Trial Outcomes & Findings for A Representational Intervention to Promote Preparation for End-of-life Decision Making (NCT NCT01259011)
NCT ID: NCT01259011
Last Updated: 2017-09-25
Results Overview
patient and surrogate congruence on the goals of care
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
2, 6, 12 months
Results posted on
2017-09-25
Participant Flow
Patients were recruited between March 2010 and December 2012 from 20 outpatient dialysis centers in eight counties in North Carolina. A short battery of questions was used to help patients identify or confirm a previously designated surrogate. Patients and surrogates provided written consent.
Participant milestones
| Measure |
Control
As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
|
SPIRIT Intervention
the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
|
|---|---|---|
|
Main Study Period
STARTED
|
101
|
109
|
|
Main Study Period
COMPLETED
|
101
|
109
|
|
Main Study Period
NOT COMPLETED
|
0
|
0
|
|
After Patient Death
STARTED
|
17
|
28
|
|
After Patient Death
COMPLETED
|
17
|
28
|
|
After Patient Death
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Representational Intervention to Promote Preparation for End-of-life Decision Making
Baseline characteristics by cohort
| Measure |
Control
n=101 Participants
As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
|
SPIRIT Intervention
n=109 Participants
the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 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
|
69 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 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
|
101 patients
n=5 Participants
|
109 patients
n=7 Participants
|
210 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 6, 12 monthsPopulation: patients on dialysis and their surrogates
patient and surrogate congruence on the goals of care
Outcome measures
| Measure |
Control
n=101 Participants
As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
|
SPIRIT Intervention
n=109 Participants
the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
|
|---|---|---|
|
Dyad Congruence
|
48 percentage of congruent dyads
|
64 percentage of congruent dyads
|
SECONDARY outcome
Timeframe: 2 Weeks, and at 3 and 6 months post deathHospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Control
n=17 Participants
As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
|
SPIRIT Intervention
n=28 Participants
the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
|
|---|---|---|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
Baseline HADS (Anxiety)
|
6.1 units on a scale
Standard Deviation 4.0
|
6.1 units on a scale
Standard Deviation 4.2
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
2-Week F-Up HADS (Anxiety)
|
6.6 units on a scale
Standard Deviation 4.0
|
6.3 units on a scale
Standard Deviation 2.6
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
3-Month F-Up HADS (Anxiety)
|
6.4 units on a scale
Standard Deviation 2.7
|
5.1 units on a scale
Standard Deviation 2.6
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
6-Month F-Up HADS (Anxiety)
|
6.6 units on a scale
Standard Deviation 2.7
|
4.7 units on a scale
Standard Deviation 3.4
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
Baseline HADS (Depression)
|
3.1 units on a scale
Standard Deviation 3.2
|
4.1 units on a scale
Standard Deviation 3.1
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
2-Week F-Up HADS (Depression)
|
6.4 units on a scale
Standard Deviation 4.4
|
4.8 units on a scale
Standard Deviation 3.2
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
3-Month F-Up HADS (Depression)
|
5.9 units on a scale
Standard Deviation 3.2
|
3.3 units on a scale
Standard Deviation 3.1
|
|
Change Over Time: Hospital Anxiety and Depression Scale Scores
6-Month F-Up HADS (Depression)
|
5.9 units on a scale
Standard Deviation 3.2
|
3.4 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 2 weeks and 3 and 6 months after patient deathThe Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of \> 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.
Outcome measures
| Measure |
Control
n=17 Participants
As required by Medicare and Medicaid programs (conditions for coverage for ESRD facilities), written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. Also, the social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
|
SPIRIT Intervention
n=28 Participants
the SPIRIT intervention: the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
|
|---|---|---|
|
Change Over Time: Post-traumatic Distress Symptom Score
Baseline
|
17.3 units on a scale
Standard Deviation 8.1
|
20.2 units on a scale
Standard Deviation 8.7
|
|
Change Over Time: Post-traumatic Distress Symptom Score
2-Week F-Up
|
27.0 units on a scale
Standard Deviation 14.0
|
23.6 units on a scale
Standard Deviation 11.8
|
|
Change Over Time: Post-traumatic Distress Symptom Score
3-Month F-Up
|
22.5 units on a scale
Standard Deviation 8.3
|
19.3 units on a scale
Standard Deviation 9.9
|
|
Change Over Time: Post-traumatic Distress Symptom Score
6-Month F-Up
|
25.5 units on a scale
Standard Deviation 12.4
|
20.3 units on a scale
Standard Deviation 11.1
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
SPIRIT Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 28 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