Complex Clinical Interventions Research Articles

A Community and Hospital cAre Bundle to improve the medical treatment of severe cLaudIcation and critical limb iSchaemia (CHABLIS).

Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.

Stakeholder perspectives of a pilot multicomponent delirium prevention intervention for adult patients with advanced cancer in palliative care units: A behaviour change theory-based qualitative study

Background: Theory-based and qualitative evaluations in pilot trials of complex clinical interventions help to understand quantitative results, as well as inform the feasibility and design of subsequent effectiveness and implementation trials. Aim: To explore patient, family, clinician and volunteer (‘stakeholder’) perspectives of the feasibility and acceptability of a multicomponent non-pharmacological delirium prevention intervention for adult patients with advanced cancer in four Australian palliative care units that participated in a phase II trial, the ‘PRESERVE pilot study’. Design: A trial-embedded qualitative study via semi-structured interviews and directed content analysis using Michie’s Behaviour Change Wheel and the Theoretical Domains Framework. Setting/participants: Thirty-nine people involved in the trial: nurses (n = 17), physicians (n = 6), patients (n = 6), family caregivers (n = 4), physiotherapists (n = 3), a social worker, a pastoral care worker and a volunteer. Results: Participants’ perspectives aligned with the ‘capability’, ‘opportunity’ and ‘motivation’ domains of the applied frameworks. Of seven themes, three were around the alignment of the delirium prevention intervention with palliative care (intervention was considered routine care; intervention aligned with the compassionate and collaborative culture of palliative care; and differing views of palliative care priorities influenced perspectives of the intervention) and four were about study processes more directly related to adherence to the intervention (shared knowledge increased engagement with the intervention; impact of the intervention checklist on attention, delivery and documentation of the delirium prevention strategies; clinical roles and responsibilities; and addressing environmental barriers to delirium prevention). Conclusion: This theory-informed qualitative study identified multiple influences on the delivery and documentation of a pilot multicomponent non-pharmacological delirium prevention intervention in four palliative care units. Findings inform future definitive studies of delirium prevention in palliative care. Australian New Zealand Clinical Trials Registry, ACTRN12617001070325; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373168

Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol

ObjectivesTo measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.SettingA single centre study, Malaysia.ParticipantsAdults aged between 18 and 60...

Fan Therapy for the Treatment of Dyspnea in Adults: A Systematic Review

ContextThe use of a handheld or electric fan has been proposed as one component of the complex clinical interventions used in the relief of dyspnea; however, there is a lack of consensus regarding its efficacy. ObjectivesWe performed a systematic review to determine the effectiveness of fan therapy for the treatment of dyspnea. MethodsWe searched the Medline, EMBASE, Web of Science, Scopus, CINAHL, PsycInfo, and Cochrane Library databases to identify all fan therapy studies published from January 1, 1946 to September 31, 2018. The search terms included “dyspnea,” “dysponea,” “dyspneic,” “short of breath,” “shortness of breath,” “breathless,” “breathlessness,” “breathing difficulty,” “labored breathing,” and “fan.” Searches were limited to articles in English or Chinese. The bibliographies of identified articles were also manually searched. Three authors independently assessed papers for inclusion. ResultsTen of the 92 unique records identified met the inclusion criteria (nine randomized controlled trials and one cohort study). Most studies (80%) were conducted in the hospital setting, and none were double blinded. Nearly half (159 [46%]) of the 344 total subjects had cancer. The most common nonmalignant disease was chronic obstructive pulmonary disease. The most common duration of fan therapy was five minutes. Six studies (60%) reported a significant improvement in dyspnea with fan therapy. There are two ongoing trials being conducted based on a search of trial registries. ConclusionLimited direct evidence from randomized controlled trials indicates that fan therapy may effectively alleviate dyspnea. Additional trials are warranted to confirm this finding and explore the use of fan therapy for the treatment of dyspnea in more diverse populations and settings.

Exploration of dynamics in a complex person-centred intervention process based on health professionals\u2019 perspectives

BackgroundThe assessment and evaluation of practical and sustainable development of health care has become a major focus of investigation in health services research. A key challenge for researchers as well as decision-makers in health care is to understand mechanisms influencing how complex interventions work and become embedded in practice, which is significant for both evaluation and later implementation. In this study, we explored nurses’ and surgeons’ perspectives on performing and participating in a complex multi-centre person-centred intervention process that aimed to support patients diagnosed with colorectal cancer to feel prepared for surgery, discharge and recovery.MethodData consisted of retrospective interviews with 20 professionals after the intervention, supplemented with prospective conversational data and field notes from workshops and follow-up meetings (n = 51). The data were analysed to construct patterns in line with interpretive description.ResultsAlthough the participants highly valued components of the intervention, the results reveal influencing mechanisms underlying the functioning of the intervention, including multiple objectives, unclear mandates and competing professional logics. The results also reveal variations in processing the intervention focused on differences in using and talking about intervention components.ConclusionsThe study indicates there are significant areas of ambiguity in understanding how theory-based complex clinical interventions work and in how interventions are socially constructed and co-created by professionals’ experiences, assumptions about own professional practice, contextual conditions and the researchers’ intentions. This process evaluation reveals insights into reasons for success or failure and contextual aspects associated with variations in outcomes. Thus, there is a need for further interpretive inquiry, and not only descriptive studies, of the multifaceted characters of complex clinical interventions and how the intervention components are actually shaped in constantly shifting contexts.

