- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00593489
Advancing Insulin Prescribing in General Practice (AIM@GP)
Advancing INSIGHT Methods in General Practice
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The 2003 Canadian Diabetes Association clinical practice guidelines recommend early and sustained glycemic control targeting an glycosylated hemoglobin (A1C) < 7%. The guideline target however is not achieved in 50% of patients with type 2 diabetes in the Canadian family practice setting. Family physicians are not comfortable initiating and managing insulin for their patients the Diabetes in Canada Evaluation (DICE) study found that only 12% of the 2473 patients audited were prescribed insulin; 6% insulin alone and 6% in combination. Harris et. al. found 20% of patients prescribed insulin, 15% insulin alone and 5% in combination. A strategy to increase physicians' knowledge, skill and comfort with insulin prescription is needed to better achieve glycemic control for patients with type 2 diabetes in Canada.
Purpose - The purpose of AIM@GP is to increase family physicians clinical experience and comfort with insulin prescription and better achieve glycemic control for patients with type 2 diabetes in Canada.
Primary Objective - To determine the effectiveness of a Basal Insulin Initiation strategy on family physician insulin prescribing behaviour. The strategy, using a multifaceted behaviour facilitation approach, includes diabetes specialist consultation support, and community pharmacy insulin initiation support.
Study Design - The study design is a stratified, parallel group, randomized control effectiveness study. All physicians will attend an insulin education workshop where they will receive a Diabetes Practice Profile and randomly allocated in a 1:1 manner into the intervention or control group.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
London, Ontario, Kanada, N6A 4G5
- Lawson Health Research Institute
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Full time family physicians (FP) >25 hours per week in office
- Ability to generate a listing of patients with type 2 diabetes (T2DM) from their practice or billing records.
- Generation of a practice list of patients with T2DM
- A minimum of 50 patients with type 2 diabetes in their practice.
- Support the generation of a Diabetes Practice Profile prior to the deadline established
- A minimum of 6 insulin-eligible patients
- Attendance at the scheduled Workshop (if unable to attend the Workshop must be available to be educated and trained by diabetes nurse educator(DNE) using a Workshop DVD)
Exclusion Criteria:
- FP does not attend Workshop or complete educational training using Workshop DVD with DNE guidance
- FPs who anticipate retiring within the post-intervention period, moving their practice to another city, or having locum coverage of their practice for more than 4 weeks during the post-intervention period
- FPs currently participating in a diabetes behaviour-change intervention trial
- FPs working in an academic environment
- FPs unlikely to comply with protocol, (uncooperative attitude, unlikelihood of completing the study).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Basal Insulin Initiation Strategy
Basal Insulin Initiation Strategy which includes:
|
This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop.
Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation.
Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose.
Ostatní jména:
|
Žádný zásah: Usual Practice
The physicians randomized to this group proceeded with their usual practice
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
Časové okno: 12 months
|
Insulin Prescription Rate (IPR) - the number of insulin-eligible patients per 12 months who are prescribed insulin in each family physician (FP) practice (Number of patients per year per FP).
The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate.
|
12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
Časové okno: 15 months
|
mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
|
15 months
|
Mean Fasting Blood Glucose of Insulin-eligible Patients
Časové okno: 15 months
|
mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
|
15 months
|
Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop
Časové okno: 12 months
|
Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop
|
12 months
|
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP
Časové okno: 15 months
|
Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
|
15 months
|
Percent of Patients at Target (A1C ≤ 6.5%) Per FP
Časové okno: 15 months
|
Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
|
15 months
|
Change in "Insulin Prescription Rate"
Časové okno: 12 months
|
change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
|
12 months
|
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation
Časové okno: 15 months
|
Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
|
15 months
|
Physician Score for Knowledge of Insulin Initiation & Titration
Časové okno: 12 months
|
physician score for knowledge of insulin initiation & titration minimum score of 0 maximum score of 17.
The greater the score the greater the knowledge.
|
12 months
|
Physician Score for Attitude Towards Insulin Initiation & Titration
Časové okno: 12 months
|
physician score for attitude towards insulin initiation & titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude.
|
12 months
|
Physician Score for Self-efficacy of Insulin Initiation & Titration
Časové okno: 12 months
|
physician score for self-efficacy of insulin initiation & titration where the minimum value was 10 and the maximum was 50.
A value of 50 indicated complete self efficacy to initiate and titrate insulin
|
12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Stewart B. Harris, MD MPH FCFP, Lawson Health Research Institute
Publikace a užitečné odkazy
Obecné publikace
- Harris SB, Stewart M, Brown JB, Wetmore S, Faulds C, Webster-Bogaert S, Porter S. Type 2 diabetes in family practice. Room for improvement. Can Fam Physician. 2003 Jun;49:778-85.
- Harris, Stewart B., Ekoe, J. M., and Webster-Bogaert, M. S. The Diabetes in Canada Evaluation (DICE) Study: Are Primary Care Physicians Achieving Target A1c? Diabetes 52(Supplement 1), A499. 2003.
- Harris SB, Gerstein HC, Yale JF, Berard L, Stewart J, Webster-Bogaert S, Tompkins JW. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial. BMC Health Serv Res. 2013 Feb 21;13:71. doi: 10.1186/1472-6963-13-71.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R-06-851
- Lantu-L-01961 (Jiné číslo grantu/financování: Sanofi-aventis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .