|- candidate number||1719|
|- NTR Number||NTR311|
|- Date ISRCTN created||30-sep-2005|
|- date ISRCTN requested|
|- Date Registered NTR||22-sep-2005|
|- Secondary IDs||945-14-217 |
|- Public Title||PRACTISE: Promoting acute thrombolysis for ischemic stroke.|
|- Scientific Title||A cluster randomized controlled trial to assess the effect of implementation strategies on the rate and effects of thrombolysis for acute ischemic stroke.|
|- hypothesis||The purpose of this study is:|
1. To evaluate the effect of a high intensity implementation strategy compared to a regular intensity strategy;
2. Identify success factors and obstacles for mplementation of thrombolysis; and 3) to assess the cost-effectiveness of thrombolysis in routine daily Dutch neurological care settings, taking into account the costs of implementation.
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- Inclusion criteria||All patients who are admitted with acute stroke, i.e. patients with an acute focal neurological deficit, which cannot be explained by a condition other than stroke, andonset of symptoms not longer than 24 hours ago, will be included in the trial. Thesepatients will be registered, and a minimal set of baseline data will be recorded. Patients with acute stroke, who are admitted within 4 hours from onset of symptoms will be registered and followed up after three months.|
|- Exclusion criteria||Age under 18.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2005|
|- planned closingdate||1-nov-2007|
|- Target number of participants||7000|
|- Interventions||The high intensity intervention consists of the introductionof a set of implementation tools, directed at the four levels where barriers against trombolysis are expected. This toolkit will be explained in a training sessions to the vascular neurologist and coordinating nurse in each center, who also act as the local agents of change. Training session takes place after 6 months and 1 year.|
|- Primary outcome||Treatment with thrombolysis or not in all registered patients.|
|- Secondary outcome||Admission within 3 hours after onset of symptoms,death or disability at three months (in the subgroup of patients withischemic stroke who were admitted within 3 hours).|
|- Trial web site||http://www.practise-trial.org/|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Maaike Dirks|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.W.J. Dippel|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Trial protocol on trial website.|
|- Brief summary||Background:|
Thrombolysis with rt-PA is an effective treatment for patients with ischemic stroke
within 3 hours from onset. More than 25% of stroke patients arrive in time to be
treated with thrombolysis. Nevertheless, in most hospitals, only 1 to 8% of all stroke
patients are treated. Professional, organizational and contextual barriers are hampering broad implementation. The purpose of this study is:
1. to evaluate the effect of a high intensity implementation strategy compared to a regular intensity strategy;
2. identify success factors and obstacles for implementation of thrombolysis; and
3. to assess the cost-effectiveness of thrombolysis in routine daily Dutch neurological care settings, taking into account the costs of implementation.
The effect of the implementation will be evaluated in a cluster randomized, controlled design. Randomization will be done on the hospital level, with pairwise stratification for thrombolysis rate, size and type of hospital (academic or non-academic, and regional versus urban).
the number of thrombolyses in the high intensity versus the regular intensity group.
the rate of symptomatic intracebral hemorrhages among thrombolysed patients, the proportion of patients admitted within 3 hours from onset of symptoms, and health status at 3
months. Twelve centers will participate, yielding a two-armed trial of 3500 stroke
patients per arm. This is sufficient to a detect a 50% increase in thrombolysis rate in centers with the high intensity intervention compared to regular intensity intervention, and a twofold increase in the rate of symptomatic intracerebral hemorrhage in thrombolysed patients, with adjustment for intracluster correlation.
The implementation strategy is based on the Breakthrough methodology, preceded by an in-depth analysis of obstacles from a regional and national point of view. A tool kit with improvement actions to be used by the vascular neurologist, the change agent,
will be developed and introduced. The improvement actions will include the FAST
test for GP’s and ambulance personnel, a less strict set of contra-indications derived
from a Delphi panel of international experts,1 tools to improve the “door to needle time”, and tools for dealing with issues of decision making under conditions of uncertainty.
The implementation process will be monitored by means of the Assertive Community Treatment approach, according to prespecified criteria, in order to identify obstacles and success factors for implementation of thrombolysis.
The results will be analyzed with a logistic regression model with a random parameter
for center effect.
|- Main changes (audit trail)|
|- RECORD||22-sep-2005 - 13-jan-2010|