Abstract：
BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known.
OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes.
METHODS: Pragmatic cluster randomized trial.
METHODS: A total of 1060 adults with type 2 diabetes in 22 primary care practices.
METHODS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors).
METHODS: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models.
RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions.
CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order.
UNASSIGNED: NCT03590041.
OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes.
METHODS: Pragmatic cluster randomized trial.
METHODS: A total of 1060 adults with type 2 diabetes in 22 primary care practices.
METHODS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors).
METHODS: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models.
RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions.
CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order.
UNASSIGNED: NCT03590041.
摘要：
背景：糖尿病自我管理教育和支持可以在初级保健中以共享医疗预约（SMA）的形式有效和高效地提供。SMA交付功能的比较有效性，如主题选择、多学科护理团队，同行导师的参与是未知的。
目的：比较标准化和患者驱动的糖尿病SMA模型对患者级糖尿病结局的影响。
方法：语用整群随机试验。
方法：在22个初级保健实践中，共有1060名2型糖尿病成年人。
方法：实践人员使用标准化（由健康教育者提供的设置内容）或患者驱动的SMA（由健康教育者提供的患者选择主题顺序）提供了为期6次的疾病管理目标培训（TTIM）课程，行为健康提供者[BHP]，和同伴导师)。
方法：结果包括来自基线和随访调查的自我报告的糖尿病困扰和糖尿病自我护理行为（在第一次和最后一次SMA会议上评估），和HbA1c,BMI,和电子健康记录中的血压。分析使用描述性统计，线性回归，和线性混合模型。
结果：标准化和患者驱动的SMA均有效改善了糖尿病困扰，自我照顾行为,BMI（平均-0.29），和HbA1c（-0.45%（mmol/mol）平均，8.3至7.8%）。控制协变量，有一个小,病情对总体糖尿病困扰的显着影响有利于标准化的SMA（F（1,841）=4.3，p=.04），可归因于病情对情绪和方案困扰分量表的显着影响。有一个小,病情对舒张压的显著影响有利于标准化SMA(F(1,5199)=4.50，p=.03)。条件之间没有其他差异。
结论：两种使用TTIM课程的SMA模型在糖尿病困扰方面均有显着改善，自我照顾,和HbA1c。涉及BHP和同伴导师以及主题选择的患者驱动的糖尿病SMA并未导致比健康教育者按照设定的主题顺序促进的标准化糖尿病SMA更好的临床或患者报告结果。
■NCT03590041。
目的：比较标准化和患者驱动的糖尿病SMA模型对患者级糖尿病结局的影响。
方法：语用整群随机试验。
方法：在22个初级保健实践中，共有1060名2型糖尿病成年人。
方法：实践人员使用标准化（由健康教育者提供的设置内容）或患者驱动的SMA（由健康教育者提供的患者选择主题顺序）提供了为期6次的疾病管理目标培训（TTIM）课程，行为健康提供者[BHP]，和同伴导师)。
方法：结果包括来自基线和随访调查的自我报告的糖尿病困扰和糖尿病自我护理行为（在第一次和最后一次SMA会议上评估），和HbA1c,BMI,和电子健康记录中的血压。分析使用描述性统计，线性回归，和线性混合模型。
结果：标准化和患者驱动的SMA均有效改善了糖尿病困扰，自我照顾行为,BMI（平均-0.29），和HbA1c（-0.45%（mmol/mol）平均，8.3至7.8%）。控制协变量，有一个小,病情对总体糖尿病困扰的显着影响有利于标准化的SMA（F（1,841）=4.3，p=.04），可归因于病情对情绪和方案困扰分量表的显着影响。有一个小,病情对舒张压的显著影响有利于标准化SMA(F(1,5199)=4.50，p=.03)。条件之间没有其他差异。
结论：两种使用TTIM课程的SMA模型在糖尿病困扰方面均有显着改善，自我照顾,和HbA1c。涉及BHP和同伴导师以及主题选择的患者驱动的糖尿病SMA并未导致比健康教育者按照设定的主题顺序促进的标准化糖尿病SMA更好的临床或患者报告结果。
■NCT03590041。
