Effects of Provider Commitments to Choose Wisely

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

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.

Study Overview

• Status: Completed
• Conditions: Guideline Adherence; Health Care Costs; Physician's Practice Patterns; Health Services Misuse; Unnecessary Procedures
• Intervention / Treatment: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention)

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.

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical School
    • Ann Arbor, Michigan, United States, 48105
      • IHA Internal Medicine - Domino's Farms
    • Ann Arbor, Michigan, United States, 48103
      • IHA Family & Internal Medicine - West Arbor
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Medicine Briarwood Medical Group
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine East Ann Arbor Health and Geriatrics Center
    • Brighton, Michigan, United States, 48116
      • Michigan Medicine Brighton Health Center
    • Canton, Michigan, United States, 48187
      • IHA Family & Internal Medicine - Cherry Hill
    • Canton, Michigan, United States, 48187
      • Michigan Medicine Canton Health Center
    • Ypsilanti, Michigan, United States, 48197
      • IHA Internal Medicine - Towsley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Donaghue Medical Research Foundation; Integrated Health Associates
• Investigators: Principal Investigator: Jeffrey T. Kullgren, MS, MD, MPH, University of Michigan; Principal Investigator: Eve Kerr, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HUM00112834

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No