Clinical trial NCT03138564: An Effectiveness-Implementation Trial of SPIRIT in ESRD
Official title: An Effectiveness-Implementation Trial of SPIRIT in ESRD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Nursing
Nephrology
Behavioral Research
Social Research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-05-03
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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: 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).

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

Primary outcomes:
measure: Dyad Congruence on Goals-of-Care Tool
timeFrame: Baseline, Week 2
measure: Patient's Decisional Conflict Scale (DCS) Score
timeFrame: Baseline, Week 2
measure: Surrogate's Decision Making Confidence (DMC) Scale Score
timeFrame: Baseline, Week 2
measure: Composite Outcome of Dyad Congruence and Surrogate DMC Score
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: End-of-life Treatment Intensity
timeFrame: Upon patient death (up to 21 months)
measure: Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
timeFrame: Baseline, 3 months after patient death (up to 24 months)
measure: Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
timeFrame: Baseline, 3 months after patient death (up to 24 months)
measure: Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score
timeFrame: Baseline, 3 months after patient death (up to 24 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dialysis at Northside
state: Georgia
city: Atlanta
country: United States
facility: Emory Dialysis at Greenbriar
state: Georgia
city: Decatur
country: United States
facility: Emory Dialysis at Candler
state: Georgia
city: N. Decatur
country: United States
facility: Emory Dialysis Center
state: Georgia
city: Acoma Pueblo
country: United States
facility: Dialysis Clinic, Inc - Acoma Canoncito Laguna
state: New Mexico
city: Albuquerque
country: United States
facility: Dialysis Clinic, Inc - Albuquerque
state: New Mexico
city: Albuquerque
country: United States
facility: Dialysis Clinic, Inc - Albuquerque South
state: New Mexico
city: Albuquerque
country: United States
facility: Dialysis Clinic, Inc - Albuquerque East
state: New Mexico
city: Carlsbad
country: United States
facility: Dialysis Clinic, Inc - Carlsbad
state: New Mexico
city: Cuba
country: United States
facility: Dialysis Clinic, Inc - Cuba
state: New Mexico
city: Grants
country: United States
facility: Dialysis Clinic, Inc - Grants
state: New Mexico
city: Raton
country: United States
facility: Dialysis Clinic, Inc - Raton
state: New Mexico
city: Rio Rancho
country: United States
facility: Dialysis Clinic, Inc - Rio Rancho
state: New Mexico
city: Santo Domingo Pueblo
country: United States
facility: Dialysis Clinic, Inc - Santo Domingo
state: New Mexico
city: Silver City
country: United States
facility: Dialysis Clinic, Inc - Silver City
state: New Mexico
city: Taos
country: United States
facility: Dialysis Clinic, Inc - Taos
state: New Mexico
city: Carrboro
country: United States
facility: Carolina Dialysis - Carrboro
state: North Carolina
city: Mebane
country: United States
facility: Carolina Dialysis - Mebane
state: North Carolina
city: Pittsboro
country: United States
facility: Carolina Dialysis - Pittsboro
state: North Carolina
city: Raleigh
country: United States
facility: Fresenius Kidney Care - Raleigh
state: North Carolina
city: Sanford
country: United States
facility: Carolina Dialysis-Sanford Lee County
state: North Carolina
city: Sanford
country: United States
facility: Carolina Dialysis-Sanford Main
state: North Carolina
city: Siler City
country: United States
facility: Carolina Dialysis - Siler City
state: North Carolina
city: Cheswick
country: United States
facility: Dialysis Clinic, Inc - Harmar Village
state: Pennsylvania
city: Monroeville
country: United States
facility: Dialysis Clinic, Inc - Monroeville/Five Points
state: Pennsylvania
city: North Versailles
country: United States
facility: Dialysis Clinic, Inc - North Versailles
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Dialysis Clinic, Inc - Oakland
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Dialysis Clinic, Inc - Banksville
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Dialysis Clinic, Inc - Wilkinsburg
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Dialysis Clinic, Inc - North Hills
state: Pennsylvania
city: Altavista
country: United States
facility: UVA Dialysis Altavista Clinic
state: Virginia
city: Amherst
country: United States
facility: UVA Dialysis Amherst Clinic
state: Virginia
city: Charlottesville
country: United States
facility: Kidney Center Outpatient Dialysis Clinic
state: Virginia
city: Farmville
country: United States
facility: UVA Dialysis Clinic Farmville
state: Virginia
city: Fishersville
country: United States
facility: UVA Augusta Dialysis
state: Virginia
city: Gordonsville
country: United States
facility: UVA Dialysis Zion Crossroads
state: Virginia
city: Lynchburg
country: United States
facility: UVA Dialysis Lynchburg
state: Virginia
city: Orange
country: United States
facility: UVA Dialysis Orange Clinic
state: Virginia
city: Staunton
country: United States
facility: UVA Dialysis Clinic Staunton
state: Virginia
Study officials:
affiliation: Emory University
name: Mi-Kyung Song, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song MK, Unruh ML, Manatunga A, Plantinga LC, Lea J, Jhamb M, Kshirsagar AV, Ward SE. SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD. Contemp Clin Trials. 2018 Jan;64:188-194. doi: 10.1016/j.cct.2017.10.005. Epub 2017 Oct 6.