Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ).

OBJECTIVES: To determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs). METHODS: In a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US clinical centers, 1360 HCWs at risk for COVID-19 infection were enrolled between April and November 2020. Participants were randomized to HCQ or matched placebo. The HCQ dosing included a loading dose of HCQ 600 mg twice on day 1, followed by 400 mg daily for 29 days. The primary outcome was a composite of confirmed or suspected COVID-19 clinical infection by day 30, defined as new-onset fever, cough, or dyspnea and either a positive SARS-CoV-2 polymerase chain reaction test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected). RESULTS: Study enrollment closed before full accrual due to recruitment challenges. The primary end point occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6-0.9%, P = 0.20) was identified nor any significant safety issues. CONCLUSION: Oral HCQ taken as prescribed appeared safe among HCWs. No significant clinical benefits were observed. The study was not powered to detect a small but potentially important reduction in infection. TRIAL REGISTRATION: NCT04334148.

Racial/Ethnic Disparities in Healthcare Worker Experiences During the COVID-19 Pandemic: An Analysis of the HERO Registry.

Background: The extent to which healthcare worker (HCWs) experiences during the COVID-19 pandemic vary by race or ethnicity after adjustment for confounding factors is not currently known. Methods: We performed an observational prospective cohort study of 24,769 healthcare workers from 50 U.S. states and the District of Columbia, enrolled between April 10, 2020 and June 30, 2021, and evaluated participant experiences during the COVID-19 pandemic, including testing, diagnosis with COVID-19, emotional experiences, burnout, and interest in vaccines and vaccine clinical trials. Findings: After adjustment for professional role, medical history, and community characteristics, Black and Asian participants were less likely to receive SARS-CoV-2 viral testing (adjusted odds ratio (aOR) 0·82 [0·70, 0·96], p=0·012 and aOR 0·77 [0·67, 0·89], p<0·001 respectively) than White participants. Hispanic participants were more likely to have evidence of COVID-19 infection (aOR 1·23 (1·00, 1·50, p=0·048). Black and Asian participants were less likely to report interest in a COVID-19 vaccine (aOR 0·11 [0·05, 0·25], p<0·001 and aOR 0·48 [0·27, 0·85] p=0·012). Black participants were less likely to report interest in participating in a COVID-19 vaccine trial (aOR = 0·39 [0·28, 0·54], p<0·001). Black participants were also less likely to report 3 or more daily emotional impacts of COVID-19 (aOR = 0·66 [0·53, 0·82], p=<0·001). Black participants were additionally less likely to report burnout (aOR = 0·66 ([0·49, 0·95], p=0·025). Interpretation: In a large, national study of healthcare workers, after adjustment for individual and community characteristics, race/ethnicity disparities in COVID-19 outcomes persist. Future work is urgently needed to understand precise mechanisms behind these disparities and to develop and implement targeted interventions to improve health equity for healthcare workers. Funding: This work was funded by the Patient-Centered Outcomes Research Institute (PCORI), Contract # COVID-19-2020-001.

Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform.

BACKGROUND: The SARS CoV-2 virus has caused one of the deadliest pandemics in recent history, resulting in over 170 million deaths and global economic disruption. There remains an urgent need for clinical trials to test therapies for treatment and prevention. DESIGN: An online research platform was created to support a registry community of healthcare workers (HCWs) to understand their experiences and conduct clinical studies to address their concerns. The first study, HERO-HCQ, was a double-blind, multicenter, randomized, pragmatic trial to evaluate the superiority of hydroxychloroquine (HCQ) vs placebo for pre-exposure prophylaxis (PrEP) of COVID-19 clinical infection in HCWs. Secondary objectives were to assess the efficacy of HCQ in preventing viral shedding of COVID-19 among HCWs and to assess the safety and tolerability of HCQ. METHODS: HCWs joined the Registry and were pre-screened for trial interest and eligibility. Trial participants were randomized 1:1 to receive HCQ or placebo. On-site baseline assessment included a COVID-19 nasopharyngeal PCR and blood serology test. Weekly follow-up was done via an online portal and included screening for symptoms of COVID-19, self-reported testing, adverse events, and quality of life assessments. The on-site visit was repeated at Day 30. DISCUSSION: The HERO research platform offers an approach to rapidly engage, screen, invite and enroll into clinical studies using a novel participant-facing online portal interface and remote data collection, enabling limited onsite procedures for conduct of a pragmatic clinical trial. This platform may be an example for future clinical trials of common conditions to enable more rapid evidence generation.

