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OpenTrials
Completed

NCT Number: NCT03411525

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.

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Key information

Conditions

Health Services Misuse Guideline Adherence Health Care Costs Physician's Practice Patterns Unnecessary Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IHA Family & Internal Medicine - West Arbor, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Commitment Invitation for Clinicians (Clinician Intervention)

Behavioral

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.

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

    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.

Secondary outcomes

  1. Patient trust in primary care provider

    Time frame: Within 1 week of primary care visit

    Self reported level of trust patient has in his or her primary care provider as measured by a 5-item scale.

  2. Patient rating of provider

    Time frame: Within 1 week of primary care visit

    Patient's self-reported rating of their primary care provider as measured on a 0 to 10 scale.

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

    Time frame: Within 1 week of primary care visit

    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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Donaghue Medical Research Foundation
  • Integrated Health Associates

Registry information

Official study title

Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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