The PCORI Engagement Rubric: Promising Practices for Partnering in Research.

PURPOSE: Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric). METHODS: PCORI developed the Rubric drawing from a synthesis of the literature, a qualitative study with patients, a targeted review of engagement plans from PCORI-funded project applications, and a moderated discussion and review with PCORI's Advisory Panel on Patient Engagement. RESULTS: The Rubric provides a framework for operationalizing engagement to incorporate patients and other stakeholders in all phases of research. It includes: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects. CONCLUSIONS: PCORI designed the Rubric to illustrate opportunities for engagement to researchers interested in applying for PCORI funding and to patients and other stakeholders interested in greater involvement in research. By encouraging PCORI applicants, awardees, and others to apply the rubric, PCORI hopes to shift the research paradigm from one of conducting research on patients as subjects to a pursuit carried out in collaboration with patients and other stakeholders to better reflect the values, preferences, and outcomes that matter to the patient community.

Effects of organizational context on Lean implementation in five hospital systems.

BACKGROUND: Despite broad agreement among researchers about the value of examining how context shapes implementation of improvement programs and projects, limited attention has been paid to contextual effects on implementation of Lean. PURPOSE: To help reduce gaps in knowledge of effects of intraorganizational context, we researched Lean implementation initiatives in five organizations and examined 12 of their Lean rapid improvement projects. All projects aimed at improving clinical care delivery. METHODOLOGY/APPROACH: On the basis of the literature on Lean, innovation, and quality improvement, we developed a framework of factors likely to affect Lean implementation and outcomes. Drawing on the framework, we conducted semistructured interviews and applied qualitative codes to the transcribed interviews. Available documents, data, and observations supplemented the interviews. We constructed case studies of Lean implementation in each organization, compared implementation across organizations, and compared the 12 projects. FINDINGS: Intraorganizational characteristics affecting organization-wide Lean initiatives and often also shaping project outcomes included CEO commitment to Lean and active support for it, prior organizational capacity for quality improvement-based performance improvement, alignment of the Lean initiative with the organizational mission, dedication of resources and experts to Lean, staff training before and during projects, establishment of measurable and relevant project targets, planning of project sequences that enhance staff capabilities and commitment without overburdening them, and ensuring communication between project members and other affected staff. Dependence of projects on inputs of new information technology was a barrier to project success. Incremental implementation of Lean produced reported improvements in operational efficiency and occasionally in care quality. However, even under the relatively favorable circumstances prevailing in our study sites, incremental implementation did not readily change organizational culture. PRACTICE IMPLICATIONS: This study should alert researchers, managers, and teachers of management to ways that contexts shape Lean implementation and may affect other types of process redesign and quality improvement.

Validation of self-reported weights and heights in the avoiding diabetes after pregnancy trial (ADAPT).

BACKGROUND: Randomized controlled trials that test the effectiveness of mobile health-based weight loss programs are attractive to participants, funders, and researchers because of the low implementation cost, minimal participant burden, and the ability to recruit participants from longer distances. Collecting weight data from geographically dispersed participants is a challenge. Relying on participant self-report is one approach to data collection, but epidemiologic studies indicate that self-reported anthropometric data may be inaccurate. METHODS: We provided women enrolled in a randomized controlled trial (RCT) of postpartum weight loss after gestational diabetes with a digital scale and training to collect and report weight via a web-based survey. To validate self-reported weights and heights, we visited 30 randomly selected women in their homes, with a reference scale and stadiometer, a mean of 34 days after the self-report. We ran linear regression models to identify characteristics that were associated with underreporting or overreporting of anthropometric measures. RESULTS: Of the 30 women we visited, 11 women (37%) were assigned to the weight loss intervention group and 19 women (63%) were in the control group. Mean age was 38.5 years (SD 4.5). The overall mean difference between participants' self-reported weights and the weights obtained at their home visit was 0.70 kg (+1.92). Women assigned to the intervention group underreported their weight in comparison with the control group by 1.29 kg (95% CI -2.52, -0.06). The overall difference in collected to self-reported height was -0.56 cm (±1.91). No characteristics were associated with underreporting or overreporting of height. CONCLUSIONS: Our research suggests that by providing a digital scale and developing a weight collection protocol, researchers can train women to collect and record their own study weights with reasonable validity. To achieve the level of validity required for clinical trials, researchers should consider additional strategies to assure the validity of the data. TRIAL REGISTRATION: NCT01923350.

Development of the Health Insurance Literacy Measure (HILM): conceptualizing and measuring consumer ability to choose and use private health insurance.

Understanding health insurance is central to affording and accessing health care in the United States. Efforts to support consumers in making wise purchasing decisions and using health insurance to their advantage would benefit from the development of a valid and reliable measure to assess health insurance literacy. This article reports on the development of the Health Insurance Literacy Measure (HILM), a self-assessment measure of consumers' ability to select and use private health insurance. The authors developed a conceptual model of health insurance literacy based on formative research and stakeholder guidance. Survey items were drafted using the conceptual model as a guide then tested in two rounds of cognitive interviews. After a field test with 828 respondents, exploratory factor analysis revealed two HILM scales, choosing health insurance and using health insurance, each of which is divided into a confidence subscale and likelihood of behavior subscale. Correlations between the HILM scales and an objective measure of health insurance knowledge and skills were positive and statistically significant which supports the validity of the measure.

Health information technology and hospital patient safety: a conceptual model to guide research.

BACKGROUND: The literature indicates that health information technology (IT) use may lead to some gains in the quality and safety of care in some situations but provides little insight into this variability in the results that has been found. The inconsistent findings point to the need for a conceptual model that will guide research in sorting out the complex relationships between health IT and the quality and safety of care. METHODS: A conceptual model was developed that describes how specific health IT functions could affect different types of inpatient safety errors and that include contextual factors that influence successful health IT implementation. The model was applied to a readily available patient safety measure and nationwide data (2009 AHA Annual Survey Information Technology Supplement and 2009 Healthcare Cost and Utilization Project State Inpatient Databases). FINDINGS: The model was difficult to operationalize because (1) available health IT adoption data did not characterize health IT features and extent of usage, and (2) patient safety measures did not elucidate the process failures leading to safety-related outcomes. The sample patient safety measure--Postoperative Physiologic and Metabolic Derangement Rate--was not significantly related to self-reported health IT capabilities when adjusted for hospital structural characteristics. CONCLUSION: These findings illustrate the critical need for collecting data that are germane to health IT and the possible mechanisms by which health IT may affect inpatient safety. Well-defined and sufficiently granular measures of provider's correct use of health IT functions, the contextual factors surrounding health IT use, and patient safety errors leading to health care-associated conditions are needed to illuminate the impact of health IT on patient safety.

People with arthritis-disability and provider experiences with chronic opioid therapy: A qualitative inquiry.

BACKGROUND: Growing concerns about opioid overprescribing, opioid use disorder (OUD), and overdose led to opioid misuse prevention practices that may impact the lives of people with disability (PWD) and chronic pain. OBJECTIVE: To investigate the experiences of providers and people with arthritis related disability with opioid prescribing and monitoring following release of the Centers for Disease Control and Prevention Guideline for prescribing opioids for chronic pain. METHODS: We conducted semi-structured interviews with 24 specialists and primary care providers and 24PWD. Providers were required to prescribe opioids to people with arthritis-disability. PWD were required to have arthritis-disability causing chronic pain and to be on chronic opioid therapy (COT) or have been treated for OUD. We used a deductive and inductive analytic approach to develop themes. RESULTS: Providers recommended COT when other pain treatment options were exhausted or unaffordable. PWD reported their provider recently reduced their opioid treatment intensity and frequent visits were required. PWD didn't remember or recalled hearing limited information about opioid risks and benefits. Some PWD were unsure if the benefits of opioids outweighed the risks. Few providers identified chronic pain care considerations specific to PWD. CONCLUSIONS: Our findings facilitate a better understanding of the challenges faced by PWD living with chronic pain and their providers related to COT. The findings show the need for better informing PWD about the risks and benefits of opioids prior to initiating treatment, training on person-centered care tailored to PWD's unique needs and improved coverage of nonopioid treatments for chronic pain.

Adapting the Current Opioid Misuse Measure (COMM) for people with chronic pain and disability due to arthritis: The development of the COMM 11-PWDA.

BACKGROUND: People with arthritis, a leading cause of disability, may be prescribed long-term opioid therapy to manage chronic pain. Regular use of opioids can increase risk of overdose and opioid use disorder (OUD). OBJECTIVE: The purpose of our research was to validate an instrument to screen for harmful opioid use in people with disability and chronic pain due to arthritis (PWDA). METHODS: We tested the Current Opioid Misuse1 Measure (COMM), an instrument designed for monitoring people with chronic pain on long-term opioids, with 318 PWDA who are taking long term opioids from February-June 2020. We validated the COMM against a Diagnostic and Statistical Manual for Mental Health Disorders, 5th edition (DSM-V) assessment instrument and risk factors for OUD. Final item selection was based on advisory group input, cognitive testing, and empirical evaluation of items. We calculated a cutoff score using receiver operating characteristic (ROC) analysis. RESULTS: Of the 17 items on the original COMM, we found that 11 items measured the intended construct-opioid use in a way that causes harm in PWDA. Once limiting the instrument to these 11 items (The COMM 11-PWDA), the items had excellent internal consistency and validity with the DSM-V measure. Reasonable sensitivity and specificity were established. CONCLUSIONS: The COMM 11-PWDA is a valid instrument for screening for and monitoring harmful opioid use in PWDA.

Patient Acceptance of Nurse Practitioners and Physician Assistants in Rheumatology Care.

OBJECTIVE: To assess whether patients with autoimmune disease would accept advanced practice providers (APPs) as an option to fill the growing shortage of rheumatologists. METHODS: We administered a cross-sectional survey to 500 patients or parents of children who reported having been diagnosed with qualifying autoimmune conditions and who had seen their primary rheumatology providers in the past 6 months. Respondents self-reported whether their primary providers were rheumatologists or APPs. Our analysis compared the attitude and experience of the patients whose primary rheumatology providers were APPs with those of patients whose primary providers were rheumatologists. RESULTS: Of respondents, 36.8% reported having APPs as primary rheumatology providers. Patients of APPs were significantly more likely to arrive at their provider's office in 15 minutes or less (P < 0.01) and to be able to schedule routine and urgent appointments sooner (P = 0.02 and 0.05, respectively). There were no significant differences in overall patient experience of care between provider types. Most patients rated their providers highly, but those who saw rheumatologists rated their providers significantly higher (P < 0.01). Patients of APPs were significantly more likely than patients of rheumatologists to prefer to see APPs over rheumatologists (P < 0.01) and to recommend APPs (P < 0.01). CONCLUSION: APPs may improve access to care and, regardless of provider type, patients rated their overall experience of care similarly. Overall, patient attitudes toward APPs were positive regardless of provider type, although APP patients held more positive overall attitudes toward APPs than did rheumatologist patients.

Intensive Approaches to Prenatal Care May Reduce Risk of Gestational Diabetes.

Objectives: To observe gestational diabetes mellitus (GDM) prevalence among participants receiving enhanced prenatal care through one of three care models: Birth Centers, Group Prenatal Care, and Maternity Care Homes. Materials and Methods: This study draws upon data collected from 2014 to 2017 as part of the Strong Start II evaluation and includes data from nearly 46,000 women enrolled across 27 awardees with more than 200 sites throughout the United States. Descriptive and statistical analyses utilized data from participant surveys completed upon entry to the program and a limited chart review. Results: A total of 6.3% of Strong Start participants developed GDM during their pregnancy. Rates varied significantly and substantially by model. After adjusting for participant risk factors, we find that Birth Center participants of all races and ethnicities experienced significantly lower rates of GDM than women of the same race/ethnicity in Maternity Care Homes. Conclusions: The lower rates of gestational diabetes among women receiving Birth Center prenatal care suggest the need for further investigation of how prenatal care approaches can reduce GDM and address health disparities.

Physician cultural competence and patient ratings of the patient-physician relationship.

OBJECTIVE: To determine the association of patients' ratings of the patient-physician relationship with physicians' self-reported cultural competence (CC). METHODS: Physicians completed a survey assessing their CC in three domains: motivation to learn about other cultures (motivation attitudes), awareness of white privilege and acceptance of a racial group's choice to retain distinct customs and values (power assimilation attitudes), and clinical behaviors reflective of CC. Their African-American and white patients completed interviews assessing satisfaction with the medical visit, trust in their physician, perceptions of their physician's respect for them and their participation in care. We conducted regression analyses to explore the associations between CC and patient ratings of the relationship. RESULTS: Patients of physicians reporting more motivation to learn about other cultures were more satisfied (OR = 2.1, 95% CI = 1.0-4.4), perceived their physicians were more facilitative (beta = 0.4, p = 0.02) and reported seeking and sharing more information during the medical visit (beta = 0.2, p = 0.03). Physicians' power assimilation attitudes were associated with patients' ratings of physician facilitation (beta = 0.4, p = 0.02). Patients of physicians reporting more frequent CC behaviors were more satisfied (OR = 3.1, 95% CI = 1.4-6.9) and reported seeking and sharing more information (beta = 0.3, p = 0.04). CONCLUSIONS: Attitudinal and behavioral components of CC are important to developing higher quality, participative relationships between patients and their physicians.

Provider and clinic cultural competence in a primary care setting.

A multilevel approach that enhances the cultural competence of clinicians and healthcare systems is suggested as one solution to reducing racial/ethnic disparities in healthcare. The primary objective of this cross-sectional study was to determine if there is a relationship between the cultural competence of primary care providers and the clinics where they work. Forty-nine providers from 23 clinics in Baltimore, Maryland and Wilmington, Delaware, USA completed an on-line survey which included items assessing provider and clinic cultural competence. Using simple linear regression, it was found that providers with attitudes reflecting greater cultural motivation to learn were more likely to work in clinics with a higher percent of nonwhite staff, and those offering cultural diversity training and culturally adapted patient education materials. More culturally appropriate provider behavior was associated with a higher percent of nonwhite staff in the clinic, and culturally adapted patient education materials. Enhancing provider and clinic cultural competence may be synergistic strategies for reducing healthcare disparities.

Ethnicity and vasomotor symptoms in postmenopausal women.

OBJECTIVE: To determine if there is a difference in the prevalence of vasomotor symptoms between African American and white postmenopausal women. METHODS: We conducted a cross-sectional study to evaluate baseline vasomotor symptoms in postmenopausal women enrolled in a randomized, placebo-controlled trial of dietary soy supplements. The Menopause-Specific Quality of Life Questionnaire (MENQOL) vasomotor subscale was used to measure vasomotor symptoms, including hot flashes and night sweats. RESULTS: In total, 104 African American and 112 white postmenopausal women (mean age 56.8 +/- 5.6 years) were studied. A multiple linear regression analysis, which controlled for differences in body mass index (BMI) and dietary fat intake, showed that race and age were significantly and independently associated with vasomotor symptoms, explaining 10% of the variance (p < 0.001). Being African American and younger age were associated with increased vasomotor symptoms. CONCLUSIONS: The most prevalent postmenopausal symptoms were vasomotor symptoms, which were more bothersome in African American women compared with white women. Factors associated with vasomotor symptoms included race, BMI, and dietary intake of fat calories. Implications for practice include increasing provider awareness to discuss vasomotor symptoms and the need for treatment in postmenopausal African American women. Further research to increase our understanding of racial differences and associated factors that influence the duration and intensity of vasomotor symptoms experienced by postmenopausal women is needed.

Cost-effectiveness of nurse practitioner management of hypercholesterolemia following coronary revascularization.

PURPOSE: To evaluate the cost-effectiveness of case management by a nurse practitioner (NP) to lower blood lipids in patients with coronary heart disease (CHD) from a managed care perspective. DATA SOURCES: A total of 228 consecutive, eligible adults with hypercholesterolemia and CHD were recruited during hospitalization after coronary revascularization. Patients were randomized to receive lipid management, including individualized lifestyle modification and pharmacologic intervention from an NP for 1 year after discharge in addition to their usual care (NURS) or to receive usual care (EUC) enhanced with feedback on lipids to their primary provider and/or cardiologist. A cost-effectiveness ratio was calculated using incremental costs of the NURS group per unit change and percent change in low-density lipoprotein cholesterol (LDL-C) for 1 year at 2004 values. CONCLUSIONS: The annual incremental cost-effectiveness of NP case management was 26.03 dollars per mg/dL and 39.05 dollars per percent reduction in LDL-C. When costs of NURS care for the second 6 months of management were compared to the first 6 months of management, nursing salary costs were lower as patients were established on cholesterol management regimens, but the reduction in costs was offset by the increase in incremental costs of drug treatment as the NP titrated the patient to higher drug dosages that were more costly. IMPLICATIONS FOR PRACTICE: The findings suggest that case management by an NP is a cost-effective approach for a managed care organization to consider in improving the care of patients with cardiovascular disease.

Promoting Excellence in Symptom Management Case Series: Case Study: A New Intervention for Rapid End-of-Life Symptom Control in the Home Setting.

The oral route is compromised for nearly all patients at the end of life (EOL). This article reviews the benefits and burdens of the usual alternative routes of medication delivery when the oral route fails and presents a case study on the use of a new innovation for the rectal delivery of medication to control EOL symptoms. A 62-year-old male hospice patient with end-stage metastatic prostate cancer presented with severe symptoms (Face, Legs, Activity, Cry and Consolability scale score, 9/10) that were uncontrollable with medications given via oral or sublingual routes. The patient goals were to remain at home with optimal symptom management. Rapid relief of symptoms was accomplished by the administration of medications already present in the home delivered with a new rectal catheter that provides discreet access for ongoing medication administration. Significant relief was noted within 20 minutes of dosing. The patient died peacefully 18 hours later, meeting his EOL goals, and the family was empowered to provide effective care for the patient at home. The family found the intervention easy to use. This case demonstrates how this new innovation can be used to ensure rapid symptom management and decreased burden of care by facilitating immediate and easy use of medications already present in the home.

Understanding why some women with a history of gestational diabetes do not get tested for diabetes.

BACKGROUND: The proportion of women with previous gestational diabetes mellitus (GDM) receiving postpartum diabetes testing is far less than desired. Even in health care systems with high testing rates, some women remain untested. We explored what helps and what hinders women to obtain recommended testing. METHODS: In this mixed methods study, we recruited 139 patients with a history of GDM in their most recent pregnancy (6 months to 4.5 years before study enrollment) from a delivery system that had instituted a quality improvement program to increase postpartum diabetes testing rates. We determined whether they had received a postpartum diabetes test according to American Diabetes Association guidelines. Using survey data, we ran logistic regression models to assess correlates of testing status, and we conducted in-depth interviews with 22 women to provide greater context to their survey responses. RESULTS: Of the 139 women, 21 women (15%) did not complete recommended diabetes testing. From the survey data, women who visited a primary care provider had 72% (95% CI, 0.09-0.83) lesser odds of not having been tested. From the qualitative interviews, difficulty fitting testing around work and caregiver demands were the most common reasons for not testing. Untested women interpreted providers' reassurances that diabetes would resolve after delivery and lack of reminders to reschedule missed appointments and to complete diabetes testing as indicators that their physicians were not concerned about their diabetes risk. CONCLUSIONS: Among hard-to-reach women, multiple demands on their time were common explanations for not receiving a postpartum diabetes test. Consistent messages regarding long-term diabetes risk during pregnancy, access to postpartum primary care and convenient lab appointments, and systematic reminders to providers and patients are approaches that, in combination, may influence more resistant women to test.

A national study of nurse leadership and supports for quality improvement in rural hospitals.

This study assessed the perceptions and actions of rural hospital nurse executives with regard to patient safety and quality improvement (QI). A national sample of rural hospital nurse executives (n = 300) completed a survey measuring 4 domains related to patient safety and QI: (a) patient "Safety Culture," (b) adequacy of QI "Resources," (c) "Barriers" related to QI, and (d) "Nurse Leader Engagement" in activities supporting QI. Perceptions of Safety Culture were strong but 47% of the Resources needed to carry out QI were inadequate, 29% of Barriers were moderate to major, and 25% of Nurse Leader Engagement activities were performed infrequently. Nurse Leader Engagement in quality-related activities was less frequent among nurses in isolated and small rural town hospitals compared with large rural city hospitals. To further QI, rural nurse executives may need to use their communications and actions to raise the visibility of QI.

Rising out-of-pocket spending for chronic conditions: a ten-year trend.

We examined the prevalence of self-reported chronic conditions and out-of-pocket spending using the 2005 Medical Expenditure Panel Survey (MEPS) and made comparisons to previously published MEPS data. Our study found that the prevalence of self-reported chronic conditions is increasing among not only the old-old but also people in midlife and earlier old age. The greatest growth occurred in the number of people affected by multiple chronic diseases, a group with sizable out-of-pocket spending. Policymakers should be aware that cost sharing at the point of care can disproportionately burden people with chronic conditions and discourage adherence to drugs that prevent disease progression.

Advancing a program of research within a nursing faculty role.

Doctoral students and new faculty members often seek advice from more senior faculty on how to advance their program of research. Students may ask whether they should choose the manuscript option for their dissertation or whether they should seek a postdoctoral fellowship. New faculty members wonder whether they should pursue a career development award and whether they need a mentor as they strive to advance their research while carrying out teaching, service, and practice responsibilities. In this article, we describe literature on the impact of selected aspects of pre- and postdoctoral training and faculty strategies on scholarly productivity in the faculty role. We also combine our experiences at a school of nursing within a research-intensive university to suggest strategies for success. Noting the scarcity of research that evaluates the effect of these strategies, we are actively engaged in collecting data on their relationship to the scholarly productivity of students and faculty members within our own institution.