Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care

NCT ID: NCT03434626

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2018-12-31

Brief Summary

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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 for people to think about their 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. In Alberta, there is a form in the health care system that is used to indicate a person's wishes if participants are unable to speak for themselves. There are tools such as brochures, questionnaires, and videos that can help participants learn about advance care planning and serious illness conversations. This research is being done to study whether using tools for advance care planning will help improve goals of care designation completion rates in such a way that they better reflect patient values. In this project, we aim to determine the efficacy of tools to increase the quality and quantity of advance care planning (ACP) and Goals of Care Determinations (GCD) in primary care settings in Alberta.

Detailed Description

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In prospective and randomized trials, advance care planning (ACP) significantly improves outcomes including increased likelihood that clinicians and families understand and comply with a patient's wishes, reduces hospitalization at the end of life, results in less intensive treatments at the end of life (according to patients' wishes) and increases use of hospice services. Trials have not been done in primary care. The aim of this study is to determine the efficacy of a care pathway designed to increase the quality and quantity of ACP in patients and their substitute decision-makers in primary care. The study is a multi-site, patient-based, unblinded, randomized trial conducted in family practices in Canada. Participants will be patients who are determined by their physician to be able to benefit from ACP, and the patient's substitute decision-maker. Participant pairs will be randomized to immediate intervention (care pathway) or delayed (8-12 weeks). The intervention is guided use of tools and decision aids to clarify values and preferences for treatments in the event of serious illness or near end of life. The outcomes will be presence of a goals of care form in the chart, substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.

Conditions

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Chronic Illness Comorbidities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor conducting interviews does not have information on group assignment

Study Groups

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ACP Education

Eligible patients in the experimental group will receive an educational intervention from an advance care planning navigator consisting of a 4-item values tool, a Goals of Care Designation form and, if applicable, watch a cardiopulmonary resuscitation video.

Group Type EXPERIMENTAL

ACP Education

Intervention Type BEHAVIORAL

Decision aid and Goals of Care Designation form information administered by Navigator

Usual care

Intervention Type OTHER

Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

Usual care

Patients in the usual care group will complete a Goals of Care Designation form with the family physician.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

Interventions

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ACP Education

Decision aid and Goals of Care Designation form information administered by Navigator

Intervention Type BEHAVIORAL

Usual care

Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 65 years or older
* have at least one chronic condition that may be life-limiting

Exclusion Criteria

* Unable to communicate with an English-speaking research coordinator
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Howard, PHD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Daren K Heyland, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Family Medical Centre

Lethbridge, Alberta, Canada

Site Status

Chinook Primary Care Network

Lethbridge, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 23545563 (View on PubMed)

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.

Reference Type RESULT
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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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 21649619 (View on PubMed)

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Reference Type RESULT
PMID: 15488217 (View on PubMed)

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.

Reference Type RESULT
PMID: 20357283 (View on PubMed)

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Reference Type RESULT
PMID: 9487236 (View on PubMed)

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.

Reference Type RESULT
PMID: 20332506 (View on PubMed)

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.

Reference Type RESULT
PMID: 11943046 (View on PubMed)

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.

Reference Type RESULT
PMID: 24598477 (View on PubMed)

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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 22611610 (View on PubMed)

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.

Reference Type RESULT
PMID: 23028000 (View on PubMed)

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.

Reference Type RESULT
PMID: 26273075 (View on PubMed)

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.

Reference Type RESULT
PMID: 24644188 (View on PubMed)

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.

Reference Type RESULT
PMID: 24299046 (View on PubMed)

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. doi: 10.1001/archinte.155.10.1025.

Reference Type RESULT
PMID: 7748044 (View on PubMed)

Other Identifiers

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06-17

Identifier Type: -

Identifier Source: org_study_id

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