Clinical trial NCT06354920: M-Well Bonding Bundle to Improve Patient-Physician Relationships
Official title: Engineering Whole Health Into Hospital Care to Improve Wellness: Bonding Bundle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physician-Patient Relations
Keywords: Empathy
Physician-Patient Relations
Health communication
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-04-09
Enrollment: 3624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Primary Subjects - Physicians

Inclusion Criteria:

* Attending physicians caring for hospitalized medical patients

Exclusion Criteria:

* Surgical attendings
* Residents

Secondary Subjects - Patients

Inclusion Criteria

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

Exclusion Criteria:

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

Primary outcomes:
measure: Jefferson Scale of Empathy (JSE)
timeFrame: Given once at the end of each work rotation in the study. Work rotations are usually 14-15 days.
measure: Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE)
timeFrame: Asked once during hospital stay, typically 1 day to 30 days.
measure: Communication Assessment Tool
timeFrame: Asked once during hospital stay, typically 1 day to 30 days.
measure: Frequency of use of intervention methods
timeFrame: During their work rotation in the study. Work rotations are usually 14-15 days.
Secondary outcomes:
measure: Perceived duration of interaction
timeFrame: Asked once during hospital stay, typically 1 day to 30 days
measure: Wake Forest Physician Trust Scale
timeFrame: Asked once during hospital stay, typically 1 day to 30 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sanjay Saint, MD
role: PRINCIPAL_INVESTIGATOR
References: