The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)
24. november 2015 oppdatert av: Alicia L. Warnock, Walter Reed National Military Medical Center
The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g.
A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses.
The software makes a recommendation about what medication changes are appropriate with potential alternates.
Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
Studietype
Intervensjonell
Registrering (Faktiske)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20889
- Walter Reed National Military Medical Center
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
- Absence of orders for deployment or permanent change of station
- Willingness to recruit up to 19 patients prior to randomization
- Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
Exclusion Criteria:
- Specialist physicians
- Orders for deployment or permanent change of station
- Unwillingness to recruit up to 19 patients prior to randomization
- No prior experience with management of type 2 diabetes in adults
- Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Computer-Assisted Decision Support
These providers will use the CADS program to treat their enrolled patients.
|
The CADS software makes a recommendation about what medication changes are appropriate with potential alternates.
CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month.
They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit.
Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in A1c
Tidsramme: baseline, 12, 24, 36, and 48 months
|
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
|
baseline, 12, 24, 36, and 48 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Major events
Tidsramme: ongoing
|
The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
|
ongoing
|
|
Other DM-related events
Tidsramme: ongoing
|
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
|
ongoing
|
|
Glucose measures
Tidsramme: baseline, 12, 24, 36, 48 months
|
Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
|
baseline, 12, 24, 36, 48 months
|
|
Blood pressure
Tidsramme: baseline, 12, 24, 36, and 48 months
|
Clinically significant or statistically detectable changes in BP
|
baseline, 12, 24, 36, and 48 months
|
|
Lipids
Tidsramme: baseline, 12, 24, 36, and 48 months
|
Clinically significant or statistically detectable changes in lipid profile.
|
baseline, 12, 24, 36, and 48 months
|
|
Patient satisfaction with treatment
Tidsramme: basline and 48 months
|
Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
|
basline and 48 months
|
|
Quality of life
Tidsramme: baseline and 48 months
|
Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
|
baseline and 48 months
|
|
Degree of Acceptance
Tidsramme: baseline and 48 months
|
The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
|
baseline and 48 months
|
|
Acceptance of uploading data
Tidsramme: baseline, 12, 24, 36, and 48 months
|
The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
|
baseline, 12, 24, 36, and 48 months
|
|
Demographic variables
Tidsramme: baseline and 48 months
|
The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
|
baseline and 48 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Robert A Vigersky, M.D., Walter Reed National Military Medical Center
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. mars 2012
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
17. juli 2012
Først innsendt som oppfylte QC-kriteriene
19. juli 2012
Først lagt ut (Anslag)
24. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
25. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 353757
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