Impact of the Early Phase of the COVID-19 Pandemic on US Healthcare Workers: Results from the HERO Registry.

BACKGROUND: The HERO registry was established to support research on the impact of the COVID-19 pandemic on US healthcare workers. OBJECTIVE: Describe the COVID-19 pandemic experiences of and effects on individuals participating in the HERO registry. DESIGN: Cross-sectional, self-administered registry enrollment survey conducted from April 10 to July 31, 2020. SETTING: Participants worked in hospitals (74.4%), outpatient clinics (7.4%), and other settings (18.2%) located throughout the nation. PARTICIPANTS: A total of 14,600 healthcare workers. MAIN MEASURES: COVID-19 exposure, viral and antibody testing, diagnosis of COVID-19, job burnout, and physical and emotional distress. KEY RESULTS: Mean age was 42.0 years, 76.4% were female, 78.9% were White, 33.2% were nurses, 18.4% were physicians, and 30.3% worked in settings at high risk for COVID-19 exposure (e.g., ICUs, EDs, COVID-19 units). Overall, 43.7% reported a COVID-19 exposure and 91.3% were exposed at work. Just 3.8% in both high- and low-risk settings experienced COVID-19 illness. In regression analyses controlling for demographics, professional role, and work setting, the risk of COVID-19 illness was higher for Black/African-Americans (aOR 2.32, 99% CI 1.45, 3.70, p < 0.01) and Hispanic/Latinos (aOR 2.19, 99% CI 1.55, 3.08, p < 0.01) compared with Whites. Overall, 41% responded that they were experiencing job burnout. Responding about the day before they completed the survey, 53% of participants reported feeling tired a lot of the day, 51% stress, 41% trouble sleeping, 38% worry, 21% sadness, 19% physical pain, and 15% anger. On average, healthcare workers reported experiencing 2.4 of these 7 distress feelings a lot of the day. CONCLUSIONS: Healthcare workers are at high risk for COVID-19 exposure, but rates of COVID-19 illness were low. The greater risk of COVID-19 infection among race/ethnicity minorities reported in the general population is also seen in healthcare workers. The HERO registry will continue to monitor changes in healthcare worker well-being during the pandemic. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04342806.

PCORnet® 2020: current state, accomplishments, and future directions.

OBJECTIVE: To describe PCORnet, a clinical research network developed for patient-centered outcomes research on a national scale. STUDY DESIGN AND SETTING: Descriptive study of the current state and future directions for PCORnet. We conducted cross-sectional analyses of the health systems and patient populations of the 9 Clinical Research Networks and 2 Health Plan Research Networks that are part of PCORnet. RESULTS: Within the Clinical Research Networks, electronic health data are currently collected from 337 hospitals, 169,695 physicians, 3,564 primary care practices, 338 emergency departments, and 1,024 community clinics. Patients can be recruited for prospective studies from any of these clinical sites. The Clinical Research Networks have accumulated data from 80 million patients with at least one visit from 2009 to 2018. The PCORnet Health Plan Research Network population of individuals with a valid enrollment segment from 2009 to 2019 exceeds 60 million individuals, who on average have 2.63 years of follow-up. CONCLUSION: PCORnet's infrastructure comprises clinical data from a diverse cohort of patients and has the capacity to rapidly access these patient populations for pragmatic clinical trials, epidemiological research, and patient-centered research on rare diseases.

Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance.

BACKGROUND/AIMS: Obtaining ethical approval from multiple institutional review boards is a long-standing challenge to multi-site clinical trials and often leads to significant delays in study activation and enrollment. As of 25 January 2018, the National Institutes of Health began requiring use of a single institutional review board for US multi-site trials. To learn more and further inform the research and regulatory communities around aspects of transitioning to single institutional review board review, this study evaluated the efficiency, resource use, and user perceptions of a nascent institutional review board reliance model (Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance). METHODS: This research was embedded within the Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure trial-a multi-site trial of two influenza vaccine formulations. In the first year of the trial, a sample of sites agreed to use the developing Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance model and participated in its evaluation. In keeping with a least burdensome approach, short surveys were developed and obtained from each reporting entity (relying sites, non-relying site, lead site, and reviewing institutional review board). Data regarding time to institutional review board approval and site activation, costs, and user perceptions of reliant review were self-reported and collected via the survey form. Quantitative and qualitative analyses were performed, with costs analyzed as actual versus estimated due to the lack of established baseline cost data. RESULTS: A total of 13 sites ceded review and received institutional review board approval. Mean time to approval was substantially faster in sites that ceded review using the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance model versus the site that did not cede review (81 vs 121 days). The mean time to approval was also faster than published averages for academic medical centers (81 vs 103 days). Time to first enrollment was faster for ceding sites versus the non-ceding site, and also faster than published averages (126 vs 149 and 169 days, respectively). Costs were higher than estimates for local institutional review board review and approval. Nearly half (47%) the stakeholders reported being very satisfied or satisfied with the reliance experience, although many noted the challenge related to institutional culture change. CONCLUSION: Implementation of a single institutional review board represents a shift in practice and culture for many institutions. Evaluation of the reliance arrangements for this study highlights both the potential of, and challenges for, institutions as they transition to single institutional review board review. Although efficiencies were observed for study start-up, we anticipate a learning curve as institutions and research teams implement necessary process and resource changes to adapt to single institutional review board oversight. Findings may inform research teams but are, however, limited by the relatively small number of sites and lack of a control group.

Assessment of Dentally Related Function in Individuals with Cognitive Impairment: The Dental Activities Test.

OBJECTIVES: To develop and validate the Dental Activities Test (DAT), a clinical tool for measuring dentally related function in cognitively impaired older adults. DESIGN: Cross-sectional study design. SETTING: Three assisted living residences in North Carolina. PARTICIPANTS: Assisted living residents with normal to impaired cognition aged 50 and older; not blind, deaf, or severely physically disabled; and English speaking (N = 90). MEASUREMENTS: Items for the DAT were developed based on focus group discussions, literature review, and clinical relevance. Cronbach alpha, interrater reliability, and test-retest reliability were examined, and construct validity was assessed in relation to correlations with cognitive and functional assessments. Correlations between the DAT and oral health measures were also analyzed to evaluate the concurrent validity of the DAT. RESULTS: The DAT has excellent internal consistency reliability (Cronbach alpha 0.90), test-retest reliability (correlation coefficient (r) = 0.84), and interrater reliability (r = 0.90). In terms of construct validity, higher DAT scores were significantly associated with better cognitive function, as well as better activity of daily living and instrumental activity of daily living function. Finally, the DAT was significantly associated with oral hygiene and gingival health. CONCLUSION: The DAT is a reliable and valid instrument to measure dentally-related function in older adults with cognitive impairment.

The Green House Model of Nursing Home Care in Design and Implementation.

OBJECTIVE: To describe the Green House (GH) model of nursing home (NH) care, and examine how GH homes vary from the model, one another, and their founding (or legacy) NH. DATA SOURCES/STUDY SETTING: Data include primary quantitative and qualitative data and secondary quantitative data, derived from 12 GH/legacy NH organizations February 2012-September 2014. STUDY DESIGN: This mixed methods, cross-sectional study used structured interviews to obtain information about presence of, and variation in, GH-relevant structures and processes of care. Qualitative questions explored reasons for variation in model implementation. DATA COLLECTION/EXTRACTION METHODS: Interview data were analyzed using related-sample tests, and qualitative data were iteratively analyzed using a directed content approach. PRINCIPAL FINDINGS: GH homes showed substantial variation in practices to support resident choice and decision making; neither GH nor legacy homes provided complete choice, and all GH homes excluded residents from some key decisions. GH homes were most consistent with the model and one another in elements to create a real home, such as private rooms and baths and open kitchens, and in staff-related elements, such as self-managed work teams and consistent, universal workers. CONCLUSIONS: Although variation in model implementation complicates evaluation, if expansion is to continue, it is essential to examine GH elements and their outcomes.

Workforce Characteristics, Perceptions, Stress, and Satisfaction among Staff in Green House and Other Nursing Homes.

