Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 18
- 主要终点
- Difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
研究概览
简要总结
Clinicians' decisions to order potentially unnecessary services -- such as those targeted in the Choosing Wisely® campaign -- are often affected by their high-pressure practice environments, which can make it hard to consistently avoid ordering low-value care. The field of behavioral economics offers a promising and highly scalable approach to decreasing use of low-value services: asking clinicians to commit to avoid ordering such services and providing them and their patients with resources to support adherence to this commitment. This project will evaluate the effects of such an intervention across 2 large health systems, Michigan Medicine and IHA, through a mixed-methods, stepped wedge cluster randomized trial. In each of the study clinics, clinicians will be invited to commit to following a set of targeted Choosing Wisely® recommendations. Clinicians who make such a commitment, and their patients, will receive access to key resources to support adherence to this commitment. To measure the effects of the intervention, automated clinical data and medical record data before and after the intervention will be examined. Surveys and semi-structured interviews of both clinicians and patients will also be conducted to determine the effects of the intervention on their decision-making and experiences.
详细描述
A mixed-methods stepped wedge cluster randomized trial will be conducted in 8 primary care clinics of IHA, a private multispecialty group practice, and Michigan Medicine, a large academic health system. The study will test whether pre-encounter clinician commitments combined with patient and provider supports decrease overtreatment of type 2 diabetes among patients 65 and older, use of benzodiazepines and sedative-hypnotics among patients age 65 and older who have insomnia or anxiety, and use of PSA tests to screen for prostate cancer among men 75 and older. These 3 recommendations were chosen because they are commonly performed in primary care practice, have Choosing Wisely® recommendations against these low-value services, and represent situations in which clinician decisions about ordering of services can be unduly swayed by interactions with patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinician participants will be drawn from the pool of physicians, nurse practitioners, and physician assistants staffing the 8 primary care clinics.
- •Patients of all 8 study clinics must meet criteria for one of the three Choosing Wisely® recommendations to be eligible to participate:
- •65 and older with type 2 diabetes
- •65 and older with insomnia and/or anxiety
- •male, 75 and older with no history of prostate cancer.
排除标准
- •Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.
研究组 & 干预措施
Commitment invitation at time 1
In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 1 month, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 8 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 1
In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 1 month, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 8 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 4
In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 4 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 5 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 2
In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 2 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 7 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 2
In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 2 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 7 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 3
In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 3 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 6 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 3
In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 3 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 6 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 4
In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 4 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 5 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 5
In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 5 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 4 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 5
In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 5 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 4 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 6
In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 6 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 3 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 6
In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 6 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 3 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 7
In the stepped wedge cluster randomized design, the seventh clinic will remain in the control period (no intervention) for 7 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 2 months.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 7
In the stepped wedge cluster randomized design, the seventh clinic will remain in the control period (no intervention) for 7 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 2 months.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
Commitment invitation at time 8
In the stepped wedge cluster randomized design, the eighth clinic will remain in the control period (no intervention) for 8 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 1 month.
干预措施: Commitment Invitation for Clinicians (Clinician Intervention) (Behavioral)
Commitment invitation at time 8
In the stepped wedge cluster randomized design, the eighth clinic will remain in the control period (no intervention) for 8 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 1 month.
干预措施: Health Education Materials to Patients (Patient Intervention) (Other)
结局指标
主要结局
Difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
时间窗: 10 months
The applicable low-value treatments or tests specified by the respective Choosing Wisely® recommendations are use of hypoglycemic medications for patients 65 years or older with diabetes and tight glycemic control, PSA testing among men 75 years or older with no history of prostate cancer, and use of benzodiazepine or sedative-hypnotic medications for patients with insomnia or anxiety who are 65 years or older.
次要结局
- Frequency of patient-provider conversations about the applicable low-value treatments or tests(Within 1 week of primary care visit)
- Patient trust in primary care provider(Within 1 week of primary care visit)
- Patient rating of provider(Within 1 week of primary care visit)
- Composite difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation(10 months)
研究者
Jeffrey T. Kullgren
Assistant Professor of Internal Medicine
University of Michigan