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Shared Decision-making on Medical Tests and Care Cascades

A Multi-pronged Intervention to Initiate Shared Decision-making on Medical Tests and Care Cascades in the Primary Care Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04902664
Enrollment
329
Registered
2021-05-26
Start date
2021-05-24
Completion date
2022-10-29
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Utilization, Health Knowledge, Attitudes, Practice

Brief summary

The purpose of this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. The investigators hypothesize that education materials and peer comparison will improve conversation quality about medical testing decisions.

Detailed description

Medical tests may show unexpected findings leading to additional tests, treatments, and visits that cost money and take time but may not have benefits. This is a prevalent issue with major consequences for patients and clinicians. Making informed decisions about when to order medical tests may help avoid unnecessary costs and worry. However, doctors don't always have detailed conversations about medical testing and there are patient gaps in knowledge. The investigators hypothesize that education materials and peer comparison to promote conversations about medical tests will improve conversation quality about medical testing decisions. The investigators have developed patient and provider-facing interventions to educate on and promote conversations about the uses and consequences of medical tests, and the investigators will test the impact of this just-in-time educational and peer comparison intervention on the likelihood of patients having productive conversations about medical tests. The effects of the intervention will be assessed using surveys before and after the study. This work has the potential to help patients feel more supported by their healthcare system, empower patients to participate in shared decision-making, and build trust between patients and clinicians.

Interventions

Patients receive a text-message and email with educational materials about medical testing.

BEHAVIORALPhysician peer-comparison email

Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.

BEHAVIORALPhysician education materials

Physicians receive reference materials on medical test interpretation and incidental findings.

BEHAVIORALGeneral visit preparation materials

Patients receive a text-message and email with general visit preparation tips.

Sponsors

RAND
CollaboratorOTHER
Robert Wood Johnson Foundation
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

20 primary care physicians will be recruited and randomized to an intervention and a control arm. For each physician, we will recruit at least 10 of their patients with upcoming scheduled physicals. All included patients of intervention physicians will receive the intervention, and all included patients of control physicians will receive general patient visit prep materials.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(Physicians): * Primary care physicians at Brigham and Women's Hospital * In active practice Inclusion criteria (Patients): * Adults age 18 years old or older * English-speaking * Access to email * Did not opt out of receiving research invitations from health system * Patients of participating physicians * Scheduled annual physical during the study period

Design outcomes

Primary

MeasureTime frameDescription
Shared Decision-Making Process 4 SurveyWithin two weeks after visitComposite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better).

Secondary

MeasureTime frameDescription
Presence of testing discussionWithin two weeks after visitBinary measure from patient post-visit survey (present vs absent)
Satisfaction with testing discussionWithin two weeks after visitBinary measure from patient post-visit survey (high vs low)
Discussion of next stepsWithin two weeks after visitBinary measure from patient post-visit survey (present vs absent)
Whether doctor explained tests in a way that was easy to understandWithin two weeks after visitBinary measure from patient post-visit survey (yes completely vs yes a little or no)
Patient knowledgeWithin two weeks after visitComposite score of survey items from patient post-visit survey. Min 0, Max 4 (higher is better).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026