No Condition is the Focus of the StudyENHANCENCT05055141
Enhancing Caregiver Empathy by Empowering Patients to Discuss Their Values
A study testing Care to Share poster in people with No Condition is the Focus of the Study, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The aim of the ENHANCE study was to determine if an intervention focused on empowering medical inpatients to discuss their values and interests with their Cleveland Clinic Caregivers leads to greater caregiver empathy, improved patient experience, and improved Caregiver experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Condition is the Focus of the Study
- What is being tested?
- Care to Share poster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 539 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 10 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients admitted to one of the study units within past 48 hours (intervention) or within 3-5 days of admission (control)
- age 18 years or older
- on the Internal Medicine service
- capable of making own medical decisions
Who cannot join
- patients not admitted to Internal Medicine service on one of the study units
- time from admission outside inclusion parameters
- less than 18 years of age
- incapable of making medical decisions
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Main Campus Hospital
Cleveland, Ohio, 44195
About this study
Official title: Enhancing Caregiver Empathy by Empowering Patients to Discuss Their Values: A Cluster Randomized Control Trial (ENHANCE)
The aim of the ENHANCE study was to determine if an intervention focused on empowering medical inpatients to discuss their values and interests with their Cleveland Clinic Caregivers leads to greater caregiver empathy, improved patient experience, and improved Caregiver experience. The intervention patient participants received a poster where they were able to share things about themselves that they wanted their Caregivers to know. These posters were hung on the wall behind their bed. A few days later, they were given a survey to assess their experiences in the hospital. On the control floors, medicine patients were recruited a few days into their admission and administered a survey. CCF Caregivers completed surveys before the intervention period and afterward. Data collection is complete, data analysis is largely finished and a manuscript is in progress. 320 patients and 219 CCF Caregivers participated in the study.
Read the detailed description
ENHANCE was a prospective cluster randomized controlled trial with patients admitted to four general medicine units at one hospital and their hospital Caregivers (nurses and hospitalists). We chose to focus on internal medicine units specifically, due to the documented need for hospitalists to establish rapport and maintain relationships with their patients. Two units were randomized to the control group and two units to the intervention group. The cluster randomized design was chosen to reduce spillover effect.
INTERVENTION The intervention was an 18"x18" poster board with a large blank surface for patients to share information about who they are as people and what is important to them. The Care to Share poster was co-designed with ten medicine inpatients during pilot testing. The goal of the poster was to equip Caregivers with humanizing information about their patients, thereby provoking more genuine empathetic interactions. Based on input from pilot testing, the researcher wrote on the poster for the patient to ensure ease of completion and legibility. The posters were displayed on the wall behind patients' beds, so Caregivers entering the room could easily see the information when facing the patient. Nurses (registered nurses, patient care nursing assistants, nurse managers and health unit coordinators) were designated as control or intervention Caregivers based on their unit, while all hospitalists (physicians and advanced practice providers) were treated as intervention Caregivers since their practice was not limited to specific medicine units.
DATA COLLECTION Data collection occurred between December 2018 and May 2019 and in three stages: Caregiver baseline survey, Intervention vs Control patient survey, and Caregiver post-intervention survey. Caregivers were recruited to the study using emails and in person surveys and were blinded to details of the intervention. Caregiver surveys contained questions about communication and experience, validated inventories on Caregiver-reported burnout and empathy, and demographic information. Caregiver surveys for all hospitalists and nurses in the intervention group, also contained questions to gather feedback on the Care to Share poster.
Patients were eligible for study recruitment when they were admitted to one of the study units (either from the ICU or as a new admission) within the past 48 hours for the intervention group, or within 3-5 days of admission for the control group, age 18 years or older, on the Internal Medicine service, and capable of making their own medical decisions. This timing was chosen so that all patient participants - both control and intervention - would complete surveys at about the same length of time into their admission.
Intervention patients were informed that the Care to Share poster was for them to share whatever they want their care team to know about them as a person. A member of the research team (CF) recorded content on the poster and immediately hung it on the wall behind the patient's bed. The intervention participants were then approached for survey administration 48 hours after the poster was hung (or after 24 hours if the patient was to be discharged the day after poster creation). Patients discharged before 24 hours after poster creation were not eligible for survey administration. The researcher administered the survey to patients unless the patient indicated they preferred to complete it on their own.
MEASURES Patient: The primary patient outcome variable was patients' perceived empathy of their hospitalist, measured by the Jefferson Scale of Patient Perceptions of Physician Empathy(JSPPPE). This 5 item 7-point scale, completed by patients, measures patient-physician empathetic engagement. Patient surveys also included covariates such as trust in their physician, measured by the Interpersonal Physician Trust Scale (IPTS), a 10 item 5-point scale, as well as a 3 item patient-reported measure of shared decision making, CollaboRATE, and demographic characteristics. The survey fielded to patients in the intervention group also contained items to gather feedback on the Care to Share poster, including two open-text questions for patients to comment in their own words. Additionally, specific medical details were gathered from the EMR, such as length of stay (LOS), and 30-day readmission rates.
