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OpenTrials
Completed

NCT Number: NCT04902664

Shared Decision-making on Medical Tests and Care Cascades

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education materials

Behavioral

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

Physician peer-comparison email

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

Behavioral

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

General visit preparation materials

Behavioral

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

Primary outcomes

  1. Shared Decision-Making Process 4 Survey

    Time frame: Within two weeks after visit

    Composite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better).

Secondary outcomes

  1. Presence of testing discussion

    Time frame: Within two weeks after visit

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

  2. Satisfaction with testing discussion

    Time frame: Within two weeks after visit

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

  3. Discussion of next steps

    Time frame: Within two weeks after visit

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

  4. Whether doctor explained tests in a way that was easy to understand

    Time frame: Within two weeks after visit

    Binary measure from patient post-visit survey (yes completely vs yes a little or no)

  5. Patient knowledge

    Time frame: Within two weeks after visit

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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • RAND
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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