Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
Caregiver/parent
Brief summary
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
Interventions
BEHAVIORALWe Chatt communication tool
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.
BEHAVIORALUsual/standard care
Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Physician Inclusion Criteria: * Physician participants will be recruited from the Division of Pediatric Cardiology at the University of Michigan. All physicians with dedicated clinical effort will be eligible. * Eligible physicians must anticipate remaining on staff \>1 year Patient/Caregiver Inclusion Criteria: * Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure * One parent/caregiver of patient participants meeting inclusion criteria will also be eligible Physician
Exclusion criteria
\- Not a physician at University of Michigan in the Division of Pediatric Cardiology Patient/Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey | 2 weeks (after intervention) | 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. |
| Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 2 weeks (after intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey | 2 weeks (after intervention) | Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) |
| Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 2 weeks (after intervention) | Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best) |
| Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians | 30 minutes (approximately) | Number of minutes to complete the intervention was collected on clinician survey. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Clinician Control Arm Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided. | 10 |
| 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). | 10 |
| Parent Caregiver One parent/caregiver of patient participants. | 9 |
| Total | 39 |
Baseline characteristics
| Characteristic | Clinician Intervention Arm | Clinician Control Arm | Patients | Total | Parent Caregiver |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 9 Participants | 9 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 1 Participants | 21 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 10 Participants | 29 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 8 Participants | 31 Participants | 8 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 10 Participants | 39 Participants | 9 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 4 Participants | 19 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 20 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 9 |
Outcome results
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.
Time frame: 2 weeks (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinicians Intervention | Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 49.5 score on a scale | Standard Deviation 5.8 |
| Caregivers | Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 53.4 score on a scale | Standard Deviation 5.2 |
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.
Time frame: 2 weeks (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinicians Intervention | Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey | 57.4 score on a scale | Standard Deviation 2.7 |
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)
Time frame: 2 weeks (after intervention)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clinicians Intervention | Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 9 score on a scale |
| Caregivers | Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey | 10 score on a scale |
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)
Time frame: 2 weeks (after intervention)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clinicians Intervention | Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey | 9 score on a scale |
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.
Time frame: 30 minutes (approximately)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clinicians Intervention | Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians | 15 minutes |