Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention,Endocrine

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Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention
Endocrine ( IF 3.0 ) Pub Date : 2021-09-09 , DOI: 10.1007/s12020-021-02861-4
Marleen Kunneman _{1,

2} , Megan E Branda _{1,

3,

4} , Jennifer L Ridgeway ₅ , Kristina Tiedje ₆ , Carl R May ₇ , Mark Linzer ₈ , Jonathan Inselman _{5,

9} , Angela L H Buffington _{10,

11} , Jordan Coffey _{12,

13} , Deborah Boehm _{14,

15,

16} , James Deming ₁₇ , Sara Dick ₁ , Holly van Houten ₅ , Annie LeBlanc _{1,

18} , Juliette Liesinger _{5,

9} , Janet Lima ₁₉ , Joanne Nordeen ₂₀ , Laurie Pencille _{1,

21} , Sara Poplau ₂₂ , Steven Reed ₂₃ , Anna Vannelli ₁₉ , Kathleen J Yost ₂₄ , Jeanette Y Ziegenfuss _{25,

26} , Steven A Smith ₂₇ , Victor M Montori ₁ , Nilay D Shah _{5,

9}

Affiliation

Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.
Medical Decision Making, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado-Denver Anschutz Medical Campus, Aurora, CO, USA.
Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Laboratoire d'anthropologie des enjeux contemporains, Lyon, France.
Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
Department of Medicine, Hennepin Healthcare and University of Minnesota, Minneapolis, MN, USA.
Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, MN, USA.
Department of Psychiatry and Psychology, Mayo Clinic Health System, Mankato, MN, USA.
Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.
Practice-Based Research Network, Mayo Clinic, Rochester, MN, US.
Center for Translational Science Activities, Mayo Clinic, Rochester, MN, USA.
Center for Patient and Provider Experience, Hennepin County Medical Center, Minneapolis, MN, USA.
School of Nursing, University of Minnesota, Minneapolis, MN, USA.
Decision Partners for Health, Richfield, MN, USA.
Mayo Clinic Health System Northwest Wisconsin, (dept) Home Health and Hospice, Eau Claire, WI, USA.
Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec, QC, Canada.
Park Nicollet International Diabetes Center, St. Louis Park, MN, USA.
Mayo Clinic Health System, La Crosse, WI, US.
Kern Center for the Science of Health Care Deliver, Mayo Clinic, Rochester, MN, USA.
Office of Professional Worklife, Hennepin Healthcare, Minneapolis, MN, USA.
Department of Internal Medicine, Park Nicollet Clinic, Brooklyn Center, MN, USA.
Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Division of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Center for Evaluation and Survey Research, HealthPartners Institute, Bloomington, USA.
Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.

Purpose

To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making.

Methods

In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives.

Results

We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them.

Conclusions

Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit.

Clinical trial registration

ClinicalTrial.gov: NCT01502891.

中文翻译：

理解糖尿病药物治疗决策：使用对话辅助干预的混合方法集群随机试验

目的

确定共享决策 (SDM) 工具与指南知情的常规护理在将证据转化为初级护理方面的有效性，并探讨该工具的使用如何改变患者对糖尿病药物决策的看法。

方法

在这项混合方法多中心整群随机试验中，我们纳入了 2 型糖尿病患者及其初级保健临床医生。我们比较了使用或不使用会内 SDM 对话辅助工具的常规护理。我们评估了参与者报告的决策和 SDM 的质量（知识、满意度和决策冲突）、临床结果、依从性和基于观察者的患者参与决策（OPTION12 量表）。我们对患者进行半结构化访谈来了解他们的观点。

结果

我们招募了来自 20 个诊所的 350 名患者和 99 名临床医生，并采访了 26 名患者。使用对话辅助工具增加了患者就诊后的知识（正确答案，52% vs. 45%， p = 0.02）和临床医生对患者的参与（OPTION12 中的平均臂间差异，7.3（95% CI 3, 12）； p = 0.003）。在治疗选择、患者或临床医生满意度、就诊时间、用药依从性或血糖控制方面没有组间差异。定性分析强调了临床医生如何让患者参与决策的差异，干预患者注意到临床医生如何使用对他们重要的因素引导他们进行对话。