The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)
24 november 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
28
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
-
Bethesda, Maryland, Förenta staterna, 20889
- Walter Reed National Military Medical Center
-
-
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
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in A1c
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Major events
Tidsram: 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
Tidsram: ongoing
|
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
|
ongoing
|
|
Glucose measures
Tidsram: 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
Tidsram: baseline, 12, 24, 36, and 48 months
|
Clinically significant or statistically detectable changes in BP
|
baseline, 12, 24, 36, and 48 months
|
|
Lipids
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline and 48 months
|
The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
|
baseline and 48 months
|
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Acceptance of uploading data
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Robert A Vigersky, M.D., Walter Reed National Military Medical Center
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 mars 2012
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2015
Studieregistreringsdatum
Först inskickad
17 juli 2012
Först inskickad som uppfyllde QC-kriterierna
19 juli 2012
Första postat (Uppskatta)
24 juli 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 november 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 353757
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