OBJECTIVE: To compare workforce characteristics and staff perceptions of safety, satisfaction, and stress between Green House (GH) and comparison nursing homes (CNHs). DATA SOURCES/STUDY SETTING: Primary data on staff perceptions of safety, stress, and satisfaction from 13 GHs and 8 comparison NHs in 11 states; secondary data from human resources records on workforce characteristics, turnover, and staffing from 01/01/2011-06/30/2012. STUDY DESIGN: Observational study. DATA COLLECTION METHODS: Workforce data were from human resources offices; staff perceptions were from surveys. PRINCIPAL FINDINGS: Few significant differences were found between GH and CNHs. Exceptions were GH direct caregivers were older, provided twice the normalized hours per week budgeted per resident than CNAs in CNHs or Legacy NHs, and trended toward lower turnover. CONCLUSIONS: GH environment may promote staff longevity and does not negatively affect worker's stress, safety perceptions, or satisfaction. Larger studies are needed to confirm findings.

Pneumonia Identification Using Nursing Home Records.

Pneumonia is a leading cause of death among nursing home residents; consequently, prevention and treatment are important for quality improvement. To be pragmatic, quality improvement depends on sensitive case identification using nursing home records; however, no studies have examined the reliability of different methods of pneumonia case finding from records. The current authors compared three established strategies for defining pneumonia using records from 1,119 residents across 16 nursing homes: recorded diagnosis of pneumonia, modified McGeer criteria (chest x-ray infiltrate plus specified signs/symptoms), and antibiotic prescription plus pneumonia-specific signs. Chart diagnosis detected 107 cases, modified McGeer criteria detected 84 cases, and antibiotic prescription detected 47 cases. Diagnosis included all cases identified by the McGeer criteria and all but one case identified by antibiotic use. Based on findings, recorded diagnosis of pneumonia is a highly sensitive and pragmatic method to ascertain pneumonia in nursing homes, and is recommended for use in quality improvement and research. [Res Gerontol Nurs. 2016; 9(3):109-114.].

New Evidence on the Green House Model of Nursing Home Care: Synthesis of Findings and Implications for Policy, Practice, and Research.

OBJECTIVE: To synthesize new findings from the THRIVE Research Collaborative (The Research Initiative Valuing Eldercare) related to the Green House (GH) model of nursing home care and broadly consider their implications. DATA SOURCES: Interviews and observations conducted in GH and comparison homes, Minimum Data Set (MDS) assessments, Medicare data, and Online Survey, Certification and Reporting data. STUDY DESIGN: Critical integration and interpretation of findings based on primary data collected 2011-2014 in 28 GH homes (from 16 organizations), and 15 comparison nursing home units (from 8 organizations); and secondary data derived from 2005 to 2010 for 72 GH homes (from 15 organizations) and 223 comparison homes. PRINCIPAL FINDINGS: Implementation of the GH model is inconsistent, sometimes differing from design. Among residents of GH homes, adoption lowers hospital readmissions, three MDS measures of poor quality, and Part A/hospice Medicare expenditures. Some evidence suggests the model is associated with lower direct care staff turnover. CONCLUSIONS: Recommendations relate to assessing fidelity, monitoring quality, capitalizing opportunities to improve care, incorporating evidence-based practices, including primary care providers, supporting high-performance workforce practices, aligning Medicare financial incentives, promoting equity, informing broad culture change, and conducting future research.

EMPOWER: an intervention to address barriers to pain management in hospice.

CONTEXT: Concerns about pain medications are major barriers to pain management in hospice, but few studies have focused on systematic methods to address these concerns. OBJECTIVES: The objective of this study was to test the preliminary efficacy of the Effective Management of Pain: Overcoming Worries to Enable Relief (EMPOWER) intervention, which included hospice staff education, staff screening of barriers to pain management at admission, and discussion about misunderstandings regarding pain management with family caregivers and patients. METHODS: We conducted a pilot, cluster randomized, controlled trial with four hospices. One hundred twenty-six family caregivers (55 interventions and 71 controls) were interviewed at two weeks after admission. If patients survived three months after admission, caregivers were reinterviewed. RESULTS: At two weeks, caregivers in the intervention group reported better knowledge about pain management (P = 0.001), fewer concerns about pain and pain medications (P = 0.008), and lower patient pain over the past week (P = 0.014) and trended toward improvement in most other areas under study. Exploratory analyses suggest that EMPOWER had a greater effect for black subjects (vs. whites) on reducing concern about stigma. At three months, the intervention group trended better on most study outcomes. CONCLUSION: EMPOWER is a promising model to reduce barriers to pain management in hospice.

