Development of a computerised decision aid for thrombolysis in acute stroke care

Flynn et al. BMC Medical Informatics and Decision Making Development of a computerised decision aid for thrombolysis in acute stroke care Darren Flynn 0 Daniel J Nesbitt Gary A Ford Peter McMeekin 0 Helen Rodgers Christopher Price Christian Kray Richard G Thomson 0 0 Institute of Health and Society, Newcastle University , Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne , UK Background: Thrombolytic treatment for acute ischaemic stroke improves prognosis, although there is a risk of bleeding complications leading to early death/severe disability. Benefit from thrombolysis is time dependent and treatment must be administered within 4.5 hours from onset of symptoms, which presents unique challenges for development of tools to support decision making and patient understanding about treatment. Our aim was to develop a decision aid to support patient-specific clinical decision-making about thrombolysis for acute ischaemic stroke, and clinical communication of personalised information on benefits/risks of thrombolysis by clinicians to patients/relatives. Methods: Using mixed methods we developed a COMPuterised decision Aid for Stroke thrombolysiS (COMPASS) in an iterative staged process (review of available tools; a decision analytic model; interactive group workshops with clinicians and patients/relatives; and prototype usability testing). We then tested the tool in simulated situations with final testing in real life stroke thrombolysis decisions in hospitals. Clinicians used COMPASS pragmatically in managing acute stroke patients potentially eligible for thrombolysis; their experience was assessed using self-completion forms and interviews. Computer logged data assessed time in use, and utilisation of graphical risk presentations and additional features. Patients'/relatives' experiences of discussions supported by COMPASS were explored using interviews. Results: COMPASS expresses predicted outcomes (bleeding complications, death, and extent of disability) with and without thrombolysis, presented numerically (percentages and natural frequencies) and graphically (pictographs, bar graphs and flowcharts). COMPASS was used for 25 patients and no adverse effects of use were reported. Median time in use was 2.8 minutes. Graphical risk presentations were shared with 14 patients/relatives. Clinicians (n = 10) valued the patient-specific predictions of benefit from thrombolysis, and the support of better risk communication with patients/relatives. Patients (n = 2) and relatives (n = 6) reported that graphical risk presentations facilitated understanding of benefits/risks of thrombolysis. Additional features (e.g. dosage calculator) were suggested and subsequently embedded within COMPASS to enhance usability. Conclusions: Our structured development process led to the development of a gamma prototype computerised decision aid. Initial evaluation has demonstrated reasonable acceptability of COMPASS amongst patients, relatives and clinicians. The impact of COMPASS on clinical outcomes requires wider prospective evaluation in clinical settings. Decision support; Decision aid; Patient information; Shared decision making; Risk communication; Thrombolysis; Acute stroke - Background Thrombolysis (the breakdown of blood clots using pharmacological agents; commonly called clot-busting drugs) administered within 4.5 hours of acute ischaemic stroke onset (caused by a sudden blockage of an artery supplying blood flow to, or within, the brain) improves outcome [1]. However, thrombolytic treatment can cause bleeding complications, the most serious being symptomatic intracranial haemorrhage (SICH) that typically occurs within 2436 hours and leads to clinical deterioration or death [2,3]; although 90 day mortality is not increased in patients treated with thrombolysis [4]. Efficacy is time dependent, with earlier treatment associated with increased likelihood of functional independence (complete recovery or minor disability) after acute stroke [4,5]. The thrombolysis decision-making context (extreme time dependent nature of treatment outcome, and the need to rapidly consider the trade-offs between the likely long-term benefit and early risk of SICH and its consequences) presents unique challenges for clinicians, patients and their relatives or proxy [6]. Aggregate-level estimates of the likely balance of benefits and risks of harm from treatment derived from event rates reported in randomised controlled trials [4,5] and patient registries [7,8] have been used to support clinical decision-making about thrombolytic treatment and to convey probabilistic information on outcome states to patients/relatives. However, benefit-to-harm ratios differ as a function of individual patient characteristics due to variation between patients who fulfil the licensing criteria for treatment. The weighing up of value in treating any individual patient and communication of this complex information (alongside eligible patients presenting too late to secondary care and lack of adequate infrastructure to support delivery of thrombolysis services [9,10]) is a key reason why thrombolysis is an underutilised treatment for acute stroke and door to needle times (arrival time at hospital to administration of thrombolysis) are sub-optimal [11,12]. Additional factors inhibiting the use of thrombolysis include physicianrelated factors such as uncertainty about effectiveness, apprehensions about increased risk of SICH, and unresolved issues on relative contraindications for treatment [5,13-15], and lack of robust data on the likely balance of benefits and risks of treatment in routine practice as a function of individual patient characteristics [16]. Evidence-based tools for thrombolysis in acute stroke such as decision aids [17] are warranted to (i) optimise treatment rates by assisting clinicians to weigh-up the potential net benefit in treating any individual patient; (ii) support clinicians in communicating accurate information on risks/benefits and prognosis to patients (or next of kin/proxy); and (iii) seamlessly support different approaches to decision-making about thrombolysis, including (where appropriate) engagement of patients/relatives in shared decision-making with stroke clinicians [6,18]. However, a recent review identified sub-optimal development (e.g., lack of testing in clinical settings) and content (e.g., failure to convey balanced synopses of benefits/risks) of decision support, patient information and risk communication tools for thrombolysis in acute stroke [6]. The thrombolysis decision-making context in acute stroke care may be viewed as one in which both clinicians and patients/relatives will gravitate toward a paternalistic model of decision-making. However, the optimal approach to decision-making in emergency contexts such as acute stroke may vary on a case-by-case basis, and stroke clinicians are best placed to facilitate the engagement of patients or their relatives/proxy in a th (...truncated)