Current Status of Postdoctoral and Graduate Programs in Dentistry.

Advanced dental education has evolved in the context of societal needs and economic trends to its current status. Graduate programs have positioned their role in the context of health systems and health science education trends in hospitals, interprofessional clinical care teams, and dental schools and oral health care systems. Graduate dental education has been a critical factor in developing teams in trauma care, craniofacial disorders, pediatric and adult medicine, and oncology. The misalignment of the mission of graduate dental programs and the demands of private practice has posed a challenge in the evolution of programs as educational programs have been directed towards tertiary and indigent care while the practice community focuses on largely healthy affluent patients for complex clinical interventions. Those seeking graduate dental education today are smaller in number and include more international dental graduates than in the past. Graduate dental education in general dentistry and in the nine recognized dental specialties now includes Commission on Dental Accreditation (CODA) recognition of training standards as part of its accreditation process and a CODA accreditation process for areas of clinical education not recognized as specialties by the American Dental Association. Current types of programs include fellowship training for students in recognized specialties. This article was written as part of the project "Advancing Dental Education in the 21st Century."

The Use of Qualitative Methods in Developing Implementation Strategies in Prevention Research for Stroke Survivors in Nigeria.

Implementing complex clinical interventions is a key challenge in many global regions. Local communities play a necessary role in enhancing feasibility and strengthening adaptive issues in the design and implementation of stroke interventions in developing countries. Drawing on the knowledge of physicians, patients, and caregivers, the authors employed qualitative methods as a phase 1 strategy to explore the challenges of stroke management and improve the adaptability and efficient delivery of a multimodal preventive intervention for secondary stroke disease in Nigeria. A total of 22 individual interviews were conducted with healthcare professionals, as well as 12 focus groups with patients and caregivers. Findings revealed four operational domains to improve strategies for phase 2 implementation and intervention: (1) barriers influencing optimal adherence in stroke survivors, (2) patient health beliefs and perceptions of patient health beliefs by others, (3) adoption of the "patient report card," and (4) "medical action plan" and family management strategies.

A Mobile Phone App to Stimulate Daily Physical Activity in Patients with Chronic Obstructive Pulmonary Disease: Development, Feasibility, and Pilot Studies.

BackgroundPatients with chronic obstructive pulmonary disease (COPD) demonstrate reduced levels of daily physical activity (DPA) compared to healthy controls. This results in a higher risk of hospital admission and shorter survival. Performing regular DPA reduces these risks.ObjectiveTo develop an eHealth intervention that will support patients with COPD to improve or maintain their DPA after pulmonary rehabilitation.MethodsThe design process consisted of literature research and the iterative developing and piloting phases of the Medical Research Council (MRC) model for complex clinical interventions and the involvement of end users. Participants were healthy adults and persons with COPD.ResultsThe mobile phone interface met all the set requirements. Participants found that the app was stimulating and that reaching their DPA goals was rewarding. The mean (SD) scores on a 7-point scale for usability, ease of use, ease of learning, and contentment were 3.8 (1.8), 5.1 (1.1), 6.0 (1.6), and 4.8 (1.3), respectively. The mean (SD) correlation between the mobile phone and a validated accelerometer was 0.88 (0.12) in the final test. The idea of providing their health care professional with their DPA data caused no privacy issues in the participants. Battery life lasted for an entire day with the final version, and readability and comprehensibility of text and colors were favorable.ConclusionsBy employing a user-centered design approach, a mobile phone was found to be an adequate and feasible interface for an eHealth intervention. The mobile phone and app are easy to learn and use by patients with COPD. In the final test, the accuracy of the DPA measurement was good. The final version of the eHealth intervention is presently being tested by our group for efficacy in a randomized controlled trial in COPD patients.

Evolving resistance among Gram-positive pathogens.

Antimicrobial therapy is a key component of modern medical practice and a cornerstone for the development of complex clinical interventions in critically ill patients. Unfortunately, the increasing problem of antimicrobial resistance is now recognized as a major public health threat jeopardizing the care of thousands of patients worldwide. Gram-positive pathogens exhibit an immense genetic repertoire to adapt and develop resistance to virtually all antimicrobials clinically available. As more molecules become available to treat resistant gram-positive infections, resistance emerges as an evolutionary response. Thus, antimicrobial resistance has to be envisaged as an evolving phenomenon that demands constant surveillance and continuous efforts to identify emerging mechanisms of resistance to optimize the use of antibiotics and create strategies to circumvent this problem. Here, we will provide a broad perspective on the clinical aspects of antibiotic resistance in relevant gram-positive pathogens with emphasis on the mechanistic strategies used by these organisms to avoid being killed by commonly used antimicrobial agents.

Economic evaluation of policy initiatives in the organisation and delivery of healthcare: a case study of gastroenterology endoscopy services

BackgroundComplex clinical interventions are increasingly subject to evaluation by randomised trial linked to economic evaluation. However evaluations of policy initiatives tend to eschew experimental designs in favour of interpretative perspectives which rarely allow the economic evaluation methods used in clinical trials. As evidence of the cost effectiveness of such initiatives is critical in informing policy, it is important to explore whether conventional economic evaluation methods apply to experimental evaluations of policy initiatives.MethodsWe used mixed methods based on a quasi-experimental design to evaluate a policy initiative whose aim was to expedite the modernisation of gastroenterology endoscopy services in England. We compared 10 sites which had received funding and support to modernise their endoscopy services with 10 controls. We collected data from five waves of patients undergoing endoscopy. The economic component of the study compared sites by levels of investment in modernisation and patients’ use of health service resources, time off work and health related quality of life.ResultsWe found no statistically significant difference between intervention and control sites in investment in modernisation or any patient outcome including health.ConclusionsThis study highlights difficulties in applying the rigour of a randomised trial and associated technique of economic evaluation to a policy initiative. It nevertheless demonstrates the feasibility of using this approach although further work is needed to demonstrate its generalisability in other applications. The present application shows that the small incentives offered to intervention sites did not enhance modernisation of gastroenterology endoscopy services or improve patient outcomes.

Linking home care interventions and hospitalization outcomes for frail and non‐frail elderly patients

Structured clinical data generated using standardized terminologies such as the Omaha System are available for evaluating healthcare quality and patient outcomes. New intervention management grouping approaches are needed to deal with large, complex clinical intervention data sets. We evaluated 56 intervention groups derived using four data management approaches with a data set of 165,700 interventions from 14 home care agencies to determine which approaches and interventions predicted hospitalizations among frail (n = 386) and non-frail (n = 1,364) elders. Hospitalization predictors differed for frail and non-frail elders. Low frequencies in some intervention groups were positively associated with hospitalization outcomes, suggesting that there may be a mismatch between the level of care that is needed and the level of care that is provided.

PRIMER ON THE PRACTICE DOCTORATE FOR NEONATAL NURSE PRACTITIONERS

Recent advances in technology, research, and knowledge have amplified the need for longer and more in-depth education for neonatal nurse practitioners (NNPs). In this article we will briefly review the history of NNP's role and education, define the Doctor of Nursing Practice (DNP), and propose that the practice doctorate is the primary mechanism to meet that need and thus is the future of our profession. Doctor of Nursing Practice programs are designed to prepare the practitioner as an expert clinical NNP. Graduates obtain the highest level of practice expertise integrated with the ability to translate scientific knowledge into complex clinical interventions tailored to meet individual, family, and community health and illness needs. Doctor of Nursing Practice education also expands the scientific basis for practice and clinical practice education, and provides organization and system management and leadership, quality improvement, analytic methods to evaluate practice and apply evidence to practice, enhanced skills in information technology, health policy development, and interdisciplinary collaboration for enhanced patient outcomes.

Evaluation of the nature of untoward clinical events in adult high dependency care

Summary Objective Critically ill patients are exposed to a high degree of clinical risk and adverse events due to a number of factors including complex clinical interventions, polypharmacy, acuity and severity of illness, and a high level of physical dependency. The incidence of adverse events has been investigated as an indicator of quality of care and clinical risk. The purpose of this evaluation was to explore the nature of untoward clinical events (UCE) experienced by adult patients admitted to a high dependency unit in order to introduce an appropriate education and training programme. Method Twenty discrete assessments were carried out involving adult patients admitted to a high dependency unit. A systematic, in-depth assessment of each patient was undertaken by a critical care nurse consultant in order to identify UCE. Quantitative clinical data and descriptive data of diagnosis, clinical interventions, treatment and nursing care were collected. Quantitative data were analysed using SPSS version 11.5 for windows and descriptive data describing the nature and type of untoward clinical events were content analysed and coded into categories. Results Twenty-eight UCE were detected involving ten patients. Four categories of UCE were identified as deviation from treatment plans, hospital standards and guidelines; inaccurate information recorded/communicated influencing a patient’s treatment/care; service/resource shortfalls; and inadequate treatment plans. Conclusions All the events were seemingly preventable and mainly attributable to nursing practice although there were possibly a number of reasons why they occurred. Further research is needed to investigate the correlation of adverse events with organisational factors, nurse staffing and patient dependency.

A critical evaluation of the past 25 years of perinatal nursing practice: opportunities for improvement.

Changes in perinatal nursing over the past 25 years have been abundant. Nursing advocacy has contributed to the introduction of innovations such as single-room maternity care and family-centered care, and to the end of restrictive practices such as the use of hand and leg restraints during birth, routine use of episiotomy, and routine general anesthesia for normal births. Perinatal nursing involves complex clinical interventions, intensive patient and family education, empathetic support and evaluation of family dynamics, and a wide range of opportunities to make a difference in the lives of mothers, babies, and families. The strengths and weaknesses of perinatal nursing practice at the beginning of the new century are chronicled, and suggestions for improvements are made.