Design Design: A prospective longitudinal implementation study. Setting and population:
The implementation will take place at Hammel Neurorehabilitation Centre and University
Research Clinic. The target population are patients with stroke.
Management The study will be organized by the Research Unit at Hammel Neurocenter, Iris
Brunner, associate professor, PhD, in collaboration with the Center Management
represented by head physician Kåre Eg Severinsen, MD, PhD and the unit for professional
development, represented by Camilla Biering Lundquist PhD.
Evaluation of the implementation The RE-AIM framework, and its extension, the Practical
Implementation Sustainability Model (PRISM) framework will be applied to guide and
evaluate the implementation process. The RE-AIM framework has been used in numerous
studies and hosts a homepage with comprehensive online resources for planning, evaluating
and reporting implementation studies.
Briefly, it consists of the following components to evaluate the success of an
implementation:
Reach. Refers to percent of individuals who are reached by the intervention. In the
context of the present study, Reach would describe the number of patients for whom the
TMS examination would be relevant, and the percentage of patients who received TMS, and
reasons for not being examined.
- Evaluation of Reach through monitoring of 4 selected wards with the help of the
Business Intelligence (BI) portal.
Effectiveness: Entails the measurement of primary and broader outcomes. In this study,
Effectiveness would assess the prediction accuracy for the specific population at the
hospital.
- Evaluation of Effectiveness. Fifty patients will be recruited consecutively from all
wards at Hammel Neurorehabilitation Center's sites Hammel and Skive. Follow-up
assessments of UL function will be conducted at 3 months post-stroke with the tests
of UL function described in 3d. It will be assessed if individual predictions based
on TMS and clinical tests will reach a specificity of 80% or more. In addition,
sensitivity, PPV, NPV and overall accuracy/ CCP including 95% CI will be calculated.
Adoption. The level of actual uptake of the new intervention. Specifically in this study
the number of referrals of relevant patients from different wards. Moreover, the number
of involved staff (therapists, MDs) with a positive attitude to the TMS examination.
- Evaluation of adoption will based on quantitative data from monitoring,
questionnaires, and interviews.
Implementation. Description of the actual resources and cost allocated, intervention
fidelity, and acceptance.
- Implementation is evaluated with regard to intervention fidelity. In this case, can
patients be examined with TMS within the planned time after stroke and is the
workload for trained examiners distributed as agreed on.
Maintenance. Measures the long-term attrition to an intervention on an individual and a
setting level.
- Among others, the following questions will be addressed: Are the potential obstacles
identified in previous components of reach addressed? Is the rate of patients
referred to TMS stable over time? Can examination skills be maintained or is there
need for a boost? Has new staff been introduced to perform the TMS procedure? Based
on these questions and the feedback from questionnaires and interviews the
investigators will continuously respond to threats to maintenance and adapt
maintenance strategies accordingly.