Legal RightsCHICA-MLPNCT01800669
Computer-Supported Management of Medical-Legal Issues Impacting Child Health
A study testing CHICA MLP Module and CHICA without the MLP module in people with Legal Rights and Medicolegal Aspects, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Legal Rights, Medicolegal Aspects
- What is being tested?
- CHICA MLP Module and CHICA without the MLP module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0 to 2 years
- Attending one of the intervention or control clinics in Indianapolis
Who cannot join
- Inability to complete study materials (provided in English and Spanish)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard/Eskenazi Hospital Clinics
Indianapolis, Indiana, 46202
About this study
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.
Read the 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).
- Conditions
- Legal Rights, Medicolegal Aspects
- Being tested
- CHICA MLP Module, CHICA without the MLP module
- Keywords
- Computer based clinical decision support, medical legal partnership, child, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA MLP ModuleOther
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 moduleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | 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. Receives: Other: CHICA MLP Module |
| Control | 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. Receives: Other: CHICA without the MLP module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of detection of medical-legal issues
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.
Measured: 1 year
Secondary outcomes (1)
Rates of resolution of medical-legal issues.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Legal RightsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy L Gilbert, JD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800669
- Sponsor's protocol ID
- 1R01HS020640-01A1
- Acronym
- CHICA-MLP
- Status last verified
- Jan 2022
- First submitted
- 26 Feb 2013
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26120893
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Supported Management of Medical-Legal Issues Impacting Child Health
- ClinicalTrials.gov ID
- NCT01800669
- Acronym / sponsor ID
- CHICA-MLP / 1R01HS020640-01A1
- Conditions
- Legal Rights, Medicolegal Aspects
- Keywords
- Computer based clinical decision support, medical legal partnership, child, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: CHICA MLP ModuleUse 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. |
| Control | Active comparator | Other: CHICA without the MLP moduleCHICA 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0 to 2 years
- Attending one of the intervention or control clinics in Indianapolis
Key exclusion criteria (1 listed)
- Inability to complete study materials (provided in English and Spanish)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHICA MLP ModuleThe 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 | Intervention |
| CHICA without the MLP moduleClinics 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. | Other | Control |
Primary outcome
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 secondary outcome
Rates of resolution of medical-legal issues.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 26120893Gilbert 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.
- Research Group Carrying out the StudyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Gilbert, JD, MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA MLP Module and CHICA without the MLP module in people with Legal Rights and Medicolegal Aspects, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of detection of medical-legal issues (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.