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Primary Care Clinician Commitments to Choosing Wisely®

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
IHA
Information provided by (Responsible Party):
Jeffrey T. Kullgren, University of Michigan
ClinicalTrials.gov Identifier:
NCT02247050
First received: September 18, 2014
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Health Services Misuse Physician's Practice Patterns Guideline Adherence Unnecessary Procedures Health Care Costs Behavioral: Commitment invitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Primary Care Clinician Commitments to Choosing Wisely®

Further study details as provided by Jeffrey T. Kullgren, University of Michigan:

Primary Outcome Measures:
  • Composite rates of ordering 3 potentially low-value services in primary care visits by adult patients [ Time Frame: Within 10 months of receiving the intervention ]
    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.


Secondary Outcome Measures:
  • Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients [ Time Frame: Within 10 months of receiving the intervention ]
    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.


Enrollment: 45
Study Start Date: September 2014
Study Completion Date: June 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247050

Locations
United States, Michigan
IHA Ann Arbor Family Medicine
Ann Arbor, Michigan, United States, 48103
IHA Family Medicine - Arbor Park
Ann Arbor, Michigan, United States, 48105
IHA Internal Medicine - Domino's Farms
Ann Arbor, Michigan, United States, 48105
IHA Brighton Family Care
Brighton, Michigan, United States, 48114
IHA Internal Medicine - Cherry Hill
Canton, Michigan, United States, 48187
IHA Reichert Internal Medicine at Towsley
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan
Robert Wood Johnson Foundation
IHA
Investigators
Principal Investigator: Jeffrey T. Kullgren, MD, MS, MPH University of Michigan
  More Information

Responsible Party: Jeffrey T. Kullgren, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02247050     History of Changes
Other Study ID Numbers: HUM00087820
71475 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
Study First Received: September 18, 2014
Last Updated: May 5, 2016

Keywords provided by Jeffrey T. Kullgren, University of Michigan:
Costs and Cost Analysis
Professional Practice
Attitude of Health Personnel
Health Knowledge, Attitudes, and Practice
Decision Making
Practice Guidelines as Topic
Physician-Patient Relations
Physician's Role
Health Care
Quality of Health Care
Quality Assurance
Physicians, Primary Care
Evidence-Based Medicine
Evidence-Based Practice
Decision Support Systems, Clinical
Reminder Systems
Judgment
Cognition
Patient Care
Health Services Misuse
Unnecessary Procedures
Prescribing Patterns, Physician
Inappropriate Prescribing
Over Prescribing
Low Back Pain
Sinusitis
Infections, Upper Respiratory
Generalized Headache
Imaging, Diagnostic
Antibiotics

ClinicalTrials.gov processed this record on September 19, 2017