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.
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
- Conditions the study is for
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence
- What is being tested?
- Commitment invitation
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence, Unnecessary Procedures, Health Care Costs
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Commitment invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Services MisuseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, IHA
- Responsible party
- Principal investigator, Jeffrey T. Kullgren, University of Michigan
- Investigators
- Jeffrey T. Kullgren, MD, MS, MPH, Principal investigator, University of Michigan
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Clinician Commitments to Choosing Wisely®
- ClinicalTrials.gov ID
- NCT02247050
- Acronym / sponsor ID
- HUM00087820
- Conditions
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence, Unnecessary Procedures, Health Care Costs
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, IHA
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Commitment invitation at time 1 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
| Commitment invitation at time 2 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
| Commitment invitation at time 3 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
| Commitment invitation at time 4 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
| Commitment invitation at time 5 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
| Commitment invitation at time 6 | Experimental | Behavioral: Commitment invitationIntervention: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinicians in 6 primary care (family medicine and internal medicine) clinics within the IHA organization of Ann Arbor, Michigan
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commitment invitationClinicians 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. | Behavioural | Commitment invitation at time 1, Commitment invitation at time 2, Commitment invitation at time 3, Commitment invitation at time 4, Commitment invitation at time 5, Commitment invitation at time 6 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Derived from this study: PubMed 29066616Kullgren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey T. Kullgren, MD, MS, MPH principal investigator
University of Michigan
6 sites in 1 country: see every site and its status.
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.