Abstract
BackgroundAdvance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention.MethodsThis RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework.DiscussionWhile the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs.Trial registrationProspectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.
Highlights
Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner
After this Phase-III randomized controlled trial (RCT), we will be able to present valuable evidence of the effects of this Advance Care Planning intervention for General Practice (ACP-general practitioner (GP)) intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice
Life-limiting illness, which are often marked by trajectories of steady illness progression or gradual health decline punctuated by acute deterioration [7], it is important that ACP is initiated in a timely manner so that sufficient time can be dedicated to conversations about values, goals and preferences [8]
Summary
Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Advance Care Planning (ACP) refers to “a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care” [1]. This may include the completion of a living will or Advance Directive (AD), which document wishes for future care should patients be unable to make their wishes known due to declining health or incapacity; and/or the appointing of a surrogate decision-maker (SDM), who can make care decisions in the place of the patient if the patient is unable to speak for themselves. While the role of the GP in initiating ACP conversations is highlighted in guidelines of care [13], currently the process of ACP between patients and GP is not often initiated [14]
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