Clinical trial NCT04902664: Shared Decision-making on Medical Tests and Care Cascades
Official title: A Multi-pronged Intervention to Initiate Shared Decision-making on Medical Tests and Care Cascades in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Health Care Utilization
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: RAND
name: Robert Wood Johnson Foundation
First posted: 2021-05-26
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Shared Decision-Making Process 4 Survey
timeFrame: Within two weeks after visit
Secondary outcomes:
measure: Presence of testing discussion
timeFrame: Within two weeks after visit
measure: Satisfaction with testing discussion
timeFrame: Within two weeks after visit
measure: Discussion of next steps
timeFrame: Within two weeks after visit
measure: Whether doctor explained tests in a way that was easy to understand
timeFrame: Within two weeks after visit
measure: Patient knowledge
timeFrame: Within two weeks after visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ishani Ganguli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Robert S Rudin, PhD
role: PRINCIPAL_INVESTIGATOR
References: