Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN
Authors: Silies Katharina , Huckle Tilman , Schnakenberg Rieke , Kirchner Änne , Berg Almuth , Köberlein-Neu Juliane , Meyer Gabriele , Hoffmann Falk , Köpke Sascha 
Published: April 2022

Abstract
Background
The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations.
Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process.

Methods
The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere.

Results
Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients’ varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident.

Conclusions
The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people’s ACP engagement, access should be simplified.
Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients’ choice for or against any ACP intervention.

Ethics and trial registration
Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019–045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019–024), and University of Lübeck (Ref.-No. 19–080).
German Clinical Trials Register: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.