Effects of Provider Commitments to Choose Wisely

Guideline Adherence Clinical Trial

Official title:

Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411525
• Other study ID #: HUM00112834
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: February 28, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Guideline Adherence
• Health Care Costs
• Health Services Misuse
• Physician's Practice Patterns
• Unnecessary Procedures

Intervention

Behavioral:
• Commitment Invitation for Clinicians (Clinician Intervention)
Clinicians will be invited to commit to follow 3 Choosing Wisely® recommendations. Those that choose to commit will sign a written document, appear on in-clinic posters along with their colleagues who have committed to the recommendations, have access to point-of-care Choosing Wisely® patient education handouts, and receive weekly emails with decision support resources.

Other:
• Health Education Materials to Patients (Patient Intervention)
During the intervention period, the letter and study information sheet that eligible patients will receive in advance of a scheduled appointment with a participating clinician will also be accompanied by a patient education handout from Consumer Reports that is publicly available and may be relevant to their health and health care. Specifically, patients with type 2 diabetes who are 65 and older will receive a handout about diabetes overtreatment, patients with insomnia or anxiety who are 65 and older will receive a handout about overuse of benzodiazepines and sedative-hypnotics, and male patients who are 75 and older with no history of prostate cancer will receive a handout about overuse of PSA tests to screen for prostate cancer.

Locations

Country	Name	City	State
United States	IHA Family & Internal Medicine - West Arbor	Ann Arbor	Michigan
United States	IHA Internal Medicine - Domino's Farms	Ann Arbor	Michigan
United States	Michigan Medicine Briarwood Medical Group	Ann Arbor	Michigan
United States	Michigan Medicine East Ann Arbor Health and Geriatrics Center	Ann Arbor	Michigan
United States	University of Michigan Medical School	Ann Arbor	Michigan
United States	Michigan Medicine Brighton Health Center	Brighton	Michigan
United States	IHA Family & Internal Medicine - Cherry Hill	Canton	Michigan
United States	Michigan Medicine Canton Health Center	Canton	Michigan
United States	IHA Internal Medicine - Towsley	Ypsilanti	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Donaghue Medical Research Foundation, Integrated Health Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 months
Secondary	Patient trust in primary care provider	Self reported level of trust patient has in his or her primary care provider as measured by a 5-item scale.	Within 1 week of primary care visit
Secondary	Patient rating of provider	Patient's self-reported rating of their primary care provider as measured on a 0 to 10 scale.	Within 1 week of primary care visit
Secondary	Frequency of patient-provider conversations about the applicable low-value treatments or tests	Self-reported frequency of patient-provider conversations about the applicable low-value treatments or tests. 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.	Within 1 week of primary care visit
Secondary	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	The study will combine data from all target recommendations (e.g., a composite outcome) where if one visit meets inclusion criteria for more than one target recommendation, they will be treated as independent visits.	10 months