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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04902664
Other study ID # 2020P001080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2021
Est. completion date October 29, 2022

Study information

Verified date November 2022
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 329
Est. completion date October 29, 2022
Est. primary completion date October 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient education materials
Patients receive a text-message and email with educational materials about medical testing.
Physician peer-comparison email
Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.
Physician education materials
Physicians receive reference materials on medical test interpretation and incidental findings.
General visit preparation materials
Patients receive a text-message and email with general visit preparation tips.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Brigham and Women's Hospital RAND, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shared Decision-Making Process 4 Survey Composite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better). Within two weeks after visit
Secondary Presence of testing discussion Binary measure from patient post-visit survey (present vs absent) Within two weeks after visit
Secondary Satisfaction with testing discussion Binary measure from patient post-visit survey (high vs low) Within two weeks after visit
Secondary Discussion of next steps Binary measure from patient post-visit survey (present vs absent) Within two weeks after visit
Secondary Whether doctor explained tests in a way that was easy to understand Binary measure from patient post-visit survey (yes completely vs yes a little or no) Within two weeks after visit
Secondary Patient knowledge Composite score of survey items from patient post-visit survey. Min 0, Max 4 (higher is better). Within two weeks after visit
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