BABEL Advance Care Planning in Long-term Care

NCT03649191 | Completed

• 1 other identifier: CFN TG2015-15
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 3

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.

Conditions

Nursing Homes; Aged; Frail Elderly Syndrome; Dementia; Chronic Disease

Keywords

Advance Care Planning; Evidence-based practice; Sustainability; Scalability

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Rate of transfer from nursing home to emergency department or hospital.

  Up to 18 months.

• Rate of admission to hospital

  Up to 18 months.

• Time from study entry to death

  Up to 18 months.

• Rate of use in nursing home of feeding tubes

  Up to 18 months.

• Rate of use in nursing home of systemic antibiotics

  Up to 18 months.

Study Arms (2)

Intervention ACP Group

OTHER

The BABEL Approach to Advance Care Planning in Nursing Homes

Other: The BABEL Approach to Advance Care Planning in Nursing Homes

Control ACP Group

OTHER

Control group Advance Care Planning

Other: Control group Advance Care Planning

Interventions

The BABEL Approach to Advance Care Planning in Nursing Homes OTHER

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.

Intervention ACP Group

Control group Advance Care Planning OTHER

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.

Control ACP Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• University of Waterloo: collaborator
• University of Calgary: collaborator
• Conestoga College: collaborator

Study Sites (3)

University of Calgary

Calgary, Alberta, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A1R9, Canada

Location

Waterloo University

Waterloo, Ontario, Canada

Location

Related Publications (28)

• Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.

  PMID: 26255709 RESULT

• Hirdes JP, Mitchell L, Maxwell CJ, White N. Beyond the 'iron lungs of gerontology': using evidence to shape the future of nursing homes in Canada. Can J Aging. 2011 Sep;30(3):371-90. doi: 10.1017/S0714980811000304. Epub 2011 Aug 19.

  PMID: 21851753 RESULT

• Estabrooks CA, Hoben M, Poss JW, Chamberlain SA, Thompson GN, Silvius JL, Norton PG. Dying in a nursing home: treatable symptom burden and its link to modifiable features of work context. J Am Med Dir Assoc. 2015 Jun 1;16(6):515-20. doi: 10.1016/j.jamda.2015.02.007. Epub 2015 Mar 21.

  PMID: 25805625 RESULT

• Garland A, Olafson K, Ramsey CD, Yogendran M, Fransoo R. Epidemiology of critically ill patients in intensive care units: a population-based observational study. Crit Care. 2013 Sep 30;17(5):R212. doi: 10.1186/cc13026.

  PMID: 24079640 RESULT

• Teixeira AA, Hanvey L, Tayler C, Barwich D, Baxter S, Heyland DK; Canadian Researchers at End of Life Network (CARENET). What do Canadians think of advanced care planning? Findings from an online opinion poll. BMJ Support Palliat Care. 2015 Mar;5(1):40-7. doi: 10.1136/bmjspcare-2013-000473. Epub 2013 Oct 4.

  PMID: 24644188 RESULT

• Heyland DK, Frank C, Groll D, Pichora D, Dodek P, Rocker G, Gafni A. Understanding cardiopulmonary resuscitation decision making: perspectives of seriously ill hospitalized patients and family members. Chest. 2006 Aug;130(2):419-28. doi: 10.1378/chest.130.2.419.

  PMID: 16899840 RESULT

• Heyland DK, Dodek P, Rocker G, Groll D, Gafni A, Pichora D, Shortt S, Tranmer J, Lazar N, Kutsogiannis J, Lam M; Canadian Researchers End-of-Life Network(CARENET). What matters most in end-of-life care: perceptions of seriously ill patients and their family members. CMAJ. 2006 Feb 28;174(5):627-33. doi: 10.1503/cmaj.050626.

  PMID: 16505458 RESULT

• Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.

  PMID: 11932474 RESULT

• Heyland DK, Barwich D, Pichora D, Dodek P, Lamontagne F, You JJ, Tayler C, Porterfield P, Sinuff T, Simon J; ACCEPT (Advance Care Planning Evaluation in Elderly Patients) Study Team; Canadian Researchers at the End of Life Network (CARENET). Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013 May 13;173(9):778-87. doi: 10.1001/jamainternmed.2013.180.

  PMID: 23545563 RESULT

• Stephens C, Halifax E, Bui N, Lee SJ, Harrington C, Shim J, Ritchie C. Provider Perspectives on the Influence of Family on Nursing Home Resident Transfers to the Emergency Department: Crises at the End of Life. Curr Gerontol Geriatr Res. 2015;2015:893062. doi: 10.1155/2015/893062. Epub 2015 Aug 24.

  PMID: 26379704 RESULT

• In der Schmitten J, Lex K, Mellert C, Rotharmel S, Wegscheider K, Marckmann G. Implementing an advance care planning program in German nursing homes: results of an inter-regionally controlled intervention trial. Dtsch Arztebl Int. 2014 Jan 24;111(4):50-7. doi: 10.3238/arztebl.2014.0050.

  PMID: 24612497 RESULT

• Baron K, Hodgson A, Walshe C. Evaluation of an advance care planning education programme for nursing homes: A Longitudinal study. Nurse Educ Today. 2015 May;35(5):689-95. doi: 10.1016/j.nedt.2015.01.005. Epub 2015 Jan 23.

  PMID: 25638279 RESULT

• Hammes BJ, Rooney BL. Death and end-of-life planning in one midwestern community. Arch Intern Med. 1998 Feb 23;158(4):383-90. doi: 10.1001/archinte.158.4.383.

  PMID: 9487236 RESULT

• Schwartz CE, Wheeler HB, Hammes B, Basque N, Edmunds J, Reed G, Ma Y, Li L, Tabloski P, Yanko J; UMass End-of-Life Working Group. Early intervention in planning end-of-life care with ambulatory geriatric patients: results of a pilot trial. Arch Intern Med. 2002 Jul 22;162(14):1611-8. doi: 10.1001/archinte.162.14.1611.

  PMID: 12123405 RESULT

• Morrison RS, Chichin E, Carter J, Burack O, Lantz M, Meier DE. The effect of a social work intervention to enhance advance care planning documentation in the nursing home. J Am Geriatr Soc. 2005 Feb;53(2):290-4. doi: 10.1111/j.1532-5415.2005.53116.x.

  PMID: 15673354 RESULT

• Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.

  PMID: 20357283 RESULT

• Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.

  PMID: 20332506 RESULT

• Chiarchiaro J, Buddadhumaruk P, Arnold RM, White DB. Prior Advance Care Planning Is Associated with Less Decisional Conflict among Surrogates for Critically Ill Patients. Ann Am Thorac Soc. 2015 Oct;12(10):1528-33. doi: 10.1513/AnnalsATS.201504-253OC.

  PMID: 26240996 RESULT

• Molloy DW, Guyatt GH, Russo R, Goeree R, O'Brien BJ, Bedard M, Willan A, Watson J, Patterson C, Harrison C, Standish T, Strang D, Darzins PJ, Smith S, Dubois S. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA. 2000 Mar 15;283(11):1437-44. doi: 10.1001/jama.283.11.1437.

  PMID: 10732933 RESULT

• Levy C, Morris M, Kramer A. Improving end-of-life outcomes in nursing homes by targeting residents at high-risk of mortality for palliative care: program description and evaluation. J Palliat Med. 2008 Mar;11(2):217-25. doi: 10.1089/jpm.2007.0147.

  PMID: 18333736 RESULT

• Hirdes JP, Poss JW, Mitchell L, Korngut L, Heckman G. Use of the interRAI CHESS scale to predict mortality among persons with neurological conditions in three care settings. PLoS One. 2014 Jun 10;9(6):e99066. doi: 10.1371/journal.pone.0099066. eCollection 2014.

  PMID: 24914546 RESULT

• Hirdes JP, Frijters DH, Teare GF. The MDS-CHESS scale: a new measure to predict mortality in institutionalized older people. J Am Geriatr Soc. 2003 Jan;51(1):96-100. doi: 10.1034/j.1601-5215.2002.51017.x.

  PMID: 12534853 RESULT

• Tjam EY, Heckman GA, Smith S, Arai B, Hirdes J, Poss J, McKelvie RS. Predicting heart failure mortality in frail seniors: comparing the NYHA functional classification with the Resident Assessment Instrument (RAI) 2.0. Int J Cardiol. 2012 Feb 23;155(1):75-80. doi: 10.1016/j.ijcard.2011.01.031. Epub 2011 Feb 3.

  PMID: 21292334 RESULT

• Flacker JM, Kiely DK. Mortality-related factors and 1-year survival in nursing home residents. J Am Geriatr Soc. 2003 Feb;51(2):213-21. doi: 10.1046/j.1532-5415.2003.51060.x.

  PMID: 12558718 RESULT

• Austin CA, Mohottige D, Sudore RL, Smith AK, Hanson LC. Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review. JAMA Intern Med. 2015 Jul;175(7):1213-21. doi: 10.1001/jamainternmed.2015.1679.

  PMID: 25985438 RESULT

• Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):211-7. doi: 10.1001/jama.294.2.211.

  PMID: 16014595 RESULT

• Vandervoort A, Houttekier D, Van den Block L, van der Steen JT, Vander Stichele R, Deliens L. Advance care planning and physician orders in nursing home residents with dementia: a nationwide retrospective study among professional caregivers and relatives. J Pain Symptom Manage. 2014 Feb;47(2):245-56. doi: 10.1016/j.jpainsymman.2013.03.009. Epub 2013 Jun 21.

  PMID: 23796587 RESULT

• Ampe S, Sevenants A, Smets T, Declercq A, Van Audenhove C. Advance care planning for nursing home residents with dementia: policy vs. practice. J Adv Nurs. 2016 Mar;72(3):569-81. doi: 10.1111/jan.12854. Epub 2015 Nov 12.

  PMID: 26558358 RESULT

Related Links

• . Living arrangements of seniors: Families, households and marital status; Structural type of dwelling and collectives
• InterRAI Instruments Worldwide

MeSH Terms

Conditions

Dementia; Chronic Disease

Interventions

Nursing Homes

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Residential Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Allan Garland, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Community Health Sciences

Model Details: Cluster-randomized study

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 28, 2018
• Study Start: August 28, 2018
• Primary Completion: August 9, 2020
• Study Completion: August 9, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CA (3)