Trial Outcomes & Findings for Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness (NCT NCT03391115)
NCT ID: NCT03391115
Last Updated: 2021-02-18
Results Overview
Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.
Recruitment status
COMPLETED
Target enrollment
38 participants
Primary outcome timeframe
1-2 weeks
Results posted on
2021-02-18
Participant Flow
Two Nurse participants in the dyadic patient-nurse enrollment were not successfully recruited.
Participant milestones
| Measure |
Inpatient Participants
Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
|
Nurse Participants
Bedside nurses who provide care at the inpatient level for the following diseases:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness
Baseline characteristics by cohort
| Measure |
Inpatient Participants
n=20 Participants
Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
|
Nurse Participants
n=18 Participants
Bedside nurses who provide care at the inpatient level for the following diseases:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
52.15 years
n=5 Participants
|
31.39 years
n=7 Participants
|
41.77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 weeksUsing an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.
Outcome measures
| Measure |
Inpatient Participants
n=20 Participants
Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
|
Nurse Participants
n=18 Participants
Bedside nurses who provide care at the inpatient level for the following diseases:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.
|
|---|---|---|
|
Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR
|
20 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-2 weeksPopulation: Patient Participants did not complete this secondary measure. This was only the nurse participants completing the NIH System Usability Scale
This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.
Outcome measures
| Measure |
Inpatient Participants
Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
|
Nurse Participants
n=18 Participants
Bedside nurses who provide care at the inpatient level for the following diseases:
* Heart Failure
* COPD
* Cancer
Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.
|
|---|---|---|
|
Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome.
|
—
|
89.71 score on a scale
Interval 75.0 to 100.0
|
Adverse Events
Inpatient Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurse Participants
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
Heather Coats, PhD, APRN-BC, PI
University of Colorado, College of Nursing
Phone: 303-724-3740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place