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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL145096-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this study is improving patient-centered communication for young people with advanced heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| We Chatt communication tool | Experimental |
| |
| Usual care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| We Chatt communication tool | Behavioral | This arm involves the collaborative completion of a 2-page communication preferences document between a primary physician and an adolescent/young adult patient. Physicians will participate in a 1-hour training led by study principal investigator featuring didactic, multimedia, and experiential-based learning to support the facilitation of the WE CHATT intervention with patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey | Satisfaction was based on the answers for 12 questions in which clinicians selected from a Likert scale from strongly disagree (1) -Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction. | 2 weeks (after intervention) |
| Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | Parent/Caregiver completed 12 questions in which participants selected from a Likert scale from Strongly disagree (1) to Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction. | 2 weeks (after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey | Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) | 2 weeks (after intervention) |
| Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey |
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Physician Inclusion Criteria:
Patient/Caregiver Inclusion Criteria:
Physician Exclusion Criteria:
- Not a physician at University of Michigan in the Division of Pediatric Cardiology
Patient/Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Cousino, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinician Intervention Arm | Clinicians who were randomized to this arm used the WE CHATT tool in communicating with patient participants. Clinician participants in this arm completed a 1-hour training to support their facilitation of the WE CHATT intervention with patients. |
| FG001 | Clinician Control Arm | Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided. |
| FG002 | Patients | Patient participants (12-24 years of age) with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure (i.e., limitations in physical activity, fatigue, palpitations, dyspnea). |
| FG003 | Parent Caregiver | One parent/caregiver of patient participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinician Intervention Arm | Clinicians who were randomized to this arm used the WE CHATT tool in communicating with patient participants. Clinician participants in this arm completed a 1-hour training to support their facilitation of the WE CHATT intervention with patients. |
| BG001 | Clinician Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age data was not collected for participants in the Parent arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey | Satisfaction was based on the answers for 12 questions in which clinicians selected from a Likert scale from strongly disagree (1) -Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks (after intervention) |
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Up to 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinician Intervention Arm | Clinicians who were randomized to this arm used the WE CHATT tool in communicating with patient participants. Clinician participants in this arm completed a 1-hour training to support their facilitation of the WE CHATT intervention with patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Cousino | University of Michigan | (734) 936-4220 | melcousi@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2023 | Jun 2, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | May 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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A total of 20 physicians will be recruited. 10 will be randomized to participate in the intervention arm and 10 will be randomized to the control arm. Participants and caretakers will account for approximately 60 enrolled participants that will not be randomized.
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| Usual/standard care | Behavioral | Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention. |
|
Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) |
| 2 weeks (after intervention) |
| Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians | Number of minutes to complete the intervention was collected on clinician survey. | 30 minutes (approximately) |
Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided. |
| BG002 | Patients | Patient participants (12-24 years of age) with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure (i.e., limitations in physical activity, fatigue, palpitations, dyspnea). |
| BG003 | Parent Caregiver | One parent/caregiver of patient participants. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity data was not collected for participants in the Parent arm. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
|
|
| Primary | Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | Parent/Caregiver completed 12 questions in which participants selected from a Likert scale from Strongly disagree (1) to Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks (after intervention) |
|
|
|
| Secondary | Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey | Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks (after intervention) |
|
|
|
| Secondary | Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks (after intervention) |
|
|
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| Secondary | Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians | Number of minutes to complete the intervention was collected on clinician survey. | Posted | Median | Inter-Quartile Range | minutes | 30 minutes (approximately) |
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Clinician Control Arm | Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Patients | Patient participants (12-24 years of age) with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure (i.e., limitations in physical activity, fatigue, palpitations, dyspnea). | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Parent Caregiver | One parent/caregiver of patient participants. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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