Dementia Clinical Trial
— BABELOfficial 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)
Verified date | October 2020 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 713 |
Est. completion date | August 9, 2020 |
Est. primary completion date | August 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Residents of participating nursing homes - =65 y.o. - At high risk of death in the next 6-12 months, as indicated by data collected on the RAI (Resident Assessment Instrument) that completed quarterly in most Canadian nursing homes. Specifically the high-risk elements are any of: CHESS score =3; cancer; congestive heart failure; leave >25% of their food uneaten - Resident and resident's substitute decision-maker provide informed consent to participate. Exclusion Criteria: - Resident and substitute decision-maker do not speak either English or French. - Residents who are deemed not be competent to make their own medical decisions AND their substitute decision-maker is a legally assigned public guardian, or they have no substitute decision-maker. - Residents who are transferred to a BABEL study home from another BABEL study home, with the date of transfer being after study initiation. Residents who transferred into a study home from a non-study home are eligible. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | Waterloo University | Waterloo | Ontario |
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Conestoga College, University of Calgary, University of Waterloo |
Canada,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Advance Care Planning (ACP) Audit | 7 item survey as described in: Heyland et al. Journal of Palliative Care Medicine 2(5), 2012. This will be obtained from the resident for those that have capacity, while for residents lacking capacity it will be completed by the Substitute Decision Maker. Each of the 7 items is scored as Yes (1) or No (0) -- thus the scale has a range of 0-7 representing the number of items answered 'Yes', with a higher score representing better processes of Advance Care Planning. |
6 weeks after study entry | |
Primary | Comfort in Dying of Nursing Home Residents (CAD-EOLD) | This is the 14 item version of this scale scale, as described in these 2 papers: Volicer et al., Alzheimer's Disease and Associated Disorders 15(4):194-200, 2001. Kiely et al., Alzheimer Dis Assoc Disord. 2006 Jul-Sep;20(3):176-81 As described in the Volicer paper, each item is scores 1-3, with total score then on a scale of 14-42, with lower values indicating greater comfort during the final week of life. |
After death in nursing home, up to 18 months. | |
Secondary | Rate of transfer from nursing home to emergency department or hospital. | Rate, per person-years of follow-up, of either of these events among nursing home resident subjects. | Up to 18 months. | |
Secondary | Rate of admission to hospital | Rate of this event, per person-years of follow-up, among nursing home resident subjects. | Up to 18 months. | |
Secondary | Time from study entry to death | Self-explanatory, with censoring at study end, or when the resident is discharged alive from the study nursing home. | Up to 18 months. | |
Secondary | Rate of use in nursing home of feeding tubes | Rate of this event, per person-years of follow-up, among nursing home resident subjects. | Up to 18 months. | |
Secondary | Rate of use in nursing home of systemic antibiotics | Rate of this event, per person-years of follow-up, among nursing home resident subjects. | Up to 18 months. | |
Secondary | Rate in nursing home of transition to palliative (comfort) care | Rate of this event, per person-years of follow-up, among nursing home resident subjects. | Up to 18 months. | |
Secondary | Discordance in care at the end of life | Assessed as the fraction of decedents in Intervention homes for whom, during the final month of life in the nursing home, application of any of five medical interventions was contrary to the stated wishes from the Full BABEL ACP Discussion. The five are: CPR/resuscitation, transfer to emergency, transfer to hospital, use of antibiotics, and insertion of a feeding tube. | Up to 18 months. | |
Secondary | ACP Self-efficacy of Nursing Home Resident Subjects | 5 item self-efficacy scale as described by: Sudore et al., J Pain Symptom Manage 53(4):669-681 e8, 2017 The scale from this survey is the sum of the score (1-5) for each of the five items. This outcome will be assessed only for nursing home residents who possess capacity to complete it. |
6 weeks after study entry -- given along with the ACP Audit tool (outcome#1) | |
Secondary | Nursing Home staff self-efficacy in Advance Care Planning (ACP) | This 17-item scale is described in Baughman et al., Am J Hosp Palliat Care. Jun 2017;34(5):435-441. Each item is scored on a 1-5 scale of how confident the respondent is in a given aspect of ACP. The scale is formed by summing scores for all 17 items, thus the range is 17-85, with higher scores indicating greater self-efficacy. |
Completed by staff in all participating nursing homes both before nursing home resident recruitment begins, and again at study completion (18 months after study initiation). | |
Secondary | Thematic analysis of experiences and feelings of nursing home staff about Advance Care Planning. | Evaluated via thematic analysis of semi-structured interviews of staff in all participating nursing homes. Approximately 3-5 staff in each NH will be invited to participate. | Performed 18 months after study initiation. | |
Secondary | Satisfaction with Care at End of Life (SWC-EOLD) | This is a 10 item scale, as described in Volicer et al., Alzheimer's Disease and Associated Disorders 15(4):194-200, 2001. It is to be completed by family members of deceased nursing home resident subjects. Each item is scored on a 1-4 scale, so that the overall score ranges 10-40, with higher values indicating greater satisfaction. |
Survey sent to family member 4 weeks after death of nursing home resident. | |
Secondary | Whether plan of care was followed. | Single item, on a 1-5 scale of level of agreement, sent after nursing home resident death to the substitute decision maker, asking for level of agreement with the statement "The plan of care that was decided upon for your loved one in the nursing home was what was followed". To be send along with the survey in outcome#13. | Survey sent to family member 4 weeks after death of nursing home resident. |
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