SEEK: Dissemination and Implementation

Child Maltreatment Clinical Trial

Official title:

The Safe Environment for Every Kid (SEEK) Model: Dissemination and Implementation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03642327
• Other study ID #: HP-00078770
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

Behavioral:
• Experimental: Maintenance of Certification (MOC)
MOC training will lead to more positive attitudes, comfort level and competence in addressing risk factors for Child Maltreatment.

Other:
• Independent online training (IND)
IND refers to practitioners Independently doing the online training.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Chestnut Health Systems, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stages of SEEK Implementation Completion (SIC).	The Stages of Implementation Completion (SIC) is an observational assessment tool with 8 stages extending from Engagement to achievement of practitioner Competency. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainment). Competency is viewed as entering into the Sustainment phase. Three scores are calculated for each SIC stage: The time that a practice takes for a stage is calculated (Duration Score) with scores ranging from 0 days to infinity on a continuous scale; Optimal Duration varies by practice but in general longer scores are less desirable.; The percentage of activities completed within a stage is calculated (Proportion Score) with the proportion ranging from 0/48 to 46/46; Higher proportion is better.; The SIC Stage Score marks the final stage that a site reaches with scores ranging from 1-8. Higher staged score is better 4.) Duration, proportion, and final stage are combined to measure implementation process.	baseline-48 months
Secondary	SEEK PCP Questionnaire (PCPQ)- Thinking and Behaviors re. Addressing Targeted Risk Factors.	The PCPQ, used in both SEEK RCTs 20,21, has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Each vignette is followed by statements such as "I know how to motivate parents who may be resistant to suggestions" rated on a Likert scale. Items were grouped conceptually into 4 topical scales (e.g., Substance Abuse) and also cross-cutting themes (e.g., Perceived Competence). Cronbach's 107 alphas were adequate for most scales: Depression (.76), IPV (.80), Major Stress (.80) and Substance Abuse (.58), and for most themes: Attitudes (.77), Knowledge (.55), Comfort (.68), Competence (.74) and Practice (.70). Items are scored so that higher scale scores are optimal.	baseline-48 months
Secondary	SEEK Parent View of Child's PCP.	Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale; reliability and validity are good. The Likert scale was changed to a yes-no response. Individual scores range from 0 - 20; higher scores indicate greater satisfaction.	baseline-48 months
Secondary	Rates of Diagnosis of Child Maltreatment.	ICD-10 codes related to CM are readily accessible through EHRs. De-identified aggregate data will be gathered toward study end for all children 0-5 attending the practices during the study - for up to 2 years prior to and during the study. The rates of diagnoses related to child abuse and neglect will be compared in practices trained via the MOC approach and those trained Independently.	period extending from 2 years prior to the study - 48 months