Medically Complex ChildrenI3CNNCT01587105
Improving Care for Children With Complex Needs
A study testing Comprehensive Case Management Service in people with Medically Complex Children and Care Coordination, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington State Department of Social and Health Services developed the Comprehensive Case Management (CCM) program with the goal to reduce costs of care for medically complex children cared for at SCH as well as improve their health… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Medically Complex Children, Care Coordination, Case Manager
- What is being tested?
- Comprehensive Case Management Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 29 Sep 2017
- Phase
- Interventional
- 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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between the ages of 3 months and 18 years,
- have at least three chronic medical conditions requiring active management
- were hospitalized or had an emergency department (ED) visit at SCH within the last year
- their PCP is enrolled in the study
Who cannot join
- had 2+ visits to Pulmonary, Craniofacial, or Rheumatology within the last year
- had 3+ visits to Nephrology, Gastroenterology and has either Short Gut Syndrome or Crohn's Disease, Endocrinology or Neuromuscular Clinic within the last year
- has had 2+ visits to the Neurodevelopmental clinic and is followed by a NDV doctor
- cancer patient
- transplant recipient
- has cystic fibrosis, muscular dystrophy or sickle cell anemia
Show all 9Show fewer
- has Down Syndrome and does not have any other medical issues aside from developmental delays
- renal patient on dialysis
- had a hospitalization for > 27 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Improving Care for Children With Complex Needs (I3CN) Study
Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington State Department of Social and Health Services developed the Comprehensive Case Management (CCM) program with the goal to reduce costs of care for medically complex children cared for at SCH as well as improve their health status and the quality of care they receive. The CCM program aims to develop and facilitate a reliable and standardized process that empowers the child's primary care provider and provides him/her with the resources s/he needs to avoid unnecessary emergency department visits and admissions. Our study will include children who had a hospitalization or emergency department visit at Seattle Children's between 2009-2012 and, at that time, had multiple active chronic medical issues but had no specialty service at Seattle Children's to help their primary care providers manage them.
Read the detailed description
Children with complex health care needs often lack a comprehensive care plan and access to case management. They are at risk for frequent and prolonged hospitalizations, fragmented care, parental stress/burnout and unsafe care. To address this issue, Seattle Children's Hospital developed the Comprehensive Case Management (CCM) program, which includes access to a special clinic at Seattle Children's with case managers and a health care team that works with parents and community physicians to create care plans for children with complex needs.
The investigators goal is to evaluate whether children who participate in the CCM program have better parent reported access to needed care, timeliness of receiving needed services, more coordinated care, improved health status, and higher parent satisfaction with care compared to children who receive care outside the CCM program. In addition, the investigators will examine whether these children experience decreased annual costs of care, emergency department visits, hospital admissions, and hospital lengths of stay compared to children receiving care outside the program. The investigators also want to understand whether community physicians who have patients enrolled in the CCM program are more satisfied with caring for children with complex medical needs than physicians caring for these children outside the program.
The investigators plan to enroll 650 parents of eligible children into the I3CN study. Three hundred twenty five of these parents will have children enrolled in the CCM program and 325 will have children who continue to receive usual care. Enrolled parents complete a survey every 6 months during the study (5 surveys over 2 ½ years) in order to assess study outcomes including parent perceived. Parent participation in the study will be completed 2 ½ years after enrollment.
When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. The CCM team includes physicians, nurse practitioners, social workers, nutritionists, and nurse case managers. This plan will include all of the child's routine health care needs in addition to information about what to do when the child gets sick. Community providers will also be asked to review and provide input on the shared care plan. Once the shared care plan is in place, the parent, primary care provider (PCP), and the CCM clinic will follow the standardized processes established by the program and the shared care plan when the child becomes ill.
During the course of the 2 ½ year study, the investigators will analyze our outcomes of interest every 6 months. If the investigators find that children in the CCM the program are experiencing significantly better outcomes than children receiving care outside the program, they will stop the study and open the program to all eligible children.
- Conditions
- Medically Complex Children, Care Coordination, Case Manager, Care Manager, Collaborative Care, Disease Management
- Being tested
- Comprehensive Case Management Service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Case Management ServiceBehavioural
When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care Group |
| Comprehensive Care Management Service | Experimental | Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital Receives: Behavioral: Comprehensive Case Management Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Care
The investigators will examine whether the children in the CCM group experience decreased annual costs of care.
Measured: Baseline, 12 month, 18 month
Health Care Quality Ranking
For Healthcare Quality Rating, the construct is Parent Satisfaction. Parents were asked to rate the quality of the health care their child received. Overall range is 0-100. Higher values equal a better outcome or more satisfaction. Sub scales are not combined. The scale is considered continuous.
Measured: Baseline, 12-months, 18-months
ED Visits Per Child
Measured: Baseline, 12-month, 18-month
Inpatient Admissions Per Child
Measured: Baseline, 12 month, 18 month
Hospital Days Per Child
Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data
Measured: Baseline, 12-Month, 18-Month
Secondary outcomes (1)
Physician Satisfaction
Primary care provider (PCP)'s satisfaction with the care coordination program was measured on a scale of 0-100, where the higher number indicates more satisfaction. This variable was collected at baseline and 12-months but was dropped from the 18 month follow-up as previous analysis suggested it was not relevant to the stated objective.
Measured: Baseline, 12 Months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionSep 2014
- Study completion29 Sep 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.
- Other trials for Medically Complex ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Mangione-Smith, Seattle Children's Hospital
- Investigators
- Rita Mangione-Smith, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587105
- Sponsor's protocol ID
- CCMS
- Acronym
- I3CN
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2012
- Last updated
- 13 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Children With Complex Needs (I3CN) Study
- ClinicalTrials.gov ID
- NCT01587105
- Acronym / sponsor ID
- I3CN / CCMS
- Conditions
- Medically Complex Children, Care Coordination, Case Manager, Care Manager, Collaborative Care, Disease Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Posted 20 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington State Department of Social and Health Services developed the Comprehensive Case Management (CCM) program with the goal to reduce costs of care for medically complex children cared for at SCH as well as improve their health status and the quality of care they receive. The CCM program aims to develop and facilitate a reliable and standardized process that empowers the child's primary care provider and provides him/her with the resources s/he needs to avoid unnecessary emergency department visits and admissions. Our study will include children who had a hospitalization or emergency department visit at Seattle Children's between 2009-2012 and, at that time, had multiple active chronic medical issues but had no specialty service at Seattle Children's to help their primary care providers manage them.
Detailed description
Children with complex health care needs often lack a comprehensive care plan and access to case management. They are at risk for frequent and prolonged hospitalizations, fragmented care, parental stress/burnout and unsafe care. To address this issue, Seattle Children's Hospital developed the Comprehensive Case Management (CCM) program, which includes access to a special clinic at Seattle Children's with case managers and a health care team that works with parents and community physicians to create care plans for children with complex needs.
The investigators goal is to evaluate whether children who participate in the CCM program have better parent reported access to needed care, timeliness of receiving needed services, more coordinated care, improved health status, and higher parent satisfaction with care compared to children who receive care outside the CCM program. In addition, the investigators will examine whether these children experience decreased annual costs of care, emergency department visits, hospital admissions, and hospital lengths of stay compared to children receiving care outside the program. The investigators also want to understand whether community physicians who have patients enrolled in the CCM program are more satisfied with caring for children with complex medical needs than physicians caring for these children outside the program.
The investigators plan to enroll 650 parents of eligible children into the I3CN study. Three hundred twenty five of these parents will have children enrolled in the CCM program and 325 will have children who continue to receive usual care. Enrolled parents complete a survey every 6 months during the study (5 surveys over 2 ½ years) in order to assess study outcomes including parent perceived. Parent participation in the study will be completed 2 ½ years after enrollment.
When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. The CCM team includes physicians, nurse practitioners, social workers, nutritionists, and nurse case managers. This plan will include all of the child's routine health care needs in addition to information about what to do when the child gets sick. Community providers will also be asked to review and provide input on the shared care plan. Once the shared care plan is in place, the parent, primary care provider (PCP), and the CCM clinic will follow the standardized processes established by the program and the shared care plan when the child becomes ill.
During the course of the 2 ½ year study, the investigators will analyze our outcomes of interest every 6 months. If the investigators find that children in the CCM the program are experiencing significantly better outcomes than children receiving care outside the program, they will stop the study and open the program to all eligible children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care Group |
| Comprehensive Care Management Service | Experimental | Behavioral: Comprehensive Case Management ServiceCare Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- between the ages of 3 months and 18 years,
- have at least three chronic medical conditions requiring active management
- were hospitalized or had an emergency department (ED) visit at SCH within the last year
- their PCP is enrolled in the study
Key exclusion criteria (9 listed)
- had 2+ visits to Pulmonary, Craniofacial, or Rheumatology within the last year
- had 3+ visits to Nephrology, Gastroenterology and has either Short Gut Syndrome or Crohn's Disease, Endocrinology or Neuromuscular Clinic within the last year
- has had 2+ visits to the Neurodevelopmental clinic and is followed by a NDV doctor
- cancer patient
- transplant recipient
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 |
|---|---|---|
| Comprehensive Case Management ServiceWhen a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse. | Behavioural | Comprehensive Care Management Service |
Primary outcome
Cost of Care
Time frame: Baseline, 12 month, 18 month
The investigators will examine whether the children in the CCM group experience decreased annual costs of care.
Health Care Quality Ranking
Time frame: Baseline, 12-months, 18-months
For Healthcare Quality Rating, the construct is Parent Satisfaction. Parents were asked to rate the quality of the health care their child received. Overall range is 0-100. Higher values equal a better outcome or more satisfaction. Sub scales are not combined. The scale is considered continuous.
ED Visits Per Child
Time frame: Baseline, 12-month, 18-month
Inpatient Admissions Per Child
Time frame: Baseline, 12 month, 18 month
Hospital Days Per Child
Time frame: Baseline, 12-Month, 18-Month
Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data
1 secondary outcome
Physician Satisfaction
Time frame: Baseline, 12 Months, 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rita Mangione-Smith, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Case Management Service in people with Medically Complex Children and Care Coordination, run by Seattle Children's Hospital 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 4 inclusion and 9 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 13 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2017). 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?
Cost of Care (time frame: Baseline, 12 month, 18 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2017.