Effectiveness of Structured Care Coordination for Children With Medical Complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial

Abstract

Importance: Children with medical complexity (CMC) have chronic conditions and high health needs and may experience fragmented care.

Objective: To compare the effectiveness of a structured complex care program, Complex Care for Kids Ontario (CCKO), with usual care.

Design, setting, and participants: This randomized clinical trial used a waitlist variation for randomizing patients from 12 complex care clinics in Ontario, Canada, over 2 years. The study was conducted from December 2016 to June 2021. Participants were identified based on complex care clinic referral and randomly allocated into an intervention group, seen at the next available clinic appointment, or a control group that was placed on a waitlist to receive the intervention after 12 months.

Intervention: Assignment of a nurse practitioner-pediatrician dyad partnering with families in a structured complex care clinic to provide intensive care coordination and comprehensive plans of care.

Main outcomes and measures: Co-primary outcomes, assessed at baseline and at 6, 12, and 24 months postrandomization, were service delivery indicators from the Family Experiences With Coordination of Care that scored (1) coordination of care among health care professionals, (2) coordination of care between health care professionals and families, and (3) utility of care planning tools. Secondary outcomes included child and parent health outcomes and child health care system utilization and cost.

Results: Of 144 participants randomized, 141 had complete health administrative data, and 139 had complete baseline surveys. The median (IQR) age of the participants was 29 months (9-102); 83 (60%) were male. At 12 months, scores for utility of care planning tools improved in the intervention group compared with the waitlist group (adjusted odds ratio, 9.3; 95% CI, 3.9-21.9; P < .001), with no difference between groups for the other 2 co-primary outcomes. There were no group differences for secondary outcomes of child outcomes, parent outcomes, and health care system utilization and cost. At 24 months, when both groups were receiving the intervention, no primary outcome differences were observed. Total health care costs in the second year were lower for the intervention group (median, CAD$17 891; IQR, 6098-61 346; vs CAD$37 524; IQR, 9338-119 547 [US $13 415; IQR, 4572-45 998; vs US $28 136; IQR, 7002-89 637]; P = .01).

Conclusions and relevance: The CCKO program improved the perceived utility of care planning tools but not other outcomes at 1 year. Extended evaluation periods may be helpful in assessing pediatric complex care interventions.

Trial registration: ClinicalTrials.gov Identifier: NCT02928757.

Figure 1.. Trial Flow Diagram

Among the 144 included included in the study, 3 participants did not have a valid identifier to link to administrative data. Therefore, 141 were included in the health care utilization and cost analysis (79 and 76 in the intervention group in year 1 and 2, respectively; 62 and 59 in the waitlist group in year 1 and 2, respectively). ^aThese participants were not included because the family declined services (n = 4) or did not give consent (n = 12), their language skills were inadequate to comprehend the study surveys (n = 5), or there was no continuous caregiver (n = 3). ^bThese participants were not included because they were already being followed up by a complex care team (n = 2), they died before consent was given (n = 2), the family declined services (n = 1) or did not give consent (n = 23), their language skills were inadequate (n = 6), or there was no continuous caregiver (n = 5).

Figure 2.. Comparison of Study Primary Outcomes Between Intervention and Waitlist Groups

Family Experience With Care Coordination (FECC) scores were based on the sum scores of the indicators FECC 8a and 8b (coordination of care among health care professionals), FECC 5 (coordination of care between health care professionals and families), and FECC 16 and 17 (utility of care planning tools). Larger values indicate better perceived care. All P values are calculated based on comparisons of outcomes at the end of 12 months (year 1) and 24 months (year 2) using ordinal regression for FECC indicators. All models included center as a random intercept and are adjusted for baseline values and expressed as an adjusted odds ratio (95% CI), shown under each follow-up time with the P value. The comparison in panel C for year 1 reached statistical significance according to thresholds based on the Holm-Bonferroni method to adjust for false positives, where the overall target type I error rate was .05.

Figure 3.. Comparison of Parent-Reported Study Secondary Outcomes Between Intervention and Waitlist Groups

Child outcomes include quality of life; emotional health, measured by parent-proxy respectively using subscales from the KIDSCREEN-52^,; and physical pain, measured with a 10-cm linear visual analog scale.^, Parent or caregiver outcomes include perceived physical health, mental health, fatigue and sleep disturbance (measured by the Patient Reported Outcomes Measurement Information System^,), and satisfaction with life (measured with the Satisfaction With Life Scale).^, Higher scores indicate more of the outcome of interest, which can mean improvement (child quality of life and emotional health; parental physical health, mental health, and satisfaction with life) or deterioration (child physical pain, parent fatigue and sleep disturbance) depending on the outcome. All outcomes were modeled using linear regression including center as a random intercept, adjusted for baseline values, and expressed as an adjusted mean difference (95% CI), shown above or below each follow-up data point. ^aStatistical significance using thresholds based on the Holm-Bonferroni method to adjust for false positives, where the overall target type I error rate was .05.