Dementia Clinical Trial
Official title:
Improving Advance Care Planning for Frail, Elderly Residents in Canadian Nursing Homes: A Subproject of the BABEL Study (Better tArgetting, Better Outcomes for Frail ELderly Patients)
1.0 SUMMARY Most Canadian nursing home (NH) residents are elderly and frail, have multiple
chronic health conditions and impairments, and have dementia. In 2014, 244,000 Canadians
lived in NHs, including 6% of those ≥65 y.o., at a cost of >$10 billion/yr. NH residents
experience high rates of acute illness; approximately 33% have emergency department (ED)
visits and 23% are hospitalized yearly. Many of these visits are avoidable, and expose
residents to iatrogenic complications. In Manitoba >1.5% of NH residents are admitted to
intensive care units yearly, where they receive highly aggressive care. Approximately 30-50%
of NH residents die each year, experiencing a progressive burden of severe symptoms leading
up to death. Thus, there are serious concerns about Advance Care Planning (ACP) and
end-of-life (EOL) care in NHs.
Canadians in general have mediocre knowledge of, and engagement in ACP. Also, studies show
that values such as quality of life and aversion to being dependent trump survival in
determining care preferences. Among hospitalized octogenarians, 61% desired comfort care
only, or just a brief trial of aggressive care. A U.S. study found that decisions for LTC
residents to be sent to ED were frequently driven by families who felt unprepared for their
loved ones' death, and insecure about the quality of NH care, where there had been little or
no discussion about ACP.
Systematic approaches to ACP in NHs have demonstrated benefits, including: increases in ACP
uptake, higher compliance with EOL wishes, higher satisfaction with care and emotional
well-being, reduced family stress and anxiety, and lower rates of hospitalization. Generally,
multimodal ACP interventions have shown the most benefits.
Thus, ACP can improve outcomes for NH residents, their families, and society. The goal of
this proposal is to apply best practices in ACP, and demonstrate that it can be implemented
it in a scalable, sustainable way across provinces. This will result from delivering the ACP
intervention within the existing envelope of NH staffing, and by acquiring most of the data
from the Resident Assessment Instrument (RAI), which is completed quarterly for NH residents
in 9 provinces. As RAI contains information identifying NH residents at the highest risk for
dying within 6-12 months, it will be used to target the ACP intervention to such individuals.
2.0 SPECIFIC AIMS
2.1. Aim 1. Improve intervention acceptability, buy-in, and usability by engaging a diverse
group of stakeholders to collaboratively design key details of the study.
- Aim 1A: The stakeholder group work to identify and agree upon key principles and
practical aspects of ACP in the NH setting.
- Aim 1B: Using the key principles and practical aspects, and existing evidence about
beneficial approaches to ACP in NHs, the investigator group will devise an
evidence-based, integrated ACP intervention that can be applied by existing NH
personnel.
- Aim 1C: Guided by the results of the stakeholder meeting, the investigator group will
identify characteristics of NH residents -- available from RAI data routinely and
repeatedly available in Canadian NHs -- to identify a cohort of residents who are at the
highest risk of dying in the following 6-12 months.
- Aim 1D: Informed by the results of the stakeholder meeting, and existing data, the
investigator group, will agree upon the outcomes to be assessed in this study.
2.2. Aim 2. Design and implement training of NH personnel in application of the systematic
approach to ACP devised in Aim#1B.
2.3. Aim 3. For each participating NH, devise an approach for real-time access to, and use
of, the RAI data for residents.
2.4. Aim 4. Applying the systematic approach to ACP devised in Aim#1B, to high-risk NH
residents identified in Aim#1C, will result in improvement in relevant outcomes identified in
Aim#1D.
3.0 METHODOLOGICAL APPROACH
3.1. Aim 1A. During a 1 day meeting in Toronto, the investigators will convene stakeholders
including: investigators, NH residents and families, advocacy groups for the elderly, legal
experts, NH management, NH staff, an expert on inter-professional care, NH physician,
geriatrician, palliative care physician, ethicist, ICU physician, and dietitian. Directed
discussions and breakout sessions will be utilized to identify key principles and practical
components of ACP in the NH setting. All sessions will be recorded.
