Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532487
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities
The aims of the study are
1 To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership CTI-MLP on patient outcomes
2 To determine the most efficient mechanisms for CTI-MLP delivery
3 To develop innovative community engagement strategies for addressing health-harming legal needs within community health centers
Eligible patients will be asked to complete a questionnaire 4 times first when they join the study and then at 3 months 6 months and 12 months In the survey they will be asked to provide information about themselves their health care aspects of their daily life and hardships they face They will also allow researchers to access their electronic health record information housed in the community-based organization and attorney notes
Patient information will be completely confidential and de-identified meaning the research team will not know the identity of the person who answered the questions
Participating community health centers will be randomized assigned by chance to provide basic legal information and referral to legal aid or have an attorney on-site to provide legal aid to those who screen for legal needs
The aims of the study are
1 To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership CTI-MLP on patient outcomes
2 To determine the most efficient mechanisms for CTI-MLP delivery
3 To develop innovative community engagement strategies for addressing health-harming legal needs within community health centers
Eligible patients will be asked to complete a questionnaire 4 times first when they join the study and then at 3 months 6 months and 12 months In the survey they will be asked to provide information about themselves their health care aspects of their daily life and hardships they face They will also allow researchers to access their electronic health record information housed in the community-based organization and attorney notes
Patient information will be completely confidential and de-identified meaning the research team will not know the identity of the person who answered the questions
Participating community health centers will be randomized assigned by chance to provide basic legal information and referral to legal aid or have an attorney on-site to provide legal aid to those who screen for legal needs
Detailed Description:
In this study we proposed that providing legal services within primary care can enhance healthcare delivery efficiency by addressing legal needs such as barriers to health insurance medical treatments housing safety employment stability and other legal needs that can disrupt care to patients
The proposed study led by researchers at Stony Brook University Boston University University of Central Florida UCF and the University of Puerto Rico in partnership with the National Center for Medical-Legal Partnerships UCF School of Medicines Implementation Science Lab and six federally qualified health centers will precisely examine the effects of legal services on primary care outcomes for medically underserved communities We will conduct a hybrid type II effectiveness-implementation trial with a cluster randomized design in 6 federally qualified health centers FQHCs in Pennsylvania New York and Puerto Rico to test a Critical-time Intervention Medical-Legal Partnership CTI-MLP approach compared to the standard of care Three FQHCs will receive a CTI-MLP approach that includes provision of legal aid and capacity building through team-facing legal support The other three FQHCs will receive legal education and awareness including information about community-based legal organizations Over a 12-month period the team will collect 1 patients health and functioning including overall physical health mental health social health pain fatigue and overall perceived quality of life 2 data on legal needs and risk factors 3 longitudinal patient clinical outcomes N960 and 4 FQHC staff N180 and clinic-level indicators including provider-patient communication and readiness for continued implementation and sustainability
We will assemble a Latinx and migrant community advisory board and a scientific advisory board with medical-legal partnership expertise Active engagement will ensure the effective translation and dissemination of our findings into practice With new Medicaid models emerging that offer reimbursement for some social care provision state officials can also use data to consider expansion of Medicaid services to include the coordination and provision of social and legal services Completion of this project will result in an innovative evidence-based intervention package to improve health outcomes for highly vulnerable communities
The proposed study led by researchers at Stony Brook University Boston University University of Central Florida UCF and the University of Puerto Rico in partnership with the National Center for Medical-Legal Partnerships UCF School of Medicines Implementation Science Lab and six federally qualified health centers will precisely examine the effects of legal services on primary care outcomes for medically underserved communities We will conduct a hybrid type II effectiveness-implementation trial with a cluster randomized design in 6 federally qualified health centers FQHCs in Pennsylvania New York and Puerto Rico to test a Critical-time Intervention Medical-Legal Partnership CTI-MLP approach compared to the standard of care Three FQHCs will receive a CTI-MLP approach that includes provision of legal aid and capacity building through team-facing legal support The other three FQHCs will receive legal education and awareness including information about community-based legal organizations Over a 12-month period the team will collect 1 patients health and functioning including overall physical health mental health social health pain fatigue and overall perceived quality of life 2 data on legal needs and risk factors 3 longitudinal patient clinical outcomes N960 and 4 FQHC staff N180 and clinic-level indicators including provider-patient communication and readiness for continued implementation and sustainability
We will assemble a Latinx and migrant community advisory board and a scientific advisory board with medical-legal partnership expertise Active engagement will ensure the effective translation and dissemination of our findings into practice With new Medicaid models emerging that offer reimbursement for some social care provision state officials can also use data to consider expansion of Medicaid services to include the coordination and provision of social and legal services Completion of this project will result in an innovative evidence-based intervention package to improve health outcomes for highly vulnerable communities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None