Advancing Insulin Prescribing in General Practice (AIM@GP)
10 de novembro de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
154
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Ontario
-
London, Ontario, Canadá, N6A 4G5
- Lawson Health Research Institute
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
|
|
Sem intervenção: Usual Practice
The physicians randomized to this group proceeded with their usual practice
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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"
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stewart B. Harris, MD MPH FCFP, Lawson Health Research Institute
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2006
Conclusão Primária (Real)
1 de março de 2010
Conclusão do estudo (Real)
1 de março de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
4 de janeiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de janeiro de 2008
Primeira postagem (Estimativa)
15 de janeiro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de dezembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de novembro de 2020
Última verificação
1 de novembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R-06-851
- Lantu-L-01961 (Número de outro subsídio/financiamento: Sanofi-aventis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
There is no plan to make individual participant data available to other researchers
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Basal Insulin Initiation Strategy
-
Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbHConcluídoFarmacocinética (PK) Bioequivalência e Farmacodinâmica (PD) de Julphar Insulin N e Huminsulin® BasalDiabetes MellitusAlemanha