M-Well Bonding Bundle to Improve Patient-Physician Relationships

NCT ID: NCT06354920

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2026-06-30

Brief Summary

The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:

• Will using the intervention strategies improve doctors' empathy towards their patients?
• Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?

There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.

Researchers will compare the doctors in the intervention arm to those in the control arm.

Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:

1. Allow study staff to observe the interaction between them and their patients.

2. Complete a brief survey at the end of their 2-week work rotation.

Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital.

Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following:

1. Allow study staff to observe the interaction between them and their doctors.

2. Complete a brief survey after meeting with their doctor.

Detailed Description

A sound relationship between doctors and patients forms the foundation of effective, safe, and high-quality care. This encourages empathy from the doctor and trust from the patient. Doctors caring for hospitalized patients have limited time with which to establish rapport with their patients. Doctors in the hospital are often new to the patient and only caring for them for a few days. This limited time means that without effective communication, patients may not share or receive necessary information to improve their quality of care. Studies have found that a significant number of hospitalized patients can't name even one doctor from their inpatient care team. Further, many do not understand their plan of care as explained by these same doctors. This gap in communication can reduce the patient's ability to give informed consent to treatments. It can also lead to poor patient outcomes as they are less likely to follow their plan of care post-discharge.

The goal of this study is to test an intervention to improve the relationship between patients and doctors, specifically whether small adjustments to a doctor's communication style will improve interactions and enhance the relationship between patients and their doctors.

This is a quasi-experimental randomized controlled trial. The study will be conducted at two hospitals. Two doctors will be recruited every 2-week work rotation. Participants will be randomized to either the intervention or control study arm. Those assigned to the control arm will conduct rounds as usual. Those in the intervention arm will be encouraged to use the intervention approaches when visiting with patients. These approaches are designed to foster connectedness between patients and doctors.

The primary subject will be the attending doctor. Patients of those doctors will serve as secondary subjects. Study staff will shadow the doctors when they visit with patients during rounds. Study staff will ask for verbal consent from patients before entering their room to conduct these observations. Staff will note the occurrence of any of the intervention elements, as well as duration of the interaction. A sub-sample of patients will be asked to complete a survey after the doctor leaves their room. The survey will evaluate the patient's perspective of the encounter with their doctor. Doctors will be asked to complete a survey about empathy at the end of their time on service. A few doctors and patients will be asked to participate in a study interview. The interviews are to better understand intervention experiences as well as barriers and facilitators to improving relationships between doctors and patients.

Conditions

Physician-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Bonding Bundle Intervention

Doctors in the intervention arm will be asked to use suggested approaches while meeting with their hospitalized patients. The goal of these strategies is to improve the relationship and interactions between patients and physicians.

Group Type: EXPERIMENTAL

Bonding Bundle

Intervention Type: BEHAVIORAL

Doctors in the intervention arm will be asked to use suggested approaches while meeting with their hospitalized patients. The goal of these strategies is to improve the relationship and interactions between patients and physicians.

Control

Doctors in the control arm will be asked to visit with their patients as they would normally.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bonding Bundle

Doctors in the intervention arm will be asked to use suggested approaches while meeting with their hospitalized patients. The goal of these strategies is to improve the relationship and interactions between patients and physicians.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Attending physicians caring for hospitalized medical patients

• Hospitalized adult patient
• Patient of an enrolled physician in the study

Exclusion Criteria

• Surgical attendings
• Residents

Secondary Subjects - Patients

• Cognitively impaired
• Unable to provide informed consent
• Does not speak English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sanjay Saint

George Dock Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanjay Saint, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Sanjay Saint, MD

Role: CONTACT

Saint@umich.edu

734-615-8341

Karen E Fowler, MPH

Role: CONTACT

Karen.Fowler@va.gov

734-845-3611

Facility Contacts

Sanjay Saint, MD, MPH

Role: primary

Saint@umich.edu

734-615-8341

Karen Fowler, MPH

Role: backup

Karen.Fowler@va.gov

734-845-3611

Nathan Houchens, MD

Role: primary

nathanho@med.umich.edu

734-845-5922

Karen Fowler, MPH

Role: backup

Karen.Fowler@va.gov

734-845-3611

Other Identifiers

R18HS028963

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HUM00247781

Identifier Type: -

Identifier Source: org_study_id