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Open Access Methodology

Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries

Cornelia Jäger1*, Tobias Freund1, Jost Steinhäuser1, Eivind Aakhus2, Signe Flottorp34, Maciek Godycki-Cwirko5, Jan van Lieshout6, Jane Krause7, Joachim Szecsenyi1 and Michel Wensing6

Author Affiliations

1 Department of General Practice and Health Services Research, University Hospital of Heidelberg, Voßstraße 2, Geb. 37, 69115 Heidelberg, Germany

2 Research Centre for Old Age Psychiatry in Innlandet Hospital Trust, N-2312 Ottestad, Norway

3 Norwegian Knowledge Centre for the Health Services, Postboks 7004 St. Olavs plass, 0130 Oslo, Norway

4 The Department of Health Management and Health Economics, University of Oslo, Postboks 1089 Blindern, 0317 Oslo, Norway

5 Centre for Family and Community Medicine, Medical University of Lodz, ul. Kopcinskiego 20, 90-153 Lodz, Poland

6 Scientific Institute for Quality of Healthcare, Radboud University, Medical Centre, PO Box 9101, 114 IQ Healthcare, 6500 HB Nijmegen, The Netherlands

7 Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester LE1 6TP, UK

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Trials 2014, 15:87  doi:10.1186/1745-6215-15-87

Published: 21 March 2014

Abstract

Background

In the ‘Tailored Implementation for Chronic Diseases (TICD)’ project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol describes the process evaluation across these trials, which aims to identify determinants of change in chronic illness care, to examine the validity of the tailoring methods that were applied, and to analyze the association of implementation activities and the effectiveness of the program.

Methods

A multilevel approach was used to develop five tailored implementation interventions. In order to guide the process evaluation in five distinct trials, the study protocols for the cluster randomized trials and the related process evaluations were developed simultaneously and iteratively.

Results

The process evaluation comprises three main components: a structured survey with health professionals in the trials, semi-structured interviews with a purposeful sample of this study population, and standardized documentation of organizational practice characteristics. Norway will only conduct the qualitative part of the analysis because the survey and documentation of practice characteristics are considered to be not feasible. The evaluation is guided by ‘logic models’ of the implementation programs: frameworks that specify the linkages between the strategies used, the determinants addressed by tailoring, and the anticipated outcomes. Standardization of measures across trials is sought to facilitate analysis of aggregated data from the trials.

Conclusions

This process evaluation will need to find a balance between standardization of methods across trials and the tailoring of measures to the specificities of each trial.

Keywords:
process evaluation; tailored implementation intervention; chronic illness care