Computer-Supported Management of Medical-Legal Issues Impacting Child Health (CHICA-MLP)

January 19, 2022 updated by: Indiana University
The investigators hypothesize that by adding a patient screening and physician alerting module to a computer-based decision support system, the investigators can improve the detection and management of legal issues that may affect children's health. this randomized controlled trial will place the module in two clinics using the CHICA decision support system and compare the rate of detection and resolution of medical-legal issues in those clinics compared to two clinics using the CHICA system without the medical-legal module.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Social determinants of health are the circumstances in which people are born, live, work and age; as well as the systems that are put in place to deal with illness and disability. Dramatic differences in health are closely related to degrees of social and economic disadvantage. For example, poverty-induced hardships such as food insecurity, utility shut-offs and substandard housing all have the potential to negatively impact health. In the United States, there exist many laws and policies designed to address such issues. For example, the Supplemental Nutrition Assistance Program (SNAP) seeks to address food insecurity by providing a means for financially eligible recipients to access nutritious food. When an individual is wrongly denied SNAP benefits, legal remedies are available. Access to legal aid, much like access to nutritious food, is often limited by social and economic disadvantage. It has been demonstrated that most legal problems experienced by low-income individuals remain unresolved, with fewer than one in five being addressed with the help of a lawyer.

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).

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard/Eskenazi Hospital Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 0 to 2 years
  • Attending one of the intervention or control clinics in Indianapolis

Exclusion Criteria:

  • Inability to complete study materials (provided in English and Spanish)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of detection of medical-legal issues
Time Frame: 1 year
Rates of detection of medical-legal issues among families of children attending intervention or control clinics. Outcome will be assessed by chart abstraction before and one year after onset of the intervention.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of resolution of medical-legal issues.
Time Frame: 1 year
Rates of resolution of medical-legal issues among families with medical-legal issues will be assessed by face-to-face interviews of care givers seeking healthcare for their children in one of the study clinics.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Amy L Gilbert, JD, MPH, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01HS020640-01A1 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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