Abstract
BackgroundProcess evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention.MethodsThe planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients’ wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data.DiscussionThe comprehensive process evaluation will provide essential information on the feasibility of implementation strategies and the clinical relevance of a nurse-led ACP intervention in home care recipients and its generalizability and transferability to other settings.Trial registrationGerman Clinical Trials Register: DRKS00016886. Registered retrospectively on June 4, 2019, first participant included on May 29, 2019.
Highlights
Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions
The process evaluation as outlined in this paper will indicate how the advance care planning (ACP) intervention is related to patient activation, ACP engagement, and surrogate designation and evaluate its feasibility in the home care setting
In Germany, advance directives are legally binding by law since 2009 (German Advance Directives Act [Patientenverfügungsgesetz]) and ACP conversations costs can be covered by the statutory health insurance for people living in nursing homes or facilities providing integration assistance for disabled people since 2015 (Hospice and Palliative Care Act [Hospiz- und Palliativgesetz])
Summary
Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. In Germany, advance directives are legally binding by law since 2009 (German Advance Directives Act [Patientenverfügungsgesetz]) and ACP conversations costs can be covered by the statutory health insurance for people living in nursing homes or facilities providing integration assistance for disabled people since 2015 (Hospice and Palliative Care Act [Hospiz- und Palliativgesetz]). Despite such legislation, ACP and advance directives (AD) have not been sufficiently implemented [10]. We will conduct a cluster-randomized controlled trial assessing a complex intervention aiming to promote ACP in community-dwelling older persons (the STADPLAN study: STudy on ADvance care PLANning in caredependent community dwelling older persons) [11]
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