Primary Care Clinician Commitments to Choosing Wisely®

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.

Study Overview

• Status: Completed
• Conditions: Guideline Adherence; Health Care Costs; Physician's Practice Patterns; Health Services Misuse; Unnecessary Procedures
• Intervention / Treatment: Behavioral: Commitment invitation

Detailed Description

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.

Hypothesis 2: Inviting primary care clinicians to commit to avoid ordering imaging for low back pain, antibiotics for acute sinusitis, and imaging for headaches will reduce health care costs in patient visits for low back pain, acute sinusitis, and headaches.

Hypothesis 3: Inviting primary care clinicians to commit to avoid ordering low-value services will reduce per-clinician per-visit health care costs across clinical conditions.

For each outcome investigators will also compare differences between clinicians who did and did not commit to follow the 3 Choosing Wisely recommendations. Additionally, investigators will compare differences in outcomes between the 3-month follow-up period (immediately after the intervention has ended) and the control and intervention periods.

After the intervention period, the study team will conduct surveys and semi-structured interviews with study clinicians. The survey results will be used to identify correlates of primary care clinician uptake of invitations to commit to avoid ordering low-value services. The semi-structured interviews will elicit qualitative data on clinician attitudes towards overuse of low-value services, clinicians' responses to the intervention, and facilitators of and barriers to avoidance of delivering low-value care.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • IHA Ann Arbor Family Medicine
    • Ann Arbor, Michigan, United States, 48105
      • IHA Family Medicine - Arbor Park
    • Ann Arbor, Michigan, United States, 48105
      • IHA Internal Medicine - Domino's Farms
    • Brighton, Michigan, United States, 48114
      • IHA Brighton Family Care
    • Canton, Michigan, United States, 48187
      • IHA Internal Medicine - Cherry Hill
    • Ypsilanti, Michigan, United States, 48197
      • IHA Reichert Internal Medicine at Towsley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Commitment invitation at time 1; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
Experimental: Commitment invitation at time 2; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
Experimental: Commitment invitation at time 3; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
Experimental: Commitment invitation at time 4; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
Experimental: Commitment invitation at time 5; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
Experimental: Commitment invitation at time 6; 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.	Behavioral: Commitment invitation; Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients	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.	Within 10 months of receiving the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients	Composite rates of ordering potential substitute services for 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.	Within 10 months of receiving the intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Robert Wood Johnson Foundation; IHA
• Investigators: Principal Investigator: Jeffrey T. Kullgren, MD, MS, MPH, University of Michigan

Publications and helpful links

General Publications

• Kullgren JT, Krupka E, Schachter A, Linden A, Miller J, Acharya Y, Alford J, Duffy R, Adler-Milstein J. Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial. BMJ Qual Saf. 2018 May;27(5):355-364. doi: 10.1136/bmjqs-2017-006699. Epub 2017 Oct 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Low Back Pain; Antibiotics; Decision Making; Quality of Health Care; Cognition; Costs and Cost Analysis; Evidence-Based Medicine; Choosing Wisely; Health Care; Quality Assurance; Evidence-Based Practice; Decision Support Systems, Clinical; Sinusitis; Cluster Randomized Trial; Patient Care; Physicians, Primary Care; Imaging, Diagnostic; Physician-Patient Relations; Reminder Systems; Inappropriate Prescribing; Pragmatic Trial; Attitude of Health Personnel; Practice Guidelines as Topic; Professional Practice; Health Knowledge, Attitudes, and Practice; Physician's Role; Judgment; Health Services Misuse; Unnecessary Procedures; Prescribing Patterns, Physician; Over Prescribing; Infections, Upper Respiratory; Generalized Headache; Overuse of Low-Value Services; Stepped Wedge Design
• Other Study ID Numbers: HUM00087820; 71475 (Other Grant/Funding Number: Robert Wood Johnson Foundation)