Trial Outcomes & Findings for End-of-Life Care for African Americans (NCT NCT02320123)
NCT ID: NCT02320123
Last Updated: 2020-08-12
Results Overview
The primary decision-making outcome is change in intent to discuss advance directives based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Within six months after patient enrolls in study, June 2017.
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
Patients - Intervention
For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).
Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Patients - Intervention
For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).
Usual Care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Death
|
6
|
5
|
Baseline Characteristics
End-of-Life Care for African Americans
Baseline characteristics by cohort
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
For the control arm of the study, patients will receive usual care (not view the DVD or meet with the lay health advisor).
Usual Care
|
Total
n=22 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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
n=5 Participants
|
58.6 years
n=7 Participants
|
59.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Hospitalized patients with cancer
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.The primary decision-making outcome is change in intent to discuss advance directives based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Pre-contemplation
|
0 Participants
|
1 Participants
|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Contemplation
|
1 Participants
|
3 Participants
|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Preparation
|
2 Participants
|
4 Participants
|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Action
|
0 Participants
|
0 Participants
|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Maintenance
|
4 Participants
|
0 Participants
|
|
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Participant doesn't know
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.The primary decision-making outcome is change in intent to discuss medical power of attorney based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Pre-contemplation
|
0 Participants
|
3 Participants
|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Contemplation
|
3 Participants
|
1 Participants
|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Preparation
|
2 Participants
|
5 Participants
|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Action
|
0 Participants
|
1 Participants
|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Maintenance
|
2 Participants
|
0 Participants
|
|
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Participant doesn't know
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.The primary decision-making outcome is change in intent to discuss palliative care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Action
|
2 Participants
|
3 Participants
|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Maintenance
|
0 Participants
|
0 Participants
|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Pre-contemplation
|
2 Participants
|
4 Participants
|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Contemplation
|
2 Participants
|
2 Participants
|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Preparation
|
1 Participants
|
1 Participants
|
|
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Participant doesn't know
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.The primary decision-making outcome is change in intent to discuss hospice care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Pre-contemplation
|
7 Participants
|
10 Participants
|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Contemplation
|
1 Participants
|
1 Participants
|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Preparation
|
1 Participants
|
0 Participants
|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Action
|
0 Participants
|
0 Participants
|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Maintenance
|
0 Participants
|
0 Participants
|
|
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Participant doesn't know
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.Population: All study participants were assessed by using the McGill QOL questionnaire
This will be assessed by using the McGill QOL Questionnaire, Part A, which measures overall quality of life in a 48 hour period: "Considering all parts of my life - physical, emotional, social, spiritual, and financial - over the past two (2) days the quality of my life has been: 0-10," with 0=very bad and 10=excellent.
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Quality of Life at the End of Life
|
6.4 score on a scale
Interval 3.68 to 9.12
|
6.1 score on a scale
Interval 3.67 to 8.5
|
SECONDARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.Health care utilization will be measured mean number of ER visits for the intervention and control groups.
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Health Care Utilization: Emergency Room
|
4.5 ER Visits
Interval 0.91 to 8.08
|
2.5 ER Visits
Interval 0.55 to 4.44
|
SECONDARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.Population: Deceased at six months
The principal investigator or research staff will attempt to determine the date and location of death for patients who have died while enrolled in the study by reviewing the patient's electronic health record.
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Number of Patients Who Died
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.The number of participants who have documentation of advance care planning, palliative care clinic visits, and/or hospice enrollment.
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Utilization of Advance Care Planning and End-of-life Care
Documentation of enrollment in hospice
|
3 Participants
|
3 Participants
|
|
Utilization of Advance Care Planning and End-of-life Care
Documentation of medical power of attorney
|
4 Participants
|
4 Participants
|
|
Utilization of Advance Care Planning and End-of-life Care
Documentation of living will
|
1 Participants
|
0 Participants
|
|
Utilization of Advance Care Planning and End-of-life Care
Documentaon of palliative care
|
4 Participants
|
4 Participants
|
|
Utilization of Advance Care Planning and End-of-life Care
Deceased
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within six months after patient enrolls in study, June 2017.Health care utilization will be measured mean number of hospitalizations by group, obtained by chart abstraction.
Outcome measures
| Measure |
Patients - Intervention
n=10 Participants
For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion.
Educational DVD: African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
|
Patients - Control
n=12 Participants
Patients will receive usual care (nor view the DVD or meet with the lay health advisor).
|
|---|---|---|
|
Health Care Utilization: Mean Number of Hospitalizations in Six Months by Group
|
4.2 Hospitalizations
Interval 1.3 to 7.09
|
2.2 Hospitalizations
Interval 0.71 to 3.62
|
Adverse Events
Patients - Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Patients - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 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