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Randomized Controlled Trial
. 2022 Mar;12(1):99-106.
doi: 10.1136/bmjspcare-2021-003040. Epub 2021 Jun 30.

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

Michelle Howard  1 , Dawn Elston  2 , Sayem Borhan  3 , Abe Hafid  2 , Neha Arora  2 , Ruth Forbes  4 , Carrie Bernard  2   5 , Daren K Heyland  6
Affiliations
Randomized Controlled Trial

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

Michelle Howard et al. BMJ Support Palliat Care. 2022 Mar.

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.

Keywords: clinical decisions; communication; end of life care; terminal care.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials flow diagram. ACP, advance care planning.
Figure 2
Figure 2
Mean between-group differences and 95% CIs for the change in the substitute decision-maker (SDM) advance care planning (ACP) Engagement Survey overall score (ACP 17) and subscale scores. MD, mean difference; ITT, intention-to-treat.
Figure 3
Figure 3
Mean between-group differences and 95% CIs for the change in patient advance care planning (ACP) Engagement Survey overall score (ACP 15) and subscale scores. MD, mean difference; ITT, intention-to-treat.
Figure 4
Figure 4
Mean between-group differences and 95% CIs for the change in the substitute decision-maker (SDM) advance care planning (ACP) Engagement Survey overall score (ACP 17) and subscale scores: subgroup analysis by at or below baseline median versus above baseline median (adjusted for study site, no imputation for missing data). MD, mean difference.
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References

    1. Raymont V, Bingley W, Buchanan A, et al. . Prevalence of mental incapacity in medical inpatients and associated risk factors: cross-sectional study. Lancet 2004;364:1421–7. 10.1016/S0140-6736(04)17224-3 - DOI - PubMed
    1. Fried TR, Zenoni M, Iannone L, et al. . Engagement in advance care planning and surrogates' knowledge of patients' treatment goals. J Am Geriatr Soc 2017;65:1712–8. 10.1111/jgs.14858 - DOI - PMC - PubMed
    1. Sudore RL, Lum HD, You JJ, et al. . Defining advance care planning for adults: a consensus definition from a multidisciplinary Delphi panel. J Pain Symptom Manage 2017;53:821–32. 10.1016/j.jpainsymman.2016.12.331 - DOI - PMC - PubMed
    1. Hammes BJ, Rooney BL. Death and end-of-life planning in one midwestern community. Arch Intern Med 1998;158:383–90. 10.1001/archinte.158.4.383 - DOI - PubMed
    1. Silveira MJ, Kim SYH, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med Overseas Ed 2010;362:1211–8. 10.1056/NEJMsa0907901 - DOI - PMC - PubMed

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