Trial Outcomes & Findings for Improving Care for Children With Complex Needs (NCT NCT01587105)
NCT ID: NCT01587105
Last Updated: 2017-11-13
Results Overview
The investigators will examine whether the children in the CCM group experience decreased annual costs of care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
331 participants
Primary outcome timeframe
Baseline, 12 month, 18 month
Results posted on
2017-11-13
Participant Flow
Participant milestones
| Measure |
Control
Usual Care Group
|
Comprehensive Care Management Service
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
181
|
|
Overall Study
COMPLETED
|
144
|
138
|
|
Overall Study
NOT COMPLETED
|
6
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Care for Children With Complex Needs
Baseline characteristics by cohort
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
150 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.4 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
8.2 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
181 participants
n=7 Participants
|
331 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 month, 18 monthThe investigators will examine whether the children in the CCM group experience decreased annual costs of care.
Outcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Cost of Care
Health Plan Costs Baseline
|
71692 US Dollars
Interval 54511.0 to 103212.0
|
70618 US Dollars
Interval 57858.0 to 95562.0
|
|
Cost of Care
Health Plan Costs12 month
|
37,677 US Dollars
Interval 25811.0 to 55276.0
|
56702 US Dollars
Interval 44691.0 to 80881.0
|
|
Cost of Care
Health Plan Costs 18 month
|
36012 US Dollars
Interval 22888.0 to 51702.0
|
52955 US Dollars
Interval 40932.0 to 74077.0
|
PRIMARY outcome
Timeframe: Baseline, 12-months, 18-monthsFor 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.
Outcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Health Care Quality Ranking
Baseline
|
79.6 units on a scale
Interval 76.9 to 82.4
|
81.9 units on a scale
Interval 79.4 to 84.4
|
|
Health Care Quality Ranking
12-Month
|
80.9 units on a scale
Interval 78.0 to 83.9
|
88.6 units on a scale
Interval 85.7 to 91.4
|
|
Health Care Quality Ranking
18-Month
|
81.4 units on a scale
Interval 78.2 to 84.6
|
88.2 units on a scale
Interval 85.0 to 91.3
|
PRIMARY outcome
Timeframe: Baseline, 12-month, 18-monthOutcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
ED Visits Per Child
Baseline
|
0.28 ED visits
Interval 0.2 to 0.4
|
0.32 ED visits
Interval 0.24 to 0.43
|
|
ED Visits Per Child
12-Month
|
.20 ED visits
Interval 0.14 to 0.29
|
.29 ED visits
Interval 0.21 to 0.4
|
|
ED Visits Per Child
18-Month
|
.19 ED visits
Interval 0.13 to 0.27
|
.25 ED visits
Interval 0.18 to 0.34
|
PRIMARY outcome
Timeframe: Baseline, 12 month, 18 monthOutcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Inpatient Admissions Per Child
Baseline
|
.57 admissions per child
Interval 0.43 to 0.74
|
.70 admissions per child
Interval 0.56 to 0.88
|
|
Inpatient Admissions Per Child
12-Month
|
.38 admissions per child
Interval 0.28 to 0.51
|
.51 admissions per child
Interval 0.4 to 0.65
|
|
Inpatient Admissions Per Child
18-Month
|
.28 admissions per child
Interval 0.21 to 0.39
|
.31 admissions per child
Interval 0.23 to 0.41
|
PRIMARY outcome
Timeframe: Baseline, 12-Month, 18-MonthNumber of days each participant stayed in the hospital; assessed from hospital administrative discharge data
Outcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Hospital Days Per Child
12-Month
|
.49 days
Interval 0.34 to 0.7
|
.84 days
Interval 0.61 to 1.14
|
|
Hospital Days Per Child
Baseline
|
1.21 days
Interval 0.86 to 1.74
|
1.34 days
Interval 0.98 to 1.81
|
|
Hospital Days Per Child
18-Month
|
.33 days
Interval 0.23 to 0.47
|
.50 days
Interval 0.37 to 0.69
|
SECONDARY outcome
Timeframe: Baseline, 12 Months, 18 monthsPrimary 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.
Outcome measures
| Measure |
Control
n=150 Participants
Usual Care Group
|
Comprehensive Care Management Service
n=181 Participants
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Comprehensive Case Management Service: 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.
|
|---|---|---|
|
Physician Satisfaction
Baseline
|
69 units on a scale
Standard Deviation 14
|
67 units on a scale
Standard Deviation 16
|
|
Physician Satisfaction
12-Month
|
71 units on a scale
Standard Deviation 13
|
70 units on a scale
Standard Deviation 13
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comprehensive Care Management Service
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place