Physician-Patient RelationsNCT06354920
M-Well Bonding Bundle to Improve Patient-Physician Relationships
A study testing Bonding Bundle in people with Physician-Patient Relations, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physician-Patient Relations
- What is being tested?
- Bonding Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending physicians caring for hospitalized medical patients
- Hospitalized adult patient
- Patient of an enrolled physician in the study
Who cannot join
- Surgical attendings
- Residents
- Secondary Subjects - Patients
- Cognitively impaired
- Unable to provide informed consent
- Does not speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48109
About this study
Official title: Engineering Whole Health Into Hospital Care to Improve Wellness: Bonding Bundle
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?
Read more
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.
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:
- Allow study staff to observe the interaction between them and their doctors.
- Complete a brief survey after meeting with their doctor.
Read the 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
- Being tested
- Bonding Bundle
- Keywords
- Empathy, Physician-Patient Relations, Health communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonding BundleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bonding Bundle |
| Control | No intervention | Doctors in the control arm will be asked to visit with their patients as they would normally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During their work rotation in the study. Work rotations are usually 14-15 days.
Secondary outcomes (2)
Perceived duration of interaction
Patients will be asked to estimate the duration of their physician interaction.
Measured: Asked once during hospital stay, typically 1 day to 30 days
Wake Forest Physician Trust Scale
The Wake Forest Physician Trust Scale is a 10-item validated instrument that measures levels of patient trust in their health care providers. Patients are asked to rate their disagreement or agreement with individual statements on a 5-point Likert scale (1 = Strongly Disagree; 5 = Strongly Agree). Using a scoring algorithm, a total Trust score will be generated with a range from 10-50, with higher scores indicating a higher degree of trust in their physician.
Measured: Asked once during hospital stay, typically 1 day to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start8 Apr 2024
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician-Patient RelationsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Sanjay Saint, University of Michigan
- Investigators
- Sanjay Saint, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354920
- Sponsor's protocol ID
- HUM00247781
- Other IDs
- R18HS028963
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created. Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at Jennifer.Burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. The most cost-effective means for sharing data after a data-sharing agreement has been reached will be used. For example, data may be copied to a compact disk (CD) or digital versatile disk (DVD), be posted on a password protected and secure website, or made available through a third-party data archive service. Resources that are patentable and/or protectable under intellectual property rights will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Whole Health Into Hospital Care to Improve Wellness: Bonding Bundle
- ClinicalTrials.gov ID
- NCT06354920
- Acronym / sponsor ID
- HUM00247781
- Conditions
- Physician-Patient Relations
- Keywords
- Empathy, Physician-Patient Relations, Health communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Allow study staff to observe the interaction between them and their doctors.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bonding Bundle Intervention | Experimental | Behavioral: Bonding BundleDoctors 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 | No intervention | –Doctors in the control arm will be asked to visit with their patients as they would normally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Attending physicians caring for hospitalized medical patients
- Hospitalized adult patient
- Patient of an enrolled physician in the study
Key exclusion criteria (6 listed)
- Surgical attendings
- Residents
- Secondary Subjects - Patients
- Cognitively impaired
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bonding BundleDoctors 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. | Behavioural | Bonding Bundle Intervention |
Primary outcome
Jefferson Scale of Empathy (JSE)
Time frame: Given once at the end of each work rotation in the study. Work rotations are usually 14-15 days.
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.
Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE)
Time frame: Asked once during hospital stay, typically 1 day to 30 days.
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.
Communication Assessment Tool
Time frame: Asked once during hospital stay, typically 1 day to 30 days.
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.
Frequency of use of intervention methods
Time frame: During their work rotation in the study. Work rotations are usually 14-15 days.
Percentage of times that the physician used intervention methods during interactions with patients.
2 secondary outcomes
Perceived duration of interaction
Time frame: Asked once during hospital stay, typically 1 day to 30 days
Wake Forest Physician Trust Scale
Time frame: Asked once during hospital stay, typically 1 day to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created. Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at Jennifer.Burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. The most cost-effective means for sharing data after a data-sharing agreement has been reached will be used. For example, data may be copied to a compact disk (CD) or digital versatile disk (DVD), be posted on a password protected and secure website, or made available through a third-party data archive service. Resources that are patentable and/or protectable under intellectual property rights will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Saint, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonding Bundle in people with Physician-Patient Relations, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jefferson Scale of Empathy (JSE) (time frame: Given once at the end of each work rotation in the study. Work rotations are usually 14-15 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.