Clinical trial NCT03642327: SEEK: Dissemination and Implementation
Official title: The Safe Environment for Every Kid (SEEK) Model: Dissemination and Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Maltreatment
Keywords: Child Abuse Prevention
Primary Care
Professional Education in Primary Care
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Chestnut Health Systems
name: University of California, San Diego
First posted: 2018-08-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief summary: This study aims to understand what influences the adoption and implementation of an innovative approach to pediatric primary care by medical professionals and staff providing that care. The innovation concerns addressing common psychosocial problems such as parental depression and substance abuse. Different approaches to training medical professionals will be examined as well as the use of software versus traditional 'paper and pencil' to facilitate implementation.

Detailed description: The proposed study, based on SEEK I and II findings is designed to study the effectiveness of technology driven training strategies to facilitate use of SEEK in helping prevent child maltreatment (CM) and its adoption and implementation in pediatric and family medicine settings. The implementation approach is anchored in four stages of the EPIS conceptual model: Exploration, adoption/Preparation, Implementation, and Sustainment. The strong evidence for SEEK's effectiveness has been underscored by its listing on the websites of the CDC, AHRQ, AAP, and by the California Clearinghouse for Evidence-Based Interventions in Child Welfare. Early adopters are increasingly implementing SEEK in primary care settings, including in Sweden. Four of the 5 healthcare systems in this proposal have implemented SEEK in some of their practices. However, practices within these systems operate independently of one another, and there should not be contamination among them. Each practice has its own lead physician, primary care providers (PCPs) and administrative staff and several have integrated behavioral health.

Design. The investigator selected a rigorous Hybrid Type III design which is an approach to examine implementation outcomes while also examining SEEK's effectiveness in preventing CM, measured by electron health record (EHR) indicators. Type III designs are facilitated by good EHR systems due to the low cost of data routinely gathered for clinical, services, and financial purposes. Five healthcare systems have committed to participating in the project, without committing individual practices and primary care providers (PCPs). Professionals, office staff and parents are nested within practices which are nested within the 5 participating healthcare systems. Practices will choose whether to participate, as will medical professionals within those practices. Participating practices will be randomized to one of the two training strategies for PCPs - Independent online training vs. a Maintenance of Certification (MOC) activity approved by the Boards of Pediatrics and of Family Physicians. Practices will be able to select the facilitation strategy (SEEKonline software or Traditional 'paper and pencil'). Participating professionals and staff within practices will need to adhere to the approach adopted by the practice. The design accounts for heterogeneity in geography, size of healthcare systems, type of primary care (pediatric and family medicine), and presence of integrated behavioral health. A small random sample of parents will be recruited from each practice.

For Aim 1, practices and PCPs will be randomized to one of the two training approaches. Using baseline and follow-up surveys, the investigators will assess the impact of each approach on PCPs' attitudes, knowledge, sense of competence, level of comfort and practice behavior with regard to addressing the targeted problems (e.g., parental depression).

Aim 2 focuses on the implementation of the SEEK model in pediatric and family medicine primary care practices. Practices will have the option of implementing the model using the SEEKonline software or the "traditional" paper and pencil approach. The evaluation involves measuring aspects of implementation such rates of adoption, fidelity to the model, and sustainment beyond the training. In addition, qualitative interviews will provide data regarding what facilitates or impedes optimal implementation.

For Aim 3, The investigators will assess the impact of the interventions on rates of child maltreatment (CM) based on ICD 10 diagnoses in EHRs. The investigators will include a cost-effectiveness analysis by estimating the costs associated with the different approaches to implementing SEEK.

Eligibility criteria: Inclusion Criteria:

* Practice not already implementing the SEEK model.
* The practice provides primary care to children.
* The practice agrees to participate in the study.
* PCPs, office staff and parents of children 0-5 years agree to participate.
* Able to comprehend basic English
* Access to a computer to complete online surveys.

Exclusion Criteria:

* None

Primary outcomes:
measure: Stages of SEEK Implementation Completion (SIC) - Startup (at a Practice Level)
timeFrame: up to 30 months
measure: Stages of Implementation Completion (SIC) - as Assessed by the Safe Environment for Every Kid (SEEK) Fidelity Score (at a Practice Level)
timeFrame: up to 30 months
measure: Stages of SEEK Implementation Completion (SIC) - Sustainability
timeFrame: up to 30 months
Secondary outcomes:
measure: Overall Rates of Children With Possible Abuse and Neglect.
timeFrame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
measure: Rates of Children With Possible Neglect.
timeFrame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
measure: Rates of Children With Non-adherence to Medical Care
timeFrame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
measure: Rates of Under Immunized Children
timeFrame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
measure: Rates of Children With Possible Abuse.
timeFrame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
measure: The Safe Environment for Every Kid (SEEK) PCP Questionnaire (PCPQ) - Addressing Depression Subscale
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Addressing Food Insecurity
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Addressing Major Stress
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Addressing Intimate Partner Violence
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Addressing Harsh Punishment
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Addressing Substance Abuse
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Attitudes Regarding Addressing Health-related Social Needs
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Comfort Level Regarding Addressing Health-related Social Needs
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Perceived Competence Regarding Addressing Health-related Social Needs
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Knowledge Regarding Addressing Health-related Social Needs
timeFrame: 30 months
measure: SEEK PCP Questionnaire (PCPQ) - Practice Behavior Regarding Addressing Health-related Social Needs
timeFrame: 30 months
measure: SEEK Parent View of Relationship With Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
timeFrame: 24 months
measure: SEEK Parent View of the Attentiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
timeFrame: 24 months
measure: SEEK Parent View of the Comprehensiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
timeFrame: 24 months
measure: SEEK Parent View of the Communication Skills of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Howard Dubowitz, MD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubowitz H, Belanger R, Magder L, Palinkas LA, Kim H, Muralidharan V. Comparing 2 Training Modalities Supporting the Adoption of the Safe Environment for Every Kid Approach in Pediatric Primary Care. Acad Pediatr. 2025 Jan-Feb;25(1):102534. doi: 10.1016/j.acap.2024.07.001. Epub 2024 Jul 14.
citation: Dubowitz H, Finkelhor D, Zolotor A, Kleven J, Davis N. Addressing Adverse Childhood Experiences in Primary Care: Challenges and Considerations. Pediatrics. 2022 Apr 1;149(4):e2021052641. doi: 10.1542/peds.2021-052641.
citation: Dubowitz H, Saldana L, Magder LA, Palinkas LA, Landsverk JA, Belanger RL, Nwosu US. Protocol for comparing two training approaches for primary care professionals implementing the Safe Environment for Every Kid (SEEK) model. Implement Sci Commun. 2020 Sep 22;1:78. doi: 10.1186/s43058-020-00059-9. eCollection 2020.
citation: Palinkas LA, Belanger R, Newton S, Saldana L, Landsverk J, Dubowitz H. Assessment of Adoption and Early Implementation Barriers and Facilitators of the Safe Environment for Every Kid (SEEK) Model. Acad Pediatr. 2023 Sep-Oct;23(7):1434-1445. doi: 10.1016/j.acap.2023.06.024. Epub 2023 Jun 22.