Informed decision-making with and for people with dementia – efficacy of the PRODECIDE education program for legal representatives: protocol of a randomized controlled trial (PRODECIDE-RCT)

Abstract

BackgroundIn Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes for people with dementia. Previously, we developed an education program (PRODECIDE) to address this shortcoming and tested it for feasibility. Typical, autonomy-restricting decisions in the care of people with dementia—namely, using percutaneous endoscopic gastrostomy (PEG) or physical restrains (PR), or the prescription of antipsychotic drugs (AP)—were the subject areas trained. The training course aims to enhance the competency of legal representatives in informed decision-making. In this study, we will evaluate the efficacy of the PRODECIDE education program.MethodsA randomized controlled trial with a six-month follow-up will be conducted to compare the PRODECIDE education program with standard care, enrolling legal representatives (N = 216). The education program lasts 10 h and comprises four modules: A, decision-making processes and methods; and B, C and D, evidence-based knowledge about PEG, PR and AP, respectively.The primary outcome measure is knowledge, which is operationalized as the understanding of decision-making processes in healthcare affairs and in setting realistic expectations about benefits and harms of PEG, PR and AP in people with dementia. Secondary outcomes are sufficient and sustainable knowledge and percentage of persons concerned affected by PEG, FEM or AP. A qualitative process evaluation will be performed. Additionally, to support implementation, a concept for translating the educational contents into e-learning modules will be developed.DiscussionThe study results will show whether the efficacy of the education program could justify its implementation into the regular training curricula for legal representatives. Additionally, it will determine whether an e-learning course provides a valuable backup or even alternative learning strategy.Trial registrationTRN: ISRCTN17960111, Date: 01/06/2017.

Informed Decision-Making with and for People with Dementia—Efficacy of the PRODECIDE Education Program for Legal Representatives: A Randomized Controlled Trial (PRODECIDE-RCT) and Process Evaluation

“…The ethics committee of the German Society of Nursing Science approved the study. Details of the trial design and rationale have been reported previously [ 22 ].…”

“…At T1 (at the end of/up to 2 weeks after the intervention), the primary outcome knowledge was assessed. The questionnaire was developed and pretested with a before-after design [ 20 , 22 ]. It comprises thirteen multiple choice items (four choices, with only one correct answer each) on the understanding of decision-making processes (two items), on quality and validity of study results (two items) and on realistic expectations regarding probabilities of benefits and harms of a PEG, PRs and APs to people with dementia (three items per intervention).…”

Expectations of Representatives on Shared Decision-Making in the Context of Dementia – An Integrative Model

“…Considering there is an inconsistent variety of wording for these concepts such as proxy, surrogate, or representative (Fetherstonhaugh et al, 2017;Kwak et al, 2016;Lühnen et al, 2017), we propose the term representatives' shared decision-making (RSDM) for our paper, as the word Representative best fits in the legal sense addressed in this study. We define RSDM as follows:…”