AzTrials
AzTrials

Low Back PainGIPhTNCT00962169

Guideline Implementation in Physiotherapy

A study testing Behavioral and managerial and Behavioral and IT in people with Low Back Pain, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Low Back Pain
What is being tested?
Behavioral and managerial and Behavioral and IT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
Jul 2009to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Physiotherapists enrolled in other quality improvement programs

Trial locations and contacts

1 site in 1 country.

Geert Rutten, MPH contact

+31 24 361 0591

g.rutten@iq.umcn.nl

Janneke Harting, PhD contact

+31 24 361 0591

j.harting@iq.umcn.nl

Netherlands1 site, 1 recruiting
  • IQ healthcare / Radboud UMCN

    Nijmegen

    Janneke Harting, PhD, +31 24 361 0591, j.harting@iq.umcn.nl

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the 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).

Conditions
Low Back Pain
Being tested
Behavioral and managerial, Behavioral and IT
Keywords
Guideline adherence, Implementation, Physical therapy, Low back pain, Health plan implementation
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral and managerialOther

    The quality improvement program is a multi-level intervention program to increase adherence to the Dutch physical therapy Guidelines for Low Back Pain. It consists of two program parts, one for practice quality managers and the other for individual therapists. The management part aims to increase commitment amongst practice owners towards high quality of care, including the appropriate use of guidelines, and addresses the structure and the culture of the physical therapy practice. This part of the program is based on the INK management model and the colour model of De Caluwé. The individual part of the intervention is aimed at increasing physical therapists' guideline adherence by raising awareness and improving recording and clinical reasoning. This part of the intervention is based on psychosocial and educational theories and especially on the principles of Self Regulation.

  • Behavioral and ITOther

    Also called FysioDesk EPD.

    The interventions makes use of an improved EPD for physical therapists. Compared to the existing EPDs, the EPD for the present study presents decision information for physical therapists. This decision information is directly based on the recently revised physical therapy guidelines for Low Back Pain and attached to the subsequent steps of clinical reasoning that are inherent to the diagnostic and treatment stages of the usual process of physical therapy care.

Study groups in NCT00962169
Study groupRoleWhat they receive
Quality improvement programExperimentalNot described
Receives: Other: Behavioral and managerial
Electronic patient device (EPD)ExperimentalNot described
Receives: Other: Behavioral and IT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Guideline adherence

    Measured: 3 months

Secondary outcomes (1)
  1. Determinants of guideline adherence

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00962169
Sponsor's protocol ID
ZonMw 80-007028-98-07309
Other IDs
CMO 2007/172
Acronym
GIPhT
Status last verified
Aug 2009
First submitted
17 Aug 2009
Last updated
19 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral and managerial and Behavioral and IT in people with Low Back Pain, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Geert Rutten, MPH (+31 24 361 0591, g.rutten@iq.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Guideline adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.

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