A measure of person-centered practices in assisted living: the PC-PAL.

OBJECTIVES: Develop self-administered questionnaires of person-centeredness for completion by residents and staff in assisted living (AL), in response to concerns that AL is not person-centered; also, demonstrated person-centeredness is necessary for Medicaid support as a home- and community-based services provider. DESIGN: Community-based participatory research partnership among a research team, a consortium of 11 stakeholder organizations, and others. Methods included literature review, item generation and reduction, cognitive testing, field testing, exploratory factor analysis, and convergent and discriminant validity testing. SETTING: Cognitive testing conducted in 2 AL residences and field testing conducted in 19 diverse, stratified AL residences in 6 states. PARTICIPANTS: Eight residents and staff participated in cognitive testing, and 228 residents and 123 staff participated in field testing. MEASUREMENTS: Feasibility and psychometric testing of draft questionnaires that included 75 items (resident version) and 102 items (staff version), with parallel items on both versions as appropriate. RESULTS: The final resident questionnaire included 49 items and 4 factors: well-being and belonging, individualized care and services, social connectedness, and atmosphere. The staff questionnaire included 62 items and 5 factors: workforce practices, social connectedness, individualized care and services, atmosphere, and caregiver-resident relationships. Staff scored person-centeredness higher than did residents, reflecting their different perspectives. CONCLUSION: The Person-Centered Practices in Assisted Living (PC-PAL) questionnaires measure person-centeredness from the perspectives of residents and staff, meaning that they reflect the concepts and items considered to be important to these key stakeholders. Use of these instruments to describe, assess, quantify, ensure, and ultimately improve person-centeredness in AL is feasible and appropriate for all AL settings, and supported by numerous national organizations.

Dementia in relation to family caregiver involvement and burden in long-term care.

To better understand the process and outcomes of family involvement for long-term care residents with varying stages of dementia, we analyzed family and staff data for 467 residents of 24 residential care/assisted living and nursing-home settings. Adjusted analyses found that although the amount of family visitation did not significantly vary by resident cognitive status (15 versus 20 visits/month to persons with and without dementia, respectively), the nature of the visit did. Families of cognitively intact residents spent more time in activities related to social and community engagement, such as taking residents on trips and calling and writing letters (p<.001), while families of more impaired residents spent more time on care-related activities, including tasks related to nutrition (p<.027), mobility (p=.001), and discussing care with staff (p=.007), the latter of which was associated with greater burden (p<.001). Staff identified similar patterns but perceived less family involvement.

A "recipe" for culture change? Findings from the THRIVE survey of culture change adopters.

PURPOSE OF THE STUDY: Descriptions of culture change adoption are often complex and varied, creating a challenge for those seeking guidance about which of the many components of culture change to adopt and in what order and combination. DESIGN AND METHODS: To begin to address this question, members of The Research Initiative Valuing Eldercare (THRIVE) developed and distributed an online survey to 327 known culture change adopters. Of these, 164 (50%) completed the survey. Data were analyzed to identify adopted components, co-occurrence of adopted components, and differences in these across various types of nursing home models (i.e., traditional unit, household, and small house). RESULTS: Our findings support unique co-occurrence of components across nursing home models. Results also show that homes with more traditional environments have been able to implement certain culture change components without large capital investments required by renovations. IMPLICATIONS: The adoption patterns suggest that the co-occurrence of components should be considered when pursuing organizational transformations to support culture change.

Changing the culture of mouth care: mouth care without a battle.

PURPOSE OF THE STUDY: Culture change aims to fundamentally improve care provision in a manner consistent with individual preferences. However, few studies of culture change have focused on the quality of daily care, despite the fact that system-wide efforts are important to assure the effectiveness, adoption, and sustainability of person-centered care to meet daily needs. This paper describes a new culture change practice, Mouth Care Without a Battle. The focus on mouth care is predicated on the important association between person-centered support for oral hygiene and quality of life. DESIGN AND METHODS: Mouth Care Without a Battle is a person-centered approach to quality mouth care for persons with cognitive and physical impairment. It was developed by an interdisciplinary team of clinician researchers based on literature review, consultation with experts, environmental scan of existing programs, and testing in nursing homes. Building from the success of Bathing Without a Battle, Mouth Care Without a Battle was evaluated in terms of changed care practices and outcomes, developed into a training program, and packaged for dissemination as a digital video disk (DVD) and website. RESULTS: The development and evaluation of Mouth Care Without a Battle demonstrate attention to the areas necessary to establish the evidence-base for culture change, to ultimately empower and support staff to provide care to achieve quality outcomes. IMPLICATIONS: As illustrated in this paper, it is beneficial to build the evidence base for culture change by attending to care processes and outcomes benefiting all residents, ability to implement culture change, and costs of implementation.

