Experiences With Health Care CoordinationNCT02304380
Care Coordination for Children With Disabilities
An observational study of Experiences With Health Care Coordination, run by University of North Carolina, Chapel Hill.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Experiences With Health Care Coordination
- How many people
- 2,188 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 30 Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Non-English-speaking
- For youth focus groups, intellectual disabilities that preclude being able to participate in a focus group
About this study
Official title: Improving Care Coordination for Children With Disabilities Through an Accountable Care Organization
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Caregivers Who Reported That Their Child Has a Designated Care Coordinator
This outcome was measured using the validated tool, "Family Experiences with Coordination of Care" (FECC) survey. The FECC survey is made up of 20 separate and independent quality indicators related to care coordination for children with medical complexity. To be included in the denominator for this measure, caregivers first had to report that their child visited more than one doctor's office or used more than one kind of health care service in the 12 months prior to the survey date. To measure the percent of caregivers who reported that their child has a designated care coordinator among those in the denominator, caregivers needed to have answered yes to one of the following two questions: "Did anyone in the main provider's office help you to manage your child's care or treatment from different doctors or care providers?" or "Did anyone outside of the main provider's office help you to manage your child's care or treatment from different doctors or care providers?".
Measured: 12 month lookback from time of survey
Secondary outcomes (22)
Percent of Caregivers Who Reported That Their Care Coordinator Asked About Caregiver Concerns and Changes in the Child's Health
This outcome was measured using FECC survey. To be included in the denominator for this measure, caregivers first had to report that their child visited more than one doctor's office or used more than one kind of health care service in the 12 months prior to the survey date AND were contacted by their care coordinator in the past 3 months. Caregivers then had to respond positively to both of the following two questions: "In the last 3 months, when the person who helped you with managing your child's care contacted you, how often did he or she ask if you had any concerns about your child's health or treatment?" and "In the last 3 months, when the person who helped you with managing your child's care contacted you, how often did he or she ask if your child's health had changed in any way?".
Measured: 3 month lookback from time of survey
Percent of Caregivers Who Reported Receiving a Comprehensive Written After-visit Summary in the Past 12 Months
This outcome was measured using FECC survey. To be included in the denominator for this measure, caregivers first had to report that they received a written after-visit summary from their child's main provider's office. Caregivers then had to report that the written after-visit summary contained all of the following elements: current problem list, current medication list, drug allergies, specialists involved in the child's care, planned follow-up, and what to do for problems related to the outpatient visit.
Measured: 12 month lookback from time of survey
Percent of Caregivers Who Reported That Their Child's Primary Care Provider Created a Shared Care Plan for Their Child
This outcome was measured using FECC survey. Caregivers needed to have answered yes to the following question: "Has the main provider created a shared care plan for your child?".
Measured: 12 month lookback from time of survey
Use of One or More Well-child Visits <=6 Years Old
Indicator of use of an age-appropriate well-child visit for children less than or equal to 6 years of age according to the Healthcare Effectiveness Data and Information Set (HEDIS) due to the Accountable Care Organization (ACO). ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Use of One or More Well-child Visits >=12 Years Old
Use of an age-appropriate well-child visits for children greater than or equal to 12 years of age according to the Healthcare Effectiveness Data and Information Set (HEDIS) due to the ACO. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Indicator of Use of Primary Care
An indicator of one or more outpatient visits to primary care providers (PCP). ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Use of Outpatient Medicaid Visits to Other Behavioral Health Providers
Use of one or more outpatient visits to other mental health specialists besides psychiatrists. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Emergency Department Use
Indicator of utilization of emergency department. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Use of Hospitalizations
Indicator of hospitalization for patients. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Follow-up Within 7 Days After Hospitalization
Indicator of follow-up within 7 days after hospitalization. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 30 months post
Follow-up Within 30 Days After Hospitalization
Indicator of having follow-up within 30 days after hospitalization. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Hospital Readmissions Within 30 Days After Discharge
Indicator of hospital readmissions within 30 days after discharge. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control group include any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of readmissions in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Hospitalization for Mental Illness
Indicator of hospitalization for mental illness for patients. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Follow-up Within 7 Days After Hospitalization for Mental Illness
Indicator of follow-up within 7 days after hospitalization for mental illness. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Follow-up Within 30 Days After Hospitalization for Mental Illness
Indicator of follow-up within 30 days after hospitalization for mental illness. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - Antidepressants
Indicator of antidepressant medication fills. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - Anticonvulsants
Indicator of use of anticonvulsant medication fills. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - Anti-anxiety Medications
Indicator of use of anti-anxiety medication. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - Anti-psychotic Medications
Indicator of use of anti-psychotic medication. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - ADHD Medications
Indicator of use of attention deficit hyperactivity disorder (ADHD) medications. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Medication Use - Asthma Medications
Indicator of asthma medications fills. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of medication fills in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Follow-up Within 30 Days After ADHD Prescription
Indicator of one or more follow-up visits within 30 days after ADHD (attention deficit hyperactivity disorder) prescription. ACO sample includes any child who was ABD at any point during the study time period enrolled in the ACO. Control sample includes any child who was ABD and who moved from fee-for-service coverage to non-ACO managed care during the study period. Transforms a count of actual number of visits in a year to an indicator that the number was greater than zero.
