Completed

CHICA-MLPComputer-Supported Management of Medical-Legal Issues Impacting Child Health

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What is being tested

CHICA MLP Module

+ CHICA without the MLP module

Other
Who is being recruted

Until 24 Months
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorIndiana University
Last updated: January 25, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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).

Principal SponsorIndiana University
Last updated: January 25, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

582 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 24 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Age 0 to 2 years

Attending one of the intervention or control clinics in Indianapolis

1 exclusion criteria prevent from participating
Inability to complete study materials (provided in English and Spanish)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Wishard/Eskenazi Hospital Clinics

Indianapolis, United StatesOpen Wishard/Eskenazi Hospital Clinics in Google Maps
CompletedOne Study Center