Abstract
BackgroundInternational research concerning end-of-life issues emphasizes the importance of health care professionals (HCPs) being prepared to deal with existential aspects, like loneliness, in order to provide adequate care. The last phase of life is often related to losses of different kinds, which might trigger feelings of isolation in general and existential loneliness (EL) in particular. There is a large body of research concerning loneliness among older people in general, but little is known about the phenomenon and concept of EL in old age.ObjectiveThis study aims to describe the framing, design, and first results of the exploratory phase of an intervention study focusing on EL among older people: the LONE study. This stage of the study corresponds to the development phase, according to the Medical Research Council framework for designing complex interventions.MethodsThe LONE study contains both theoretical and empirical studies concerning: (1) identifying the evidence base; (2) identifying and developing theory through individual and focus group interviews with frail older people, significant others, and HCPs; and (3) modeling process and outcomes for the intervention. This project involves sensitive issues that must be carefully reviewed. The topic in itself concerns a sensitive matter and the study group is vulnerable, therefore, an ethical consciousness will be applied throughout the project.ResultsThe results so far show that EL means being disconnected from life and implies a feeling of being fundamentally separated from others and the world, whether or not one has family, friends, or other close acquaintances. Although significant others highlighted things such as lack of activities, not participating in a social environment, and giving up on life as aspects of EL, the older people themselves highlighted a sense of meaningless waiting, a longing for a deeper connectedness, and restricted freedom as their origins of EL. The views of HCPs on the origin of EL, the place of care, and their own role differed between contexts.ConclusionsThe studies focusing on identifying the evidence base and developing theory are published. These results will now be used to identify potential intervention components, barriers, and enablers for the implementation of an intervention aimed at supporting HCPs in encountering EL among older people.International Registered Report Identifier (IRRID)RR1-10.2196/13607
Highlights
Complex interventions are widely used in the health service, in public health practice, and in areas of social policy such as education, transport and housing that have important health consequences
Participants identified a number of limitations in the 2000 Framework, including: (1) the adoption of a model based on the phases conventionally used in the evaluation of new drugs, and the linearity implied by the diagram of the model; (2) the lack of evidence for many of the recommendations; (3) the limited guidance on how to approach developmental and implementation phase studies; (4) an assumption that conventional clinical trials provide a template for all the different approaches to evaluation; (5) a lack of guidance on how to tackle highly complex or non-health sector interventions, e.g. programmes made up of several complex interventions; and (6) the lack of attention to the social, political or geographical context in which interventions take place
Ideas for complex interventions emerge from various sources, including: past practice, existing evidence, theory, an investigator, policy makers or practitioners, new technology, or commercial interests
Summary
This document provides guidance on the development, evaluation and implementation of complex interventions to improve health. Developing, piloting, evaluating, reporting and implementing a complex intervention can be a lengthy process. If you are evaluating a policy or a service change as it is being implemented, rather than carrying out an experimental intervention study, you still need to be clear about the rationale for the change and the likely size and type of effects, in order to design the evaluation appropriately. Questions to ask yourself include: Have you done enough piloting and feasibility work to be confident that the intervention can be delivered as intended? Questions to ask yourself include: Have you reported your evaluation appropriately, and have you updated your systematic review? It is important to provide a detailed account of the intervention,as well as a standard report of the evaluation methods and findings, to enable replication studies, or wider scale implementation. If the intervention is translated into routine practice, monitoring should be undertaken to detect adverse events or long term outcomes that could not be observed directly in the original evaluation, or to assess whether the effects observed in the study are replicated in routine practice
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