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Clinical Trials/NCT04902664
NCT04902664CompletedNot Applicable

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

Brigham and Women's Hospital1 site in 1 country329 target enrollmentStarted: May 24, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
329
Locations
1
Primary Endpoint
Shared Decision-Making Process 4 Survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervention Arm

Experimental

Intervention arm physicians will receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals, along with physician-facing education materials. This email will be sent before each patient study visit for all patients in the study. Participating patients of intervention arm physicians will receive patient education materials one to two days before their study visit.

Intervention: Patient education materials (Behavioral)

Intervention Arm

Experimental

Intervention arm physicians will receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals, along with physician-facing education materials. This email will be sent before each patient study visit for all patients in the study. Participating patients of intervention arm physicians will receive patient education materials one to two days before their study visit.

Intervention: Physician peer-comparison email (Behavioral)

Intervention Arm

Experimental

Intervention arm physicians will receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals, along with physician-facing education materials. This email will be sent before each patient study visit for all patients in the study. Participating patients of intervention arm physicians will receive patient education materials one to two days before their study visit.

Intervention: Physician education materials (Behavioral)

Control Arm

Placebo Comparator

Control arm physicians receive an email with information on the general visit preparation tips that their patients will receive. Participating patients of control arm physicians will receive general visit preparation tips one to two days before their study visit.

Intervention: General visit preparation materials (Behavioral)

Outcomes

Primary Outcomes

Shared Decision-Making Process 4 Survey

Time Frame: Within two weeks after visit

Composite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better).

Secondary Outcomes

  • Satisfaction with testing discussion(Within two weeks after visit)
  • Patient knowledge(Within two weeks after visit)
  • Presence of testing discussion(Within two weeks after visit)
  • Discussion of next steps(Within two weeks after visit)
  • Whether doctor explained tests in a way that was easy to understand(Within two weeks after visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ishani Ganguli MD, MPH

Assistant Professor of Medicine

Brigham and Women's Hospital

Study Sites (1)

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