End Stage Renal Disease
Conditions
Keywords
end stage renal disease, dialysis, end of life decision making, surrogate psychological morbidities
Brief summary
The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that (1) SPIRIT will lead to significantly less patient decisional conflict and significantly greater dyad congruence and surrogate decision making confidence than the standard care control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate decisional conflict and psychosocial morbidities at 2 weeks after the patient's hospitalization requiring surrogate decision making significantly more than the standard care control.
Detailed description
Dialysis is central to survival for 450,000 Americans with end-stage renal disease (ESRD). Yet patients on dialysis have significant comorbidities and high mortality rates (24% annually). One out of four ESRD patient deaths occurs after a decision to stop dialysis. However, when persons have lost their decision capacity if there has been no prior discussion between the patient and surrogate regarding goals of care, the issue of whether to continue dialysis can pose an ethical impasse and cause profound psychological distress for surrogate decision makers. Using the representational approach to patient education, we developed and pilot tested 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. SPIRIT is a 6-step, 2-session, face-to-face intervention presented to both patient and surrogate by a trained interventionist in an interview format. The proposed randomized controlled trial will test the effects of the SPIRIT intervention in improving preparedness for end-of-life decision making among ESRD patients and their surrogates and reducing surrogates' conflict during decision making and psychosocial morbidities. Subjects will be 200 Caucasian and African-American patients with ESRD recruited from outpatient dialysis clinics and their chosen surrogate decision makers. Preparedness outcomes (dyad congruence, patient decisional conflict, and surrogate decision making confidence) will be measured at 2, 6, and 12 months post-intervention. Surrogate decisional conflict and psychosocial morbidities (anxiety, depression, and post-traumatic distress symptoms) will be measured 2 weeks after the patient's hospitalization that required surrogate decision making. To compare the effects of SPIRIT to those of standard care on surrogates after the patient's death, psychosocial morbidities will be measured at 3 and 6 months after the patient's death. We will also explore the potential impact of race on intervention effects and examine mediators and moderators of the intervention effects.
Interventions
BEHAVIORALthe 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
Sponsors
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for patients, * self-identified Caucasian or African American; * receiving either center-hemodialysis or home-peritoneal dialysis for at least 6 months prior to enrollment; * availability of an individual chosen by the patient who can be present during the intervention as a surrogate decision maker; * age 18 years or older; * ability to participate in health care decisions as evidenced by less than 3 errors on the Short Portable Mental Status Questionnaire (SPMSQ), suggesting normal mental functioning; * ability to read, write, and speak English. * a CCI score of ≥6; * hospitalization in the last 6 months, a CCI score of 5, including congestive heart failure (CHF). for surrogates, * age 18 years or older (to serve as a surrogate decision maker, the individual must be an adult); * willingness to serve as the surrogate decision maker and participate in the intervention with the patient; * ability to read, write, and speak English.
Exclusion criteria
-Patients who are too sick to participate in an hour-long interview, who require special care and assistance, who would not be able to care for their needs will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyad Congruence | 2, 6, 12 months | patient and surrogate congruence on the goals of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Over Time: Hospital Anxiety and Depression Scale Scores | 2 Weeks, and at 3 and 6 months post death | Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity. |
| Change Over Time: Post-traumatic Distress Symptom Score | 2 weeks and 3 and 6 months after patient death | The 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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 | 109 |
| Total | 210 |
Baseline characteristics
| Characteristic | Control | Total | SPIRIT Intervention |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 11.1 | 62.1 years STANDARD_DEVIATION 11.3 | 61.1 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 141 Participants | 72 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 69 Participants | 37 Participants |
| Region of Enrollment United States | 101 patients | 210 patients | 109 patients |
| Sex: Female, Male Female | 55 Participants | 120 Participants | 65 Participants |
| Sex: Female, Male Male | 46 Participants | 90 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 101 | 28 / 109 |
| other Total, other adverse events | 0 / 101 | 0 / 109 |
| serious Total, serious adverse events | 0 / 101 | 0 / 109 |
Outcome results
Primary
Dyad Congruence
patient and surrogate congruence on the goals of care
Time frame: 2, 6, 12 months
Population: patients on dialysis and their surrogates
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Dyad Congruence | 48 percentage of congruent dyads |
| SPIRIT Intervention | Dyad Congruence | 64 percentage of congruent dyads |
p-value: <0.0595% CI: [1.1, 3.3]Mixed Models Analysis
Secondary
Change Over Time: Hospital Anxiety and Depression Scale Scores
Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.
Time frame: 2 Weeks, and at 3 and 6 months post death
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | 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 |
| Control | Change Over Time: Hospital Anxiety and Depression Scale Scores | Baseline HADS (Depression) | 3.1 units on a scale | Standard Deviation 3.2 |
| Control | Change Over Time: Hospital Anxiety and Depression Scale Scores | 2-Week F-Up HADS (Anxiety) | 6.6 units on a scale | Standard Deviation 4 |
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Control | Change Over Time: Hospital Anxiety and Depression Scale Scores | Baseline HADS (Anxiety) | 6.1 units on a scale | Standard Deviation 4 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 6-Month F-Up HADS (Depression) | 3.4 units on a scale | Standard Deviation 2.8 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 3-Month F-Up HADS (Depression) | 3.3 units on a scale | Standard Deviation 3.1 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | Baseline HADS (Anxiety) | 6.1 units on a scale | Standard Deviation 4.2 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 2-Week F-Up HADS (Anxiety) | 6.3 units on a scale | Standard Deviation 2.6 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 3-Month F-Up HADS (Anxiety) | 5.1 units on a scale | Standard Deviation 2.6 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 6-Month F-Up HADS (Anxiety) | 4.7 units on a scale | Standard Deviation 3.4 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | Baseline HADS (Depression) | 4.1 units on a scale | Standard Deviation 3.1 |
| SPIRIT Intervention | Change Over Time: Hospital Anxiety and Depression Scale Scores | 2-Week F-Up HADS (Depression) | 4.8 units on a scale | Standard Deviation 3.2 |
p-value: 0.1295% CI: [-2.8, 0.3]Regression, Linear
p-value: <0.0595% CI: [-4.2, -0.3]Regression, Linear
Secondary
Change Over Time: Post-traumatic Distress Symptom Score
The 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.
Time frame: 2 weeks and 3 and 6 months after patient death
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change Over Time: Post-traumatic Distress Symptom Score | Baseline | 17.3 units on a scale | Standard Deviation 8.1 |
| Control | Change Over Time: Post-traumatic Distress Symptom Score | 2-Week F-Up | 27.0 units on a scale | Standard Deviation 14 |
| Control | Change Over Time: Post-traumatic Distress Symptom Score | 3-Month F-Up | 22.5 units on a scale | Standard Deviation 8.3 |
| Control | Change Over Time: Post-traumatic Distress Symptom Score | 6-Month F-Up | 25.5 units on a scale | Standard Deviation 12.4 |
| SPIRIT Intervention | Change Over Time: Post-traumatic Distress Symptom Score | 6-Month F-Up | 20.3 units on a scale | Standard Deviation 11.1 |
| SPIRIT Intervention | Change Over Time: Post-traumatic Distress Symptom Score | Baseline | 20.2 units on a scale | Standard Deviation 8.7 |
| SPIRIT Intervention | Change Over Time: Post-traumatic Distress Symptom Score | 3-Month F-Up | 19.3 units on a scale | Standard Deviation 9.9 |
| SPIRIT Intervention | Change Over Time: Post-traumatic Distress Symptom Score | 2-Week F-Up | 23.6 units on a scale | Standard Deviation 11.8 |
p-value: 0.2195% CI: [-10.2, 2.2]Regression, Linear