Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Improving Care for Children With Complex Needs (I3CN)

10 oktober 2017 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

331

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Seattle Children's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 månader till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollera
Vanlig vårdgrupp
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cost of Care
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 12-month, 18-month
Baseline, 12-month, 18-month
Inpatient Admissions Per Child
Tidsram: Baseline, 12 month, 18 month
Baseline, 12 month, 18 month
Hospital Days Per Child
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physician Satisfaction
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2010

Primärt slutförande (Faktisk)

1 september 2014

Avslutad studie (Faktisk)

29 september 2017

Studieregistreringsdatum

Först inskickad

25 april 2012

Först inskickad som uppfyllde QC-kriterierna

25 april 2012

Första postat (Uppskatta)

27 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • CCMS

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera