SHARING Choices: Lessons Learned from a Primary-Care Focused Advance Care Planning Intervention.

BACKGROUND: Few advance care planning (ACP) interventions have been scaled in primary care. PROBLEM: Best practices for delivering ACP at scale in primary care do not exist and prior efforts have excluded older adults with Alzheimer's Disease and Related Dementias (ADRD). INTERVENTION: SHARING Choices (NCT#04819191) is a multicomponent cluster-randomized pragmatic trial conducted at 55 primary care practices from two care delivery systems in the Mid-Atlantic region of the U.S. We describe the process of implementing SHARING Choices within 19 practices randomized to the intervention, summarize fidelity to planned implementation, and discuss lessons learned. OUTCOMES: Embedding SHARING Choices involved engagement with organizational and clinic-level partners. Of 23,220 candidate patients, 17,931 outreach attempts by phone (77.9%) and the patient portal (22.1%) were made by ACP facilitators and 1215 conversations occurred. Most conversations (94.8%) were less than 45 minutes duration. Just 13.1% of ACP conversations included family. Patients with ADRD comprised a small proportion of patients who engaged in ACP. Implementation adaptations included transitioning to remote modalities, aligning ACP outreach with the Medicare Annual Wellness Visit, accommodating primary care practice flexibility. LESSONS LEARNED: Study findings reinforce the value of adaptable study design; co-designing workflow adaptations with practice staff; adapting implementation processes to fit the unique needs of two health systems; and modifying efforts to meet health system goals and priorities.

Patient-Reported Quality Measures for Palliative Care: The Time is now.

CONTEXT: While progress has been made in the ability to measure the quality of hospice and specialty palliative care, there are notable gaps. A recent analysis conducted by Center for Medicare and Medicaid Services (CMS) revealed a paucity of patient-reported measures, particularly in palliative care domains such as symptom management and communication. OBJECTIVES: The research team, consisting of quality measure and survey developers, psychometricians, and palliative care clinicians, used established state-of-the art methods for developing and testing patient-reported measures. METHODS: We applied a patient-centered, patient-engaged approach throughout the development and testing process. This sequential process included 1) an information gathering phase; 2) a pre-testing phase; 3) a testing phase; and 4) an endorsement phase. RESULTS: To fill quality measure gaps identified during the information gathering phase, we selected two draft measures ("Feeling Heard and Understood" and "Receiving Desired Help for Pain") for testing with patients receiving palliative care in clinic-based settings. In the pre-testing phase, we used an iterative process of cognitive interviews to refine draft items and corresponding response options for the proposed measures. The alpha pilot test supported establishment of protocols for the national beta field test. Measures met conventional criteria for reliability, had strong face and construct validity, and there was diversity in program level scores. The measures received National Quality Forum (NQF) endorsement. CONCLUSION: These measures highlight the key role of patient voices in palliative care and fill a much-needed gap for patient-reported experience measures in our field.

Medicare Advantage coverage restrictions for the costliest physician-administered drugs.

OBJECTIVES: To examine the use of step therapy, prior authorization, and Part D formulary exclusion by 4 large Medicare Advantage (MA) insurers to manage 20 physician-administered drugs with the highest total Medicare expenditures (top 20 drugs). STUDY DESIGN: We collected data for United Healthcare, CVS/Aetna, Humana, and Kaiser plans to create a database of 2020 Part B coverage restrictions and conducted a retrospective analysis of 2018-2020 Part D formularies. METHODS: For each insurer, we calculated the number of top 20 physician-administered drugs subject to prior authorization and step therapy. For physician-administered drugs for which there were no similar or interchangeable alternatives, we examined which insurers required prior authorization or step therapy. Finally, we examined whether insurers restricted access to physician-administered drugs by reducing coverage on Part D formularies. RESULTS: Of the top 20 physician-administered drugs, 17 were subject to prior authorization and 10 were subject to step therapy by at least 1 insurer. For 5 physician-administered drugs without a similar or interchangeable alternative, none were subject to step therapy and all were subject to prior authorization by at least 1 insurer. Across the 4 insurers, 16 physician-administered drugs were covered on all or some of the Part D formularies in 2018, which decreased to 6 in 2020. CONCLUSIONS: Four large MA insurers managed access to expensive physician-administered drugs with a combination of prior authorization, step therapy, and Part D formulary design. When a low-cost alternative exists, these tools can help reduce wasteful spending, but the administrative barriers may also reduce access.

Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms.

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was <$15 USD, whereas newer agents such as methylnaltrexone were expensive ($1,001 USD). For diarrhea, the cost of generic loperamide or diphenoxylate-atropine tablets was <$15 USD. For exocrine pancreatic insufficiency, only brand-name formulations were available, range of cost, $1,072 USD-$1,514 USD. For cancer-associated fatigue, the cost of generic dexamethasone or dexmethylphenidate was <$15 USD, whereas brand-name modafinil was more costly ($1,284 USD). For a 4-drug nausea and vomiting prophylaxis regimen, costs ranged from $181 USD to $1,430 USD. CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible.

Use of Peripheral µ-Opioid Receptor Antagonists for Treating Opioid-Induced Constipation among US Medicare Beneficiaries from 2014 to 2018.

Background: Opioid-induced constipation (OIC) remains the most common adverse event associated with opioid use. Treatment with more novel and costly agents (such as peripheral µ-opioid receptor antagonists [PAMORAs]) may be indicated in patients with laxative-refractory OIC. Three PAMORAs are U.S. Food and Drug Administration approved for managing OIC-methylnaltrexone (FDA approved in 2008), naloxegol (in 2014), and naldemedine (in 2017). These drugs are indicated only in limited scenarios. Their contemporary patterns of use and burden of spending remain unknown. Objective: To evaluate the trends in use and expenditures for the three PAMORAs approved for treating OIC. Design: Retrospective cross-sectional study using the 2014-2018 Medicare Part D Prescription Drug Event data and the 2018 Part D Prescriber Public Use File. Setting: Prescribers and beneficiaries using PAMORAs. Measurements: The annual spending, number of beneficiaries, number of claims, and spending per beneficiary and claim for each PAMORA. The distribution by prescriber specialty using PAMORA. Results: From 2014 to 2018, aggregate spending on PAMORAs increased, from $13.6 to $150.9 million, and use increased, from 4221 to 72,592 beneficiaries. After FDA approval in 2014, naloxegol overtook methylnaltrexone in the number of users in 2015 and spending in 2016. In 2018, 6989 unique prescribers used any PAMORA. Among them, the most common specialties/professions were family practice (20.2%), internal medicine (18.0%), and nurse practitioner (15.4%). Conclusions: Our findings-significant and increasing expenditure on PAMORAs, and broad use across specialties-serve as a call for defining and implementing appropriate use of PAMORAs.

Patient- and Caregiver-Reported Assessment Tools for Palliative Care: Summary of the 2017 Agency for Healthcare Research and Quality Technical Brief.

CONTEXT: Assessment tools are data collection instruments that are completed by or with patients or caregivers and which collect data at the individual patient or caregiver level. OBJECTIVES: The objectives of this study are to 1) summarize palliative care assessment tools completed by or with patients or caregivers and 2) identify needs for future tool development and evaluation. METHODS: We completed 1) a systematic review of systematic reviews; 2) a supplemental search of previous reviews and Web sites, and/or 3) a targeted search for primary articles when no tools existed in a domain. Paired investigators screened search results, assessed risk of bias, and abstracted data. We organized tools by domains from the National Consensus Project Clinical Practice Guidelines for Palliative Care and selected the most relevant, recent, and highest quality systematic review for each domain. RESULTS: We included 10 systematic reviews and identified 152 tools (97 from systematic reviews and 55 from supplemental sources). Key gaps included no systematic review for pain and few tools assessing structural, cultural, spiritual, or ethical/legal domains, or patient-reported experience with end-of-life care. Psychometric information was available for many tools, but few studies evaluated responsiveness (sensitivity to change) and no studies compared tools. CONCLUSION: Few to no tools address the spiritual, ethical, or cultural domains or patient-reported experience with end-of-life care. While some data exist on psychometric properties of tools, the responsiveness of different tools to change and/or comparisons between tools have not been evaluated. Future research should focus on developing or testing tools that address domains for which few tools exist, evaluating responsiveness, and comparing tools.

Use of Newly Covered Versus Established Preventive Care Screening: Comparison of Depression and Smoking Screening.

Pay-for-value initiatives include both depression and smoking screening. Evaluating how patterns of care differ for an established screening (smoking) versus newer screening (depression) can help programs better implement these measures. Our objective is to evaluate (1) patterns of smoking and depression screening and (2) how patient factors affect screening patterns. We analyzed retrospectively collected electronic health record data from 4,763 Medicare-patients in 34 primary care practices between 2010 and 2012. The relationship between multimorbidity, history of stroke, and having depression on receipt of screening was evaluated. The outcome variables were no screening, smoking screening only, or concurrent smoking and depression screening. Fifty percent of patients were screened for smoking at every visit and never screened for depression (n = 2,378). Twelve percent of patients with ≥five visits received both depression and smoking-status screens on each of their first five visits. Screening patterns varied significantly across sites. For example, one site screened approximately 87% of patients for both depression and smoking-status at every visit. Another site screened 93% of patients for smoking during the first visit but did not conduct depression screening. Programs considering initiating new screenings should evaluate the clinic-specific workflow of successful screenings and integrate new screenings using the same strategy.

Implementation of the World Health Organization Trauma Care Checklist Program in 11 Centers Across Multiple Economic Strata: Effect on Care Process Measures.

BACKGROUND: Trauma contributes more than ten percent of the global burden of disease. Initial assessment and resuscitation of trauma patients often requires rapid diagnosis and management of multiple concurrent complex conditions, and errors are common. We investigated whether implementing a trauma care checklist would improve care for injured patients in low-, middle-, and high-income countries. METHODS: From 2010 to 2012, the impact of the World Health Organization (WHO) Trauma Care Checklist program was assessed in 11 hospitals using a stepped wedge pre- and post-intervention comparison with randomly assigned intervention start dates. Study sites represented nine countries with diverse economic and geographic contexts. Primary end points were adherence to process of care measures; secondary data on morbidity and mortality were also collected. Multilevel logistic regression models examined differences in measures pre- versus post-intervention, accounting for patient age, gender, injury severity, and center-specific variability. RESULTS: Data were collected on 1641 patients before and 1781 after program implementation. Patient age (mean 34 ± 18 vs. 34 ± 18), sex (21 vs. 22 % female), and the proportion of patients with injury severity scores (ISS) ≥ 25 (10 vs. 10 %) were similar before and after checklist implementation (p > 0.05). Improvement was found for 18 of 19 process measures, including greater odds of having abdominal examination (OR 3.26), chest auscultation (OR 2.68), and distal pulse examination (OR 2.33) (all p < 0.05). These changes were robust to several sensitivity analyses. CONCLUSIONS: Implementation of the WHO Trauma Care Checklist was associated with substantial improvements in patient care process measures among a cohort of patients in diverse settings.

Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review.

IMPORTANCE: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes. OBJECTIVE: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system. EVIDENCE REVIEW: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015). RESULTS: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10). CONCLUSIONS: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

Impact of Medicare Annual Wellness Visits on Uptake of Depression Screening.

OBJECTIVE: Depression screening is a required part of an initial annual wellness visit (AWV), a benefit for Medicare Part B beneficiaries. It is uncertain whether AWVs will increase depression screening. This study assessed whether patients with an AWV were more likely to be screened for depression than those with a primary care visit. METHODS: A cross-sectional analysis of electronic health record data was conducted for 4,245 Medicare patients who had at least one primary care visit at one of 34 practices within a large multisite provider network between September 2010 and August 2012. Quota sampling was used so that half of the participants had an AWV and half had a randomly selected primary care visit during the study period (the index visit). Multilevel logistic regressions were used to determine whether patients with an AWV had increased odds of depression screening compared with patients with a primary care visit, after adjustment for physician and clinic clustering. RESULTS: Fifteen percent of patients with non-AWVs and 10% of patients with AWVs received depression screening. After accounting for clustering, there was no statistically significant difference in depression screening by visit type. There was a strong site effect, with one site conducting screening during 78% of AWVs and 82% of non-AWVs. Six sites screened none of their patients. CONCLUSIONS: Overall, depression screening during the index AWV was uncommon. By itself, the AWV benefit does not appear to be a strong enough incentive to increase depression screening.

Conformance to Depression Process Measures of Medicare Part B Beneficiaries in Primary Care Settings.

OBJECTIVES: To evaluate conformance to depression screening, management, and outcome quality indicators and to evaluate individual characteristics associated with conformance to these indicators. DESIGN: Cross-sectional study using electronic health record (EHR) data. SETTING: Thirty-four clinics in one healthcare system. PARTICIPANTS: Medicare beneficiaries aged 65 and older with at least one primary care visit between September 2010 and August 2012 (N = 5,000). MEASUREMENTS: Seven measures, current as of 2013, were found for which all the necessary specifications were available in the EHR: general screening, screening within 4 months of diagnosis, screening after stroke, screening after heart disease, depression reassessment, depression response, and depression remission. Multilevel logistic regression analyses were used to determine factors associated with conformance. RESULTS: Screening for depression in Medicare beneficiaries was low (17%). Conformance to measures varied from 10% for the depression response measure to 77% for the depression remission measure. In the adjusted regression analyses for the general screening (adjusted odds ratio (AOR) = 1.45, 95% confidence interval (CI) = 1.01-2.08), depression reassessment (AOR = 4.19, 95% CI = 1.16-15.19), and screening after heart disease (AOR = 5.57, 95% CI = 1.37-22.57) measures, black participants were more likely to be given care that conformed to the numerator criteria than white participants. A strong site effect was found, with 90% of the depression screens being administered at three sites. CONCLUSION: Only a small proportion of Medicare beneficiaries received the recommended screening and follow-up care needed to conform to the quality measures for depression in the primary care setting. Further evaluation of measures of depression care should be conducted before these measures are implemented widely.

Quality of care and short- and long-term outcomes of laryngeal cancer care in the elderly.

OBJECTIVES/HYPOTHESIS: To examine associations between quality of care, short- and long-term treatment-related outcomes, and costs in elderly patients treated for laryngeal squamous cell cancer (SCCA). STUDY DESIGN: Retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data. METHODS: We evaluated longitudinal data from 2,370 patients diagnosed with laryngeal SCCA from 2004 to 2007 using cross-tabulations, multivariate regression, and survival analysis. Using quality indicators derived from guidelines for recommended care and performance measures, an overall summary measure of quality was calculated incorporating summary quality measures for diagnosis, initial treatment, performance, surveillance, treatment for recurrence, and end-of-life care. RESULTS: Higher-quality care was associated with a lower likelihood of long-term weight loss (odds ratio [OR] = 0.6 [0.5-0.8]), stricture (OR = 0.5 [0.3-0.8]), gastrostomy dependence (OR = 0.5 [0.4-0.7]), airway obstruction (OR = 0.7 [0.6-0.9]), tracheostomy (OR = 0.5 [0.3-0.7]), and pneumonia (OR = 0.7 [0.5-0.9]), but had no impact on the likelihood of dysphagia. Higher-quality care was associated with lower risk of death in patients with dysphagia (hazard ratio [HR] = 0.7 [0.6-0.8]), weight loss (HR = 0.8 [0.6-0.9]), airway obstruction (HR = 0.7 [0.6-0.8]), tracheostomy (HR = 0.7 [0.5-0.9]), and pneumonia (HR = 0.8 [0.6-0.9]), but was not associated with survival differences in patients with gastrostomy dependence or stricture. Costs associated with dysphagia, weight loss, stricture, airway obstruction, and pneumonia were lower for patients receiving higher-quality care. CONCLUSIONS: Higher-quality larynx cancer care was associated with a reduced incidence of late airway and swallowing impairment after laryngeal SCCA treatment in elderly patients, with improved survival and reduced costs. These data suggest that greater attention to evidence-based practices associated with quality indicators may lead to improved functional outcomes in the elderly. LEVEL OF EVIDENCE: 2c.

The quality imperative for palliative care.

Palliative medicine must prioritize the routine assessment of the quality of clinical care we provide. This includes regular assessment, analysis, and reporting of data on quality. Assessment of quality informs opportunities for improvement and demonstrates to our peers and ourselves the value of our efforts. In fact, continuous messaging of the value of palliative care services is needed to sustain our discipline; this requires regularly evaluating the quality of our care. As the reimbursement mechanisms for health care in the U.S. shift from fee-for-service to fee-for-value models, palliative care will be expected to report robust data on quality of care. We must move beyond demonstrating to our constituents (including patients and referrers), "here is what we do," and increase the focus on "this is how well we do it" and "let us see how we can do it better." It is incumbent on palliative care professionals to lead these efforts. This involves developing standardized methods to collect data without adding additional burden, comparing and sharing our experiences to promote discipline-wide quality assessment and improvement initiatives, and demonstrating our intentions for quality improvement on the clinical frontline.

Association between palliative case management and utilization of inpatient, intensive care unit, emergency department, and hospice in Medicaid beneficiaries.

Association between palliative case management (PCM) and the utilization of major health services during the last 30 days of life in Medicaid patients with cancer was assessed using retrospective cohort analysis. There were 132 PCM enrollees in the intervention group and 54 non-PCM enrollees in the comparison group. The intervention group had lower inpatient admission rate than that of the comparison group (56.8% vs 74.1%), lower ICU admission rate (12.9% vs 24.1%), longer mean hospice days (45.8 vs 31.1 days), and lower percentage of persons with death in hospital (24.2% vs 35.9%). No statistically significant differences were found in mean intensive care unit days (8.7 vs 9.7 days), treat-and-release emergency department visit rate (22.0% vs 16.7%), or hospice election rate (65.9% vs 70.4%). Palliative case management may reduce hospitalization and increase hospice use in patients nearing death.

Treatment, survival, and costs of laryngeal cancer care in the elderly.

OBJECTIVES/HYPOTHESIS: To examine associations between treatment and volume with survival and costs in elderly patients with laryngeal squamous cell cancer (SCCA). STUDY DESIGN: Retrospective cross-sectional analysis of Surveillance, Epidemiology, and End Results-Medicare data. METHODS: We evaluated 2,370 patients diagnosed with laryngeal SCCA from 2004 to 2007 using cross-tabulations, multivariate logistic and generalized linear regression modeling, and survival analysis. RESULTS: Chemoradiation was significantly associated with supraglottic tumors (relative risk ratio: 2.6, 95% confidence interval [CI]: 1.7-4.0), additional cancer-directed treatment (odds ratio [OR]: 1.8, 95% CI: 1.2-2.7), and a reduced likelihood of surgical salvage (OR: 0.3, 95% CI: 0.2-0.6). Surgery with postoperative radiation was associated with significantly improved survival (hazard ratio [HR]: 0.7, 95% CI: 0.6-0.9), after controlling for patient and tumor variables including salvage. High-volume care was not associated with survival for nonoperative treatment but was associated with improved survival (HR: 0.7, 95% CI: 0.5-0.8) among surgical patients. Initial treatment and 5-year overall costs for chemoradiation were higher than for all other treatment categories. High-volume care was associated with significantly lower costs of care for surgical patients but was not associated with differences in costs of care for nonoperative treatment. CONCLUSIONS: Chemoradiation in elderly patients with laryngeal cancer was associated with increased costs, additional cancer-directed treatment, and a reduced likelihood of surgical salvage. Surgery with postoperative radiation was associated with improved survival in this cohort, and high-volume hospital surgical care was associated with improved survival and lower costs. These findings have implications for improving the quality of laryngeal cancer treatment at a time of both rapid growth in the elderly population and diminishing healthcare resources.

Quality indicators of laryngeal cancer care in the elderly.

OBJECTIVES/HYPOTHESIS: To examine associations between quality of care, survival, and costs in elderly patients treated for laryngeal squamous cell cancer (SCCA). STUDY DESIGN: Retrospective analysis of Surveillance, Epidemiology, and End Results Medicare data. METHODS: We evaluated 2,370 patients diagnosed with laryngeal SCCA from 2004 to 2007 using multivariate regression and survival analysis. Using quality indicators derived from guidelines for recommended care, summary measures of quality were calculated for diagnosis, initial treatment, surveillance, treatment of recurrence, end-of-life care, performance, and an overall summary measure of quality. RESULTS: High-quality care was associated with significant differences in survival for diagnosis [HR = 0.80, 95% CI (0.66-0.97)], initial treatment [HR = 0.75 (0.63-0.88)], surveillance [HR = 0.54 (0.44-0.66)], treatment of recurrence [HR = 1.54 (1.26-1.89)], end-of-life care [HR = 0.69 (0.52-0.92)], performance [HR = 0.41 (0.33-0.52)], and an overall summary measure of quality [HR = 0.66 (0.54-0.80)], which was significantly associated with lower mean incremental costs [-$24,958 (-$35,873 - -$14,042)]. There was a significant survival advantage for initial treatment with surgery and postoperative radiation [HR = 0.66 (0.53-0.82)] and high-volume surgical care [HR = 0.64 (0.43-0.96)] after controlling for all other variables, including quality of care. CONCLUSIONS: High-quality larynx cancer care in elderly patients was associated with improved survival and reduced costs; however, high-quality care for treatment of recurrence was associated with poorer survival. These data suggest that survival outcomes in elderly patients with laryngeal cancer are not entirely explained by differences in the receipt of quality care using existing treatment and performance quality indicators and also suggest a need to develop sensitive and valid quality indicators of larynx cancer care in this population.

Health-related quality of life and functional status quality indicators for older persons with multiple chronic conditions.

OBJECTIVES: To explore central challenges with translating self-reported measurement tools for functional status and health-related quality of life (HRQOL) into ambulatory quality indicators for older people with multiple chronic conditions (MCCs). DESIGN: Review. SETTING: Sources including the National Quality Measures Clearinghouse and National Quality Forum were reviewed for existing ambulatory quality indicators relevant to functional status, HRQOL, and people with MCCs. PARTICIPANTS: Seven informants with expertise in indicators using functional status and HRQOL. MEASUREMENTS: Informant interviews were conducted to explore knowledge about these types of indicators, particularly usability and feasibility. RESULTS: Nine important existing indicators were identified in the review. For process, identified indicators addressed whether providers assessed functional status; outcome indicators addressed quality of life. In interviews, informants agreed that indicators using self-reported data were important in this population. Challenges identified included concerns about usability due to inability to discriminate quality of care adequately between organizations and feasibility concerns regarding high data collection burden, with a correspondingly low response rate. Validity was also a concern because evidence is mixed that healthcare interventions can improve HRQOL or functional status for this population. As a possible first step, a structural standard could be systematic collection of these measures in a specific setting. CONCLUSION: Although functional status and HRQOL are important outcomes for older people with MCCs, few relevant ambulatory quality indicators exist, and there are concerns with usability, feasibility, and validity. Further research is needed on how best to incorporate these outcomes into quality indicators for people with MCCs.

Promoting a culture of safety as a patient safety strategy: a systematic review.

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre-post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm.

Rapid-response systems as a patient safety strategy: a systematic review.

Rapid-response systems (RRSs) are a popular intervention in U.S. hospitals and are supported by accreditors and quality improvement organizations. The purpose of this review is to evaluate the effectiveness and implementation of these systems in acute care settings. A literature search was performed between 1 January 2000 through 30 October 2012 using PubMed, PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials. Studies published in any language evaluating outcome changes that occurred after implementing an RRS and differences between groups using and not using an RRS (effectiveness) or describing methods used by RRSs (implementation) were reviewed. A single reviewer (checked by a second reviewer) abstracted data and rated study quality and strength of evidence. Moderate-strength evidence from a high-quality meta-analysis of 18 studies and 26 lower-quality before-and-after studies published after that meta-analysis showed that RRSs are associated with reduced rates of cardiorespiratory arrest outside of the intensive care unit and reduced mortality. Eighteen studies examining facilitators of and barriers to implementation suggested that the rate of use of RRSs could be improved.

Advancing the science of patient safety.

Despite a decade's worth of effort, patient safety has improved slowly, in part because of the limited evidence base for the development and widespread dissemination of successful patient safety practices. The Agency for Healthcare Research and Quality sponsored an international group of experts in patient safety and evaluation methods to develop criteria to improve the design, evaluation, and reporting of practice research in patient safety. This article reports the findings and recommendations of this group, which include greater use of theory and logic models, more detailed descriptions of interventions and their implementation, enhanced explanation of desired and unintended outcomes, and better description and measurement of context and of how context influences interventions. Using these criteria and measuring and reporting contexts will improve the science of patient safety.