NCT02247050

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

September 18, 2014

Last Update Submit

May 5, 2016

Conditions

Keywords

Costs and Cost AnalysisProfessional PracticeAttitude of Health PersonnelHealth Knowledge, Attitudes, and PracticeDecision MakingPractice Guidelines as TopicPhysician-Patient RelationsPhysician's RoleHealth CareQuality of Health CareQuality AssurancePhysicians, Primary CareEvidence-Based MedicineEvidence-Based PracticeDecision Support Systems, ClinicalReminder SystemsJudgmentCognitionPatient CareHealth Services MisuseUnnecessary ProceduresPrescribing Patterns, PhysicianInappropriate PrescribingOver PrescribingLow Back PainSinusitisInfections, Upper RespiratoryGeneralized HeadacheImaging, DiagnosticAntibioticsHumansOveruse of Low-Value ServicesPragmatic TrialStepped Wedge DesignCluster Randomized TrialChoosing Wisely

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Composite rates of ordering potential substitute services for 3 potentially low-value services in primary care visits by adult patients

    Within 10 months of receiving the intervention

Study Arms (6)

Commitment invitation at time 1

EXPERIMENTAL

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

Commitment invitation at time 2

EXPERIMENTAL

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

Commitment invitation at time 3

EXPERIMENTAL

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

Commitment invitation at time 4

EXPERIMENTAL

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

Commitment invitation at time 5

EXPERIMENTAL

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

Commitment invitation at time 6

EXPERIMENTAL

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

Interventions

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.

Commitment invitation at time 1Commitment invitation at time 2Commitment invitation at time 3Commitment invitation at time 4Commitment invitation at time 5Commitment invitation at time 6

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

IHA Ann Arbor Family Medicine

Ann Arbor, Michigan, 48103, United States

Location

IHA Family Medicine - Arbor Park

Ann Arbor, Michigan, 48105, United States

Location

IHA Internal Medicine - Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

IHA Brighton Family Care

Brighton, Michigan, 48114, United States

Location

IHA Internal Medicine - Cherry Hill

Canton, Michigan, 48187, United States

Location

IHA Reichert Internal Medicine at Towsley

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

BehaviorLow Back PainSinusitisRespiratory Tract InfectionsHeadacheDisease

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPathologic Processes

Study Officials

  • Jeffrey T. Kullgren, MD, MS, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 23, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations