Developing a Practice‐Based Research Network by Integrating Quality Improvement: Challenges and Ingredients for Success

Improving patient outcomes in community‐based settings is the goal of both the Clinical Translational Science Award program and practice‐based quality improvement (QI) programs. Given this common goal, integrating QI and outcomes research is a promising strategy for developing, implementing, and evaluating clinical interventions. This article describes the challenges and strengths illuminated by the conduct of a combined research/QI study in a nascent practice‐based research network. Challenges include research''s exclusion of clinic patients who might benefit from the intervention; QI programs’ less uniform approach to intervention implementation; and the need for both academic and clinically relevant products and publications. A major strength is the increased likelihood of both engaging clinical practices in research and developing successful clinical interventions. Required elements for success include identification of enthusiastic clinical research “champions,” involvement of researchers with clinical experience, and adequate funding to support both research and clinical resources and dissemination. Combined Ql/research projects in the practice‐based research environment have the potential to improve and shorten the cycle from good idea to improved clinical outcomes in real‐world settings. Clin Trans Sci 2012; Volume 5: 351–355     

Goal attainment scaling as a method of clinical service evaluation

The demand for clinical accountability and the documentation of therapeutic effectiveness continues to increase in health-related settings. Therapists are attempting to address this increasing demand by adapting methods based on traditional experimental models of research to evaluate their clinical practice. Experimental and quasi-experimental designs, however, are often limited usefulness in clinical environments for a variety of practical and ethical reasons. This paper presents a method of evaluating the effectiveness of a therapeutic intervention called goal attainment scaling, which involves goal setting procedures and assessment techniques that are practice-based and practitioner-oriented. The procedures are presented and the argument made that goal attainment scaling is a viable method by which one can document therapeutic change and demonstrate clinical accountability.     

Evaluation framework for a multi-site practice-based interprofessional education intervention

The interprofessional literature suggests that there is a lack of evidence of the effectiveness of interprofessional education (IPE) on patient outcomes and critiques the methodology used to determine the evidence. This paper describes and critiques a comprehensive evaluation of a practice-based IPE intervention. The evaluation was challenged by the complexity of the project such as having multiple sites with great variability in settings and participants which required a multifaceted evaluation approach. Rather than reporting evaluation findings, this paper discusses the methodological successes and challenges of the evaluation framework used. The evaluation consisted of four components: process, outcomes, context and systems evaluation. A mixed method approach was used to collect information from a variety of data sources. Each evaluation component captured distinctive but complementary aspects of the intervention, providing a more complete understanding of the intervention. However, challenges also emerged, in particular for the outcomes component. Discussion of the challenges and benefits of each evaluation component are intended to inform future evaluation designs of complex practice-based IP education interventions. Specifically, adding systems concepts into evaluation can strengthen the evidence base of the effectiveness of IP education on IP practice and patient outcomes.     

Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence

Nonpharmacological treatments are considered first-line pain management strategies, but they remain clinically underused. For years, pain-focused pragmatic clinical trials (PCTs) have generated evidence for the enhanced use of nonpharmacological interventions in routine clinical settings to help overcome implementation barriers. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework describes the degree of pragmatism across 9 key domains. Among these, “flexibility in delivery” and “flexibility in adherence,” address a key goal of pragmatic research by tailoring approaches to settings in which people receive routine care. However, to maintain scientific and ethical rigor, PCTs must ensure that flexibility features do not compromise delivery of interventions as designed, such that the results are ethically and scientifically sound. Key principles of achieving this balance include clear definitions of intervention core components, intervention monitoring and documentation that is sufficient but not overly burdensome, provider training that meets the demands of delivering an intervention in real-world settings, and use of an ethical lens to recognize and avoid potential trial futility when necessary and appropriate.PerspectiveThis article presents nuances to be considered when applying the PRECIS-2 framework to describe pragmatic clinical trials. Trials must ensure that patient-centered treatment flexibility does not compromise delivery of interventions as designed, such that measurement and analysis of treatment effects is reliable.     

护理临床研究中干预方案的制定

干预方案的设计是实验性研究中的一个重要环节,直接影响护理和研究的质量和结局。有效护理干预方案的制定须经历一个严谨的过程。本文借助笔者的设计经验提出护理临床研究中干预方案的制定的三个重要步骤：1围绕研究主题建立干预的概念框架;2建立以循证为基础的干预方案,包含目标群体、实施方法、干预特性、护理剂量（成分、数量、频次和周期）、干预者和干预管理;3实施前对干预方案进行审核和测试。     

Talking Health,A pragmatic randomized-controlled health literacy trial targeting sugar-sweetened beverage consumption among adults: Rationale,design & methods

High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤ 8 oz per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings.     

Feasibility of a smoking cessation intervention for teens in the emergency department: reach, implementation fidelity, and acceptability.

BACKGROUND: Traditional efficacy research alone is insufficient to move interventions from research to practice. Motivational interviewing has been adapted for brief encounters in a variety of health care settings for numerous problem behaviors among adolescents and adults. Some experts suggest that motivational interviewing can support a population health approach to reach large numbers of teen smokers without the resource demands of multi-session interventions. OBJECTIVES: To determine the reach, implementation fidelity, and acceptability of a brief motivational tobacco intervention for teens who had treatment in a hospital emergency department. METHODS: Among 74 teens 14 to 19 years old, 40 received a brief motivational tobacco intervention and 34 received brief advice/care as usual at baseline. Follow-up data were collected from the interventional group at 1, 3, and 6 months and from the control group at 6 months. For the interventional group, data also were collected from the teens' parents, the health care personnel who provided the intervention, and emergency department personnel. RESULTS: Findings indicated low levels of reach, high levels of implementation fidelity, and high levels of acceptability for teen patients, their parents, and emergency department personnel. Data suggest that practitioners can operationalize motivational interventions as planned in a clinical setting and that patients and others with an interest in the outcomes may find the interventions acceptable. However, issues of reach may hinder use of the intervention among teens in clinical settings. CONCLUSIONS: Further investigation is needed on mechanisms to reduce barriers to participation, especially barriers related to patient acuity.     

Behavioral therapies trials: a case example

BACKGROUND: Behavior change is integral to the prevention and treatment of many disorders associated with deleterious lifestyles. Rigorous scientific testing of behavior change interventions is an important goal for nursing research. APPROACH: The stage model for behavioral therapy development is recommended as a useful framework for evaluating behavior change strategies. The NIH model specifies three stages from initial testing of novel behavioral therapies to their dissemination in community settings. Definitions of each step in a Stage I trial and a case example of Mindfulness-Based Stress Reduction (MBSR) in therapeutic community treatment are provided. RESULTS: It is feasible to adapt a behavioral therapy such as MBSR using the stage model framework. Steps in the process include: (a) determining pilot study design and describing the population; (b) modifying the intervention and developing the manual; (c) training the teachers; (d) implementing a pilot study; and (e) monitoring treatment integrity. DISCUSSION: The development of behavior therapies requires the same scientific rigor used in pharmacotherapy research. Stage I of the model enables consideration of the "dose" of a behavioral intervention necessary to achieve behavior change in a defined population. The stage model offers an excellent approach to achieving rigor in a variety of potentially useful therapies of interest to nurse researchers.     

Pain,distress, and anticipated recovery for older versus younger emergency department patients after motor vehicle collision

There is a strong reciprocal association between two highly prevalent public health problems: intimate partner violence and heavy drinking, both of which remain major sources of morbidity and mortality. Brief interventions in the Emergency Department setting have been found to be effective in reducing alcohol-related injury but neither classic intimate partner violence nor substance abuse interventions have adequately integrated assessment and treatment for these co-occurring conditions. The overall goal of this study is to determine whether a motivational intervention delivered at the time of an Emergency Department visit will reduce heavy drinking and improve the safety of women experiencing intimate partner violence. We are completing data collection for a randomized controlled trial enrolling 600 female patients, age 18–64, presenting to one of two urban Emergency Departments, who self-disclose both problem drinking and intimate partner violence. Eligible patients are randomized to a brief manual-guided motivational intervention, and a phone booster at 10 days. The intervention, which is delivered by masters-level therapists during the Emergency Department visit, is recorded and monitored for fidelity. Primary outcomes are episodes of heavy drinking and incidents of intimate partner violence, assessed weekly by Interactive Voice Response System for 12 weeks and at 3, 6 and 12 months by interviewers blinded to group assignment. To identify the impact of assessment alone, we included a no-contact control group assessed only once at 3 months. Secondary outcomes include violence severity, changes in the Composite Abuse Scale and alcohol quantity/frequency, along with other health-related behaviors. The analysis will also explore the impact of likely mediators and moderators of the intervention. While screening and intervention for intimate partner violence is now recommended for women of child bearing age in health care settings, there is a need for rigorous evaluations of what works for whom. Upon completion, we will have high-quality evidence regarding the effectiveness of a low-intensity, brief motivational intervention, delivered by social workers in the Emergency Department setting, for decreasing episodes of heavy drinking and intimate partner violence. Ultimately, this is a model could be generalizable to other acute health care settings. ClinicalTrials.gov Registration Number: NCT01207258     

Quality improvement strategies for hypertension management: a systematic review

BACKGROUND: Care remains suboptimal for many patients with hypertension. PURPOSE: The purpose of this study was to assess the effectiveness of quality improvement (QI) strategies in lowering blood pressure. DATA SOURCES: MEDLINE, Cochrane databases, and article bibliographies were searched for this study. STUDY SELECTION: Trials, controlled before-after studies, and interrupted time series evaluating QI interventions targeting hypertension control and reporting blood pressure outcomes were studied. DATA EXTRACTION: Two reviewers abstracted data and classified QI strategies into categories: provider education, provider reminders, facilitated relay of clinical information, patient education, self-management, patient reminders, audit and feedback, team change, or financial incentives were extracted. DATA SYNTHESIS: Forty-four articles reporting 57 comparisons underwent quantitative analysis. Patients in the intervention groups experienced median reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) that were 4.5 mm Hg (interquartile range [IQR]: 1.5 to 11.0) and 2.1 mm Hg (IQR: -0.2 to 5.0) greater than observed for control patients. Median increases in the percentage of individuals achieving target goals for SBP and DBP were 16.2% (IQR: 10.3 to 32.2) and 6.0% (IQR: 1.5 to 17.5). Interventions that included team change as a QI strategy were associated with the largest reductions in blood pressure outcomes. All team change studies included assignment of some responsibilities to a health professional other than the patient's physician. LIMITATIONS: Not all QI strategies have been assessed equally, which limits the power to compare differences in effects between strategies. CONCLUSION: QI strategies are associated with improved hypertension control. A focus on hypertension by someone in addition to the patient's physician was associated with substantial improvement. Future research should examine the contributions of individual QI strategies and their relative costs.     

A systematic review of peer teaching and learning in clinical education

Aims and objectives. The purpose of this review is to provide a framework for peer teaching and learning in the clinical education of undergraduate health science students in clinical practice settings and make clear the positive and negative aspects of this teaching and learning strategy. Background. The practice of using peers incidentally or purposefully in the clinical education of apprentice or undergraduate health science students is a well‐established tradition and commonly practiced, but lacks definition in its implementation. Method. The author conducted a search of health science and educational electronic databases using the terms peer, clinical education and undergraduate. The set limitations were publications after 1980 (2005 inclusive), English language and research papers. Selection of studies occurred: based on participant, intervention, research method and learning outcomes, following a rigorous critical and quality appraisal with a purposefully developed tool. The results have been both tabled and collated in a narrative summary. Results. Twelve articles met the inclusion criteria, representing five countries and four health science disciplines. This review reported mostly positive outcomes on the effectiveness of peer teaching and learning; it can increase student's confidence in clinical practice and improve learning in the psychomotor and cognitive domains. Negative aspects were also identified; these include poor student learning if personalities or learning styles are not compatible and students spending less individualized time with the clinical instructor. Conclusions. Peer teaching and learning is an effective educational intervention for health science students on clinical placements. Preclinical education of students congruent with the academic timetable increases student educational outcomes from peer teaching and learning. Strategies are required prior to clinical placement to accommodate incompatible students or poor student learning. Relevance to clinical practice. The findings from this systematic review, although not statistically significant, do have pragmatic implications for clinical practice. It can increase clinical placement opportunities for undergraduate health students, assist clinical staff with workload pressures and increase clinician time with clients, while further developing students’ knowledge, skills and attitudes.     

医学领域质量改进与卓越质量改进报告规范

近年来,质量改进方法学在各领域的应用日益增多,其在医学领域的应用也逐渐受到重视。医学领域的质量改进是在需达到的医疗目标指引下,采用不断循环改进的方法将现有知识转化为临床实践,通过可量化改进指标的变化验证所采取的改进措施是否有效,从而完善医疗过程、改善医疗质量。本文介绍医疗领域质量改进项目的结构及论文报告规范,包括标题与摘要、引言、方法、结果、讨论部分的内容及要素,并举例解析,为医护人员开展医疗领域质量改进研究提供参考。     

A systematic review of heart failure dyadic self-care interventions focusing on intervention components,contexts, and outcomes

BackgroundHaving support from an informal carer is important for heart failure patients. Carers have the potential to improve patient self-care. At the same time, it should be acknowledged that caregiving could affect the carer negatively and cause emotional reactions of burden and stress. Dyadic (patient and informal carer) heart failure self-care interventions seek to improve patient self-care such as adherence to medical treatment, exercise training, symptom monitoring and symptom management when needed. Currently, no systematic assessment of dyadic interventions has been conducted with a focus on describing components, examining physical and delivery contexts, or determining the effect on patient and/or carer outcomes.ObjectiveTo examine the components, context, and outcomes of dyadic self-care interventions.DesignA systematic review registered in PROSPERO, following PRISMA guidelines with a narrative analysis and realist synthesis. Data Sources: PubMed, EMBASE, Web of Science, PsycINFO, and Cochrane Central Register of Controlled Trials were searched using MeSH, EMTREE terms, keywords, and keyword phrases for the following concepts: dyadic, carers, heart failure and intervention. Eligible studies were original research, written in English, on dyadic self-care interventions in adult samples.Review methodsWe used a two-tiered analytic approach including both completed studies with power to determine outcomes and ongoing studies including abstracts, small pilot studies and protocols to forecast future directions.ResultsEighteen papers – 12 unique, completed intervention studies (two quasi- and ten experimental trials) from 2000 to 2016 were reviewed.Intervention components fell into three groups – education, support, and guidance. Interventions were implemented in 5 countries, across multiple settings of care, and involved 3 delivery modes – face to face, telephone or technology based. Dyadic intervention effects on cognitive, behavioral, affective and health services utilization outcomes were found within studies. However, findings across studies were inconclusive as some studies reported positive and some non-sustaining outcomes on the same variables. All the included papers had methodological limitations including insufficient sample size, mixed intervention effects and counter-intuitive outcomes.ConclusionsWe found that the evidence from dyadic interventions to promote heart failure self-care, while growing, is still very limited. Future research needs to involve advanced sample size justification, innovative solutions to increase and sustain behavior change, and use of mixed methods for capturing a more holistic picture of effects in clinical practice.     

Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

BackgroundIn recent years there has been much emphasis on ‘research waste’ caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial.ObjectiveWe therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practiceMethodsBased on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design.ResultsA comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context.ConclusionThis comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user.     

The impact of pharmacist interventions on health-related quality of life

OBJECTIVE: To describe and evaluate pharmacy practice-based studies that include health-related quality of life (HRQL) as an outcome measure in assessments of pharmacist interventions and to recommend approaches for incorporating HRQL as a patient outcome in pharmacy practice-based intervention studies. METHODS: Citations were identified in MEDLINE, Healthstar, EMBASE, and International Pharmaceutical Abstracts from January 1988 to February 1999 using terms for health-related quality of life and pharmacist interventions. Abstracts were screened by two reviewers and articles that reported a pharmacist intervention performed with HRQL as an outcome measure were included. RESULTS: Of 689 citations identified by the literature search terms, 11 met the inclusion criteria. Nine studies contained a disease-specific focus. The SF-36, or its variations, was the only generic instrument used, and seven studies described using a disease-specific instrument. Pharmacist interventions inconsistently demonstrated positive effects on patient HRQL. DISCUSSION: Possible reasons for not detecting significant differences in HRQL include length of study period, insufficient sample size and power, selection bias, labeling effects, the type of measure applied, and lack of actual influence of pharmaceutical services on HRQL. Strategies to strengthen the design and methodologic approach, such as the reporting of effect size, are recommended. CONCLUSIONS: In order to demonstrate the positive effect of pharmaceutical services on patient health, pharmacy practice researchers should continue incorporating HRQL outcome measures, complemented by clinical, economic, and other humanistic outcome indicators.     

An alternative paradigm for clinical nursing research: an exemplar

Effectiveness research is undertaken to evaluate the effects of interventions in achieving desired outcomes when tested in the real-world conditions of everyday practice. Although the randomized clinical trial (RCT) is considered the gold standard for effectiveness research, its feasibility, generalizability, and the clinical utility of its results are being questioned. This state of the science prompted the call for a paradigm shift, characterized by alternative methods for clinical research. The alternative methods attempt to account for clinical realities when conducting research, with the goal of minimizing discrepancies in the perspective and assumptions underlying practice and research. In this article a theory-driven approach to intervention evaluation is presented as a viable alternative paradigm for clinical research. The application of this approach demands changes in four aspects of research: participant selection criteria, assignment to treatment options, delivery of the intervention, and selection of outcome measures. The changes are discussed at the conceptual level and illustrated with examples from an ongoing multisite study aimed at determining the usefulness of this theory-driven approach to intervention evaluation.     

Research needs and strategies to establish best practices and cost effective models for chronic critical illness

Past research in chronic critical illness has been effective in defining the population and identifying unique aspects of their outcomes and resource needs, but there has been little research focused on interventions to improve outcomes. This review discusses some research priorities that could have immediate impact on patient outcomes. General topics include prevention or limiting the incidence of chronic critical illness; specific topics related to patient management, such as interventions for weaning, rehabilitation, nutrition or infections; and methods to enhance communication and end-of-life care. In addition to specific patient management interventions, further comparative effectiveness research on care settings is indicated, considering the expected growth in the patient population and the substantial resource needs.     

A qualitative study of patients' and physicians' views about practice-based functional health assessment

BACKGROUND: Interest has increased in using patient-based measures of health status in everyday clinical practice. Patient reports of functioning and well-being have been most commonly used in clinical-practice settings at the group-level for research rather than at the individual-patient level for clinical decision-making. OBJECTIVES: Little is known about patients' and physicians' preferences for practice-based functional health assessment. Qualitative methods were used to discover patient and physician attitudes about the use of functional health assessment tools in everyday clinical practice. RESEARCH DESIGN: Six focus groups were conducted with 39 asthma patients who had been invited to participate in practice-based functional health assessment (FHA). Thirty in-depth, semistructured interviews were conducted with physicians in a single health maintenance organization to discover their attitudes about practice-based FHA. SETTING: A large group-model health maintenance organization in Southeastern Wisconsin that consists of 200,000 members and 315 providers across 22 locations. Patients were selected from the Asthma Clinic and physicians were selected among all MD providers. RESULTS: Patients identified numerous practical implementation problems with practice-based FHA, including the site of data collection, feedback on their responses, and who would have access to the data. Patients also identified several barriers and benefits of practice-based FHA. Before they would commit financial and human capital resources and time, clinicians wanted information about the effectiveness and value of practice-based FHA. CONCLUSIONS: Several barriers to practice-based FHA were identified by patients and physicians. The evidence-based barrier identified by physicians needs to be overcome with additional intervention studies that push the envelope on several fronts including: (1) the type of tool; (2) the type of patient; (3) the type of setting; and (4) the recipients of the information. Interpretation guides and assessment linkage steps need to be developed and tested.