ClinicalTrials.gg
CompletedNCT04902664Updated Nov 17, 2022

Shared Decision-making on Medical Tests and Care Cascades

An interventional study of Patient education materials and Physician peer-comparison email in Health Knowledge, Attitudes, Practice and Health Care Utilization, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
329
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Health Knowledge, Attitudes, Practice
  • Health Care Utilization
03

In context

Behavior

406 studies on the registry are indexed under Behavior; 167 are open to participants now.

This study's enrollment of 329 is above the median of 120 across 316 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
329 participants (actual)

Study arms

  • 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 · Behavioral: Physician peer-comparison email · Behavioral: Physician education materials

  • 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

Interventions

  • BehavioralPatient education materials

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

  • BehavioralPhysician peer-comparison email

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

  • BehavioralPhysician education materials

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

  • BehavioralGeneral visit preparation materials

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

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Within two weeks after visit

Secondary outcomes

  1. Presence of testing discussion

    Binary measure from patient post-visit survey (present vs absent)

    Time frame: Within two weeks after visit

  2. Satisfaction with testing discussion

    Binary measure from patient post-visit survey (high vs low)

    Time frame: Within two weeks after visit

  3. Discussion of next steps

    Binary measure from patient post-visit survey (present vs absent)

    Time frame: Within two weeks after visit

  4. 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)

    Time frame: Within two weeks after visit

  5. Patient knowledge

    Composite score of survey items from patient post-visit survey. Min 0, Max 4 (higher is better).

    Time frame: Within two weeks after visit

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02120, United States
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References and documents

Publications

  • 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. PubMed 37943557 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04902664
Collaborators
RAND, Robert Wood Johnson Foundation
Responsible party
Ishani Ganguli MD, MPH (Assistant Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
May 26, 2021
Start date
May 24, 2021
Primary completion
Oct 6, 2022
Completion
Oct 29, 2022
Last update
Nov 17, 2022

Study contacts

Ishani Ganguli, MD, MPH
principal investigator · Brigham and Women's Hospital
Robert S Rudin, PhD
principal investigator · RAND

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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