M-Well Bonding Bundle to Improve Patient-Physician Relationships

NCT06354920 | Completed

• 2 other identifiers: HUM00247781R18HS028963
• Study Type: interventional
• Target: 967
• Locations: 1 country
• Sites: 2

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:
• Allow study staff to observe the interaction between them and their patients.
• Complete a brief survey at the end of their 2-week work rotation.
• Allow study staff to observe the interaction between them and their doctors.
• Complete a brief survey after meeting with their doctor.

Conditions

Physician-Patient Relations

Keywords

Empathy; Physician-Patient Relations; Health communication

Outcome Measures

Primary Outcomes (4)

• Jefferson Scale of Empathy (JSE)

  The JSE is a 20-item validated instrument that measures a physicians empathy for their patients. Physicians are asked to rate their disagreement or agreement with individual statements on a 7-point Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). Using a scoring algorithm, a total Empathy score will be generated with a range from 20-140, with higher scores indicating a higher degree of empathy.

  Given once at the end of each work rotation in the study. Work rotations are usually 14-15 days.

• Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE)

  The JSPPPE is a 5-item validated instrument that measures patients' perception of physicians' empathic orientation and behavior. Patients are asked to rate their disagreement or agreement with individual statements to describe their physician after an encounter with that physician on a 7-point Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). A total JSPPPE score will be generated with a range from 5-45, with higher scores indicating a higher degree of perceived empathy.

  Asked once during hospital stay, typically 1 day to 30 days.

• Communication Assessment Tool

  The Communication Assessment Tool is a validated 15-item survey to measure patient perspective of the interaction and communication with a healthcare provider. We are using 14 questions from the Communication Assessment Tool that ask about a patient's opinion about their communication with their doctor. One item was dropped as it does not apply to the inpatient setting. Patients are asked to rate each item on a 5-point Likert scale (1=poor to 5 =excellent). Scores for individual questions will be assessed. A summary score will also be calculated with a range of 14-70, with higher scores indicating better communication.

  Asked once during hospital stay, typically 1 day to 30 days.

• Frequency of use of intervention methods

  Percentage of times that the physician used intervention methods during interactions with patients.

  During their work rotation in the study. Work rotations are usually 14-15 days.

Secondary Outcomes (2)

• Perceived duration of interaction

  Asked once during hospital stay, typically 1 day to 30 days

• Wake Forest Physician Trust Scale

  Asked once during hospital stay, typically 1 day to 30 days

Study Arms (2)

Bonding Bundle Intervention

EXPERIMENTAL

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.

Behavioral: Bonding Bundle

Control

NO INTERVENTION

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

Interventions

Bonding Bundle 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.

Bonding Bundle Intervention

Eligibility Criteria

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

You may qualify if:

• Attending physicians caring for hospitalized medical patients

You may not qualify if:

• Surgical attendings
• Residents
• Secondary Subjects - Patients
• Hospitalized adult patient
• Patient of an enrolled physician in the study
• Cognitively impaired
• Unable to provide informed consent
• Does not speak English

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Sanjay Saint, MD

  University of Michigan

  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: George Dock Professor of Internal Medicine

Model Details: Quasi-experimental randomized controlled trial

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 8, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the final publication from this study, for at least 6 years.
• Access Criteria: De-identified data will be provided after requesters sign a Letter of Agreement (LOA) detailing the mechanisms by which the data will be kept secure. The LOA will also state that the recipient will not attempt to identify any individual in the data, will not share the data outside of their research team, and will provide information on any files to be linked to the data. The dataset will not include personal identifying information and all dates will be changed to integers to allow for calculation of time periods.

Locations

US (2)