Health Services MisuseNCT03411525
Effects of Provider Commitments to Choose Wisely
A study testing Commitment Invitation for Clinicians (Clinician Intervention) and Health Education Materials to Patients (Patient Intervention) in people with Health Services Misuse and Physician's Practice Patterns, run by University of Michigan at 9 sites in United States.
Trial summary
Clinicians' decisions to order potentially unnecessary services -- such as those targeted in the Choosing Wisely® campaign -- are often affected by their high-pressure practice environments, which can make it hard to consistently avoid ordering low-value care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence
- What is being tested?
- Commitment Invitation for Clinicians (Clinician Intervention) and Health Education Materials to Patients (Patient Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 9 sitesUnited States
- Study dates
- 26 Jan 2018to 28 Feb 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinician participants will be drawn from the pool of physicians, nurse practitioners, and physician assistants staffing the 8 primary care clinics.
- Patients of all 8 study clinics must meet criteria for one of the three Choosing Wisely® recommendations to be eligible to participate:
- 65 and older with type 2 diabetes
- 65 and older with insomnia and/or anxiety
- male, 75 and older with no history of prostate cancer.
Who cannot join
- Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
IHA Family & Internal Medicine - West Arbor
Ann Arbor, Michigan, 48103
IHA Internal Medicine - Domino's Farms
Ann Arbor, Michigan, 48105
Michigan Medicine Briarwood Medical Group
Ann Arbor, Michigan, 48108
Michigan Medicine East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, 48109
University of Michigan Medical School
Ann Arbor, Michigan, 48109
Michigan Medicine Brighton Health Center
Brighton, Michigan, 48116
IHA Family & Internal Medicine - Cherry Hill
Canton, Michigan, 48187
Michigan Medicine Canton Health Center
Canton, Michigan, 48187
IHA Internal Medicine - Towsley
Ypsilanti, Michigan, 48197
About this study
Official title: Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely
Clinicians' decisions to order potentially unnecessary services -- such as those targeted in the Choosing Wisely® campaign -- are often affected by their high-pressure practice environments, which can make it hard to consistently avoid ordering low-value care. The field of behavioral economics offers a promising and highly scalable approach to decreasing use of low-value services: asking clinicians to commit to avoid ordering such services and providing them and their patients with resources to support adherence to this commitment. This project will evaluate the effects of such an intervention across 2 large health systems, Michigan Medicine and IHA, through a mixed-methods, stepped wedge cluster randomized trial. In each of the study clinics, clinicians will be invited to commit to following a set of targeted Choosing Wisely® recommendations. Clinicians who make such a commitment, and their patients, will receive access to key resources to support adherence to this commitment. To measure the effects of the intervention, automated clinical data and medical record data before and after the intervention will be examined. Surveys and semi-structured interviews of both clinicians and patients will also be conducted to determine the effects of the intervention on their decision-making and experiences.
Read the detailed description
A mixed-methods stepped wedge cluster randomized trial will be conducted in 8 primary care clinics of IHA, a private multispecialty group practice, and Michigan Medicine, a large academic health system. The study will test whether pre-encounter clinician commitments combined with patient and provider supports decrease overtreatment of type 2 diabetes among patients 65 and older, use of benzodiazepines and sedative-hypnotics among patients age 65 and older who have insomnia or anxiety, and use of PSA tests to screen for prostate cancer among men 75 and older. These 3 recommendations were chosen because they are commonly performed in primary care practice, have Choosing Wisely® recommendations against these low-value services, and represent situations in which clinician decisions about ordering of services can be unduly swayed by interactions with patients.
- Conditions
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence, Unnecessary Procedures, Health Care Costs
- Being tested
- Commitment Invitation for Clinicians (Clinician Intervention), Health Education Materials to Patients (Patient Intervention)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commitment Invitation for Clinicians (Clinician Intervention)Behavioural
Clinicians will be invited to commit to follow 3 Choosing Wisely® recommendations. Those that choose to commit will sign a written document, appear on in-clinic posters along with their colleagues who have committed to the recommendations, have access to point-of-care Choosing Wisely® patient education handouts, and receive weekly emails with decision support resources.
Health Education Materials to Patients (Patient Intervention)Other
During the intervention period, the letter and study information sheet that eligible patients will receive in advance of a scheduled appointment with a participating clinician will also be accompanied by a patient education handout from Consumer Reports that is publicly available and may be relevant to their health and health care. Specifically, patients with type 2 diabetes who are 65 and older will receive a handout about diabetes overtreatment, patients with insomnia or anxiety who are 65 and older will receive a handout about overuse of benzodiazepines and sedative-hypnotics, and male patients who are 75 and older with no history of prostate cancer will receive a handout about overuse of PSA tests to screen for prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Commitment invitation at time 1 | Experimental | In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 1 month, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 8 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 2 | Experimental | In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 2 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 7 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 3 | Experimental | In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 3 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 6 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 4 | Experimental | In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 4 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 5 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 5 | Experimental | In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 5 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 4 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 6 | Experimental | In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 6 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 3 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 7 | Experimental | In the stepped wedge cluster randomized design, the seventh clinic will remain in the control period (no intervention) for 7 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 2 months. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
| Commitment invitation at time 8 | Experimental | In the stepped wedge cluster randomized design, the eighth clinic will remain in the control period (no intervention) for 8 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 1 month. Receives: Behavioral: Commitment Invitation for Clinicians (Clinician Intervention); Other: Health Education Materials to Patients (Patient Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
The applicable low-value treatments or tests specified by the respective Choosing Wisely® recommendations are use of hypoglycemic medications for patients 65 years or older with diabetes and tight glycemic control, PSA testing among men 75 years or older with no history of prostate cancer, and use of benzodiazepine or sedative-hypnotic medications for patients with insomnia or anxiety who are 65 years or older.
Measured: 10 months
Secondary outcomes (4)
Patient trust in primary care provider
Self reported level of trust patient has in his or her primary care provider as measured by a 5-item scale.
Measured: Within 1 week of primary care visit
Patient rating of provider
Patient's self-reported rating of their primary care provider as measured on a 0 to 10 scale.
Measured: Within 1 week of primary care visit
Frequency of patient-provider conversations about the applicable low-value treatments or tests
Self-reported frequency of patient-provider conversations about the applicable low-value treatments or tests. The applicable low-value treatments or tests specified by the respective Choosing Wisely® recommendations are use of hypoglycemic medications for patients 65 years or older with diabetes and tight glycemic control, PSA testing among men 75 years or older with no history of prostate cancer, and use of benzodiazepine or sedative-hypnotic medications for patients with insomnia or anxiety who are 65 years or older.
Measured: Within 1 week of primary care visit
Composite difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
The study will combine data from all target recommendations (e.g., a composite outcome) where if one visit meets inclusion criteria for more than one target recommendation, they will be treated as independent visits.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start26 Jan 2018
- Primary completion1 Nov 2018
- Study completion28 Feb 2019
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
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation, Integrated Health Associates
- Responsible party
- Principal investigator, Jeffrey T. Kullgren, University of Michigan
- Investigators
- Jeffrey T. Kullgren, MS, MD, MPH, Principal investigator, University of MichiganEve Kerr, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411525
- Sponsor's protocol ID
- HUM00112834
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kullgren JT, Kim HM, Slowey M, Colbert J, Soyster B, Winston SA, Ryan K, Forman JH, Riba M, Krupka E, Kerr EA. Using Behavioral Economics to Reduce Low-Value Care Among Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2024 Mar 1;184(3):281-290. doi: 10.1001/jamainternmed.2023.7703.
PubMed 38285565
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely
- ClinicalTrials.gov ID
- NCT03411525
- Acronym / sponsor ID
- HUM00112834
- Conditions
- Health Services Misuse, Physician's Practice Patterns, Guideline Adherence, Unnecessary Procedures, Health Care Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation, Integrated Health Associates
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
Clinicians' decisions to order potentially unnecessary services -- such as those targeted in the Choosing Wisely® campaign -- are often affected by their high-pressure practice environments, which can make it hard to consistently avoid ordering low-value care. The field of behavioral economics offers a promising and highly scalable approach to decreasing use of low-value services: asking clinicians to commit to avoid ordering such services and providing them and their patients with resources to support adherence to this commitment. This project will evaluate the effects of such an intervention across 2 large health systems, Michigan Medicine and IHA, through a mixed-methods, stepped wedge cluster randomized trial. In each of the study clinics, clinicians will be invited to commit to following a set of targeted Choosing Wisely® recommendations. Clinicians who make such a commitment, and their patients, will receive access to key resources to support adherence to this commitment. To measure the effects of the intervention, automated clinical data and medical record data before and after the intervention will be examined. Surveys and semi-structured interviews of both clinicians and patients will also be conducted to determine the effects of the intervention on their decision-making and experiences.