What does the evidence really say about culture change in nursing homes?

PURPOSE OF THE STUDY: Although nursing home culture change efforts are becoming more widespread, there have been few efforts to systematically compile the evidence related to the efficacy of culture change. This study uses an analytic framework to evaluate the existing evidence for the impact of culture change on nursing home quality. We focus on the nature and scope of culture change interventions, measurement of culture change and adherence to interventions, measurement of culture change outcomes, and the relationship between culture change and its outcomes. DESIGN AND METHODS: We conducted a comprehensive review of peer-reviewed and gray literature published between 2005 and 2012 to identify intervention evaluations that addressed at least one culture change domain. Of 4,982 identified publications, 625 underwent full review; 27 peer-reviewed and 9 gray literature studies met inclusion criteria. RESULTS: Studies varied widely in scope and outcomes. Most addressed more than one culture change domain; resident direction, home environment, and close relationships were most common. Few studies measured culture change implementation, but most used validated tools to measure outcomes. Although few studies reported negative outcomes, there was little consistent evidence of positive effects. IMPLICATIONS: Nursing home culture change remains an evolving field. Although culture change has clear face validity, the current evidence does not give providers sufficient information for selecting interventions based on the expectation of improving outcomes. Rigorous research on implementation and outcomes of culture change is needed to determine the specific impact of culture change on quality and to provide guidance to providers and policy makers.

Who are the innovators? Nursing homes implementing culture change.

PURPOSE OF THE STUDY: A key directive of the Affordable Care Act of 2010 is to transform both institutional and community-based long-term care into a more person-centered system. In the nursing home industry, the culture change movement is central to this shift in philosophy. If policymakers are to further encourage implementation of culture change, they need to better understand the factors associated with implementation. DESIGN AND METHODS: Using logistic regression (N = 16,835), we examined the extent to which resident, facility, and state characteristics relate to a nursing home being identified by experts as having implemented culture change over the period 2004 through 2011. RESULTS: At baseline, the 291 facilities that were later identified by experts to have implemented culture change were more often nonprofit-owned, larger in size, and had fewer Medicaid and Medicare residents. Implementers also had better baseline quality with fewer health-related survey deficiencies and greater licensed practical nurse and nurse aide staffing. States experienced greater culture change implementation when they paid a higher Medicaid per diem. IMPLICATIONS: To date, nursing home culture change has been implemented differentially by higher resource facilities, and nursing homes have been responsive to state policy factors when implementing culture change.

Development and preliminary testing of the quality of spiritual care scale.

CONTEXT: The provision of spiritual care is considered a key element of hospice and palliative care, but there is a paucity of empirically developed quality-of-care measures in this domain. OBJECTIVES: To describe the development and reliability and validity of the Quality of Spiritual Care (QSC) scale in family caregivers. METHODS: We conducted analyses of interviews conducted that included the QSC scale with family members of residents who died in long-term care settings taken after the resident had died. To determine reliability and validity of the QSC scale, we examined internal consistency, concurrent construct validity, and factor analysis with promax rotation. RESULTS: Of 165 family caregivers of decedents who were asked whether they received spiritual care, 91 (55%) responded yes, and 89 of these (98%) completed at least 80% of the QSC items. Two items (i.e., satisfaction with and value of spiritual care) were perfectly correlated so the latter item was dropped in scale development. Factor analysis identified two factors, personal spiritual enrichment (mean pattern matrix loading = 0.77) and relationship enrichment (mean pattern matrix loading = 0.72). Reliability analysis yielded a Cronbach's alpha of 0.87, and item-total correlations for all items were in excess of 0.55. Preliminary validity of the QSC was supported by significant and expected correlations in both direction and magnitude with items from validated instruments conceptually associated with the quality of spiritual care. CONCLUSION: Preliminary testing of the QSC scale suggests that it is a valid and reliable outcome measure of the quality of spiritual care at the end of life.