- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00365885
Showing Health Information Value in a Community Network
9. juli 2014 opdateret af: Duke University
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina.
The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership.
In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial.
Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions.
The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients.
The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system.
To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project.
The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions.
At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction.
Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers.
From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting.
In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone.
The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20108
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1
electronic mail notifications to care managers about sentinel health events
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computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andre navne:
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Eksperimentel: 2
feedback reports with notifications to clinic managers about sentinel health events
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computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andre navne:
|
|
Eksperimentel: 3
letters to patients with notifications about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Andre navne:
|
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Ingen indgriben: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
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Ingen indgriben: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
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Ingen indgriben: 6
letters to patients with notifications about sentinel health events -- generated but withheld
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Emergency department utilization rates and hospitalization rates
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
ED encounter rates for low severity conditions
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
ED encounter rates for asthma
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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ED encounter rates for diabetes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Hospitalization rates
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization rates for asthma (also PQI)
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization rates for diabetes (also PQI)
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Glycemic control (hemoglobin A1c)
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Medication contraindications
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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HEDIS - Preventive services
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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HEDIS - # WCC visits
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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AHRQ Prevention Quality Indicators
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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HEDIS - Asthma and diabetes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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# of messages triggered for health risks
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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# of messages triggered for barriers to care
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Missed appointment rates
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Primary care appointment rates
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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F/U rates post-partum
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Patient satisfaction instruments (CHAPS)
Tidsramme: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
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at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
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EuroQoL
Tidsramme: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
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at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
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Provider opinion surveys
Tidsramme: At conclusion of study
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At conclusion of study
|
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Costs of ED utilization for all causes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for asthma
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for diabetes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for low severity visits
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for all causes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for asthma
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for diabetes
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Reimbursement for labs+other ancillary services
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Primary care reimbursement
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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ED rates for recurrent ED encounters
Tidsramme: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David F Lobach, MD, PhD, Duke University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2006
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. august 2008
Datoer for studieregistrering
Først indsendt
16. august 2006
Først indsendt, der opfyldte QC-kriterier
16. august 2006
Først opslået (Skøn)
18. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2014
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Pro00006833
- R01HS015057 (U.S.A. AHRQ bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .