Advancing Insulin Prescribing in General Practice (AIM@GP)
2020年11月10日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
154
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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London、Ontario、カナダ、N6A 4G5
- Lawson Health Research Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Basal Insulin Initiation Strategy
Basal Insulin Initiation Strategy which includes:
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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.
他の名前：
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介入なし：Usual Practice
The physicians randomized to this group proceeded with their usual practice
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
時間枠：12 months
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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.
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
時間枠：15 months
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mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
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15 months
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Mean Fasting Blood Glucose of Insulin-eligible Patients
時間枠：15 months
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mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
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15 months
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Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop
時間枠：12 months
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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
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12 months
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Percentage of Patients at Target (A1C ≤ 7.0%) Per FP
時間枠：15 months
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Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
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15 months
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Percent of Patients at Target (A1C ≤ 6.5%) Per FP
時間枠：15 months
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Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
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15 months
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Change in "Insulin Prescription Rate"
時間枠：12 months
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change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
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12 months
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Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation
時間枠：15 months
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Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
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15 months
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Physician Score for Knowledge of Insulin Initiation & Titration
時間枠：12 months
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physician score for knowledge of insulin initiation & titration minimum score of 0 maximum score of 17.
The greater the score the greater the knowledge.
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12 months
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Physician Score for Attitude Towards Insulin Initiation & Titration
時間枠：12 months
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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.
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12 months
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Physician Score for Self-efficacy of Insulin Initiation & Titration
時間枠：12 months
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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
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Stewart B. Harris, MD MPH FCFP、Lawson Health Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2006年7月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2008年1月4日
QC基準を満たした最初の提出物
2008年1月4日
最初の投稿 (見積もり)
2008年1月15日
学習記録の更新
投稿された最後の更新 (実際)
2020年12月3日
QC基準を満たした最後の更新が送信されました
2020年11月10日
最終確認日
2020年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- R-06-851
- Lantu-L-01961 (その他の助成金/資金番号：Sanofi-aventis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
There is no plan to make individual participant data available to other researchers
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Basal Insulin Initiation Strategyの臨床試験
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