Shared Decision-making on Medical Tests and Care Cascades

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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* Patients receive a text-message and email with educational materials about medical testing.<br>Behavioral: Physician peer-comparison email<br>* Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.<br>Behavioral: Physician education materials<br>* Physicians receive reference materials on medical test interpretation and incidental findings.<br>|
| Placebo Comparator: Control Arm<br>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<br>* Patients receive a text-message and email with general visit preparation tips.<br>|

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 |