORATORS: NHRC is a Department of the Navy Bureau of Medicine and Surgery research command located in San Diego, California. Abt Global is a leading civilian professional research corporation with extensive experience in military health research. Investigators from these two institutions are collaborating to conduct this outcome evaluation. STUDY POPULATION: Participating pilot program clinics included 7 military pediatric clinic locations selected by DHA and serving personnel and their families from all U.S. military service branches. All families with children aged 0-4 months seeking well-baby care at participating MTF pilot pediatric clinics were eligible for HS program services and for study recruitment. Additionally, beneficiaries similarly seeking care for a newborn at 11 MTF pediatric clinics providing treatment as usual were eligible for the comparison condition. Medical records for this population were reviewed and prospective survey evaluation data were collected and merged together for ongoing analysis and reporting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment HealthySteps for Social Determinants of Health?

The research highlights that addressing social determinants of health (SDOH) through screening and care coordination can improve patient well-being and health outcomes. Implementing tools to identify social risk factors and providing care coordination based on these factors have shown positive impacts on patient health, suggesting that similar approaches like HealthySteps could be effective.12345

How is the HealthySteps treatment different from other treatments for addressing social determinants of health?

HealthySteps is unique because it focuses on addressing the social factors that affect health, such as living conditions and access to resources, rather than just medical symptoms. This approach involves collaboration across different sectors to improve overall health equity, which is not typically the focus of standard medical treatments.678910

Research Team

VA

Valerie A. Stander, Ph.D.

Principal Investigator

Naval Health Research Center

Eligibility Criteria

This study is for families with children aged 0-4 months who are receiving well-baby care at selected military pediatric clinics. It's open to all U.S. military service branch personnel and their families. The trial compares the effectiveness of a program called HealthySteps in a military setting against usual pediatric care.

Inclusion Criteria

English-speaking
Seeking well-baby care at a participating military treatment facility pediatric clinic
TRICARE eligible
See 2 more

Exclusion Criteria

Expecting to leave service or transfer locations/clinics within less than 6 months of WBWF enrollment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Enrollment

Recruitment of primary caregivers of newborns aged 0-4 months for the HealthySteps program and comparison group

2 years
In-person and remote recruitment at clinic visits

Data Collection

Collection of baseline, 6-month, and 12-month survey data from participants

12 months
Remote data collection via mail, email, and phone

Follow-up

Participants are monitored for outcomes such as well-baby care engagement and social determinants of health

First year of infant's life

Treatment Details

Interventions

  • HealthySteps
Trial OverviewThe trial is testing the HealthySteps program, which integrates educational support and resources into pediatric care to help parents with challenges like feeding and sleep. Families enrolled in this program at certain clinics are being compared to those receiving standard treatment at other locations.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HealthySteps PilotExperimental Treatment1 Intervention
The intervention arm included 3 tiers of targeted care following the HS model (https://www.zerotothree.org/our-work/healthysteps/). At tier 1, the standard Bright Futures screenings used in DoD pediatrics for children age 0 to 3 years were augmented to assess child social emotional development and family needs. For tiers 2 and 3, pediatricians/medical staff could refer eligible families with children aged 0 to 3 years to a HS Specialist either to address a specific issue requiring time-limited services (tier 2) or for comprehensive services (tier 3) to receive support at all well-child visits. Further, to meet the requirements of NDAA FY19, section 578, the HS Specialists were instructed to offer tier 3 services to all families of infants aged 0-4 months; this population was the WBWF intervention population eligible for the intervention arm of this study.
Group II: Treatment as usualActive Control1 Intervention
DoD military treatment facility pediatric clinics follow American Academy of Pediatrics Bright Futures guidelines in providing well-baby care. The comparison arm of this study enrolled parents receiving treatment as usual under these guidelines at participating clinics assigned to this condition.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Naval Health Research Center

Lead Sponsor

Trials
21
Recruited
177,000+

Abt Global

Collaborator

Trials
1
Recruited
1,200+

Findings from Research

The implementation of the Core 5 social risk screening tool in a presurgical spine population successfully identified social risk factors in 59% of patients, highlighting the importance of addressing social determinants of health before surgery.
Staff reported high usability and acceptance of the screening tool, with an average score of 4.4 out of 5, indicating that it can be effectively integrated into clinical workflows to connect patients with necessary resources.
Implementing screening for social determinants of health using the Core 5 screening tool.Bradywood, A., Leming-Lee, TS., Watters, R., et al.[2021]
There is a significant gap in guidance for healthcare practitioners on how to address patients' social needs in clinical settings, despite evidence linking social circumstances to health outcomes.
The article proposes a three-tier framework for implementing social determinants interventions in healthcare, focusing on individual patients, healthcare institutions, and broader population strategies, along with methods for data collection and targeted interventions.
Collecting and applying data on social determinants of health in health care settings.Gottlieb, L., Sandel, M., Adler, NE.[2022]

References

Patient-Reported Social and Behavioral Determinants of Health and Estimated Risk of Hospitalization in High-Risk Veterans Affairs Patients. [2022]
Compliance With Surgical Oncology Specialty Care at a Safety Net Facility. [2021]
Improving patient well-being in the United States through care coordination interventions informed by social determinants of health. [2023]
Implementing screening for social determinants of health using the Core 5 screening tool. [2021]
Collecting and applying data on social determinants of health in health care settings. [2022]
The PhenX Toolkit: Measurement Protocols for Assessment of Social Determinants of Health. [2023]
Action on the social determinants for advancing health equity in the time of COVID-19: perspectives of actors engaged in a WHO Special Initiative. [2023]
Public policy and the social determinants of health: the challenge of the production and use of scientific evidence. [2019]
Intersectoral action for health equity: a rapid systematic review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Incorporation of Social Determinants of Health in the Peer-Reviewed Literature: A Systematic Review of Articles Authored by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. [2022]