Clinical trial NCT03411525: Effects of Provider Commitments to Choose Wisely
Official title: Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Services Misuse
Physician's Practice Patterns
Guideline Adherence
Unnecessary Procedures
Health Care Costs
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
name: Integrated Health Associates
First posted: 2018-01-26
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.

Primary outcomes:
measure: 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
timeFrame: 10 months
Secondary outcomes:
measure: Patient trust in primary care provider
timeFrame: Within 1 week of primary care visit
measure: Patient rating of provider
timeFrame: Within 1 week of primary care visit
measure: Frequency of patient-provider conversations about the applicable low-value treatments or tests
timeFrame: Within 1 week of primary care visit
measure: 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
timeFrame: 10 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: IHA Family & Internal Medicine - West Arbor
state: Michigan
city: Ann Arbor
country: United States
facility: IHA Internal Medicine - Domino's Farms
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Medicine Briarwood Medical Group
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Medicine East Ann Arbor Health and Geriatrics Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Brighton
country: United States
facility: Michigan Medicine Brighton Health Center
state: Michigan
city: Canton
country: United States
facility: IHA Family & Internal Medicine - Cherry Hill
state: Michigan
city: Canton
country: United States
facility: Michigan Medicine Canton Health Center
state: Michigan
city: Ypsilanti
country: United States
facility: IHA Internal Medicine - Towsley
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey T. Kullgren, MS, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Eve Kerr, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: