An Effectiveness-Implementation Trial of SPIRIT in ESRD

Study Overview
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Brief Summary
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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.

Detailed Description
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End-stage renal disease (ESRD) currently affects nearly 662,000 people in the U.S. While dialysis is the treatment of choice for over 90% of patients with ESRD and is universally covered by Medicare regardless of patient age or means, the likelihood that dialysis can restore health or prolong life is limited; only 50% of dialysis patients are alive 3 years after the onset of ESRD. Thus many dialysis patients and their family members or surrogate decision-makers have to face difficult end-of-life decisions. Although advance care planning (ACP), in which patients and surrogate decision-makers discuss future health states and treatment options, is a central tenet of dialysis care, the vast majority of dialysis patients (>90%) report never engaging in ACP discussions with their care providers. The lack of effective ACP to prepare patients and their surrogates for end-of-life decision making with sufficient time before death has deleterious consequences at all levels of society. Consequences have been well documented: prolonged use of futile treatment at the end of life, which misuses the healthcare system, high levels of surrogate distress during decision making, which emanates from not having a clear understanding of the patient's wishes, and surrogates experiencing later sequelae of psychosocial morbidities, such as depression and family discord. Sharing Patient's Illness Representation to Increase Trust (SPIRIT), a patient and family-centered ACP intervention based on the Representational Approach to Patient Education, was designed by the research team to establish a testable model of how end-of-life care discussions could occur between a dialysis patient and his/her chosen surrogate (usually a spouse or adult child). The discussions, which are facilitated by a trained care provider, are framed around addressing each individual's representations of (beliefs about) the illness and views of life-sustaining measures at the end of life. SPIRIT follows a six-step learning objective over two-sessions, which together take about 60 minutes. The care provider, who is value-neutral, guides the patient in examining his/her values related to end-of-life care, helps the surrogate understand the patient's illness progression, and prepares the surrogate for his/her role as a surrogate in a highly emotionally charged medical setting. Over the last decade, SPIRIT has been tested to establish feasibility, patient-surrogate acceptability, and efficacy. In these explanatory trials carried out in dialysis clinics, SPIRIT was delivered by trained research nurses. Patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, including the extent to which: a) the patient and surrogate agreed on end-of-life care goals, b) the patient had reduced conflict about the benefits and burdens of life-sustaining treatments, and c) the surrogate had increased confidence about the role of surrogate. Key to establishing the utility of this approach for broader generalizability, surrogates who received SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to those who did not. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world clinical settings with less control? To address this very issue, the researchers will conduct a real-world effectiveness-implementation study, an essential step prior to widespread implementation of SPIRIT. 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. Simultaneously, the researchers will evaluate the implementation of SPIRIT, including sustainability. This study will use a Type I effectiveness-implementation hybrid approach that combines testing intervention effectiveness and gathering information about implementation of an efficacious intervention in a real world setting. To maximize data on the implementation process and sustainability, the researchers chose a delayed intervention design in which clinics are randomized either to implement SPIRIT immediately after randomization (i.e., initial implementation) or to maintain usual care for a comparison condition and then implement the intervention in control clinics following conclusion of this clinical trial (i.e., delayed implementation). The intent of the delayed implementation group was provide descriptive data for translation of the intervention into clinical practice (versus data collected on dyad participants in this current study), however, this portion of the study could not be performed due to the coronavirus disease 2019 (COVID-19) pandemic. The short-term goal is to generate sufficient evidence to accelerate the integration of SPIRIT into dialysis practice and policy. This study will recruit 400 dyads of patients at high risk of death in the next year and their surrogates (a total of 800 individuals) from dialysis clinics in four states. The dialysis clinics will be randomized to implement SPIRIT or to maintain usual care to serve as a control to the intervention. Participants will complete a follow-up assessment two weeks after the the study intervention. They will then be observed for 9 months (or until the death of the patient) with an optional extension of the observational period for an additional 12 months, for up to 21 months of observation. Individual patient participation will end after the observation period (9 or 21 months) or death, whichever occurs first; surrogate participation will end after the observation period (9 or 21 months) or at the completion of the post-bereavement surveys which are administered 3-months after the death of the patient (up to 24 months).

