Clinical trial NCT00962169: Guideline Implementation in Physiotherapy
Official title: Development and Pilot Testing of an Implementation Strategy to Increase Physiotherapists'Adherence to Evidence-based Guideline for Patients With Low Back Pain: a Planned, Systematic and Theory-based Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Guideline adherence
Implementation
Physical therapy
Low back pain
Health plan implementation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: The University of Texas Health Science Center, Houston
name: Royal Dutch Society for Physiotherapy
name: Dutch Institute for Allied Health Care
First posted: 2009-08-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is 1) to develop an intervention strategy to increase physiotherapists' adherence to evidence-based practice guidelines, 2) to try out this intervention on a small scale to determine what efficacy may be expected from it, and 3) to determine the value of a planned, systematic and theory-based approach that was followed in developing and implementing the intervention.

Detailed description: Summary

The main objective is the planned, systematic, and theory-based development and pilot testing of an intervention strategy to increase physiotherapists' adherence to evidence-based practice guidelines for low back pain. Although it has been demonstrated that the recommendations of these guidelines are effective, its implementation in physiotherapy practice remains limited. This incomplete implementation results in a considerable inefficiency in physiotherapy practice (e.g. the regular use of less effective treatment strategies) and consequently contributes to the extensive socio-economic problems associated with low back pain (1.7% of the BNP). Until now, however, implementation strategies to increase guideline adherence have not been very effective. The lack of a coherent theoretical framework has been pointed out as a possibly important explanatory factor. Recent reports therefore emphasize an expansion of the theoretical basis with regards implementation problems.

The present project (January 2007) will build on the promising results of a cross-sectional study among Dutch physiotherapists, which applied the Precede-Proceed planning model to assess determinants of guideline adherence. To that end, a theoretical framework was constructed that combined the Diffusion of Innovations Theory, the Precaution Adoption Process Model, and elements of Organization Development. The questionnaire based on this framework turned out to be a very useful tool for systematically studying barriers and facilitators associated with guideline adherence. However, a similar, but longitudinal study is needed to assess determinants that actually predict guideline adherence. For this longitudinal study, the framework needs to be slightly revised (5 months). The adapted theoretical framework in turn, will guide the subsequent revision of the determinant questionnaire (3 months).

The longitudinal determinant study (10 months) among primary care physiotherapists (N = 1,600) will be performed via mail. Determinants of guideline adherence will be assessed with the revised questionnaire. Actual guideline adherence will be determined with recently developed longitudinal paper\&pencil vignettes that cover the eleven most important indicators of adherence. Statistical analyses of these combined data will disclose which individual, social and / or organizational determinants in fact predict guideline adherence.

The results of the longitudinal study will be used to systematically develop an implementation enhancing strategy (8 months), specifically aimed at modifying the determinants predicting adherence. The development will be based on the Intervention Mapping approach. This approach will, for instance, assists in choosing objectives and strategies of change, and in combining these into a coherent program plan. To assess the efficacy of this combination of implementation strategies, a pilot test (4 months) will be performed among primary care physiotherapists (N = 30) within a network of physiotherapy practices (N = 10). The short-term effects on determinants predicting guideline adherence and on actual guideline implementation will be assessed in a similar way as during the preceding longitudinal study. Additional process information will be collected to refine the implementation enhancing strategy and to explore opportunities for further implementation of this strategy in primary care. A secondary objective of the present study is to further examine the value of the planned, systematic, and theory-based approach for the implementation of practice guidelines in general. Depending on the findings of the present study, we expect to be able to formulate implications for the use of a coherent theoretical framework in the current practice of guideline implementation and in the development of strategies to increase guideline adherence among a wider variety of health care professions, as well as the use of planning models and systematic intervention development models in future implementation efforts and guideline adherence studies.

This study will be the first in the field of guideline implementation that applies (1) a comprehensive theoretical framework for guideline adherence, (2) the Precede-Proceed planning model for the assessment of determinants predicting guideline adherence, and (3) the systematic approach of Intervention Mapping for the development of an implementation strategy. The results will be reported in peer-reviewed articles and included in a dissertation (December 2009).

Eligibility criteria: Inclusion Criteria:

Arm 1 Quality improvement program

* Physiotherapy practices that have started or finalized a quality registration procedure (HNK)

Arm 2 Electronic patient device

* Physiotherapists that are acquainted with the use of EPDs in their practice

Exclusion Criteria:

* Physiotherapists enrolled in other quality improvement programs

Primary outcomes:
measure: Guideline adherence
timeFrame: 3 months
Secondary outcomes:
measure: Determinants of guideline adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: IQ healthcare / Radboud UMCN
Study officials:
affiliation: University Medical Center St Radboud Nijmegen
name: Rob Oostendorp, Professor
role: STUDY_DIRECTOR
References:
citation: Bekkering GE. Physiotherapy guidelines for low back pain. Development, implementation, and evaluation. Vrije Universiteit Amsterdam, 2004. Fritz JM, Cleland JA, Brennan GP. Does adherence to the guideline recommendation for active treatments improve the quality of care for patients with acute low back pain delivered by physical therapists? Med Care 2007;45(10):973-80. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004;8(6 iii-iv):1-72. Harting J, Rutten GM, Rutten ST, Kremers SP. A Qualitative Application of the Diffusion of Innovations Theory to Examine Determinants of Guideline Adherence Among Physical Therapists. Phys Ther 2009. Rutten G, Kremers S, Rutten S, Harting J. A theory-based cross-sectional survey demonstrated the important role of awareness in guideline implementation. J Clin Epidemiol 2009;62(2):167-176 e1. Rutten GMJ, Harting J, Rutten STJ, Bekkering GE, Kremers SPJ. Measuring physiotherapists' guideline adherence by means of clinical vignettes: a validation study. J Eval Clin Pract 2006;12(5):491-500.