Viewing Study NCT06354920



Ignite Creation Date: 2024-05-06 @ 8:22 PM
Last Modification Date: 2024-10-26 @ 3:26 PM
Study NCT ID: NCT06354920
Status: RECRUITING
Last Update Posted: 2024-04-10
First Post: 2024-04-03

Brief Title: M-Well Bonding Bundle to Improve Patient-Physician Relationships
Sponsor: University of Michigan
Organization: University of Michigan

Study Overview

Official Title: Engineering Whole Health Into Hospital Care to Improve Wellness Bonding Bundle
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 cant 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 patients 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 doctors 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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R18HS028963 AHRQ None httpsreporternihgovquickSearchR18HS028963