Official Title
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An Effectiveness-Implementation Trial of SPIRIT in ESRD

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Behavioral: SPIRIT
* Behavioral: Comparison Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dialysis clinics are randomized to provide the intervention or usual care. Patients of those clinics will be given the opportunity to participate in the study and will receive the intervention or usual care based on which clinic they attend.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIRIT Clinic<br>Patients at clinics that have been randomized to the SPIRIT arm will be given the option to participate in the intervention. SPIRIT is a two-session, 60-minute, structured psychoeducational intervention, targeting both patient and surrogate. Using a provider manual, the care provider follows six steps: 1) assessing illness presentation, 2) identifying gaps and concerns, 3) creating conditions for conceptual change, 4) introducing replacement information, 5) summarizing, and 6) setting goals and planning. | Behavioral: SPIRIT<br>* SPIRIT is a two-session, structured psychoeducational intervention assisting patients clarify their end-of-life preferences and helping surrogates understand the patient's wishes and prepare for the surrogate role. During the first session (about 45 minutes) individualized information is provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the care provider will assist the patient to examine his/her values about life-sustaining treatment. The surrogate will receive help preparing for end-of-life decision-making and the emotional burden of decision-making. A Goals-of-Care document will be completed to indicate the patient's preferences. Two weeks later, the second session (about 15 minutes) addresses remaining or new concerns. The patient's Goals-of-Care document will be reviewed. The patient's end-of-life preferences and surrogate's name and relationship to the patient will be documented in the medical record.<br>* Other names: Sharing Patient's Illness Representation to Increase Trust;|
| Active Comparator: Comparison Condition Clinic<br>Patients at clinics that have been randomized to the control arm will be given the option to participate as a study control. The control clinics will have delayed implementation of the SPIRIT intervention. | Behavioral: Comparison Condition<br>* As required by Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes.<br>* Other names: Usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyad Congruence on Goals-of-Care Tool | The Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in end-stage renal disease (ESRD) patients. Possible responses to the scenarios are: The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment, The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis, and I am not sure. Patients and surrogates complete this tool independently and their responses are compared to determine dyad congruence. A dyad is assigned with 1 if each member of the dyad chose the same response (either comfort care only or continue aggressive care) in both scenarios. In all other cases, the dyad is assigned with 0, which includes: 1) the patient and surrogate responses are the same in one of the two scenarios, 2) the patient and surrogate responses differ in both scenarios, and 3) the patient and surrogate responses are both I am not sure. | Baseline, Week 2 | 
| Patient's Decisional Conflict Scale (DCS) Score | Patient decisional conflict is measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 to 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making. | Baseline, Week 2 | 
| Surrogate's Decision Making Confidence (DMC) Scale Score | Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) Not confident at all to (4) Very confident. Total scores range from 0 to 20, with higher scores indicating greater confidence. | Baseline, Week 2 | 
| Composite Outcome of Dyad Congruence and Surrogate DMC Score | The composite outcome combines dyad congruence on Goals-of-Care scenarios and surrogate DMC scores. If the dyad congruence is 1 and the surrogate's DMC >=3, then the composite outcome value for the dyad is 1. In all other cases, the dyad's composite outcome value is 0. | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-of-life Treatment Intensity | The use of intensive procedures during end-of-life treatment will be identified through the United States Renal Data System (USRDS). The use of mechanical ventilation as part of the patient's end-of-life (EOL) treatment will be documented (e.g., mechanical ventilation, feeding tube, dialysis, CPR). The EoL treatment intensity data acquisition will take at least two more years after the participant's death due to the 2-year gap in the administrative data release. | Upon patient death (up to 21 months) | 
| Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score | Surrogate post-bereavement anxiety symptoms were measured with the Hospital Anxiety and Depression Scale (HADS) Anxiety subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Scores for the anxiety subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates normal, 8-10 indicates borderline abnormal, and 11-21 indicates abnormal levels of anxiety. | Baseline, 3 months after patient death (up to 24 months) | 
| Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | Surrogate post-bereavement symptoms of depression were measured with the Hospital Anxiety and Depression Scale (HADS) Depression subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Total scores of the depression subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates normal, 8-10 indicates borderline abnormal, and 11-21 indicates abnormal levels of depression. | Baseline, 3 months after patient death (up to 24 months) | 
| Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score | Surrogate post-bereavement traumatic distress was measured with the Post-Traumatic Symptoms Scale-10 (PTSS-10). Surrogates indicate how often they have experienced symptoms of post-traumatic stress by responding to 10 symptoms on a scale of 1 to 7 where 1 = never and 7 = always. Total scale scores range from 10 to 70 and higher scores indicate more intense symptoms. | Baseline, 3 months after patient death (up to 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing, Nephrology, Behavioral Research, Social Research