Building a Program Theory of Implementation Using Process Evaluation of a Complex Quality Improvement Trial in Nursing Homes.

BACKGROUND AND OBJECTIVES: Significant quality problems exist in long-term care (LTC). Interventions to improve care are complex and often have limited success. Implementation remains a black box. We developed a program theory explaining how implementation of a complex intervention occurs in LTC settings-examining mechanisms of impact, effects of context on implementation, and implementation outcomes such as fidelity. RESEARCH DESIGN AND METHODS: Concurrent process evaluation of Safer Care for Older Persons in residential Environments (SCOPE)-a frontline worker (care aide) led improvement trial in 31 Canadian LTC homes. Using a mixed-methods exploratory sequential design, qualitative data were analyzed using grounded theory to develop a conceptual model illustrating how teams implemented the intervention and how it produced change. Quantitative analyses (mixed-effects regression) tested aspects of the program theory. RESULTS: Implementation fidelity was moderate. Implementation is facilitated by (a) care aide engagement with core intervention components; (b) supportive leadership (internal facilitation) to create positive team dynamics and help negotiate competing workplace priorities; (c) shifts in care aide role perceptions and power differentials. Mixed-effects model results suggest intervention acceptability, perceived intervention benefits, and leadership support predict implementation fidelity. When leadership support is high, fidelity is high regardless of intervention acceptability or perceived benefits. DISCUSSION AND IMPLICATIONS: Our program theory addresses important knowledge gaps regarding implementation of complex interventions in nursing homes. Results can guide scaling of complex interventions and future research.

Development and validation of the Overall Fidelity Enactment Scale for Complex Interventions (OFES-CI).

BACKGROUND: In many quality improvement (QI) and other complex interventions, assessing the fidelity with which participants 'enact' intervention activities (ie, implement them as intended) is underexplored. Adapting the evaluative approach used in objective structured clinical examinations, we aimed to develop and validate a practical approach to assessing fidelity enactment-the Overall Fidelity Enactment Scale for Complex Interventions (OFES-CI). METHODS: We developed the OFES-CI to evaluate enactment of the SCOPE QI intervention, which teaches nursing home teams to use plan-do-study-act (PDSA) cycles. The OFES-CI was piloted and revised early in SCOPE with good inter-rater reliability, so we proceeded with a single rater. An intraclass correlation coefficient (ICC) was used to assess inter-rater reliability. For 27 SCOPE teams, we used ICC to compare two methods for assessing fidelity enactment: (1) OFES-CI ratings provided by one of five trained experts who observed structured 6 min PDSA progress presentations made at the end of SCOPE, (2) average rating of two coders' deductive content analysis of qualitative process evaluation data collected during the final 3 months of SCOPE (our gold standard). RESULTS: Using Cicchetti's classification, inter-rater reliability between two coders who derived the gold standard enactment score was 'excellent' (ICC=0.93, 95% CI=0.85 to 0.97). Inter-rater reliability between the OFES-CI and the gold standard was good (ICC=0.71, 95% CI=0.46 to 0.86), after removing one team where open-text comments were discrepant with the rating. Rater feedback suggests the OFES-CI has strong face validity and positive implementation qualities (acceptability, easy to use, low training requirements). CONCLUSIONS: The OFES-CI provides a promising novel approach for assessing fidelity enactment in QI and other complex interventions. It demonstrates good reliability against our gold standard assessment approach and addresses the practicality problem in fidelity assessment by virtue of its suitable implementation qualities. Steps for adapting the OFES-CI to other complex interventions are offered.

Assessing quality of older persons' emergency transitions between long-term and acute care settings: a proof-of-concept study.

BACKGROUND: Long-term care (LTC) residents frequently experience transitions in the location of more advanced care delivery, including receiving emergency department (ED) care. In this proof-of-concept study, we aimed to determine if we could identify measures in quality of care across transitions from LTC to the ED, via emergency medical services and back, by applying Institute of Medicine (IOM) Quality of Care Domains to an existing dataset. METHODS: In the Older Persons' Transitions in Care (OPTIC) study, we collected information on residents' transitions in two Western Canadian cities. We applied the IOM's Quality of Care Domains to the OPTIC data to create binary measures of transition quality. We report the median (MED) per cent and IQR of measures met within each domain of quality. RESULTS: We tracked 637 transitions over a 12-month period, with data collected from each setting. We developed 19 safety measures, 20 measures of resident-centred care, 3 measures of timely care and 5 measures of effective care. We were unable to develop measures for equitable care at an individual transfer level. Domain scores varied across individual transitions, with the highest scores in safety (MED 79%, IQR: 63-95), efficiency (66%; IQR: 66-99), and resident-centred (45%; IQR: 25-65), followed by effectiveness (36%; IQR: 16-56), and timeliness (0%; IQR: 0-50). CONCLUSIONS: Our results show variation in scores across the domains of quality suggesting that it is possible to track quality of transitions for individuals across all settings, and not only within settings. We recommend that future work in tracking quality of care be performed at several levels (LTC, region, health authority, province). Such tracking is necessary to evaluate and improve overall quality of care.

Patterns of Use of Opioid Sparing Adjuncts for Perioperative Pain Management of Patients on Chronic Opioids.

BACKGROUND: Perioperative pain management of patients on chronic opioids is challenging. Although experts recommend regional anesthesia and multimodal analgesics for their opioid sparing effects, their use and predictors of use are unknown. OBJECTIVES: To examine the patterns and predictors of use of regional anesthesia and multimodal analgesics for perioperative pain control of patients on chronic opioids. A secondary objective was to examine the association of patient and surgical factors with 24-hour postoperative opioid use. STUDY DESIGN: Retrospective cross sectional. SETTING: Single center tertiary care academic hospital. METHODS: We studied patients with chronic opioid use undergoing painful operations such as abdominal, gynecologic, breast, orthopedic, spine, amputation, and laparoscopic surgeries. Chronic opioid use was identified using the narcotic score - a score generated from the state prescription drug monitoring database via the NarxCare platform. A narcotic score >= 320 corresponding to a preoperative home dose of approximately 40 milligram morphine equivalents (MMEs) daily, was chosen as a cutoff since the risk of overdose death increases above 40 MMEs. We reported the use of regional anesthesia and >= 3 multimodal analgesics in this cohort (n = 155) and examined the association of this use with patient and surgical factors such as preoperative narcotic score, age, race, comorbidity index, operative timetime, and intraoperative opioid use. In addition, we examined the association of patient and surgical factors with 24-hour postoperative opioid use. RESULTS: Out of 2470 patients undergoing painful surgeries between July 2017and- December 2018, 155 patients had a narcotic score >= 320. The median narcotic score was 411 (interquartile range (IQR) 351-520), the median preoperative home MME dose was 67.5 (IQR 32-180) mg daily. Regional anesthesia was used in only 9.7% of cases and was associated with intraoperative opioid used, but not the preoperative narcotic score. Patients receiving 1 SD more MMEs intraoperatively had a higher odds of receiving regional anesthesia (OR = 1.57, 95% CI [1.06, 2.32]). Three or more multimodals were used in 83% of cases. Every 10-point increase in narcotic score and every additional hour of operative time was associated with higher odds of receiving >= 3 multimodals (OR = 1.05, 95% CI [1.00, 1.11] and OR = 1.49, 95% CI [1.11, 1.99] respectively). Total 24 hour post-operative opioid dose was associated with narcotic score, with an 8.6 higher mean MME for every 10-point increase in narcotic score (mean difference = 8.6, 95% CI [4.1, 13.1]). It was also moderately associated with age, where patients an year older received 4.7 MMEs less (mean difference = - 4.7, 95% CI [-9.3, -0.5]). LIMITATIONS: This was a single center retrospective observational study. We could not adjust for inter-physician or inter-surgery effect on use of regional anesthesia or multimodal analgesics. Since this was one of the first studies to use narcotic scores to identify patients on chronic opioids, comparing the outcomes of interest to a control group was beyond the scope of the current study. Narcotic scores need to be validated to identify chronic opioid use. CONCLUSIONS: Despite consensus guidelines, regional anesthesia remains underutilized. Multimodals are used frequently and are modestly associated with preoperative narcotic scores.

