Randomized Control Trial of Advance Care Planning in Primary Care

NCT03239639 | Completed

• 1 other identifier: 3714
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 7

Brief Summary

Sometimes people with health conditions become ill suddenly and can no longer speak for themselves and another person (such as a family member) will make health care decisions for them. This means it is important to think about your wishes and tell others about them. This is called advance care planning. When people have done advance care planning, if they become very sick and cannot speak for themselves they are more likely to get the kind of health care they want and it is easier for the people who make decisions for them. There are tools such as brochures, questionnaires, and videos that can help people learn about these things. This research is being to done to study whether using tools for advance care planning and goals of care discussions will improve how patients and their substitute decision makers do advance care planning. This study is a randomized trial. This means half of the people in this study will meet with someone at their family practice to talk about advance care planning and review some tools and half will get usual care (a Speak Up workbook). The study will 1) evaluate if reviewing the tools, and having help to complete them, helps patients and their substitute decision maker do advance care planning 2) if this intervention will encourage patients to talk to their family doctor about these issues.

Conditions

Chronic Illness

Keywords

Substitute decision makers of patient

Outcome Measures

Primary Outcomes (1)

• Advance care planning engagement of substitute decision-maker

  A survey of the substitute decision-maker's engagement in advance care planning

  8 to 12 weeks (6 weeks for patients from cancer centre)

Secondary Outcomes (4)

• Advance care planning engagement of patient

  8 to 12 weeks (6 weeks for patients from cancer centre)

• Substitute decision-maker self-efficacy survey

  8 to 12 weeks (6 weeks for patients from cancer centre)

• Decisional conflict

  immediately after intervention

• Satisfaction with intervention

  immediately after intervention

Study Arms (2)

Advance care planning education session

EXPERIMENTAL

Delivery of an advance care planning education session at the family doctor's office

Behavioral: Advance care planning education session

Wait list control

SHAM COMPARATOR

The intervention is not provided.

Other: Wait list control

Interventions

Advance care planning education session BEHAVIORAL

Administration of values clarification tool, elicitation of preference for treatment options, if preference for resuscitation, shown an educational video about cardiopulmonary resuscitation, summary document of values and preferences created by a facilitator to share with doctor

Advance care planning education session

Wait list control OTHER

No intervention

Wait list control

Eligibility Criteria

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

You may qualify if:

• Patients being treated for serious illness in outpatient settings or;
• Patients who could benefit from advance care planning self-assessed or assessed by their physician
• Patient able and willing to identify a substitute decision-maker who will participate in the study
• Patient cognitively able to participate

You may not qualify if:

• Patient or their substitute decision-maker does not speak English
• Patient unable to identify a substitute decision-maker who will consent to participation
• Patient does not consent to participation

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Queen's University: collaborator

Study Sites (7)

Dundas Family Health Team

Dundas, Ontario, Canada

Location

Michael West Doctor Office

Dundas, Ontario, Canada

Location

Burlington Family Health Team

Hamilton, Ontario, L7S 0A1, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

McMaster Family Health Team

Hamilton, Ontario, L8P 1H6, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

Juravinski Cancer Centre Pain and Symptom Management Team

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (22)

• De Vleminck A, Houttekier D, Pardon K, Deschepper R, Van Audenhove C, Vander Stichele R, Deliens L. Barriers and facilitators for general practitioners to engage in advance care planning: a systematic review. Scand J Prim Health Care. 2013 Dec;31(4):215-26. doi: 10.3109/02813432.2013.854590.

  PMID: 24299046 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

• Howard M, Bernard C, Tan A, Slaven M, Klein D, Heyland DK. Advance care planning: Let's start sooner. Can Fam Physician. 2015 Aug;61(8):663-5. No abstract available.

  PMID: 26273075 RESULT

• Rhee JJ, Zwar NA, Kemp LA. Advance care planning and interpersonal relationships: a two-way street. Fam Pract. 2013 Apr;30(2):219-26. doi: 10.1093/fampra/cms063. Epub 2012 Oct 1.

  PMID: 23028000 RESULT

• Robinson C, Kolesar S, Boyko M, Berkowitz J, Calam B, Collins M. Awareness of do-not-resuscitate orders: what do patients know and want? Can Fam Physician. 2012 Apr;58(4):e229-33.

  PMID: 22611610 RESULT

• Sudore RL, Lum HD, You JJ, Hanson LC, Meier DE, Pantilat SZ, Matlock DD, Rietjens JAC, Korfage IJ, Ritchie CS, Kutner JS, Teno JM, Thomas J, McMahan RD, Heyland DK. Defining Advance Care Planning for Adults: A Consensus Definition From a Multidisciplinary Delphi Panel. J Pain Symptom Manage. 2017 May;53(5):821-832.e1. doi: 10.1016/j.jpainsymman.2016.12.331. Epub 2017 Jan 3.

