跳至主要内容
临床试验/NCT02247050
NCT02247050已完成不适用

Primary Care Clinician Commitments to Choosing Wisely®

University of Michigan6 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
6
主要终点
Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients

研究概览

简要总结

This pragmatic trial examines the uptake and effects of primary care clinician commitments to follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter invitations to clinicians to commit to the recommendations will decrease ordering of: (1) imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a randomly assigned order.

详细描述

Clinicians often make decisions about ordering low-value services in the midst of clinical encounters when their thinking can be rushed and susceptible to patient demands. This pragmatic trial examines the uptake and effects of shifting clinicians' decisions about ordering low-value services to the pre-encounter period when their thinking is slower and more deliberative; inviting clinicians to commit to avoid ordering those services during patient encounters; and providing to clinicians who committed decision support resources such as point-of-care reminders, patient education handouts, and access to brief communications training.

The investigators will conduct a mixed-methods, stepped wedge cluster randomized trial in 6 IHA primary care clinics in southeastern Michigan. The intervention will be introduced in each clinic in sequence approximately one month apart and in a randomly assigned order (i.e., temporal randomization). In each clinic the intervention will continue for 1 to 6 months so that the intervention ends in all clinics at the same time. For example, in the first clinic the intervention will run for 6 months; in the sixth clinic the intervention will run for 1 month. The total length of the control period plus the intervention period will be 8 months at all clinics.

Prior to the start of the study, IHA made its primary care clinicians aware of publicly available recommendations from the ABIM Foundation's Choosing Wisely® campaign applicable to avoiding overuse of low-value services for 3 common conditions: (1) low back pain, (2) acute sinusitis, and (3) headaches. However, research has shown that clinician behavior seldom changes as a result of information alone. Therefore, at the start of the intervention period clinicians will be invited to make a pre-encounter commitment to follow the 3 Choosing Wisely recommendations. Clinicians who choose to commit will throughout the intervention period receive point-of-care commitment reminders, Choosing Wisely patient education handouts, and weekly emails with decision support resources. Clinicians will remain free to order services at any time without penalty.

The investigators will measure whether the clinician-focused intervention leads to declines in rates of ordering imaging tests for low back pain, antibiotics for acute sinusitis, and imaging tests for headaches. The study team will analyze ordering patterns and costs using clinical operations datasets (drawn from electronic health records and from the billing and practice management system). The following hypotheses will be tested:

Hypothesis 1: Inviting primary care clinicians to commit to avoid ordering imaging for low back pain, antibiotics for acute sinusitis, and imaging for headaches will decrease ordering of these services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Primary care clinicians in 6 primary care (family medicine and internal medicine) clinics within the IHA organization of Ann Arbor, Michigan

排除标准

  • 未提供

研究组 & 干预措施

Commitment invitation at time 1

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 2 months and then cross over to the intervention period for 6 months.

干预措施: Commitment invitation (Behavioral)

Commitment invitation at time 2

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 3 months and then cross over to the intervention period for 5 months.

干预措施: Commitment invitation (Behavioral)

Commitment invitation at time 3

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 4 months and then cross over to the intervention period for 4 months.

干预措施: Commitment invitation (Behavioral)

Commitment invitation at time 4

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 5 months and then cross over to the intervention period for 3 months.

干预措施: Commitment invitation (Behavioral)

Commitment invitation at time 5

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 6 months and then cross over to the intervention period for 2 months.

干预措施: Commitment invitation (Behavioral)

Commitment invitation at time 6

Experimental

Intervention: Behavioral: Commitment Invitation

In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 7 months and then cross over to the intervention period for 1 month.

干预措施: Commitment invitation (Behavioral)

结局指标

主要结局

Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients

时间窗: Within 10 months of receiving the intervention

Composite rates of ordering lumbar spine imaging tests in visits for low back pain, ordering antibiotics in visits for acute sinusitis, and ordering head imaging tests in visits for headaches.

次要结局

  • Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients(Within 10 months of receiving the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey T. Kullgren

Assistant Professor

University of Michigan

研究点 (6)

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