- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02715934
Glucose to Goal: A Model to Support Diabetes Management in Primary Care
6 de abril de 2018 atualizado por: Linda Siminerio, University of Pittsburgh
Diabetes education is a very important part of diabetes care.
Most people with diabetes receive care in primary care practices where diabetes education is not always available.
This project tests a model designed to improve access to diabetes education services.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Evidence that diabetes self-management education (DSME) can improve health outcomes has repeatedly been shown and is considered to be a critical component of care.
Diabetes educators are highly skilled at addressing diabetes-related clinical and behavioral needs through DSME, but engagement with diabetes educators is underutilized.
It has been suggested that poor referral practices and the way in which DSME service is delivered are the problems.
Most patients receive diabetes care in primary care yet most DSME programs are distinctly separate from primary care practice.
This limits care coordination and diabetes educator access to amenities currently available to primary care.
Efforts are underway to change the US health care paradigm with a focus on quality in primary care that includes practice redesign, population management, and communication through electronic medical records.
The purpose of this application is to evaluate the deployment of Glucose to Goal, a model relying on a systematic redesign of practice that links diabetes educators services with primary care.
This will be compared to the traditional process for DSME delivery, without the direct connection to primary care processes, for an eighteen month period.
The hypothesis is that the proportion of primary care provider referrals and patient utilization of diabetes educator services from primary care practices participating in Glucose to Goal will be higher compared to those associated with traditional DSME.
It is anticipated that this model will appeal to primary care providers, demonstrate a feasible approach to offering diabetes education in the current health environment, and set the stage for future testing of the model, namely its impact on meaningful improvements on diabetes outcomes and cost-effectiveness.
Tipo de estudo
Intervencional
Inscrição (Real)
4994
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
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Community Medicine, Inc.
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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
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes
- Patients referred to diabetes self-management education by their primary care provider
- Able to read and write English
Exclusion Criteria:
- Clinical diagnosis of type 1 or gestational diabetes
- Unable to speak or read English
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: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Glucose to Goal
Three diabetes educators will be assigned to the Glucose to Goal/experimental arm.
The educators will each identify two primary care practices of mid to large size to participate in the Glucose to Goal intervention.
Patients will not be formally recruited or enrolled.
Rather, information documented in the electronic medical record system will be extracted to evaluate patient-level outcomes.
Based on a random sampling of mid to large size primary care practices in study communities, an estimated 2,200 patients with diabetes per study group will meet eligibility criteria for DSME referral.
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The Glucose to Goal intervention applies elements of the Patient Centered Medical Home (i.e., practice design, decision support, population management, etc) to diabetes education services and operationalizes the current DSME objectives in the primary care setting.
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Outro: Control Group
Two usual care diabetes educators will each identify three primary care practices of mid to large size to include in the control arm and participate in the usual care intervention.
Uneven group assignment accounts for the amount of time (one day equivalent/per week) that the intervention diabetes educators will devote to each primary care practice versus the full-time availability of the usual care diabetes educators to see patients at the outpatient, hospital-based program.
Like the experimental arm, an estimated 2,200 patients with diabetes will meet eligibility criteria for DSME referral.
Patients will not be formally recruited or enrolled into the control arm; data will be extracted from the electronic medical record system to evaluate patient-level outcomes.
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The control group will follow the traditional DMSE delivery model, which includes primary care providers referring patients to an outpatient, hospital-based diabetes educator for DSME, but in a passive manner (i.e., without proactive patient identification), which is the usual process for referrals.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Provider referral
Prazo: Monitor continuously across 18 months
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The proportion of provider referrals for DSME divided by the total number of patients eligible for a referral.
Patients will be considered eligible for referral if they were seen by their primary care provider during the intervention period and the provider did not contraindicate DSME for any reason.
Referrals (eligibility for and made) will be tracked through electronic medical record review.
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Monitor continuously across 18 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient participation
Prazo: Monitor continuously across 18 months
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Patient participation will be reported as the proportion of patients who participate in DSME divided by the total number of eligible patients from each participating primary care practice during the study period and will take into account patterns and frequency of visits.
Patients will be considered eligible if they have received a referral to DSME from their primary care provider.
Patients will be offered the opportunity to meet with the diabetes educator for a series of DSME visits and these visits will occur in individual or group format, depending on space, scheduling, etc.
The number and content of the visits will be patient-centered (driven by the patient).
Patients eligible for and participating in DSME will be tracked through electronic medical record review.
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Monitor continuously across 18 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Primary care practice satisfaction with implementation process
Prazo: Baseline, 9 months, 18 months
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The research team will collect data on the implementation process at the primary care practice orientation and team huddles at the mid-point and end of the intervention.
During the practice orientation, the manner in which practices negotiate adoption of the key features of Glucose to Goal will be documented.
With the assistance of trained qualitative researchers, mid and end point team huddles will be conducted using a focus group format to review experiences, examine challenges and barriers, identify best practices, and gauge provider and diabetes educator satisfaction.
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Baseline, 9 months, 18 months
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Hemoglobin A1c
Prazo: As available across 18 months
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In preparation for a larger scale, longitudinal study testing the effectiveness of the Glucose to Goal model on diabetes control, hemoglobin A1c values and other key diabetes markers (i.e., lipid panels, blood pressure) that are documented in the electronic medical record system during the study period will be extracted and analyzed.
Dates and frequency of tests, absolute values, and whether values were within recommended target ranges will be documented.
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As available across 18 months
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Problem Assessment in Diabetes-5 (PAID-5)
Prazo: As available across 18 months
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PAID is a measure of psychosocial adjustment and diabetes emotional distress.
Psychometric reports to date on PAID have shown it to have consistently high internal and test-retest reliability; correlate strongly with a wide range of theoretically related constructs such as general emotional distress, depression, diabetes self-care behaviors, diabetes coping, and health beliefs; and be a statistically significant predictor of glycemic control (Polonsky et al, 1995).
The 5-item version (McGuire et al, 2010) will be administered at DSME visits.
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As available across 18 months
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Diabetes Empowerment Scale - Short Form (DES-SF)
Prazo: As available across 18 months
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To allow for a brief overall assessment of diabetes-related psychosocial self-efficacy, the DES-SF, an 8-item scale, was developed based on the original 37-item DES (Anderson et al, 2003).
DES-SF items address participants' perceived ability to assess readiness to change, set/reach goals, overcome barriers, cope with emotions, manage stress, obtain support, motivation, and make cost/benefit decisions.
The DES-SF will be administered at DSME visits.
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As available across 18 months
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Summary of Diabetes Self-care Activities Measure (SDSCA)
Prazo: As available across 18 months
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This instrument will be used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors related to general diet, specific diet, exercise, blood glucose testing, foot care, and smoking.
Correlations with other measures of diet and exercise generally support validity of SDSCA subscales (Toobert et al, 2000).
The SDSCA will be administered at DSME visits.
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As available across 18 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Linda Siminerio, RN, PhD, CDE, University of Pittsburgh
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
- Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
- Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
- McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodriguez-Saldana J, de Wit M, Snoek FJ. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
- Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
- Krall JS, Kanter JE, Ruppert KM, Arena VC, Solano FX, Siminerio LM. Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation. Sci Diabetes Self Manag Care. 2021 Feb;47(1):74-84. doi: 10.1177/0145721720981840.
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 (Real)
1 de abril de 2016
Conclusão Primária (Real)
1 de dezembro de 2017
Conclusão do estudo (Real)
31 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
1 de março de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de março de 2016
Primeira postagem (Estimativa)
22 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de abril de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R34DK106684-01A1 (Concessão/Contrato do NIH dos EUA)
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