Developing a complex intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patients

Abstract

BackgroundMost patients with pulmonary embolism (PE) spend 5–7 days in hospital even though only 4.5% will develop serious complications during this time. In particular, the group of patients with incidentally diagnosed PE (i-PE) includes many patients with low risk features potentially ideal for outpatient management; however the evidence for their optimal management is lacking hence relative practices may vary considerably. We describe the development process, components, links and function of a nurse-led service for the management of patients with i-PE, developed in accordance to the UK Medical Research Council complex intervention guidance.MethodsPhase 0 (Theoretical underpinning): The Pulmonary Embolism Severity Index (PESI) was selected for patient risk assessment and the American Society of Clinical Oncology (ASCO) guideline for the management of PE in cancer patients (2007) was selected as quality measure. Historical registry and audit data from our centre regarding i-PE incidence and management for the period between 2006 and 2009 illustrating the then current practices were reviewed. Phase 1 (Modelling): Modelling of the pathway included the following: a) Identification of training needs, planning and implementation of training schemes and development of transferable competencies and training materials. b) Mapping patient pathways and flow and c) Production of key documentation and Standard Operating Procedures for the delivery of the service.ResultsPhase 2 (Implementation and testing of the intervention): During the initial 12 months of implementation, remedial action was taken to address identified deficiencies regarding patient referral to the pathway, compliance with treatment protocol, patient follow up, selection challenges from the use of PESI in cancer patients and challenges regarding the “first-pass” identification of i-PE.ConclusionWe have developed and piloted a complex intervention to manage cancer patients with incidental PE in an outpatient setting. Adherence to evidence- based care, improvement of communication between professionals and patients, and improved quality of data is demonstrated.

Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used

“…Results were used to refine the programme in order to produce the finalised programmeLovell et al 2008 [35]UKGuided self-help intervention for depression in primary careMRC framework 2000Synthesise available evidence on the effectiveness of the intervention, identify key factors that may moderate effectiveness and deal with uncertainties emerging from the reviews, assess of acceptability to patients and healthcare professionalsMeta-regression, meta-analysis and a consensus process with experts, including academics ( n  = 8), health professionals ( n  = 10) and service users ( n  = 1), phone interviews with patients and healthcare professionalsThe integration of findings allowed identifying the ‘core components’ of the intervention, which was then tested in feasibility study. The intervention did not moved to the RCT phase, as it did not markedly improve outcomes in the exploratory studyMunir et al 2013 [42]UKWork-related guidance tool for people with/recovering from cancerIntervention mapping [36]Obtain consensus on the questions included in the guidance tool (a list of 43 questions was previously developed) and to which healthcare professional these should be asked, and test feasibility of the intervention to participantsA two-round Delphi study conducted online with 172 experts (round 1) and 139 experts (round 2); online survey to participants ( n  = 38) who tested the guideline tool for six weeksThe intervention was finalised by identifying the key components of the tool and a range of stakeholders and the tested in a feasibility studyMurchie et al 2007 [37]UKFollow-up programme for people treated for cutaneous malignant melanomaMRC framework 2000Seek patients and GPs’ views on feasibility, desirability, benefits and components of the programme; assess feasibility and identify problems or deficienciesSteering group consultations, semi-structured interviews with patients ( n  = 9) and GPs ( n  = 14), pre-pilot operationalisation exerciseThe components of the intervention were identified, fine-tuned and the final intervention tested in a feasibility studyPalmer et al 2013 [29]UKNurse-led intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patientsMRC framework 2008Real-time re-modelling, refinement and optimisation of the intervention to respond to problems and deviations arising in practiceObservations, audit and surveyThe intervention processes and delivery were refined on the basis of the real-time re-modelling process’ resultsRedfern et al 2008 [36]UKThe Stop Stroke intervention to improve risk factor management after strokeMRC framework 2000Achieve consensus about the factors which a novel intervention should address and how this might be delivered and test feasibility of intervention components to patients and healthcare professionalsConsensus process involving a study steering group (a team of multidisciplinary experts) and local clinicians, researchers and stroke survivors, semi-structure interviews with patients and h...…”

“…Interventions were delivered in a variety of settings (e.g. inpatient, outpatient clinics and home-based settings) and targeted a wide range of conditions, such as mental health conditions [28, 30, 35, 40, 47], stroke [31, 36, 39], cancer [29, 32, 33, 37, 42] and other chronic illnesses [25, 34, 38]. Two studies reported on preventive interventions targeting older people [24, 50] and one on a programme to empower patients undergoing gynaecological surgery during the perioperative period [43].…”

“…Fourteen studies explored the acceptability and/or feasibility of the intervention to different stakeholders, including providers, recipients or policy makers and service commissioners [27, 29–32, 34, 36, 37, 39, 40, 42, 43, 47, 48]. Seven studies were a preliminary investigation of the effect of the intervention or a combination of its components on proxy or final outcomes and intervention long-term impact [10, 24, 44–46, 49, 50].…”

“…Several studies employed well-established qualitative methods including interviews or focus groups with providers and recipients or relevant stakeholders [26, 30, 32, 34, 39, 47, 48] and observations and consensus processes including researchers, patients and clinical experts [31]. A number of studies adopted quantitative methods such as fractional factorial experiments [10, 44], economic modelling [33], small uncontrolled pilot studies (with no control group) [25, 29, 38], experimental 2 × 2 randomised controlled trials [45, 46], probability models [49, 50] and evaluation questionnaires [43]. Several studies used mixed methods, combining qualitative strategies to explore stakeholders’ perspectives and quantitative analysis to estimate the intervention effect [24, 27, 28, 33, 35–37, 40, 42].…”

“…For example, factorial experiments, uncontrolled pilot studies and probability models tended to be used to test specific components and to identify an intervention’s potential effect [10, 25, 29, 38, 44, 49, 50]. Optimisation strategies applying qualitative methods tended to explore acceptability and feasibility issues [26, 30, 32, 34, 39, 47, 48].…”