Computer-Supported Management of Medical-Legal Issues Impacting Child Health
NCT ID: NCT01800669
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
582 participants
INTERVENTIONAL
2013-02-28
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
NCT04470193
Inpatient Consultation for High-Risk Chronically Ill Children Receiving Care in an Enhanced Medical Home
NCT02870387
Discharge to Home and Chronic Illness Care Pilot
NCT02165423
Paediatric Resident Complex Care Curriculum RCT
NCT03349541
Digital-storytelling Intervention for Rural-dwelling Children
NCT04665479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A child's health status may be negatively affected when he or she does not receive the benefit of laws designed to address such social determinates of health. Unhealthy housing may lead to an increased risk of preventable injury or, in the case of dangerous molds, asthma. An excessively cold environment brought on by a utility shut-off may also trigger childhood asthma, or result in a family's decision to trade-off food for heat. Poor nutrition may contribute to any number of deficiencies impacting a child's health. Laws addressing such issues include those that require landlords to mitigate dangerous rental housing conditions, those that protect access to utilities in certain circumstances, and those that protect against unlawful denials of food-benefit programs.
Medical-legal Partnerships bring health care providers together with lawyers to address social and legal needs, such as those described above, which may result in poor health outcomes. Such partnerships across the nation provide direct legal advice and assistance to patients, create internal systems that improve health care delivery, and promote change at a policy level beyond discrete systems. This study has been designed to expand upon the current medical-legal partnership concept and mitigate health disparities by creating an innovative system that dramatically increases the identification of medical-legal issues in pediatric clinics, improves the delivery of appropriate physician counseling and streamlines access to legal resources when legal remedies are needed.
The investigators propose to intelligently insert a medical-legal issue screening tool and tailored decision support protocol into the regular health care delivery process of our existing computerized clinical decision support system (CDSS), the Child Health Improvement through Computer Automation (CHICA) system. In short, a series of screening questions regarding common legal issues that have the potential to negatively impact child health will be included on a pre-screener form for all patients ≤36 months of age. This form will be printed on paper and completed by the presenting caregiver in the waiting room. Answers to the questions will then be scanned into the CHICA system prior to the physician encounter and analyzed along with previously existing medical record information to generate the content for a tailored physician worksheet and handouts. Together, these documents will help guide physicians through the process of confirming identified medical-legal issues and providing the most appropriate interventions in terms of education and/or referrals to a medical-legal expert. This process as a whole will help physicians to accurately identify such issues and immediately address them in an appropriate and sensitive way.
The investigators hypothesize that our innovative use of the CHICA computerized decision support system to identify and address medical-legal issues in a consistent, appropriate and effective way will help diminish the barriers that physicians often cite when questioned about identifying medical-legal issues and taking steps to help address them. For example, the investigators anticipate that our utilization of waiting room time to administer the initial pre-screener questions will help minimize concerns about time constraints, and CHICA's generation of highly-tailored worksheets that direct physicians through the process of dealing with positive screens will help address physician concerns about lack of education or experience with medical-legal issues.
To summarize, the investigators intend first to expand and modify the CHICA system to assist pediatricians with the identification and management of four common medical-legal problems (homelessness, unsafe rental home conditions, inadequate access to necessary utilities and food insecurity) that have the potential to adversely impact child health (AIM 1). The investigators will then evaluate the effect of the CHICA medical-legal module on the identification and mitigation of medical-legal problems in four pediatric practices by evaluating rates of medical-legal issue identification via pre/post chart abstraction, and evaluating actions taken by physicians and patient caregivers (as reported in caregiver interviews) to mitigate identified medical-legal issues (AIM 2). Next, the investigators will evaluate physician and patient caregiver satisfaction with the CHICA medical-legal module by evaluating physician comfort with medical-legal issue identification and acceptance of the CHICA medical-legal module via physician survey, and evaluating patient caregiver perceptions (as reported in caregiver interviews) about physicians' handling of medical-legal issues and the CHICA medical-legal module process (AIM 3). Lastly, the investigators will evaluate the impact of the CHICA medical-legal module on healthcare utilization by comparing the overall utilization of Medicaid patients in our intervention population to Medicaid patients in our control population over the course of 18 months (AIM 4).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Use of the complete CHICA MLP module in routine clinical care. The MLP module screens families for medical-legal issues, alerts the physician to there presences and provides guidance and referral materials to help the physician resolve the issues.
CHICA MLP Module
The MLP module screens families for medical-legal issues, alerts the physician to there presences and provides guidance and referral materials to help the physician resolve the issues.
Control
CHICA without the MLP module. This version includes a module that screens families for medical-legal issue but does not provide additional guidance or referrals to resolve them.
CHICA without the MLP module
Clinics in the control group will have the CHICA system, but without the MLP module. It will screen for medical-legal issues but will not provide additional guidance and referrals to help resolve them.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHICA MLP Module
The MLP module screens families for medical-legal issues, alerts the physician to there presences and provides guidance and referral materials to help the physician resolve the issues.
CHICA without the MLP module
Clinics in the control group will have the CHICA system, but without the MLP module. It will screen for medical-legal issues but will not provide additional guidance and referrals to help resolve them.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Attending one of the intervention or control clinics in Indianapolis
Exclusion Criteria
24 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amy L Gilbert, JD, MPH
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wishard/Eskenazi Hospital Clinics
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gilbert AL, Downs SM. Medical legal partnership and health informatics impacting child health: Interprofessional innovations. J Interprof Care. 2015;29(6):564-9. doi: 10.3109/13561820.2015.1029066. Epub 2015 Jun 29.
Related Links
Access external resources that provide additional context or updates about the study.
Research Group Carrying out the Study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.