Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Methodology

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

Authors: Cornelia Jäger, Tobias Freund, Jost Steinhäuser, Eivind Aakhus, Signe Flottorp, Maciek Godycki-Cwirko, Jan van Lieshout, Jane Krause, Joachim Szecsenyi, Michel Wensing

Published in: Trials | Issue 1/2014

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N: Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2010, 3: CD005470-PubMed
2.
Bosch M, van der Weijden T, Wensing M, Grol R: Tailoring quality improvement interventions to identified barriers: a multiple case analysis. J Eval Clin Pract. 2007, 13: 161-168. 10.1111/j.1365-2753.2006.00660.x.CrossRefPubMed
3.
Wensing M, Oxman A, Baker R, Godycki-Cwirko M, Flottorp S, Szecsenyi J, Grimshaw J, Eccles M: Tailored implementation for chronic diseases (TICD): a project protocol. Implement Sci. 2011, 6: 103-10.1186/1748-5908-6-103.CrossRefPubMedPubMedCentral
4.
Krause J, Agarwal S, Bodicoat DH, Ring A, Shepherd D, Rogers S, Wensing M, Baker R: Evaluation of a tailored intervention to improve management of overweight and obesity in primary care; study protocol of a cluster randomised controlled trial. Trials. 2014, (submitted)
5.
Jäger C, Freund T, Steinhäuser J, Joos S, Wensing M, Szecsenyi J: A tailored implementation intervention to implement recommendations addressing polypharmacy in multimorbid patients: study protocol of a cluster randomized controlled trial. Trials. 2013, 14: 420-10.1186/1745-6215-14-420.CrossRefPubMedPubMedCentral
6.
Godycki-Cwirko M, Zakowska I, Kosiek K, Wensing M, Krawczyk J, Kowalczyk A: Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care – study protocol of a cluster randomized trial. Trials. 2014, (submitted)
7.
Aakhus E, Granlund I, Odgaard-Jensen J, Wensing M, Oxman AD, Flottorp SA: Tailored interventions to implement recommendations for elderly patients with depression in primary care: a study protocol for a pragmatic cluster randomised controlled trial. Trials. 2014, 15: 16-10.1186/1745-6215-15-16.CrossRefPubMedPubMedCentral
8.
Huntink E, Heijmans N, Wensing M, van Lieshout J: Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial. Trials. 2013, 14: 433-10.1186/1745-6215-14-433.CrossRefPubMedPubMedCentral
9.
Michie S, Fixsen D, Grimshaw JM, Eccles MP: Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci. 2009, 4: 40-10.1186/1748-5908-4-40.CrossRefPubMedPubMedCentral
10.
Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B: Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013, 14: 15-10.1186/1745-6215-14-15.CrossRefPubMedPubMedCentral
11.
Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006, 332: 413-416. 10.1136/bmj.332.7538.413.CrossRefPubMedPubMedCentral
12.
Dixon-Woods M, Bosk CL, Aveling EL, Goeschel CA, Pronovost PJ: Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q. 2011, 89: 167-205. 10.1111/j.1468-0009.2011.00625.x.CrossRefPubMedPubMedCentral
13.
Cross WF, West JC: Examining implementer fidelity: Conceptualizing and measuring adherence and competence. J Child Serv. 2011, 6: 18-33. 10.5042/jcs.2011.0123.CrossRefPubMedPubMedCentral
14.
Flottorp SA, Oxman AD, Krause J, Musila NR, Wensing M, Godycki-Cwirko M, Baker R, Eccles MP: A checklist for identifying determinants of practice: A systematic review and synthesis of frameworks and taxonomies of factors that prevent or enable improvements in healthcare professional practice. Implement Sci. 2013, 8: 35-10.1186/1748-5908-8-35.CrossRefPubMedPubMedCentral
15.
Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S: A conceptual framework for implementation fidelity. Implement Sci. 2007, 2: 40-10.1186/1748-5908-2-40.CrossRefPubMedPubMedCentral
16.
Grol R: Successes and failures in the implementation of evidence-based guidelines for clinical practice. Med Care. 2001, 39 (8 Suppl 2): II46-II54.PubMed
17.
Barnett-Page E, Thomas J: Methods for the synthesis of qualitative research: a critical review. BMC Med Res Methodol. 2009, 9: 59-10.1186/1471-2288-9-59.CrossRefPubMedPubMedCentral
18.
Campbell R, Pound P, Morgan M, Daker-White G, Britten N, Pill R, Yardley L, Pope C, Donovan J: Evaluating meta-ethnography: systematic analysis and synthesis of qualitative research. Health Technol Assess. 2011, 15: 1-164.CrossRefPubMed
Metadata
Title
Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries
Authors
Cornelia Jäger
Tobias Freund
Jost Steinhäuser
Eivind Aakhus
Signe Flottorp
Maciek Godycki-Cwirko
Jan van Lieshout
Jane Krause
Joachim Szecsenyi
Michel Wensing
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-87

Other articles of this Issue 1/2014

Trials 1/2014 Go to the issue

Study protocol

Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial

Study protocol

Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial

Study protocol

Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial

Research

The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial

Study protocol

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial

Study protocol

A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial