N/A
N=852
An Effectiveness-Implementation Trial of SPIRIT in ESRD
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03138564 ↗Enrolled (actual)
852
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Dyad Congruence on Goals-of-Care Tool — 98; 76; 133; 119 dyads
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPIRIT (Behavioral); Comparison Condition (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyad Congruence on Goals-of-Care Tool |
98; 76; 133; 119; 111; 94 | — |
| PRIMARY Patient's Decisional Conflict Scale (DCS) Score |
25.6; 24.8; 23.4; 24.1 | — |
| PRIMARY Surrogate's Decision Making Confidence (DMC) Scale Score |
18.2; 18.3; 18.9; 18.6 | — |
| PRIMARY Composite Outcome of Dyad Congruence and Surrogate DMC Score |
92; 74; 139; 121; 107; 90 | — |
| SECONDARY End-of-life Treatment Intensity Among Participants With Medicare |
13; 9; 38; 23; 0; 0 | — |
| SECONDARY End-of-life Treatment Intensity Among Participants With Medicare as the Primary Payer |
17; 13; 13; 11; 3; 1 | — |
| SECONDARY Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score |
4.80; 4.89; 4.85; 4.61; 5.59; 6.71 | — |
| SECONDARY Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score |
3.28; 2.83; 3.04; 2.71; 4.26; 4.23 | — |
| SECONDARY Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score |
19.96; 21.97; 19.30; 21.97; 26.4; 29.3 | — |
Summary
Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, the researchers have developed and iteratively tested a patient and family-centered advance care planning intervention based on the Representational Approach to Patient Education called "Sharing Patient's Illness Representation to Increase Trust" (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates.
This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from dialysis clinics in four states. Patients and surrogates will complete questionnaires at baseline and two weeks after the intervention. Surrogates will complete a post-bereavement assessment three months after the death of the patient.
Eligibility Criteria
Inclusion Criteria for Patients:
- on either hemodialysis or peritoneal dialysis
- able to understand and speak English
Exclusion Criteria for Patients:
- lack of an available surrogate
- too ill or cognitively impaired to participate based on clinicians' judgment
- already enrolled in hospice
Inclusion Criteria for Surrogates:
- are chosen as a surrogate by the patient
- paid caregivers who will not be participating in medical decisions for the patient
Exclusion Criteria for Surrogates:
- Unable to complete questionnaires due to physical or cognitive limitations
Data sourced from ClinicalTrials.gov (NCT03138564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.