Shared Decision-making on Medical Tests and Care Cascades

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902664
• Other study ID #: 2020P001080
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Health Care Utilization
• Health Knowledge, Attitudes, Practice

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