Sustainment, Sustainability, and Spread Study (SSaSSy): protocol for a study of factors that contribute to the sustainment, sustainability, and spread of practice changes introduced through an evidence-based quality-improvement intervention in Canadian nursing homes.

BACKGROUND: Implementation scientists and practitioners, alike, recognize the importance of sustaining practice change, however post-implementation studies of interventions are rare. This is a protocol for the Sustainment, Sustainability and Spread Study (SSaSSy). The purpose of this study is to contribute to knowledge on the sustainment (sustained use), sustainability (sustained benefits), and spread of evidence-based practice innovations in health care. Specifically, this is a post-implementation study of an evidence-informed, Care Aide-led, facilitation-based quality-improvement intervention called SCOPE (Safer Care for Older Persons (in long-term care) Environments). SCOPE has been implemented in nursing homes in the Canadian Provinces of Manitoba (MB), Alberta (AB) and British Columbia (BC). Our study has three aims: (i) to determine the role that adaptation/contextualization plays in sustainment, sustainability and spread of the SCOPE intervention; (ii) to study the relative effects on sustainment, sustainability and intra-organizational spread of high-intensity and low-intensity post-implementation "boosters", and a "no booster" condition, and (iii) to compare the relative costs and impacts of each booster condition. METHODS/DESIGN: SSaSSy is a two-phase mixed methods study. The overarching design is convergent, with qualitative and quantitative data collected over a similar timeframe in each of the two phases, analyzed independently, then merged for analysis and interpretation. Phase 1 is a pilot involving up to 7 units in 7 MB nursing homes in which SCOPE was piloted in 2016 to 2017, in preparation for phase 2. Phase 2 will comprise a quasi-experiment with two treatment groups of low- and high-intensity post-implementation "boosters", and an untreated control group (no booster), using pretests and post-tests of the dependent variables relating to sustained care and management practices, and resident outcomes. Phase 2 will involve 31 trial sites in BC (17 units) and AB (14 units) nursing homes, where the SCOPE trial concluded in May 2019. DISCUSSION: This project stands to advance understanding of the factors that influence the sustainment of practice changes introduced through evidence-informed practice change interventions, and their associated sustainability. Findings will inform our understanding of the nature of the relationship of fidelity and adaptation to sustainment and sustainability, and afford insights into factors that influence the intra-organizational spread of practice changes introduced through complex interventions.

Project ECHO Chronic Pain: A Qualitative Analysis of Recommendations by Expert Faculty and the Process of Knowledge Translation.

INTRODUCTION: Previous studies of the same Project ECHO Chronic Pain cohort demonstrated that recommendations to primary care providers (PCPs) by expert faculty follow CDC Guidelines for Prescribing Opioids and that participating PCPs change their practice accordingly. The purpose of this study was to identify how expert faculty translates knowledge, so that PCPs can act on it. METHODS: One hundred ninety-seven PCPs from 82 practices in 14 states attended at least one Project ECHO Chronic Pain session over 10 months, hosted by a large federally qualified health center. Expert faculty was a multidisciplinary panel of six clinicians. Recommendations for 25 randomly selected case presentations were transcribed, yielding 406 discrete units of data. A thematic analysis contributed to a concept map for knowledge translation. RESULTS: Expert faculty addressed psychosocial issues in 40% of recommendations. Three themes represented a familiar clinical decision-making process: recommendations for treatment accounted for risk factors and patient engagement and behavior. A concept map placed the recommendations for selected cases in the first phase of the action cycle in the Knowledge-to-Action framework, where knowledge is shared but not yet acted on. DISCUSSION: Project ECHO Chronic Pain is an example of iterative guided practice, wherein expert faculty use published guidelines and professional experience to make recommendations for patient care to PCPs. This occurs using shared social-cultural-historical language and context consistent with social constructivist theories of learning.

The information-seeking patterns of care aides who work in nursing homes.

