SEEK: Dissemination and Implementation

Not Applicable

Completed

Conditions: Child Maltreatment

Registration Number: NCT03642327

Lead Sponsor: University of Maryland, Baltimore

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 360

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stages of SEEK Implementation Completion (SIC) - Startup (at a Practice Level)	up to 30 months	The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Competency. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainment). Startup reflects whether the practice implemented SEEK - Yes/No. Yes = practice started implemented SEEK. Practices that did start are reported.
Stages of Implementation Completion (SIC) - as Assessed by the Safe Environment for Every Kid (SEEK) Fidelity Score (at a Practice Level)	up to 30 months	The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Fidelity. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainment). Competence/Fidelity score reflects the extent to which a practice implemented the intervention as intended. Score range: 0-100; higher is better fidelity to the intervention as planned.
Stages of SEEK Implementation Completion (SIC) - Sustainability	up to 30 months	The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Competency. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainability). Sustainability was determined if the practice was implementing SEEK 24 months after initiation and doing so with fidelity. Reporting the number of practices that achieved sustainability.

Secondary Outcome Measures

Name	Time	Method
Overall Rates of Children With Possible Abuse and Neglect.	2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.	International Classification of Diseases - 10 (ICD-10) codes related to possible child maltreatment (CM or child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
Rates of Children With Possible Neglect.	2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.	ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
Rates of Children With Non-adherence to Medical Care	2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.	ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
Rates of Under Immunized Children	2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.	ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
Rates of Children With Possible Abuse.	2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.	ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
The Safe Environment for Every Kid (SEEK) PCP Questionnaire (PCPQ) - Addressing Depression Subscale	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Addressing Food Insecurity	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Addressing Major Stress	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Addressing Intimate Partner Violence	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Addressing Harsh Punishment	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Addressing Substance Abuse	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Comfort Level Regarding Addressing Health-related Social Needs	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Perceived Competence Regarding Addressing Health-related Social Needs	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK Parent View of Relationship With Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale	24 months	Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always). Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction. The mean of the Likert subscale response is reported.
SEEK PCP Questionnaire (PCPQ) - Attitudes Regarding Addressing Health-related Social Needs	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Knowledge Regarding Addressing Health-related Social Needs	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK PCP Questionnaire (PCPQ) - Practice Behavior Regarding Addressing Health-related Social Needs	30 months	The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence). The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
SEEK Parent View of the Attentiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale	24 months	Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always). Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction. The mean of the Likert subscale response is reported.
SEEK Parent View of the Comprehensiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale	24 months	Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always). Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction. The mean of the Likert subscale response is reported.
SEEK Parent View of the Communication Skills of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale	24 months	Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always). Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction. The mean of the Likert subscale response is reported.

Trial Locations

Locations (1): University of Maryland, Baltimore
🇺🇸
Baltimore, Maryland, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States