Evaluation Design for a Complex Intervention Program Targeting Loneliness in Non- Institutionalized Elderly Dutch People

de Vlaming et al. BMC Public Health 2010, 10:552 http://www.biomedcentral.com/1471-2458/10/552 STUDY PROTOCOL Open Access Evaluation design for a complex intervention program targeting loneliness in non- institutionalized elderly Dutch people Rianne de Vlaming1*, Annemien Haveman-Nies1,2, Pieter van’t Veer2, Lisette CPGM de Groot2 Abstract Background: The aim of this paper is to provide the rationale for an evaluation design for a complex intervention program targeting loneliness among non-institutionalized elderly people in a Dutch community. Complex public health interventions characteristically use the combined approach of intervening on the individual and on the environmental level. It is assumed that the components of a complex intervention interact with and reinforce each other. Furthermore, implementation is highly context-specific and its impact is influenced by external factors. Although the entire community is exposed to the intervention components, each individual is exposed to different components with a different intensity. Methods/Design: A logic model of change is used to develop the evaluation design. The model describes what outcomes may logically be expected at different points in time at the individual level. In order to address the complexity of a real-life setting, the evaluation design of the loneliness intervention comprises two types of evaluation studies. The first uses a quasi-experimental pre-test post-test design to evaluate the effectiveness of the overall intervention. A control community comparable to the intervention community was selected, with baseline measurements in 2008 and follow-up measurements scheduled for 2010. This study focuses on changes in the prevalence of loneliness and in the determinants of loneliness within individuals in the general elderly population. Complementarily, the second study is designed to evaluate the individual intervention components and focuses on delivery, reach, acceptance, and short-term outcomes. Different means of project records and surveys among participants are used to collect these data. Discussion: Combining these two evaluation strategies has the potential to assess the effectiveness of the overall complex intervention and the contribution of the individual intervention components thereto. Background for the development of appropriate evaluation designs that General Background address these characteristics of public health interventions In the last two decades, there has been growing interest in [5,6]. Internationally, several initiatives have been taken evidence-based policymaking in the field of public health since the beginning of the new millennium, by bodies [1-4]. For this, policymakers need information about the such as the UK Medical Research Council[5,7,8], USA effectiveness and cost-effectiveness of interventions to pre- Centers for Disease Control and Prevention[9] and WHO vent disease and promote health. Public health problems European Working Group on Health Promotion Evalua- do not stand alone but are embedded in macro-level tion[10], to develop guidelines for the evaluation of socio-economic environments. Therefore, public health complex public health interventions. problems require a combination of strategies that take the In the Netherlands also, policymakers aim for more local context into account[5]. As a result, there is a need evidence-based public health interventions. For this rea- son, Academic Collaborative Centers for Public Health * Correspondence: [email protected] have been established since 2006[11,12]. Another step 1GGD Gelre-IJssel (Community Health Service), P.O. Box 51, 7300 AB forward was the development of a national certification Apeldoorn; Academic Collaborative Centre AGORA, The Netherlands system for public health interventions by the National Full list of author information is available at the end of the article © 2010 de Vlaming et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. de Vlaming et al. BMC Public Health 2010, 10:552 Page 2 of 9 http://www.biomedcentral.com/1471-2458/10/552 Institute of Public Health and the Environment (RIVM) real-life setting[15,16]. Restricting the success indicator in 2008. To date, only a few interventions have been to one single health or behavioral outcome leads to many approved as effective or cost-effective in the Netherlands unsolved questions about the success factors for, and bar- as most evaluation studies are limited to process evalua- riers to, the effectiveness of the intervention[6,17]. There- tions and therefore provide weak evidence on effective- fore, an evaluation approach is proposed that includes a ness[13]. combination of quantitative and qualitative evaluation The current study seeks to contribute to more evi- methods to answer the three research questions of this dence-based working procedures in public health prac- study. To answer the first and second question, a quasi- tice. The aim of this paper is to provide the rationale experimental pre-test post-test study design including for an evaluation design for a complex intervention tar- short-term, mid-term and long-term outcome indicators geting loneliness among non-institutionalized elderly isused.Tobeabletoanswerthe third question, inter- people in a Dutch community. The intervention is prac- vention inputs, activities, and outputs are recorded to tice driven, meaning that the intervention is newly assess the implementation process. In-depth qualitative developed by equitable partnering of researchers, practi- research is used to investigate the acceptability of the tioners, and policymakers directly affected by, and project within the target population in more detail. knowledgeable about, the local circumstances that impact health. The intervention called Healthy Ageing is Background to Healthy Ageing being conducted in the community of Epe, a rural vil- Local policymakers in Epe defined loneliness as one of lage in the eastern part of the Netherlands, with 32,970 their priority areas, as local data showed that 40% of the inhabitants,19%ofwhomwereaged65yearsandover elderly were mildly to severely lonely[18]. To develop an at the start of the initiative in January 2008[14]. The intervention program, a project group was commis- intervention commenced in September 2008 with a start sioned, including representatives of the municipality of package of intervention activities addressing the non- Epe, the regional community health service, the regional institutionalized elderly people as the primary target mental health service, and the local welfare organization group and people in the social environment of the for the elderly. The activities of the project group are elderly as the secondary target group. The planned described according to first two phases of Bracht et al.’s intervention period is two years. [19] community organization model: the community Three research questions were formulated to assess analysis phase and the intervention planning and initia- the effectiveness of the complex Healthy Ageing project. tion phase. The remaining three phases, the implemen- Firstly, can we observe changes over time in the preva- tation phase, the maintenance and consolidation phase, lence of loneliness and in the determinants of loneliness and the dissemination and reassessment phase are in the general non-institutionalized elderly population of beyond the scope of this paper. In Figure 1 the different the intervention community, Epe, and specifically in phases of the project are indicated on a timeline. How- high risk groups? Secondly, can these changes be attrib- ever, it should be borne in mind that the succession uted to the complex intervention? Thirdly, how can the from one phase to another is not clear cut. observed changes be explained and what are the active The first phase comprises the community analysis, components of the intervention? also called context analysis or needs assessment, in com- For the purpose of this paper, the term complex inter- bination with a literature study to identify the causes of vention is defined as an intervention consisting of several loneliness and potential solutions to prevent or diminish interacting components[8]. The components may include loneliness. The community analysis includes in-depth actions and activities at the individual level and at the analysis of local monitoring data and interviews with the social and physical environmental level. The level of com- elderly, organizations, and policymakers to discover the plexity may be influenced by the number of components, most important risk factors for loneliness in the local the interactions between components, the number and population and to generate ideas for an intervention difficulty of behaviors required by those delivering or strategy. receiving the interventions, the number of groups or In the literature, loneliness is described as a discre- organization levels targeted by the intervention, the num- pancy between the desired and realized social contacts ber and variability of outcomes, and the permitted degree of an individual [20]. This negative experience may be of flexibility or tailoring of the intervention[8]. This com- related to the absence of a partner or close relative, plexity makes a classical randomized controlled trial called

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