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Improving Care for Children With Complex Needs (I3CN)

10. oktober 2017 oppdatert av: Rita Mangione-Smith, Seattle Children's Hospital

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

331

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Seattle Children's Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 måneder til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontroll
Vanlig omsorgsgruppe
Eksperimentell: Comprehensive Care Management Service
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cost of Care
Tidsramme: Baseline, 12 month, 18 month
The investigators will examine whether the children in the CCM group experience decreased annual costs of care.
Baseline, 12 month, 18 month
Health Care Quality Ranking
Tidsramme: 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.
Baseline, 12-months, 18-months
ED Visits Per Child
Tidsramme: Baseline, 12-month, 18-month
Baseline, 12-month, 18-month
Inpatient Admissions Per Child
Tidsramme: Baseline, 12 month, 18 month
Baseline, 12 month, 18 month
Hospital Days Per Child
Tidsramme: Baseline, 12-Month, 18-Month
Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data
Baseline, 12-Month, 18-Month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physician Satisfaction
Tidsramme: Baseline, 12 Months, 18 months
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.
Baseline, 12 Months, 18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Rita Mangione-Smith, MD, MPH, Seattle Children's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2010

Primær fullføring (Faktiske)

1. september 2014

Studiet fullført (Faktiske)

29. september 2017

Datoer for studieregistrering

Først innsendt

25. april 2012

Først innsendt som oppfylte QC-kriteriene

25. april 2012

Først lagt ut (Anslag)

27. april 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CCMS

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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