Detailed description
A mixed-methods stepped wedge cluster randomized trial will be conducted in 8 primary care clinics of IHA, a private multispecialty group practice, and Michigan Medicine, a large academic health system. The study will test whether pre-encounter clinician commitments combined with patient and provider supports decrease overtreatment of type 2 diabetes among patients 65 and older, use of benzodiazepines and sedative-hypnotics among patients age 65 and older who have insomnia or anxiety, and use of PSA tests to screen for prostate cancer among men 75 and older. These 3 recommendations were chosen because they are commonly performed in primary care practice, have Choosing Wisely® recommendations against these low-value services, and represent situations in which clinician decisions about ordering of services can be unduly swayed by interactions with patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Commitment invitation at time 1 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the first clinic will remain in the control period (no intervention) for 1 month, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 8 months. |
| Commitment invitation at time 2 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the second clinic will remain in the control period (no intervention) for 2 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 7 months. |
| Commitment invitation at time 3 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the third clinic will remain in the control period (no intervention) for 3 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 6 months. |
| Commitment invitation at time 4 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the fourth clinic will remain in the control period (no intervention) for 4 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 5 months. |
| Commitment invitation at time 5 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the fifth clinic will remain in the control period (no intervention) for 5 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 4 months. |
| Commitment invitation at time 6 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the sixth clinic will remain in the control period (no intervention) for 6 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 3 months. |
| Commitment invitation at time 7 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the seventh clinic will remain in the control period (no intervention) for 7 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 2 months. |
| Commitment invitation at time 8 | Experimental | Behavioral: Commitment Invitation for Clinicians (Clinician Intervention), Other: Health Education Materials to Patients (Patient Intervention)In the stepped wedge cluster randomized design, the eighth clinic will remain in the control period (no intervention) for 8 months, followed by a 1 month transition period (where data will not be collected), before crossing over to the intervention period for 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinician participants will be drawn from the pool of physicians, nurse practitioners, and physician assistants staffing the 8 primary care clinics.
- Patients of all 8 study clinics must meet criteria for one of the three Choosing Wisely® recommendations to be eligible to participate:
Key exclusion criteria (1 listed)
- Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.
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 Invitation for Clinicians (Clinician Intervention)Clinicians will be invited to commit to follow 3 Choosing Wisely® recommendations. Those that choose to commit will sign a written document, appear on in-clinic posters along with their colleagues who have committed to the recommendations, have access to point-of-care Choosing Wisely® patient education handouts, and receive 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, Commitment invitation at time 7, Commitment invitation at time 8 |
| Health Education Materials to Patients (Patient Intervention)During the intervention period, the letter and study information sheet that eligible patients will receive in advance of a scheduled appointment with a participating clinician will also be accompanied by a patient education handout from Consumer Reports that is publicly available and may be relevant to their health and health care. Specifically, patients with type 2 diabetes who are 65 and older will receive a handout about diabetes overtreatment, patients with insomnia or anxiety who are 65 and older will receive a handout about overuse of benzodiazepines and sedative-hypnotics, and male patients who are 75 and older with no history of prostate cancer will receive a handout about overuse of PSA tests to screen for prostate cancer. | Other | 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, Commitment invitation at time 7, Commitment invitation at time 8 |
Primary outcome
Difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
Time frame: 10 months
The applicable low-value treatments or tests specified by the respective Choosing Wisely® recommendations are use of hypoglycemic medications for patients 65 years or older with diabetes and tight glycemic control, PSA testing among men 75 years or older with no history of prostate cancer, and use of benzodiazepine or sedative-hypnotic medications for patients with insomnia or anxiety who are 65 years or older.
4 secondary outcomes
Patient trust in primary care provider
Time frame: Within 1 week of primary care visit
Patient rating of provider
Time frame: Within 1 week of primary care visit
Frequency of patient-provider conversations about the applicable low-value treatments or tests
Time frame: Within 1 week of primary care visit
Composite difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation
Time frame: 10 months
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 7 Mar 2019.
- Derived from this study: PubMed 38285565Kullgren JT, Kim HM, Slowey M, Colbert J, Soyster B, Winston SA, Ryan K, Forman JH, Riba M, Krupka E, Kerr EA. Using Behavioral Economics to Reduce Low-Value Care Among Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2024 Mar 1;184(3):281-290. doi: 10.1001/jamainternmed.2023.7703.
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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, MS, MD, MPH principal investigator
University of Michigan
Eve Kerr, MD, MPH principal investigator
University of Michigan
9 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 for Clinicians (Clinician Intervention) and Health Education Materials to Patients (Patient Intervention) in people with Health Services Misuse and Physician's Practice Patterns, run by University of Michigan at 9 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 5 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Difference in the proportion of intervention and control period visits with an applicable low-value treatment or test as specified by each respective Choosing Wisely® recommendation (time frame: 10 months). 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 NCT03411525, 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 7 Mar 2019.