Shared Decision-making on Medical Tests and Care Cascades

NCT ID: NCT04902664

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-10-29

Brief Summary

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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

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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.

Conditions

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Health Knowledge, Attitudes, Practice Health Care Utilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient education materials

Intervention Type BEHAVIORAL

Patients receive a text-message and email with educational materials about medical testing.

Physician peer-comparison email

Intervention Type BEHAVIORAL

Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.

Physician education materials

Intervention Type BEHAVIORAL

Physicians receive reference materials on medical test interpretation and incidental findings.

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.

Group Type PLACEBO_COMPARATOR

General visit preparation materials

Intervention Type BEHAVIORAL

Patients receive a text-message and email with general visit preparation tips.

Interventions

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Patient education materials

Patients receive a text-message and email with educational materials about medical testing.

Intervention Type 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.

Intervention Type BEHAVIORAL

Physician education materials

Physicians receive reference materials on medical test interpretation and incidental findings.

Intervention Type BEHAVIORAL

General visit preparation materials

Patients receive a text-message and email with general visit preparation tips.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary care physicians at Brigham and Women's Hospital
* In active practice


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RAND

OTHER

Sponsor Role collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ishani Ganguli MD, MPH

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ishani Ganguli, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Robert S Rudin, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Ganguli I, Mulligan KL, Chant ED, Lipsitz S, Simmons L, Sepucha K, Rudin RS. Effect of a Peer Comparison and Educational Intervention on Medical Test Conversation Quality: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342464. doi: 10.1001/jamanetworkopen.2023.42464.

Reference Type DERIVED
PMID: 37943557 (View on PubMed)

Other Identifiers

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2020P001080

Identifier Type: -

Identifier Source: org_study_id

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