Clinical trial NCT02304380: Care Coordination for Children With Disabilities
Official title: Improving Care Coordination for Children With Disabilities Through an Accountable Care Organization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Experiences With Health Care Coordination
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-12-01
Enrollment: 2188
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who qualify for Medicaid under the Aged, Blind, and Disabled category, and their caregivers, who are part of the Nationwide Children's Hospital Partners for Kids Accountable Care Organization (ACO) in Columbus, Ohio.

Brief summary: The proposed study uses a recent policy change in Ohio as a natural experiment to assess outcomes and experiences of children who qualify for Medicaid under the Aged, Blind, Disabled category and their caregivers in an ACO model of care compared to their previous outcomes and experiences in a traditional fee-for-service model.

Detailed description: Children with disabilities have complex healthcare needs requiring multiple providers in multiple locations. The lack of coordinated care for this vulnerable population leads to poorer outcomes, higher costs, and increased stress and time demands for patients and their caregivers. Traditionally, under arrangements known as fee-for-service, there have been no financial incentives for providers to coordinate care; however, the Affordable Care Act is changing that. Accountable care organizations (ACOs) are groups of healthcare providers that organize in new ways to take responsibility for the care of a defined population. ACOs share in any savings associated with improved quality and efficiency of the care they provide. Although most ACOs currently do not cover children with disabilities, many are considering adding these to the populations they serve. Yet little is known about effectiveness of the care coordination strategies they employ on children with disabilities.

The goal of this research is to assess care coordination for and patient-centered outcomes of children with disabilities (who qualify for Medicaid under the Aged, Blind, Disabled category (ABD) under an ACO as compared with traditional fee-for-service plans. The investigators will use a recent policy change in Ohio that mandates children with disabilities move from traditional fee-for-service Medicaid plans into managed care arrangements such as ACOs. This mandate resulted in 8,000 disabled children automatically becoming part of the nation's largest pediatric ACO.

The investigators will use multiple methods, including focus groups, interviews, a survey, medical record data, and Medicaid claims, to compare patient experiences and care under the ACO with experiences and care under the previous fee-for-service model. What impact will this research have? Our research will inform ACOs about the relative benefits and challenges of coordinating care and improving the health outcomes of children with disabilities and will help those organizations determine whether or not they can adequately serve the needs of this population. In addition, the findings will provide patients and caregivers with valuable information that can help them make decisions when faced with an increasingly common scenario, for example: "The parents of a child with cerebral palsy receive a letter from their state Medicaid program that children are being enrolled in an 'accountable care organization.' How certain can they be that their child's care will be improved? What are the problems that might occur?" The investigators will engage patients, their caregivers, and health system stakeholders throughout the research process. Patient advocates have been involved in the design of our study. A patient advisory panel comprised of caregivers and advocates of disabled children will guide our project by providing advice at quarterly meetings. In addition, the investigators plan to collect data from more than 2,800 patient voices through direct study participation.

Eligibility criteria: Inclusion Criteria:

Stakeholder Interviews

- Be associated with the ACO as ACO leadership, a care coordinator, a payor or policy-maker.

Caregiver Interviews

* Currently live in south-central Ohio
* Have lived in south-central Ohio since July 2012
* Be a caregiver of a child ages 3-18 who qualifies for Medicaid under the Aged, Blind, and Disabled category

Focus Groups, Caregivers and Youth

* Currently live in south-central Ohio
* Have lived in south-central Ohio since July 2012
* Be a caregiver of a child ages 3-18 who qualifies for Medicaid under the Aged, Blind, and Disabled (ABD) category, who receives care at Nationwide Children's Hospital, Partners for Kids
* For youth focus groups, be a child ages 14-18 who qualifies for Medicaid under the Aged, Blind, and Disabled category, who is intellectually capable of participating in focus groups, and who receives care at Nationwide Children's Hospital, Partners for Kids

Exclusion Criteria:

* Non-English-speaking
* For youth focus groups, intellectual disabilities that preclude being able to participate in a focus group

Primary outcomes:
measure: Percent of Caregivers Who Reported That Their Child Has a Designated Care Coordinator
timeFrame: 12 month lookback from time of survey
Secondary outcomes:
measure: Percent of Caregivers Who Reported That Their Care Coordinator Asked About Caregiver Concerns and Changes in the Child's Health
timeFrame: 3 month lookback from time of survey
measure: Percent of Caregivers Who Reported Receiving a Comprehensive Written After-visit Summary in the Past 12 Months
timeFrame: 12 month lookback from time of survey
measure: Percent of Caregivers Who Reported That Their Child's Primary Care Provider Created a Shared Care Plan for Their Child
timeFrame: 12 month lookback from time of survey
measure: Use of One or More Well-child Visits <=6 Years Old
timeFrame: 23 months before policy change (2013), 36 months post
measure: Use of One or More Well-child Visits >=12 Years Old
timeFrame: 23 months before policy change (2013), 36 months post
measure: Indicator of Use of Primary Care
timeFrame: 23 months before policy change (2013), 36 months post
measure: Use of Outpatient Medicaid Visits to Other Behavioral Health Providers
timeFrame: 23 months before policy change (2013), 36 months post
measure: Emergency Department Use
timeFrame: 23 months before policy change (2013), 36 months post
measure: Use of Hospitalizations
timeFrame: 23 months before policy change (2013), 36 months post
measure: Follow-up Within 7 Days After Hospitalization
timeFrame: 23 months before policy change (2013), 30 months post
measure: Follow-up Within 30 Days After Hospitalization
timeFrame: 23 months before policy change (2013), 36 months post
measure: Hospital Readmissions Within 30 Days After Discharge
timeFrame: 23 months before policy change (2013), 36 months post
measure: Hospitalization for Mental Illness
timeFrame: 23 months before policy change (2013), 36 months post
measure: Follow-up Within 7 Days After Hospitalization for Mental Illness
timeFrame: 23 months before policy change (2013), 36 months post
measure: Follow-up Within 30 Days After Hospitalization for Mental Illness
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - Antidepressants
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - Anticonvulsants
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - Anti-anxiety Medications
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - Anti-psychotic Medications
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - ADHD Medications
timeFrame: 23 months before policy change (2013), 36 months post
measure: Medication Use - Asthma Medications
timeFrame: 23 months before policy change (2013), 36 months post
measure: Follow-up Within 30 Days After ADHD Prescription
timeFrame: 23 months before policy change (2013), 36 months post
Other outcomes:
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Paula Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilligoss B, Tanenbaum SJ, Paul MH, Ferrari RM, Song PH. What makes health services usable?: Insights from a qualitative study of caregivers of children with disabilities. Health Care Manage Rev. 2021 Apr-Jun 01;46(2):111-122. doi: 10.1097/HMR.0000000000000249.
citation: Song PH, White BA, Chisolm DJ, Berney S, Domino ME. The effect of an accountable care organization on dental care for children with disabilities. J Public Health Dent. 2020 Sep;80(3):244-249. doi: 10.1111/jphd.12375. Epub 2020 Jun 9.
citation: Sheftall AH, Chisolm DJ, Alexy ER, Chavez LJ, Mangione-Smith RM, Ferrari RM, Song PH. Satisfaction With Care Coordination for Families of Children With Disabilities. J Pediatr Health Care. 2019 May-Jun;33(3):255-262. doi: 10.1016/j.pedhc.2018.08.010. Epub 2018 Nov 16.