3.2. Aim 1B. After the stakeholder meeting, the investigator group will conduct weekly
telephone conferences to design an integrated, systematic, evidence-based ACP intervention --
which will be referred to as "The BABEL Approach to ACP". It will be informed by both: (a)
the stakeholder meeting, and (b) existing, published evidence about approaches to ACP in the
long-term care setting that have been demonstrated to improve relevant outcomes. These latter
include, but are not limited to: (i) "Let Me Decide", (ii) the methods of Morrison et al.,
and (iii) "Respecting Choices". Criteria will include: likelihood to improve relevant
outcomes, practicability, feasibility, scalability, sustainability and general acceptability.
3.3 Aim 1C. This aim will utilize national RAI data on NH residents, maintained at the
University of Waterloo by Dr. John Hirdes. Preliminary work in this direction indicates that
44% of all NH residents in the country have one or more of the following, high-risk
characteristics, all available from the RAI data: CHESS score ≥3, cancer, congestive heart
failure, leave >25% of their food uneaten.
3.4. Aim 1D. There will be discussion during the stakeholder meeting, specifically addressing
which potential outcomes are relevant and should be tracked. Informed by those discussions,
and outcomes studied in prior studies of ACP in long-term care, the investigator group will
compile a final list of outcomes for the study.
3.5. Aim 2. After design of The BABEL Approach to ACP, the investigator group will continue
weekly conference calls to develop a detailed plan to train NH staff in implementing it. The
investigators and study coordinators in each province will provide the training, which is
expected to include (but may not be limited to) applied learning, intentional case studies,
role-playing exercises, targeted discussions and adjunctive print, video, and web-based
materials. Criteria for the training methods include: practicability, feasibility,
acceptability, scalability, and sustainability. Training will occur in the NHs, and will not
include actual residents.
3.6. Aim 3. Local investigators and study coordinators will visit each participating NH, and
working with NH personnel will: (i) locate how the NH staff conduct the quarterly RAI
surveys, (ii) locate where the data is maintained in the NH, and (iii) devise a method, with
the direct assistance of NH personnel, for using the RAI data to identify residents who meet
targeting criteria (Aim#1C).
3.7. Aim 4.
3.7.A. GENERAL METHODS: This will be a cluster-randomized study in 24 NHs in Ontario,
Manitoba, and Alberta, divided equally between intervention and control (total counts are:
Ontario=13, Alberta=6, Manitoba=5). Informed consent will be obtained from cognitively intact
residents, and from their substitute decision-maker (SDM).
3.7.B. ACP IN CONTROL NURSING HOMES Eligible residents in the 12 control NHs will receive the
prevalent approach to ACP. No elements of The BABEL Approach to ACP will be introduced in the
control homes.
3.7.C. ACP INTERVENTION NURSING HOMES The intervention comprises: (i) training on, and
introduction of The BABEL Approach to ACP for targeted NH residents, and (ii) after these ACP
discussions occur, notifying the resident's primary care physician of the residents' ACP
preferences, as elicited by the ACP. Intervention homes will be asked to use the systematic,
evidence-based approach to ACP for targeted residents. They will be free to use it in
non-targeted residents, but it will not be specifically requested that they do so.
3.7.D. INFORMED CONSENT In both intervention and control homes informed consent will be
sought from eligible residents (or surrogate consent from SDMs, for residents deemed to lack
capacity to provide informed consent), and separately from SDMs. As the ACP approach of our
intervention is not investigational, the investigators believe it does not require informed
consent, per se. However, informed consent from residents is required to obtain their
personal information, track the course of their ACP wishes/decisions, obtain their clinical
outcomes, and include their data in group form in analyses, reports and manuscripts from the
research study.
Residents' clinical outcome information will be obtained from a combination of: their nursing
home records, their physician, emergency departments, urgent care, and hospitals. A separate
page on the consent form serves specifically as consent to obtain such medical information.
Informed consent from SDMs is required to contact them separately in order to send them a
survey assessing their satisfaction with care at end-of-life provided to the NH resident.
3.7.E. ANALYSIS OF RESIDENT OUTCOMES Most of these analyses will use hierarchical (2-level)
random effects models to account for clustering within NHs, and possible differences between
intervention and control groups that might occur, despite randomization. The provinces will
be included as fixed effects; interaction terms between province and Intervention/Control
will be included to account for possible influences of existing approaches to ACP undertaken
by provinces (e.g. PoET in Ontario). Logistic regression will be used for binary outcomes,
Poisson regression for rates, OLS regression for continuous variables. The time-to-event
analysis will use Cox proportional hazards regression with fixed effects to represent the
nursing homes.
Resident-level covariates, obtained from NH records and RAI will be: age at NH admission
(stratified), gender, marital status at study entry, elapsed time from NH admission to study
entry (stratified), location immediately prior to NH entry (as home, assisted living, other
LTC facility, hospital or other acute care facility, Chronic Continuing Care facility [in ON
only]), medical conditions/diagnoses, CHESS score at study entry, whether at study entry
resident was leaving ≥25% of NH food uneaten, and use of specific medications at study entry.
Nursing home-level covariates will be: # of beds (stratified), ownership (public vs.
private), and elements of pre-existing ACP approaches as derived from the Nursing Home
Environmental Scan (specific variables still to be determined, but will do so before doing
any analysis).
3.7.F. ANALYSIS OF SDM OUTCOMES Analysis will use hierarchical (2-level) mixed models to
account for clustering within NHs, and possible differences between intervention and control
groups that might occur, despite randomization. The provinces will be included as fixed
effects; interaction terms between province and Intervention/Control will be included to
account for possible influences of existing provincial approaches to ACP (e.g. PoET in
Ontario). Covariates, obtained from the SDM participants, NH records, and RAI will include
all of the covariates from Section 3.7.E, and in addition: SDM age at resident death
(stratified), SDM gender, and SDM relationship to deceased resident.
3.7.G. ANALYSIS OF NH STAFF OUTCOMES Analysis of NH staff self-efficacy in ACP will compare
the pre-study to post-study difference in self-efficacy ratings between intervention and
control NHs.
Analysis, in intervention NHs only, of NH staff perceptions of The BABEL Approach to ACP, and
to the training in it's use will be mainly descriptive.
Analysis of the semi-structured interview of NH personnel will involve thematic analysis,
compared between Control and Intervention homes.
3.7.H. ANALYSIS OF PROCESS OUTCOME OF THE RATE OF DOCUMENTED ACP DISCUSSIONS Analysis will
use the hierarchical (2-level) random effects Poisson modeling strategy of section 3.7.E.
3.7.I. SAMPLE SIZE CALCULATION
- For this calculation, use was made of PASS 2008 sample size software (NCSS, LLC,
Kaysville, Utah). Specifically, the calculation for Two Independent Means with a
cluster-randomized design.
- This calculation was for the co-primary outcome of the ACP Audit survey given 6 weeks
after study entry, specifically the fraction of items #1-7 answered 'Yes'. Thus, the
scale goes from from 0-7.
- It used the following assumptions:
• Mean±SD score:
- In Control homes = 5.0±1.5 (72% 'yes') (33, 34)
- In Intervention homes = 5.6±1.5 (85% 'yes')
- 5% Type I error rate
- Average of 150 residents in each NH, of whom 0.5% are in respite care (2)
- 44% of NH residents are at high risk of death or other acute outcomes, defined as
any of: CHESS ≥ 3, cancer, congestive heart failure, or leave >25% of their food
uneaten. (personal communication, Dr. John Hirdes, University of Waterloo)
- 75% rate of consent among eligible NH residents
- Equal proportion of NHs in intervention and control groups
- Intraclass correlation coefficient (ICC) for the primary outcome = 20% Using these
assumptions, 12 NHs in each group (24 total) gives power of 83% (total N=1164).
;
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