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

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice; Health Care Utilization
• Intervention / Treatment: Behavioral: Patient education materials; Behavioral: Physician peer-comparison email; Behavioral: Physician education materials; Behavioral: General visit preparation materials

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 Type: Interventional
• Enrollment (Actual): 329
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Behavioral: Patient education materials; Patients receive a text-message and email with educational materials about medical testing.; Behavioral: 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.; Behavioral: Physician education materials; Physicians receive reference materials on medical test interpretation and incidental findings.
Placebo Comparator: Control Arm; 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.	Behavioral: General visit preparation materials; Patients receive a text-message and email with general visit preparation tips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of testing discussion	Binary measure from patient post-visit survey (present vs absent)	Within two weeks after visit
Satisfaction with testing discussion	Binary measure from patient post-visit survey (high vs low)	Within two weeks after visit
Discussion of next steps	Binary measure from patient post-visit survey (present vs absent)	Within two weeks after visit
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
Patient knowledge	Composite score of survey items from patient post-visit survey. Min 0, Max 4 (higher is better).	Within two weeks after visit

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: RAND; Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Ishani Ganguli, MD, MPH, Brigham and Women's Hospital; Principal Investigator: Robert S Rudin, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 29, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020P001080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No