Trial Outcomes & Findings for A Study to Improve Physician-Youth Communication and Medical Decision Making (NCT NCT05835063)
NCT ID: NCT05835063
Last Updated: 2025-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
2 weeks (after intervention)
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
Clinician Control Arm
Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided.
|
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).
|
Parent Caregiver
One parent/caregiver of patient participants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data was not collected for participants in the Parent arm.
Baseline characteristics by cohort
| Measure |
Clinician Intervention Arm
n=10 Participants
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.
|
Clinician Control Arm
n=10 Participants
Clinician participants in this arm did not receive training in the WE CHATT communication intervention. Usual/standard care was provided.
|
Patients
n=10 Participants
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).
|
Parent Caregiver
n=9 Participants
One parent/caregiver of patient participants.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
9 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
—
|
9 Participants
n=30 Participants • Age data was not collected for participants in the Parent arm.
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
10 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
1 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
—
|
21 Participants
n=30 Participants • Age data was not collected for participants in the Parent arm.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Age data was not collected for participants in the Parent arm.
|
—
|
0 Participants
n=30 Participants • Age data was not collected for participants in the Parent arm.
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
19 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
20 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
1 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
—
|
1 Participants
n=30 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
9 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
10 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
—
|
29 Participants
n=30 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
0 Participants
n=10 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
—
|
0 Participants
n=30 Participants • Ethnicity data was not collected for participants in the Parent arm.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=9 Participants
|
31 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
39 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Clinicians Intervention
n=10 Participants
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.
|
Caregivers
One parent/caregiver of patient participants.
|
|---|---|---|
|
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey
|
57.4 score on a scale
Standard Deviation 2.7
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Clinicians Intervention
n=10 Participants
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.
|
Caregivers
n=10 Participants
One parent/caregiver of patient participants.
|
|---|---|---|
|
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
|
53.4 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 2 weeks (after intervention)Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Outcome measures
| Measure |
Clinicians Intervention
n=10 Participants
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.
|
Caregivers
One parent/caregiver of patient participants.
|
|---|---|---|
|
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey
|
9 score on a scale
Interval 9.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: 2 weeks (after intervention)Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Outcome measures
| Measure |
Clinicians Intervention
n=10 Participants
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.
|
Caregivers
n=9 Participants
One parent/caregiver of patient participants.
|
|---|---|---|
|
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
|
9 score on a scale
Interval 8.0 to 9.0
|
10 score on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: 30 minutes (approximately)Number of minutes to complete the intervention was collected on clinician survey.
Outcome measures
| Measure |
Clinicians Intervention
n=10 Participants
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.
|
Caregivers
One parent/caregiver of patient participants.
|
|---|---|---|
|
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians
|
15 minutes
Interval 15.0 to 25.0
|
—
|
Adverse Events
Clinician Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinician Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place