Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03642327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2018-08-01
Brief Title:
SEEK Dissemination and Implementation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Safe Environment for Every Kid SEEK Model Dissemination and Implementation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 adoptionPreparation Implementation and Sustainment The strong evidence for SEEKs 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 SEEKs 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 eg 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
Design The investigator selected a rigorous Hybrid Type III design which is an approach to examine implementation outcomes while also examining SEEKs 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None