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Health Services MisuseNCT02247050

Primary Care Clinician Commitments to Choosing Wisely®

A study testing Commitment invitation in people with Health Services Misuse and Physician's Practice Patterns, run by University of Michigan at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Commitment invitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
6 sitesUnited States
Study dates
Sep 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • IHA Ann Arbor Family Medicine

    Ann Arbor, Michigan, 48103

  • IHA Family Medicine - Arbor Park

    Ann Arbor, Michigan, 48105

  • IHA Internal Medicine - Domino's Farms

    Ann Arbor, Michigan, 48105

  • IHA Brighton Family Care

    Brighton, Michigan, 48114

  • IHA Internal Medicine - Cherry Hill

    Canton, Michigan, 48187

  • IHA Reichert Internal Medicine at Towsley

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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.

Read the 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.

Being tested
Commitment invitation
Keywords
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
Medical subject headings
Behavior, Low Back Pain, Sinusitis, Respiratory Tract Infections, Headache, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Commitment invitationBehavioural

    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.

Study groups in NCT02247050
Study groupRoleWhat they receive
Commitment invitation at time 1ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation
Commitment invitation at time 2ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation
Commitment invitation at time 3ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation
Commitment invitation at time 4ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation
Commitment invitation at time 5ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation
Commitment invitation at time 6ExperimentalIntervention: 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.
Receives: Behavioral: Commitment invitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 10 months of receiving the intervention

Secondary outcomes (1)
  1. 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.

    Measured: Within 10 months of receiving the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247050
Sponsor's protocol ID
HUM00087820
Other IDs
71475
Status last verified
May 2016
First submitted
18 Sep 2014
Last updated
6 May 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 29066616

Questions about this trial

What is this clinical trial studying?

A study testing Commitment invitation in people with Health Services Misuse and Physician's Practice Patterns, run by University of Michigan at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.

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