Measured: 23 months before policy change (2013), 36 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startMar 2015
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Experiences With Health Care CoordinationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Paula Song, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304380
- Sponsor's protocol ID
- 14-2045
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2014
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33630503Song 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.
PubMed 32519336Sheftall 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.
PubMed 30449647
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Coordination for Children With Disabilities Through an Accountable Care Organization
- ClinicalTrials.gov ID
- NCT02304380
- Acronym / sponsor ID
- 14-2045
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,188 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2015
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English-speaking
- For youth focus groups, intellectual disabilities that preclude being able to participate in a focus group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of Caregivers Who Reported That Their Child Has a Designated Care Coordinator
Time frame: 12 month lookback from time of survey
This outcome was measured using the validated tool, "Family Experiences with Coordination of Care" (FECC) survey. The FECC survey is made up of 20 separate and independent quality indicators related to care coordination for children with medical complexity. To be included in the denominator for this measure, caregivers first had to report that their child visited more than one doctor's office or used more than one kind of health care service in the 12 months prior to the survey date. To measure the percent of caregivers who reported that their child has a designated care coordinator among those in the denominator, caregivers needed to have answered yes to one of the following two questions: "Did anyone in the main provider's office help you to manage your child's care or treatment from different doctors or care providers?" or "Did anyone outside of the main provider's office help you to manage your child's care or treatment from different doctors or care providers?".
22 secondary outcomes
Percent of Caregivers Who Reported That Their Care Coordinator Asked About Caregiver Concerns and Changes in the Child's Health
Time frame: 3 month lookback from time of survey
Percent of Caregivers Who Reported Receiving a Comprehensive Written After-visit Summary in the Past 12 Months
Time frame: 12 month lookback from time of survey
Percent of Caregivers Who Reported That Their Child's Primary Care Provider Created a Shared Care Plan for Their Child
Time frame: 12 month lookback from time of survey
Use of One or More Well-child Visits <=6 Years Old
Time frame: 23 months before policy change (2013), 36 months post
Use of One or More Well-child Visits >=12 Years Old
Time frame: 23 months before policy change (2013), 36 months post
Indicator of Use of Primary Care
Time frame: 23 months before policy change (2013), 36 months post
Use of Outpatient Medicaid Visits to Other Behavioral Health Providers
Time frame: 23 months before policy change (2013), 36 months post
Emergency Department Use
Time frame: 23 months before policy change (2013), 36 months post
Use of Hospitalizations
Time frame: 23 months before policy change (2013), 36 months post
Follow-up Within 7 Days After Hospitalization
Time frame: 23 months before policy change (2013), 30 months post
Follow-up Within 30 Days After Hospitalization
Time frame: 23 months before policy change (2013), 36 months post
Hospital Readmissions Within 30 Days After Discharge
Time frame: 23 months before policy change (2013), 36 months post
Hospitalization for Mental Illness
Time frame: 23 months before policy change (2013), 36 months post
Follow-up Within 7 Days After Hospitalization for Mental Illness
Time frame: 23 months before policy change (2013), 36 months post
Follow-up Within 30 Days After Hospitalization for Mental Illness
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - Antidepressants
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - Anticonvulsants
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - Anti-anxiety Medications
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - Anti-psychotic Medications
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - ADHD Medications
Time frame: 23 months before policy change (2013), 36 months post
Medication Use - Asthma Medications
Time frame: 23 months before policy change (2013), 36 months post
Follow-up Within 30 Days After ADHD Prescription
Time frame: 23 months before policy change (2013), 36 months post
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33630503Hilligoss 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.
- Derived from this study: PubMed 32519336Song 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.
- Derived from this study: PubMed 30449647Sheftall 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.
- Individual participant dataSharing planned: No
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.
Paula Song, PhD principal investigator
UNC Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Experiences With Health Care Coordination, run by University of North Carolina, Chapel Hill.
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 11 inclusion and 2 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Caregivers Who Reported That Their Child Has a Designated Care Coordinator (time frame: 12 month lookback from time of survey). 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 NCT02304380, which also lists 3 linked publications.
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 2 Jul 2020; AzTrials last refreshed its copy on 28 Oct 2026.