Caregiver: The caregiver survey consisted of the Maslach Burnout Inventory (MBI)36, Jefferson Scale of Empathy (JCE), and demographic items. The MBI measures the frequency of job-related feelings of burnout using a scale of 0 (never) to 6 (every day). Burnout is measured on 3 dimensions- emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA). We used the burnout criteria of EE>26 and DP>9 which was used in previously reported literature on internal medicine physicians. The JCE is a 20 item 7-point Likert scale completed by the Caregiver that measures a health professional's empathy. As with the patient survey, the surveys fielded to Caregivers on intervention units (i.e., some nurses and all hospitalists) contained items to gather feedback on the Care to Share poster.
ANALYSIS Based on a priori power calculations, we required 306 patient participants and approximately 40 caregivers to detect a difference in the JSPPPE. We computed descriptive statistics to describe patient and caregiver samples, and multivariate nested regression models to test if the intervention predicted patients' perceptions of clinician empathy, shared decision-making, and trust. Data analysis was conducted using JMP, SAS and R. Verbatim comments to the two open-text questions were analyzed using content analysis.
- Conditions
- No Condition is the Focus of the Study
- Being tested
- Care to Share poster
- Keywords
- patient-centered intervention, patient perceptions of empathy, trust in clinician, shared decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care to Share posterOther
The Care to Share poster enabled patients to share written information about who they are as people with their hospital caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Care to Share Poster | Experimental | The intervention was an 18"x18" poster board with a large blank surface for patients to share information about who they are as people and what is important to them. The Care to Share poster was co-designed with ten medicine inpatients during pilot testing. The goal of the poster was to equip Caregivers with humanizing information about their patients, thereby provoking more genuine empathetic interactions. Based on input from pilot testing, the researcher wrote on the poster for the patient to ensure ease of completion and legibility. The posters were displayed on the wall behind patients' beds, so Caregivers entering the room could easily see the information when facing the patient. Receives: Other: Care to Share poster |
| Control | No intervention | Study participants hospitalized on the two control units had no Care to Share poster. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jefferson Scale of Patient Perceptions of Physician Empathy
Patients' perceived empathy of their hospitalist is measured using 5 items with a 7 point Likert scale. Scores range from 5-35, with a higher score meaning patients perceive their physician as more empathic.
Measured: 24-72 hours
Secondary outcomes (1)
Interpersonal Physician Trust Scale
Also known as the Wake Forest Trust Scale, this 10 item scale uses a 5 point Likert scale to measure patients' trust in their hospitalist. Scores range from 10-50, with a higher score indication greater trust in their physician.
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start12 Dec 2018
- Primary completion7 Jun 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition is the Focus of the StudyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susannah Rose, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055141
- Sponsor's protocol ID
- 18-923
- Acronym
- ENHANCE
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Caregiver Empathy by Empowering Patients to Discuss Their Values: A Cluster Randomized Control Trial (ENHANCE)
- ClinicalTrials.gov ID
- NCT05055141
- Acronym / sponsor ID
- ENHANCE / 18-923
- Conditions
- No Condition is the Focus of the Study
- Keywords
- patient-centered intervention, patient perceptions of empathy, trust in clinician, shared decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 24 Sep 2021 (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 aim of the ENHANCE study was to determine if an intervention focused on empowering medical inpatients to discuss their values and interests with their Cleveland Clinic Caregivers leads to greater caregiver empathy, improved patient experience, and improved Caregiver experience. The intervention patient participants received a poster where they were able to share things about themselves that they wanted their Caregivers to know. These posters were hung on the wall behind their bed. A few days later, they were given a survey to assess their experiences in the hospital. On the control floors, medicine patients were recruited a few days into their admission and administered a survey. CCF Caregivers completed surveys before the intervention period and afterward. Data collection is complete, data analysis is largely finished and a manuscript is in progress. 320 patients and 219 CCF Caregivers participated in the study.
Detailed description
ENHANCE was a prospective cluster randomized controlled trial with patients admitted to four general medicine units at one hospital and their hospital Caregivers (nurses and hospitalists). We chose to focus on internal medicine units specifically, due to the documented need for hospitalists to establish rapport and maintain relationships with their patients. Two units were randomized to the control group and two units to the intervention group. The cluster randomized design was chosen to reduce spillover effect.
INTERVENTION The intervention was an 18"x18" poster board with a large blank surface for patients to share information about who they are as people and what is important to them. The Care to Share poster was co-designed with ten medicine inpatients during pilot testing. The goal of the poster was to equip Caregivers with humanizing information about their patients, thereby provoking more genuine empathetic interactions. Based on input from pilot testing, the researcher wrote on the poster for the patient to ensure ease of completion and legibility. The posters were displayed on the wall behind patients' beds, so Caregivers entering the room could easily see the information when facing the patient. Nurses (registered nurses, patient care nursing assistants, nurse managers and health unit coordinators) were designated as control or intervention Caregivers based on their unit, while all hospitalists (physicians and advanced practice providers) were treated as intervention Caregivers since their practice was not limited to specific medicine units.
DATA COLLECTION Data collection occurred between December 2018 and May 2019 and in three stages: Caregiver baseline survey, Intervention vs Control patient survey, and Caregiver post-intervention survey. Caregivers were recruited to the study using emails and in person surveys and were blinded to details of the intervention. Caregiver surveys contained questions about communication and experience, validated inventories on Caregiver-reported burnout and empathy, and demographic information. Caregiver surveys for all hospitalists and nurses in the intervention group, also contained questions to gather feedback on the Care to Share poster.
Patients were eligible for study recruitment when they were admitted to one of the study units (either from the ICU or as a new admission) within the past 48 hours for the intervention group, or within 3-5 days of admission for the control group, age 18 years or older, on the Internal Medicine service, and capable of making their own medical decisions. This timing was chosen so that all patient participants - both control and intervention - would complete surveys at about the same length of time into their admission.
Intervention patients were informed that the Care to Share poster was for them to share whatever they want their care team to know about them as a person. A member of the research team (CF) recorded content on the poster and immediately hung it on the wall behind the patient's bed. The intervention participants were then approached for survey administration 48 hours after the poster was hung (or after 24 hours if the patient was to be discharged the day after poster creation). Patients discharged before 24 hours after poster creation were not eligible for survey administration. The researcher administered the survey to patients unless the patient indicated they preferred to complete it on their own.
MEASURES Patient: The primary patient outcome variable was patients' perceived empathy of their hospitalist, measured by the Jefferson Scale of Patient Perceptions of Physician Empathy(JSPPPE). This 5 item 7-point scale, completed by patients, measures patient-physician empathetic engagement. Patient surveys also included covariates such as trust in their physician, measured by the Interpersonal Physician Trust Scale (IPTS), a 10 item 5-point scale, as well as a 3 item patient-reported measure of shared decision making, CollaboRATE, and demographic characteristics. The survey fielded to patients in the intervention group also contained items to gather feedback on the Care to Share poster, including two open-text questions for patients to comment in their own words. Additionally, specific medical details were gathered from the EMR, such as length of stay (LOS), and 30-day readmission rates.
Caregiver: The caregiver survey consisted of the Maslach Burnout Inventory (MBI)36, Jefferson Scale of Empathy (JCE), and demographic items. The MBI measures the frequency of job-related feelings of burnout using a scale of 0 (never) to 6 (every day). Burnout is measured on 3 dimensions- emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA). We used the burnout criteria of EE>26 and DP>9 which was used in previously reported literature on internal medicine physicians. The JCE is a 20 item 7-point Likert scale completed by the Caregiver that measures a health professional's empathy. As with the patient survey, the surveys fielded to Caregivers on intervention units (i.e., some nurses and all hospitalists) contained items to gather feedback on the Care to Share poster.
ANALYSIS Based on a priori power calculations, we required 306 patient participants and approximately 40 caregivers to detect a difference in the JSPPPE. We computed descriptive statistics to describe patient and caregiver samples, and multivariate nested regression models to test if the intervention predicted patients' perceptions of clinician empathy, shared decision-making, and trust. Data analysis was conducted using JMP, SAS and R. Verbatim comments to the two open-text questions were analyzed using content analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Care to Share Poster | Experimental | Other: Care to Share posterThe intervention was an 18"x18" poster board with a large blank surface for patients to share information about who they are as people and what is important to them. The Care to Share poster was co-designed with ten medicine inpatients during pilot testing. The goal of the poster was to equip Caregivers with humanizing information about their patients, thereby provoking more genuine empathetic interactions. Based on input from pilot testing, the researcher wrote on the poster for the patient to ensure ease of completion and legibility. The posters were displayed on the wall behind patients' beds, so Caregivers entering the room could easily see the information when facing the patient. |
| Control | No intervention | –Study participants hospitalized on the two control units had no Care to Share poster. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients admitted to one of the study units within past 48 hours (intervention) or within 3-5 days of admission (control)
- age 18 years or older
- on the Internal Medicine service
- capable of making own medical decisions
Key exclusion criteria (4 listed)
- patients not admitted to Internal Medicine service on one of the study units
- time from admission outside inclusion parameters
- less than 18 years of age
- incapable of making medical decisions
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 |
|---|---|---|
| Care to Share posterThe Care to Share poster enabled patients to share written information about who they are as people with their hospital caregivers. | Other | Care to Share Poster |
Primary outcome
Jefferson Scale of Patient Perceptions of Physician Empathy
Time frame: 24-72 hours
Patients' perceived empathy of their hospitalist is measured using 5 items with a 7 point Likert scale. Scores range from 5-35, with a higher score meaning patients perceive their physician as more empathic.
1 secondary outcome
Interpersonal Physician Trust Scale
Time frame: 24-72 hours
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 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Susannah Rose, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care to Share poster in people with No Condition is the Focus of the Study, run by The Cleveland Clinic at 1 site 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 4 inclusion and 4 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Patient Perceptions of Physician Empathy (time frame: 24-72 hours). 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 Oct 2023.