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Advancing Insulin Prescribing in General Practice (AIM@GP)

10 november 2020 uppdaterad av: Stewart Harris, Lawson Health Research Institute

Advancing INSIGHT Methods in General Practice

Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy. This study will test the effectiveness of diabetes specialist consultation support, and community pharmacy insulin initiation support on the insulin prescribing behaviour of family physicians across Canada.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

154

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 4G5
        • Lawson Health Research Institute

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

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

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

Hur är studien utformad?

Designdetaljer

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

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Basal Insulin Initiation Strategy

Basal Insulin Initiation Strategy which includes:

  1. support by community pharmacist
  2. support by diabetes specialist
Övrig: Basal Insulin Initiation Strategy
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.
Andra namn:
  • Support by Specialist and Pharmacist
Inget ingripande: Usual Practice
The physicians randomized to this group proceeded with their usual practice

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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"
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Lawson Health Research Institute

Samarbetspartners

Sanofi

Utredare

  • Huvudutredare: Stewart B. Harris, MD MPH FCFP, Lawson Health Research Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 juli 2006

Primärt slutförande (Faktisk)

1 mars 2010

Avslutad studie (Faktisk)

1 mars 2010

Studieregistreringsdatum

Först inskickad

4 januari 2008

Först inskickad som uppfyllde QC-kriterierna

4 januari 2008

Första postat (Uppskatta)

15 januari 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 december 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • R-06-851
  • Lantu-L-01961 (Annat bidrag/finansieringsnummer: Sanofi-aventis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

There is no plan to make individual participant data available to other researchers

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