An Effectiveness-Implementation Trial of SPIRIT in ESRD



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:February 15, 2018
End Date:March 31, 2022
Contact:Mi-Kyung Song, PhD, RN
Email:mi-kyung.song@emory.edu
Phone:404-727-3134

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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. 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.

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 our 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. 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 30 dialysis clinics in 4
states. The dialysis clinics will be randomized to implement SPIRIT immediately or to
maintain usual care to serve as a control to the intervention. Participants will be recruited
for 15 months. The control sites will implement SPIRIT after the 15 month intervention and 9
month follow up period is complete. Individual patient participation will end at 9 months or
death, whichever occurs first; surrogate participation will end at 9 months or at the
completion of 3-month post-death follow-up.

Inclusion Criteria for Patients:

- on either hemodialysis or peritoneal dialysis

- seriously ill based on clinician's heuristic prediction of survival

- 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

Exclusion Criteria for Surrogates:

- Unable to complete questionnaires due to physical or cognitive limitations
We found this trial at
33
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4045 Jackie Road Southeast
Rio Rancho, New Mexico 87124
Phone: 505-272-0407
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80 Veterans Boulevard
Acoma Pueblo, New Mexico 87034
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1500 Indian School Road Northeast
Albuquerque, New Mexico 87102
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1725 Isleta Boulevard Southwest
Albuquerque, New Mexico 87105
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905 Louisiana Boulevard Northeast
Albuquerque, New Mexico 87110
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610 Northside Drive, NW
Atlanta, Georgia 30318
Phone: 404-686-5038
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2841 Greenbriar Parkway Southwest
Atlanta, Georgia 30331
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Atlanta, Georgia 30308
Principal Investigator: Mi-Kyung Song, PhD
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2319 Osborne Road
Carlsbad, New Mexico 88220
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105 Renee Lynne Court
Carrboro, North Carolina 27510
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725 Freeport Road
Cheswick, Pennsylvania 15024
Phone: 412-647-7062
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14 East Cordova Avenue
Cuba, New Mexico 87013
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2726 Candler Road
Decatur, Georgia 30034
Phone: 404-712-1055
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Decatur, Georgia 30030
Principal Investigator: Mi-Kyung Song, PhD
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East Point, Georgia 30344
Principal Investigator: Mi-Kyung Song, PhD
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1213 Bonita Street
Grants, New Mexico 87020
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1410 S Third Street Ext
Mebane, North Carolina 27302
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Monroeville, Pennsylvania 15146
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N. Decatur, Georgia 30033
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613 East Pittsburgh McKeesport Boulevard
North Versailles, Pennsylvania 15137
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480 Hillsboro Street
Pittsboro, North Carolina 27312
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3260 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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2727 Banksville Road
Pittsburgh, Pennsylvania 15216
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7620 Meade Street
Pittsburgh, Pennsylvania 15221
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3412 Babcock Boulevard
Pittsburgh, Pennsylvania 15237
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Raleigh, North Carolina 27610
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900 South 6th Street
Raton, New Mexico 87740
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Sanford, North Carolina 27332
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Sanford, North Carolina 27332
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125 W Highway 22
Santo Domingo Pueblo, New Mexico 87052
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192 Campus Drive
Siler City, North Carolina 27344
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1310 E Sunset Lane
Silver City, New Mexico 88061
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1335 Maestas Road
Taos, New Mexico 87571
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