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BABEL Advance Care Planning in Long-term Care (BABEL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03649191
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : September 5, 2018
University of Waterloo
University of Calgary
Conestoga College
Information provided by (Responsible Party):
Dr. Allan Garland, University of Manitoba

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Nursing Homes Aged Frail Elderly Syndrome Dementia Chronic Disease Other: The BABEL Approach to Advance Care Planning in Nursing Homes Other: Control group Advance Care Planning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized study
Masking: Single (Outcomes Assessor)
Masking Description: Once the data is collected from all participating nursing homes, anonymized and and electronically encoded, the study arm will also be encoded and the person analyzing the data will be blinded to which group is which.
Primary Purpose: Supportive Care
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)
Actual Study Start Date : August 25, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Intervention ACP Group
The BABEL Approach to Advance Care Planning in Nursing Homes
Other: The BABEL Approach to Advance Care Planning in Nursing Homes
In intervention nursing homes, eligible residents will: (i) receive The BABEL Approach to Advance Care Planning (ACP), (ii) after these ACP discussions occur, the resident's primary care physician will be notified of the residents' ACP wishes, (iii) a brightly colored document will be placed in a standard location of the NH chart that identifies the resident's ACP wishes, (iv) paramedics will be educated to know about these sheets and where to find them, and that they should be taken with any resident transferred to another care setting.

Control ACP Group
Control group Advance Care Planning
Other: Control group Advance Care Planning
Eligible residents in each control nursing homes will receive the prevalent approach to Advance Care Planning in that nursing home. No elements of The BABEL Approach to Advance Care Planning will be introduced in the control homes.

Primary Outcome Measures :
  1. Advance Care Planning (ACP) Audit [ Time Frame: 6 weeks after study entry ]

    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.

  2. Comfort in Dying of Nursing Home Residents (CAD-EOLD) [ Time Frame: After death in nursing home, up to 18 months. ]

    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.

Secondary Outcome Measures :
  1. Rate of transfer from nursing home to emergency department or hospital. [ Time Frame: Up to 18 months. ]
    Rate, per person-years of follow-up, of either of these events among nursing home resident subjects.

  2. Rate of admission to hospital [ Time Frame: Up to 18 months. ]
    Rate of this event, per person-years of follow-up, among nursing home resident subjects.

  3. Time from study entry to death [ Time Frame: Up to 18 months. ]
    Self-explanatory, with censoring at study end, or when the resident is discharged alive from the study nursing home.

  4. Rate of use in nursing home of feeding tubes [ Time Frame: Up to 18 months. ]
    Rate of this event, per person-years of follow-up, among nursing home resident subjects.

  5. Rate of use in nursing home of systemic antibiotics [ Time Frame: Up to 18 months. ]
    Rate of this event, per person-years of follow-up, among nursing home resident subjects.

  6. Rate in nursing home of transition to palliative (comfort) care [ Time Frame: Up to 18 months. ]
    Rate of this event, per person-years of follow-up, among nursing home resident subjects.

  7. Discordance in care at the end of life [ Time Frame: Up to 18 months. ]
    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.

  8. ACP Self-efficacy of Nursing Home Resident Subjects [ Time Frame: 6 weeks after study entry -- given along with the ACP Audit tool (outcome#1) ]

    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.

  9. Nursing Home staff self-efficacy in Advance Care Planning (ACP) [ Time Frame: 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). ]

    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.

  10. Thematic analysis of experiences and feelings of nursing home staff about Advance Care Planning. [ Time Frame: Performed 18 months after study initiation. ]
    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.

  11. Satisfaction with Care at End of Life (SWC-EOLD) [ Time Frame: Survey sent to family member 4 weeks after death of nursing home resident. ]

    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.

  12. Whether plan of care was followed. [ Time Frame: Survey sent to family member 4 weeks after death of nursing home resident. ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT03649191

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Contact: Allan Garland, MD 204-787-1198
Contact: George Heckman, MD 519-888-4567 ext 31028

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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Patrick Quail, MD         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Allan Garland, MD         
Canada, Ontario
Waterloo University Recruiting
Waterloo, Ontario, Canada
Contact: George Heckman, MD         
Sponsors and Collaborators
University of Manitoba
University of Waterloo
University of Calgary
Conestoga College
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Principal Investigator: Allan Garland, MD University of Manitoba

Additional Information:
Publications of Results:

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Responsible Party: Dr. Allan Garland, Professor of Medicine and Community Health Sciences, University of Manitoba Identifier: NCT03649191    
Other Study ID Numbers: CFN TG2015-15
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018

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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 Dr. Allan Garland, University of Manitoba:
Advance Care Planning
Evidence-based practice
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes