Trial Outcomes & Findings for Palliative Care for Elderly Outpatients (NCT NCT03209440)
NCT ID: NCT03209440
Last Updated: 2024-04-04
Results Overview
Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
579 participants
Primary outcome timeframe
5 weeks
Results posted on
2024-04-04
Participant Flow
Unit of analysis: outpatient palliative care sites
Participant milestones
| Measure |
Chaplain Sequence 1
12 months of usual care followed by 36 months of chaplain led dignity therapy
|
Nurse Sequence 1
12 months of usual care followed by 36 months of nurse-led dignity therapy
|
Chaplain Sequence 2
24 months of usual care followed by 24 months of chaplain led dignity therapy
|
Nurse Sequence 2
24 months of usual care followed by 24 months of nurse led dignity therapy
|
Chaplain Sequence 3
36 months of usual care followed by 12 months of chaplain led dignity therapy
|
Nurse Sequence 3
36 months of usual care followed by 12 months of nurse led dignity therapy
|
|---|---|---|---|---|---|---|
|
Step 1: Month 1-12
STARTED
|
24 1
|
22 1
|
28 1
|
14 1
|
26 1
|
28 1
|
|
Step 1: Month 1-12
COMPLETED
|
22 1
|
20 1
|
25 1
|
13 1
|
25 1
|
24 1
|
|
Step 1: Month 1-12
NOT COMPLETED
|
2 0
|
2 0
|
3 0
|
1 0
|
1 0
|
4 0
|
|
Step 2: Month 13-24
STARTED
|
15 1
|
11 1
|
18 1
|
23 1
|
32 1
|
20 1
|
|
Step 2: Month 13-24
COMPLETED
|
9 1
|
7 1
|
16 1
|
23 1
|
30 1
|
19 1
|
|
Step 2: Month 13-24
NOT COMPLETED
|
6 0
|
4 0
|
2 0
|
0 0
|
2 0
|
1 0
|
|
Step 3: Month 25-36
STARTED
|
18 1
|
13 1
|
24 1
|
11 1
|
13 1
|
14 1
|
|
Step 3: Month 25-36
COMPLETED
|
11 1
|
4 1
|
14 1
|
10 1
|
12 1
|
14 1
|
|
Step 3: Month 25-36
NOT COMPLETED
|
7 0
|
9 0
|
10 0
|
1 0
|
1 0
|
0 0
|
|
Step 4: Month 37-48
STARTED
|
65 1
|
22 1
|
39 1
|
44 1
|
27 1
|
28 1
|
|
Step 4: Month 37-48
COMPLETED
|
41 1
|
9 1
|
19 1
|
37 1
|
22 1
|
24 1
|
|
Step 4: Month 37-48
NOT COMPLETED
|
24 0
|
13 0
|
20 0
|
7 0
|
5 0
|
4 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palliative Care for Elderly Outpatients
Baseline characteristics by cohort
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Total
n=579 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
342 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
243 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
531 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
68 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
448 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Dignity Impact Scale
|
25.9 units on a scale (7-35) higher=better
STANDARD_DEVIATION 4.3 • n=5 Participants
|
24.3 units on a scale (7-35) higher=better
STANDARD_DEVIATION 4.3 • n=7 Participants
|
24.2 units on a scale (7-35) higher=better
STANDARD_DEVIATION 4.2 • n=5 Participants
|
25.0 units on a scale (7-35) higher=better
STANDARD_DEVIATION 4.4 • n=4 Participants
|
|
Preparation
|
15.4 units on a scale (4-20) higher=better
STANDARD_DEVIATION 3.2 • n=5 Participants
|
14.5 units on a scale (4-20) higher=better
STANDARD_DEVIATION 3.3 • n=7 Participants
|
14.8 units on a scale (4-20) higher=better
STANDARD_DEVIATION 3.7 • n=5 Participants
|
15.0 units on a scale (4-20) higher=better
STANDARD_DEVIATION 3.4 • n=4 Participants
|
|
Completion
|
26.8 units on a scale (7-35) higher=better
STANDARD_DEVIATION 5.2 • n=5 Participants
|
26.4 units on a scale (7-35) higher=better
STANDARD_DEVIATION 5.9 • n=7 Participants
|
27.9 units on a scale (7-35) higher=better
STANDARD_DEVIATION 5.7 • n=5 Participants
|
27.0 units on a scale (7-35) higher=better
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Peaceful Awareness
Peacefully aware
|
59 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Peaceful Awareness
Not peacefully aware
|
203 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
448 Participants
n=4 Participants
|
|
Treatment Preference
Prolong life; treat everything
|
37 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Treatment Preference
Attempt to cure but re-evaluate often
|
88 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Treatment Preference
Limit to less invasive and less burdensome interventions
|
55 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Treatment Preference
Provide comfort care only
|
82 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 weeksOur primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.
Outcome measures
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
|---|---|---|---|
|
Dignity Impact Scale
|
26.3 score on a scale
Standard Deviation 4.7
|
26.2 score on a scale
Standard Deviation 4.1
|
26.2 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 5 weeksPreparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes.
Outcome measures
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
|---|---|---|---|
|
Preparation
|
15.6 score on a scale
Standard Deviation 3.2
|
14.7 score on a scale
Standard Deviation 3.2
|
14.9 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 5 weeksLife completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes.
Outcome measures
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
|---|---|---|---|
|
Completion
|
27.0 score on a scale
Standard Deviation 4.9
|
27.2 score on a scale
Standard Deviation 4.9
|
28.2 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 5 weeksWe measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure.
Outcome measures
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
|---|---|---|---|
|
Peaceful Awareness
Peacefully aware
|
61 Participants
|
31 Participants
|
44 Participants
|
|
Peaceful Awareness
Not peacefully aware
|
201 Participants
|
98 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: 5 weeksWe measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences.
Outcome measures
| Measure |
Usual Outpatient Palliative Care
n=262 Participants
During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
|
Dignity Therapy - Nurse Led
n=129 Participants
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
Dignity Therapy - Chaplain Led
n=188 Participants
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
|
|---|---|---|---|
|
Treatment Preference
Prolong life; treat everything
|
24 Participants
|
15 Participants
|
11 Participants
|
|
Treatment Preference
Attempt to cure but re-evaluate often
|
91 Participants
|
44 Participants
|
45 Participants
|
|
Treatment Preference
Limit to less invasive and less burdensome intervention
|
56 Participants
|
25 Participants
|
51 Participants
|
|
Treatment Preference
Provide comfort care only
|
91 Participants
|
45 Participants
|
81 Participants
|
Adverse Events
Usual Outpatient Palliative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Dignity Therapy - Nurse Led
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Dignity Therapy - Chaplain Led
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 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