  PMID: 28062339 RESULT

• Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2.

  PMID: 24598477 RESULT

• Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical care inconsistent with patients' treatment goals: association with 1-year Medicare resource use and survival. J Am Geriatr Soc. 2002 Mar;50(3):496-500. doi: 10.1046/j.1532-5415.2002.50116.x.

  PMID: 11943046 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

• 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

• 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

• Raymont V, Bingley W, Buchanan A, David AS, Hayward P, Wessely S, Hotopf M. Prevalence of mental incapacity in medical inpatients and associated risk factors: cross-sectional study. Lancet. 2004 Oct 16-22;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

  PMID: 15488217 RESULT

• Fried TR, Redding CA, Robbins ML, O'Leary JR, Iannone L. Agreement between older persons and their surrogate decision-makers regarding participation in advance care planning. J Am Geriatr Soc. 2011 Jun;59(6):1105-9. doi: 10.1111/j.1532-5415.2011.03412.x. Epub 2011 Jun 7.

  PMID: 21649619 RESULT

• Heyland DK, Ilan R, Jiang X, You JJ, Dodek P. The prevalence of medical error related to end-of-life communication in Canadian hospitals: results of a multicentre observational study. BMJ Qual Saf. 2016 Sep;25(9):671-9. doi: 10.1136/bmjqs-2015-004567. Epub 2015 Nov 9.

  PMID: 26554026 RESULT

• You JJ, Dodek P, Lamontagne F, Downar J, Sinuff T, Jiang X, Day AG, Heyland DK; ACCEPT Study Team and the Canadian Researchers at the End of Life Network (CARENET). What really matters in end-of-life discussions? Perspectives of patients in hospital with serious illness and their families. CMAJ. 2014 Dec 9;186(18):E679-87. doi: 10.1503/cmaj.140673. Epub 2014 Nov 3.

  PMID: 25367427 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

• Cook D, Rocker G, Marshall J, Sjokvist P, Dodek P, Griffith L, Freitag A, Varon J, Bradley C, Levy M, Finfer S, Hamielec C, McMullin J, Weaver B, Walter S, Guyatt G; Level of Care Study Investigators and the Canadian Critical Care Trials Group. Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit. N Engl J Med. 2003 Sep 18;349(12):1123-32. doi: 10.1056/NEJMoa030083.

  PMID: 13679526 RESULT

• Gruneir A, Mor V, Weitzen S, Truchil R, Teno J, Roy J. Where people die: a multilevel approach to understanding influences on site of death in America. Med Care Res Rev. 2007 Aug;64(4):351-78. doi: 10.1177/1077558707301810.

  PMID: 17684107 RESULT

• Heyland DK, Lavery JV, Tranmer JE, Shortt SE, Taylor SJ. Dying in Canada: is it an institutionalized, technologically supported experience? J Palliat Care. 2000 Oct;16 Suppl:S10-6.

  PMID: 11075528 RESULT

• Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA, Stapleton RD. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009 Jul 2;361(1):22-31. doi: 10.1056/NEJMoa0810245.

  PMID: 19571280 RESULT

• Howard M, Elston D, Borhan S, Hafid A, Arora N, Forbes R, Bernard C, Heyland DK. Randomised trial of a serious illness decision aid (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning. BMJ Support Palliat Care. 2022 Mar;12(1):99-106. doi: 10.1136/bmjspcare-2021-003040. Epub 2021 Jun 30.

  PMID: 34193434 DERIVED

• Howard M, Slaven M, Bernard C, Borhan S, Elston D, Arora N, Tan A, Heyland DK. Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial. BMJ Open. 2019 Sep 20;9(9):e027897. doi: 10.1136/bmjopen-2018-027897.

  PMID: 31542737 DERIVED

Related Links

• Metzger M, Song M-K, Ward S, Chang PP-Y, Hanson LC, Lin F-C. A randomized controlled pilot trial to improve advance care planning for LVAD patients and their surrogates. Hear Lung J Acute Crit Care. 2016 May;45(3):186-92
• Johnston SC, Pfeifer MP, McNutt R. The discussion about advance directives. Patient and physician opinions regarding when and how it should be conducted. End of Life Study Group. Arch Intern Med. 1995 May 22;155(10):1025-30
• Rhee JJ, Zwar NA, Kemp LA. Advance care planning and interpersonal relationships: a two-way street. Fam Pract. 2013 Apr 1;30(2):219-26

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Howard, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned in 1:1 ratio to intervention or wait list control group

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)