NCT03411525

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
489

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

January 19, 2018

Last Update Submit

March 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 months

Secondary Outcomes (4)

  • Patient trust in primary care provider

    Within 1 week of primary care visit

  • Patient rating of provider

    Within 1 week of primary care visit

  • Frequency of patient-provider conversations about the applicable low-value treatments or tests

    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

    10 months

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: Commitment Invitation for Clinicians (Clinician Intervention)Other: Health Education Materials to Patients (Patient Intervention)

Interventions

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.

Commitment invitation at time 1Commitment invitation at time 2Commitment invitation at time 3Commitment invitation at time 4Commitment invitation at time 5Commitment invitation at time 6Commitment invitation at time 7Commitment invitation at time 8

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.

Commitment invitation at time 1Commitment invitation at time 2Commitment invitation at time 3Commitment invitation at time 4Commitment invitation at time 5Commitment invitation at time 6Commitment invitation at time 7Commitment invitation at time 8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • and older with type 2 diabetes
  • and older with insomnia and/or anxiety
  • male, 75 and older with no history of prostate cancer.

You may not qualify if:

  • Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

IHA Family & Internal Medicine - West Arbor

Ann Arbor, Michigan, 48103, United States

Location

IHA Internal Medicine - Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

Michigan Medicine Briarwood Medical Group

Ann Arbor, Michigan, 48108, United States

Location

Michigan Medicine East Ann Arbor Health and Geriatrics Center

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Michigan Medicine Brighton Health Center

Brighton, Michigan, 48116, United States

Location

IHA Family & Internal Medicine - Cherry Hill

Canton, Michigan, 48187, United States

Location

Michigan Medicine Canton Health Center

Canton, Michigan, 48187, United States

Location

IHA Internal Medicine - Towsley

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Jeffrey T. Kullgren, MS, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Eve Kerr, MD, 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
Model Details: Stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

January 26, 2018

Primary Completion

November 1, 2018

Study Completion

February 28, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations