Shared Decision-making on Medical Tests and Care Cascades

NCT04902664 | Completed

• 1 other identifier: 2020P001080
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Knowledge, Attitudes, Practice; Health Care Utilization

Outcome Measures

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).

  Within two weeks after visit

Secondary Outcomes (5)

• Presence of testing discussion

  Within two weeks after visit

• Satisfaction with testing discussion

  Within two weeks after visit

• Discussion of next steps

  Within two weeks after visit

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

  Within two weeks after visit

• Patient knowledge

  Within two weeks after visit

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

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

Patient education materials BEHAVIORAL

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

Intervention Arm

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.

Intervention Arm

Physician education materials BEHAVIORAL

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

Intervention Arm

General visit preparation materials BEHAVIORAL

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• RAND: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

• 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.

  PMID: 37943557 DERIVED

MeSH Terms

Conditions

Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior

Study Officials

• Ishani Ganguli, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Robert S Rudin, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: May 24, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 29, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)