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An Effectiveness-Implementation Trial of SPIRIT in ESRD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138564
Recruitment Status : Suspended (Enrollment is temporarily suspended due to COVID-19.)
First Posted : May 3, 2017
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mi-Kyung Song, Emory University

Brief 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. In these explanatory trials carried out in dialysis clinics, SPIRIT was delivered by trained research nurses. The researchers have established feasibility, patient-surrogate acceptability, and efficacy. Patients and surrogates participating in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world settings with less control? To address this very issue, The researchers will conduct a real-world effectiveness-implementation study. 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. This study will evaluate the implementation of SPIRIT, including sustainability.

The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in 4 states. Patients and surrogates will complete questionnaires at baseline and after the intervention; all participants will be followed for up to 9 months.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: SPIRIT Behavioral: Comparison Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dialysis clinics will be 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)
Primary Purpose: Supportive Care
Official Title: An Effectiveness-Implementation Trial of SPIRIT in ESRD
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
Experimental: SPIRIT Clinic
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

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.

Other Name: Sharing Patient's Illness Representation to Increase Trust

Active Comparator: Comparison Condition Clinic
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
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.
Other Name: Usual care




Primary Outcome Measures :
  1. Change in dyad congruence [ Time Frame: Baseline, Week 2 ]
    Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in 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 then compared to determine dyad congruence.

  2. Change in Patient's Decisional Conflict Scale (DCS) score [ Time Frame: Baseline, Week 2 ]
    Patient decisional conflict will be 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 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.

  3. Change in Surrogate's Decision Making Confidence (DMC) scale score [ Time Frame: Baseline, Week 2 ]
    Surrogate decision-making confidence will be 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 (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.

  4. Change in composite outcome of dyad congruence and surrogate DMC score [ Time Frame: Baseline, Week 2 ]
    A composite outcome combining dyad congruence and surrogate DMC be created to differentiate surrogates who understand the patient's wishes and feel confident in their role from those who don't (understand the wishes but lack confidence, misunderstand the wishes but feel confident, neither understand nor feel confident).


Secondary Outcome Measures :
  1. End-of-life treatment intensity [ Time Frame: Upon patient death ]
    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 treatment will be documented (e.g., mechanical ventilation, feeding tube, dialysis, CPR).

  2. Change in Surrogate's Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: At baseline and 3 months after patient death ]
    Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). 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). The separate anxiety and depression subscale scores 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 or depression.

  3. Change in Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) score [ Time Frame: At baseline and 3 months after patient death ]
    Surrogate post-bereavement traumatic distress will be 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 0-7 where 0="never" and 7=Always). Total scale scores range from 10-70 and higher scores indicate more intense symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138564


Locations
Show Show 39 study locations
Sponsors and Collaborators
Emory University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Mi-Kyung Song, PhD, RN Emory University
  Study Documents (Full-Text)

Documents provided by Mi-Kyung Song, Emory University:
Statistical Analysis Plan  [PDF] July 6, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mi-Kyung Song, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03138564    
Other Study ID Numbers: IRB00094859
1R01NR017018-01 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mi-Kyung Song, Emory University:
Nursing
Nephrology
Behavioral Research
Social Research
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency