Better Respiratory Education and Treatment Help Empower (BREATHE) study: Methodology and baseline characteristics of a randomized controlled trial testing a transitional care program to improve patient-centered care delivery among chronic obstructive pulmonary disease patients.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home. METHODS: In the study's initial phase, we co-developed the BREATHE transitional care program with COPD patients, family-caregivers, and stakeholders. The program offers tailored services to address individual patients' needs and priorities at the hospital and for 3months post discharge. We tested the program in a single-blinded RCT with 240 COPD patients who were randomized to receive the program or 'usual care'. Program participants were offered the opportunity to invite a family caregiver, if available, to enroll with them into the study. The primary outcomes were the combined number of COPD-related hospitalizations and Emergency Department (ED) visits per participant at 6months post discharge, and the change in health-related quality of life over the 6months study period. Other measures include 'all cause' hospitalizations and ED visits; patient activation; self-efficacy; and, self-care behaviors. DISCUSSION: Unlike 1month transitional care programs that focus on patients' post-acute care needs, the BREATHE program helps hospitalized COPD patients manage the post discharge period as well as prepare them for long term self-management of COPD. If proven effective, this program may offer a timely solution for hospitals in their attempts to reduce COPD rehospitalizations.

Post-traumatic stress disorder symptoms after acute lung injury: a 2-year prospective longitudinal study.

BACKGROUND: Survivors of critical illnesses often have clinically significant post-traumatic stress disorder (PTSD) symptoms. This study describes the 2-year prevalence and duration of PTSD symptoms after acute lung injury (ALI), and examines patient baseline and critical illness/intensive care-related risk factors. METHOD: This prospective, longitudinal cohort study recruited patients from 13 intensive care units (ICUs) in four hospitals, with follow-up 3, 6, 12 and 24 months after ALI onset. The outcome of interest was an Impact of Events Scale - Revised (IES-R) mean score ≥1.6 ('PTSD symptoms'). RESULTS: During the 2-year follow-up, 66/186 patients (35%) had PTSD symptoms, with the greatest prevalence by the 3-month follow-up. Fifty-six patients with post-ALI PTSD symptoms survived to the 24-month follow-up, and 35 (62%) of these had PTSD symptoms at the 24-month follow-up; 50% had taken psychiatric medications and 40% had seen a psychiatrist since hospital discharge. Risk/protective factors for PTSD symptoms were pre-ALI depression [hazard odds ratio (OR) 1.96, 95% confidence interval (CI) 1.06-3.64], ICU length of stay (for a doubling of days, OR 1.39, 95% CI 1.06-1.83), proportion of ICU days with sepsis (per decile, OR 1.08, 95% CI 1.00-1.16), high ICU opiate doses (mean morphine equivalent ≥100 mg/day, OR 2.13, 95% CI 1.02-4.42) and proportion of ICU days on opiates (per decile, OR 0.83, 95% CI 0.74-0.94) or corticosteroids (per decile, OR 0.91, 95% CI 0.84-0.99). CONCLUSIONS: PTSD symptoms are common, long-lasting and associated with psychiatric treatment during the first 2 years after ALI. Risk factors include pre-ALI depression, durations of stay and sepsis in the ICU, and administration of high-dose opiates in the ICU. Protective factors include durations of opiate and corticosteroid administration in the ICU.

Making health care safer II: an updated critical analysis of the evidence for patient safety practices.

OBJECTIVES: To review important patient safety practices for evidence of effectiveness, implementation, and adoption. DATA SOURCES: Searches of multiple computerized databases, gray literature, and the judgments of a 20-member panel of patient safety stakeholders. REVIEW METHODS: The judgments of the stakeholders were used to prioritize patient safety practices for review, and to select which practices received in-depth reviews and which received brief reviews. In-depth reviews consisted of a formal literature search, usually of multiple databases, and included gray literature, where applicable. In-depth reviews assessed practices on the following domains: • How important is the problem? • What is the patient safety practice? • Why should this practice work? • What are the beneficial effects of the practice? • What are the harms of the practice? • How has the practice been implemented, and in what contexts? • Are there any data about costs? • Are there data about the effect of context on effectiveness? We assessed individual studies for risk of bias using tools appropriate to specific study designs. We assessed the strength of evidence of effectiveness using a system developed for this project. Brief reviews had focused literature searches for focused questions. All practices were then summarized on the following domains: scope of the problem, strength of evidence for effectiveness, evidence on potential for harmful unintended consequences, estimate of costs, how much is known about implementation and how difficult the practice is to implement. Stakeholder judgment was then used to identify practices that were "strongly encouraged" for adoption, and those practices that were "encouraged" for adoption. RESULTS: From an initial list of over 100 patient safety practices, the stakeholders identified 41 practices as a priority for this review: 18 in-depth reviews and 23 brief reviews. Of these, 20 practices had their strength of evidence of effectiveness rated as at least "moderate," and 25 practices had at least "moderate" evidence of how to implement them. Ten practices were classified by the stakeholders as having sufficient evidence of effectiveness and implementation and should be "strongly encouraged" for adoption, and an additional 12 practices were classified as those that should be "encouraged" for adoption. CONCLUSIONS: The evidence supporting the effectiveness of many patient safety practices has improved substantially over the past decade. Evidence about implementation and context has also improved, but continues to lag behind evidence of effectiveness. Twenty-two patient safety practices are sufficiently well understood, and health care providers can consider adopting them now.

Measurement error in performance studies of health information technology: lessons from the management literature.

Just as researchers and clinicians struggle to pin down the benefits attendant to health information technology (IT), management scholars have long labored to identify the performance effects arising from new technologies and from other organizational innovations, namely the reorganization of work and the devolution of decision-making authority. This paper applies lessons from that literature to theorize the likely sources of measurement error that yield the weak statistical relationship between measures of health IT and various performance outcomes. In so doing, it complements the evaluation literature's more conceptual examination of health IT's limited performance impact. The paper focuses on seven issues, in particular, that likely bias downward the estimated performance effects of health IT. They are 1.) negative self-selection, 2.) omitted or unobserved variables, 3.) mis-measured contextual variables, 4.) mismeasured health IT variables, 5.) lack of attention to the specific stage of the adoption-to-use continuum being examined, 6.) too short of a time horizon, and 7.) inappropriate units-of-analysis. The authors offer ways to counter these challenges. Looking forward more broadly, they suggest that researchers take an organizationally-grounded approach that privileges internal validity over generalizability. This focus on statistical and empirical issues in health IT-performance studies should be complemented by a focus on theoretical issues, in particular, the ways that health IT creates value and apportions it to various stakeholders.

Drivers and barriers in health IT adoption: a proposed framework.

Despite near (and rare) consensus that the adoption and diffusion of health information technology (health IT) will bolster outcomes for organizations, individuals, and the healthcare system as a whole, there has been surprisingly little consideration of the structures and processes within organizations that might drive the adoption and effective use of the technology. Management research provides a useful lens through which to analyze both the determinants of investment and the benefits that can ultimately be derived from these investments. This paper provides a conceptual framework for understanding health IT adoption. In doing so, this paper highlights specific organizational barriers or enablers at different stages of the adoption process - investment, implementation, and use - and at different levels of organizational decision-making - strategic, operational, and frontline. This framework will aid both policymakers and organizational actors as they make sense of the transition from paper-based to electronic systems.

Novel analysis of clinically relevant diagnostic errors in point-of-care devices.

BACKGROUND: To ensure proper clinical decision-making and avoid preventable harm, the quality of point-of-care (POC) device measures is routinely assessed. Traditional analyses may not reveal clinically important diagnostic errors. OBJECTIVES: To compare results between a novel analytic framework and traditional analyses. METHODS: Patients in four anticoagulation clinics provided two measures of the International Normalized Ratio (INR) at the same visit as part of routine quality assurance: one via a venous sample and one fingerstick. These were assessed with Hemochron POC devices. Traditional, quarterly, quality assurance assessments emphasized correlation analysis. The novel analysis used enhanced graphics and a validated assessment of clinical decision-making. RESULTS: 1518 paired INRs were analyzed. The correlation between the POC and laboratory assessments ranged between 0.84 and 0.91. Traditional quality assurance showed that the Hemochron devices were acceptable for continued use in each quarterly analysis. Enhanced graphical analysis demonstrated that the Hemochron devices never reported seven common INR values. The Hemochron devices systematically inflated values < 3 and deflated values > 4, biasing results towards the target INR range. Consequently, the Hemochron devices lead to a different clinical decision than the clinical laboratory measure in 31% of cases (458/1466; 95% confidence interval [CI] 29-34). When the reference INR was low, the Hemochron devices would not result in appropriate dose increases in 52% of cases (95% CI 48-56), placing these patients at risk for a significant adverse drug event. CONCLUSIONS: Our novel, clinically relevant analysis revealed previously undetected deficiencies in our POC INR devices, and our approach should be adopted by industry, regulators, and institutions.

Public reporting of health care-associated infections (HAIs): approach to choosing HAI measures.

OBJECTIVE: To develop a method for selecting health care-associated infection (HAI) measures for public reporting. CONTEXT: HAIs are common, serious, and costly adverse outcomes of medical care that affect 2 million people in the United States annually. Thirty-seven states have introduced or passed legislation requiring public reporting of HAI measures. State legislation varies widely regarding which HAIs to report, how the data are collected and reported, and public availability of results. DESIGN: The Maryland Health Care Commission developed an HAI Technical Advisory Committee (TAC) that consisted of a group of experts in the field of healthcare epidemiology, infection prevention and control (IPC), and public health. This group reviewed public reporting systems in other states, surveyed Maryland hospitals to determine the current state of IPC programs, performed a literature review on HAI measures, and developed six criteria for ranking the measures: impact, improvability, inclusiveness, frequency, functionality, and feasibility. The committee and experts in the field then ranked each of 18 proposed HAI measures. A composite score was determined for each measure. RESULTS: Among outcome measures, the rate of central line-associated bloodstream infections ranked highest, followed by the rate of post-coronary artery bypass grafting surgical-site infections. Among process measures, perioperative antimicrobial prophylaxis, compliance with central-line bundles, compliance with hand hygiene, and healthcare-worker influenza vaccination ranked highest. CONCLUSIONS: Our qualitative criteria facilitated consensus on the HAI TAC and provided a useful framework for public reporting of HAI measures. Validation will be important for such approaches to be supported by the scientific community.

Beyond "see one, do one, teach one": toward a different training paradigm.

In the process of acquiring new skills, physicians-in-training may expose patients to harm because they lack the required experience, knowledge and technical skills. Yet, most teaching hospitals use inexperienced residents to care for high-acuity patients in complex and dynamic environments and provide limited supervision from experienced clinicians. Multiple efforts in the last few years have started to address the problem of patient safety. Examples include voluntary incident-reporting systems and team training workshops for practising clinicians. Fewer efforts have addressed the deficits in training new physicians, especially related to knowledge, skills and competence. The current apprenticeship or "see one, do one, teach one" model is insufficient because trainees learn by practising on real patients, which is particularly an issue when performing procedures. Residents have expressed that they do not feel adequately trained to perform procedures safely by themselves. In this paper, we conduct an informal review of the impact of current training methods on patient safety. In addition, we propose a new training paradigm that integrates competency-based knowledge and clinical skills, with deliberate attitudinal and behavioural changes focused on patient safety in a safe medically simulated environment. We do so with the hope of creating a better marriage between the missions of training and patient safety.

Beyond "see one, do one, teach one": toward a different training paradigm.

In the process of acquiring new skills, physicians-in-training may expose patients to harm because they lack the required experience, knowledge and technical skills. Yet, most teaching hospitals use inexperienced residents to care for high-acuity patients in complex and dynamic environments and provide limited supervision from experienced clinicians. Multiple efforts in the last few years have started to address the problem of patient safety. Examples include voluntary incident-reporting systems and team training workshops for practising clinicians. Fewer efforts have addressed the deficits in training new physicians, especially related to knowledge, skills and competence. The current apprenticeship or "see one, do one, teach one" model is insufficient because trainees learn by practising on real patients, which is particularly an issue when performing procedures. Residents have expressed that they do not feel adequately trained to perform procedures safely by themselves. In this paper, we conduct an informal review of the impact of current training methods on patient safety. In addition, we propose a new training paradigm that integrates competency-based knowledge and clinical skills, with deliberate attitudinal and behavioural changes focused on patient safety in a safe medically simulated environment. We do so with the hope of creating a better marriage between the missions of training and patient safety.

The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration.

As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work. This "Explanation and Elaboration" document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org.

Improving comfort and communication in the ICU: a practical new tool for palliative care performance measurement and feedback.

OBJECTIVE: To develop a practical set of measures for routine monitoring, performance feedback, and improvement in the quality of palliative care in the intensive care unit (ICU). DESIGN: Use of an interdisciplinary iterative process to create a prototype "bundle" of indicators within previously established domains of ICU palliative care quality; operationalization of indicators as specified measures; and pilot implementation to evaluate feasibility and baseline ICU performance. SETTING: The national Transformation of the Intensive Care Unit program developed in the United States by VHA Inc. PATIENTS: Critically ill patients in ICUs for 1, > 3, and > 5 days. MEASUREMENTS AND MAIN RESULTS: Palliative care processes including identification of patient preferences and decision making surrogates, communication between clinicians and patients/families, social and spiritual support, and pain assessment and management, as documented in medical records. Application is triggered by specified lengths of ICU stay. Pilot testing in 19 ICUs (review of > 100 patients' records) documented feasibility, while revealing opportunities for quality improvement in clinician-patient/family communication and other key components of ICU palliative care. CONCLUSIONS: The new bundle of measures is a prototype for routine measurement of the quality of palliative care in the ICU. Further investigation is needed to confirm associations between measured processes and outcomes of importance to patients and families, as well as other aspects of validity.

Variation in caregiver perceptions of teamwork climate in labor and delivery units.

OBJECTIVE: To test the psychometric soundness of a teamwork climate survey in labor and delivery, examine differences in perceptions of teamwork, and provide benchmarking data. DESIGN: Cross-sectional survey of labor and delivery caregivers in 44 hospitals in diverse regions of the US, using the Safety Attitudes Questionnaire teamwork climate scale. RESULTS: The response rate was 72% (3382 of 4700). The teamwork climate scale had good internal reliability (overall alpha = 0.78). Teamwork climate scale factor structure was confirmed using multilevel confirmatory factor analyses (CFI = 0.95, TLI = 0.92, RMSEA = 0.12, SRMR(within) = 0.04, SRMR(between) = 0.09). Aggregation of individual-level responses to the L&D unit-level was supported by ICC (1) = 0.06 (P < 0.001), ICC (2) = 0.83 and mean r (wg(j)) = 0.83. ANOVA demonstrated differences between caregivers F (7, 3013) = 10.30, P < 0.001 and labor and delivery units, F (43, 1022) = 3.49, P < 0.001. Convergent validity of the scale scores was measured by correlations with external teamwork-related items: collaborative decision making (r = 0.780, P < 0.001), use of briefings (r = 0.496, P < 0.001) and perceived adequacy of staffing levels (r = 0.593, P < 0.001). CONCLUSION: We demonstrate a psychometrically sound teamwork climate scale, correlate it to external teamwork-related items, and provide labor and delivery teamwork benchmarks. Further teamwork climate research should explore the links to clinical and operational outcomes.

What is the patient really taking? Discrepancies between surgery and anesthesiology preoperative medication histories.

BACKGROUND: Surgical patients may be at risk for medication discrepancies that may lead to medication errors because both the anesthesiologist and the surgeon write separate preoperative medication histories. METHODS: A prospective observational study was conducted to examine the extent of medication and allergy discrepancies between surgical and anesthesia preoperative medication histories for patients admitted to two surgical intensive care units in an academic medical center. RESULTS: Of the 79 patient records reviewed, 58 (73%) contained at least one discrepancy, 23% had different allergy information, 56% had different preoperative medications, and 43% had different doses or dosing frequencies listed in the medication histories. Of the 988 allergies, medications, and doses or dosing frequencies documented in the two histories, 456 (46%) contained discrepancies. Of these discrepancies, 20 (5%) were due to different allergies, 293 (64%) to different medications, and 143 (31%) to different doses or dosing frequencies. CONCLUSIONS: Discrepancies in preoperative medication histories between surgical and anesthesia records occur in most patients and further work is required to help improve agreement of patient medication histories between services.

Evaluation of the culture of safety: survey of clinicians and managers in an academic medical center.

BACKGROUND: Despite the emphasis on patient safety in health care, few organizations have evaluated the extent to which safety is a strategic priority or their culture supports patient safety. In response to the Institute of Medicine's report and to an organizational commitment to patient safety, we conducted a systematic assessment of safety at the Johns Hopkins Hospital (JHH) and, from this, developed a strategic plan to improve safety. The specific aims of this study were to evaluate the extent to which the culture supports patient safety at JHH and the extent to which safety is a strategic priority. METHODS: During July and August 2001 we implemented two surveys in disparate populations to assess patient safety. The Safety Climate Scale (SCS) was administered to a sample of physicians, nurses, pharmacists, and other ICU staff. SCS assesses perceptions of a strong and proactive organizational commitment to patient safety. The second survey instrument, called Strategies for Leadership (SLS), evaluated the extent to which safety was a strategic priority for the organization. This survey was administered to clinical and administrative leaders. RESULTS: We received 395 completed SCS surveys from 82% of the departments and 86% of the nursing units. Staff perceived that supervisors had a greater commitment to safety than senior leaders. Nurses had higher scores than physicians for perceptions of safety. Twenty three completed SLS surveys were received from 77% of the JHH Patient Safety Committee members and 50% of the JHH Management Committee members. Management Committee responses were more positive than Patient Safety Committee, indicating that management perceived safety efforts to be further developed. Strategic planning received the lowest scores from both committees. CONCLUSIONS: We believe this is one of the first large scale efforts to measure institutional culture of safety and then design improvements in health care. The survey results suggest that strategic planning of patient safety needs enhancement. Several efforts to improve our culture of safety were initiated based on these results, which should lead to measurable improvements in patient safety.

Intensive care unit nurse staffing and the risk for complications after abdominal aortic surgery.

CONTEXT: We previously found that length of stay in the intensive care unit (ICU) after abdominal aortic surgery increased when fewer ICU nurses were available per patient. We hypothesized that having fewer nurses increases the risk for medical complications. OBJECTIVE: To evaluate the association between nurse-to-patient ratio in the ICU and risk for medical and surgical complications after abdominal aortic surgery. DESIGN: Observational study. SETTING: All nonfederal acute care hospitals in Maryland. DATA SOURCES: Information about patients came from hospital discharge data on all patients in Maryland with a principal procedure code for abdominal aortic surgery from 1994 through 1996 (n = 2606). The organizational characteristics of ICUs were obtained by surveying ICU medical and nursing directors in 1996 at the 46 Maryland hospitals that performed abdominal aortic surgery. Thirty-nine of the ICU directors (85%) completed the survey. EXPOSURE: Surgery in hospitals with fewer ICU nurses (in which each nurse cared for three or four patients) compared with hospitals with more ICU nurses (in which each nurse cared for one or two patients). OUTCOME: Proportion of patients who developed postoperative complications. RESULTS: Seven hospitals with 478 patients had fewer ICU nurses, and 31 hospitals with 2128 patients had more ICU nurses. Patients in hospitals with fewer nurses were more likely than patients in hospitals with more nurses to have complications: 47% vs. 34% had any complication, 43% vs. 28% had any medical complication, 24% vs. 9% had pulmonary insufficiency after a procedure, and 21% vs. 13% were reintubated (P < 0.001 for all comparisons). After adjustment for patient, hospital, and surgeon characteristics, having fewer versus more ICU nurses was associated with an increased risk for any complication (relative risk, 1.7 [95% CI, 1.3 to 2.4]), any medical complication (relative risk, 2.1 [CI, 1.5 to 2.9]), pulmonary insufficiency after procedure (relative risk, 4.5 [CI, 2.9 to 6.9]) and reintubation (relative risk, 1.6 [CI, 1.1 to 2.5]). CONCLUSION: Having fewer ICU nurses per patient is associated with increased risk for respiratory-related complications after abdominal aortic surgery.

Effect of nurse-to-patient ratio in the intensive care unit on pulmonary complications and resource use after hepatectomy.

BACKGROUND: Nurse-to-patient ratios in the intensive care unit are associated with postoperative mortality, morbidity, and costs after some high-risk surgery. OBJECTIVE: To determine if having 1 nurse caring for 1 or 2 patients ("more nurses") versus 1 nurse caring for 3 or more patients ("fewer nurses") in the intensive care unit at night is associated with differences in clinical and economic outcomes after hepatectomy. METHODS: Statewide observational cohort study of 569 adults who had hepatic resection, 1994 to 1998. Hospital discharge data were linked to a prospective survey of organizational characteristics in the intensive care unit. Multivariate analysis was used to determine the association of nighttime nurse-to-patient ratios with in-hospital mortality, length of stay, hospital costs, and specific postoperative complications. RESULTS: A total of 240 patients at 25 hospitals had fewer nurses; 316 patients in 8 hospitals had more nurses. No significant association between nighttime nurse-to-patient ratios and in-hospital mortality was detected. The overall complication rate was 28%. By univariate analysis, patients with fewer nurses had increased risks for pulmonary failure (5.8% vs 1.6%, relative risk, 3.6; 95% CI, 1.3-10.1; P=.006) and reintubation (10.8% vs 1.9%, relative risk, 5.7; 95% CI, 2.4-13.7; P<.001). By multivariate analysis, patients with fewer nurses had increased risk for reintubation (odds ratio, 2.9; 95% CI, 1.0-8.1; P=.04) and a 14% increase (95% CI, 3%-23%; P=.007) or an additional $1248 (95% CI, $384-$2112; P = .005) in total hospital costs. CONCLUSIONS: Fewer nurses at night is associated with increased risk for specific postoperative pulmonary complications and with increased resource use in patients undergoing hepatectomy.

Developing and implementing measures of quality of care in the intensive care unit.

As consumers, payers, and regulatory agencies require evidence regarding quality of care, the demand for intensive care unit (ICU) quality measures will likely grow. ICU providers and professional societies may need to partner with experts in quality measurement to develop and implement quality measures. This essay outlines the steps for developing and implementing quality measures and provides examples of potential ICU quality indicators. Outcome measures, in particular mortality rates, require risk adjustment, making data collection burdensome and broad implementation unlikely. On the other hand, structure and process measures may be feasible to implement broadly. Given the steps for developing quality measures outlined in this essay and the growing evidence in the literature regarding the impact of ICU care, the future should realize the development and implementation of ICU quality indicators that are rigorously developed and provide insights into opportunities to improve the quality of ICU care.