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Original research
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
  1. Michelle Howard1,
  2. Dawn Elston1,
  3. Sayem Borhan2,
  4. Abe Hafid1,
  5. Neha Arora1,
  6. Ruth Forbes3,
  7. Carrie Bernard1,4 and
  8. Daren K Heyland5
  1. 1 Department of Family Medicine, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  2. 2 Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  3. 3 School of Nursing, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  4. 4 Department of Family and Community Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  5. 5 Department of Critical Care Medicine, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada
  1. Correspondence to Michelle Howard, Department of Family Medicine, McMaster University Faculty of Health Sciences, Hamilton, Canada; mhoward{at}mcmaster.ca

Abstract

Objective To evaluate the feasibility and efficacy of a serious illness decision aid (Plan Well Guide) in increasing the engagement of substitute decision-makers (SDM) in advance care planning (ACP).

Methods This trial was conducted (2017–2019) in outpatient settings in Ontario, Canada, aiming to recruit 90 dyads of patients aged 65 years and older at high risk of needing future medical decisions and their SDM. Participants were randomised to receive the intervention immediately or to a 3-month wait period. The Plan Well Guide was administered to the patient and SDM by a facilitator. Outcomes were change on the validated 17-item SDM ACP Engagement Survey (primary) and 15-item patient ACP Engagement Survey (secondary).

Results Of 136 dyads approached, 58 consented and were randomised and 45 completed the study (28 immediate intervention, 17 delayed intervention). The trial was stopped early because of difficulties with enrolling and following up participants. The mean changes on the SDM ACP Engagement Survey and the patient ACP Engagement Survey favoured the first group but were not statistically significant (mean difference (MD)=+0.2 (95% CI: −0.3 to 0.6) and MD=+0.4 (95% CI: −0.1 to 0.8), respectively). In a post-hoc subgroup analysis, significant treatment effects were seen in SDMs with a lower-than-median baseline score compared with those at or above the median.

Conclusions In this statistically underpowered randomised trial, differences in SDM ACP engagement between groups were small. Further information is needed to overcome recruitment challenges and to identify people most likely to benefit from the Plan Well Guide.

Trial registration number NCT03239639

  • clinical decisions
  • communication
  • end of life care
  • terminal care

Data availability statement

Data from this study are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjspcare-2021-003040

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    Data availability statement

    Data from this study are available upon reasonable request.

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    Footnotes

    • Twitter @mhoward101

    • Contributors MH and DKH conceived of the study. MH wrote the paper. RF, DE, AH and NA collected data. MH, CB, SB, DE, AH, RF and NA contributed to interpretation of results. SB conducted statistical analyses. MH, CB, SB, DE, RF, AH, NA and DKH critically revised the manuscript and approved the final version for submission.

    • Funding This work was supported by the Canadian Institutes of Health Research grant number PHE-135930. The funder had no role in the design of the study, collection, management, analysis or interpretation of data, writing of any reports or the decision to submit any report for publication.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.