Bringing palliative care for dementia patients into agreement with their wishes and needs: development and evaluation of Decidem

Background: Patients with dementia have limited access to palliative care. At the end of their lives, aggressive and unwanted interventions like resuscitation and hospitalization regularly take place. Physical symptoms in patients such as pain or dyspnea and neuropsychiatric symptoms and depression in both patients and family caregivers are often undertreated. This threatens the quality of life of dementia patients and their family caregivers. Palliative care can bring actual care into agreement with patients’ and caregivers’ needs and wishes. Therefore an innovative intervention in dementia care combining the strengths of advance care planning (ACP) and shared decision making (SDM) called Decidem will be developed. The research aim of this project is to evaluate its effects on care, patients and caregivers, and costs. We hypothesize that Decidem will bring actual care into agreement with patients’ and caregivers’ wishes/preferences and needs. This patient-centered, personalized intervention may increase their satisfaction with care, decrease caregivers’ burden and increase quality of life. Decrease of under- and over treatment, of hospitalizations and of unplanned visits may reduce costs. ACP is occasionally practiced in Dutch nursing homes, and rarely in primary care. Primary care is a suitable setting for initiating ACP and SDM for several reasons. First, 2/3 of the dementia patients in the Netherlands live in the community. Second, they usually have a long-time relationship with their general practitioner (GP), which makes it easier to discuss difficult issues. Third, cognitive impairment is less in community-dwelling dementia patients than in institutionalized patients, which makes them more able to (co-)decide on future care. Therefore, we will target this project on community-dwelling dementia patients, their family caregivers and primary health care professionals (GPs and primary care nurses (PCNs)) Methods: This project will use the MRC framework for development and evaluation of complex interventions as a guide. However, we will introduce a methodological novelty by assessing barriers and facilitators prior to the development of the intervention. Hereby we aim to avoid implementation failure: bad adherence to the intervention leading to negative trial outcomes. The work plan consists of the following steps: 1. Theory development In an integrative literature review, we will study concepts and theories of ACP and SDM, facilitators and barriers to ACP and SDM implementation, and we aim to identify effective ACP and SDM interventions and implementation strategies to serve as a basis for the development of Decidem. Previous reviews and the results of our ongoing pilot study on shared decision making with dementia patients in nursing homes will be the starting point. 2. Modeling 2.1. Exploration of facilitators and barriers In interviews with all stakeholders (patients, family caregivers, GPs and PCNs), we will explore barriers and facilitators known from the literature more in-depth, and aim to reveal new barriers. Family caregivers, GPs and PCNs will be interviewed in focus groups. Patients will be interviewed in the comfort of their own homes. Data will be analyzed using content analysis, according to the principles of iterative comparison. 2.2. Development of Decidem Information gathered in step 1 and 2.1. will be combined to develop Decidem: an ACP and SDM intervention for dementia patients, their family caregivers and health care professionals aimed at planning future care. It will consist of a structured protocol, training for GPs and PCNs, and will be supported with existing ICT tools. 3. Evaluation of Decidem Decidem’s effects will be studied in a cluster-randomized controlled trial in 30 general practices and about 150 dementia patients with a follow-up of six months. Primary outcome is whether a patient's wishes are known and respected. Secondary outcomes are patients’ quality of life and depression; caregivers’ satisfaction and burden; and health care professionals satisfaction with the intervention. For the economic evaluation of Decidem, a traditional cost-effectiveness analysis will be performed in which utilities are generated with the EQ-6D and resources are measured using the Recourse Utilities in Dementia (RUD). A mixed methods process evaluation will evaluate its feasibility.