AIM: To explore the information-seeking patterns of care aides who work in nursing homes. BACKGROUND: Under the direction and supervision of nursing professionals, care aides provide the majority of direct care to nursing home residents. Understanding how, why, when and where they seek information to perform their duties is important for managers, policymakers and stakeholders. METHOD: Semi-structured interviews with eight care aides employed in three Canadian nursing homes were analysed using the Braun and Clarke method of thematic analysis. RESULTS: Five prominent information-seeking patterns emerged as themes. CONCLUSIONS: Care aides were motivated to seek information for personal and job-based reasons that included wanting to avoid mistakes and preparing physically, mentally and emotionally for the work ahead. They described depending on a social hierarchy of verbal information and using personal time (before/after work) to seek the information they needed. Due to time constraints, they relied on established patterns, accessed online information once a day at most and preferred paper-based sources. IMPLICATIONS FOR NURSING MANAGEMENT: Programs to enhance care aide communication skills to include the importance of information-seeking are warranted. Time for formal information-seeking during working hours should be provided and encouraged. When care aides initiate information-seeking to improve care this should be recognized and respected by others on the team. Programs to enhance care aide communication skills to include the importance of information-seeking are warranted. Time for formal information-seeking during working hours should be provided and encouraged. When care aides initiate information-seeking to improve care this should be recognized and respected by others on the team.

Fit for purpose? Introducing a rational priority setting approach into a community care setting.

Purpose - Program budgeting and marginal analysis (PBMA) is a priority setting approach that assists decision makers with allocating resources. Previous PBMA work establishes its efficacy and indicates that contextual factors complicate priority setting, which can hamper PBMA effectiveness. The purpose of this paper is to gain qualitative insight into PBMA effectiveness. Design/methodology/approach - A Canadian case study of PBMA implementation. Data consist of decision-maker interviews pre (n=20), post year-1 (n=12) and post year-2 (n=9) of PBMA to examine perceptions of baseline priority setting practice vis-à-vis desired practice, and perceptions of PBMA usability and acceptability. Findings - Fit emerged as a key theme in determining PBMA effectiveness. Fit herein refers to being of suitable quality and form to meet the intended purposes and needs of the end-users, and includes desirability, acceptability, and usability dimensions. Results confirm decision-maker desire for rational approaches like PBMA. However, most participants indicated that the timing of the exercise and the form in which PBMA was applied were not well-suited for this case study. Participant acceptance of and buy-in to PBMA changed during the study: a leadership change, limited organizational commitment, and concerns with organizational capacity were key barriers to PBMA adoption and thereby effectiveness. Practical implications - These findings suggest that a potential way-forward includes adding a contextual readiness/capacity assessment stage to PBMA, recognizing organizational complexity, and considering incremental adoption of PBMA's approach. Originality/value - These insights help us to better understand and work with priority setting conditions to advance evidence-informed decision making.

Orbital Exenteration to Manage Infiltrative Sinonasal, Orbital Adnexal, and Cutaneous Malignancies Provides Acceptable Survival Outcomes: An Institutional Review, Literature Review, and Meta-Analysis.

PURPOSE: Orbital exenteration (OE) is an aggressive operative undertaking that results in a disfiguring and dysfunctional outcome for patients. The purpose of our study was to determine the survival outcome for patients who underwent OE for malignant disease that had invaded the orbit. MATERIALS AND METHODS: We conducted an ambispective cohort study based on a review of the records of 31 consecutive patients who had undergone OE within John Hunter Hospital. The study period was 2006 to 2013. The predictor variables were the demographic, tumor site, and clinicopathologic characteristics that might influence survival. The secondary outcome variable was survival. Descriptive statistics were calculated for the categorical and continuous variables. Kaplan-Meier estimates of the survival distribution were plotted. We also performed a review of published studies and a meta-analysis to investigate the nature of OE performed by various surgical disciplines. RESULTS: Of the 31 patients included in the present study, 24 were men and 7 were women. The mean age was 65 years. Of the 31 cases, 15 were squamous cell carcinoma, 8 were basal cell carcinoma, and 8 were a mixture of other pathologic types. The time to median (50%) survival for all patients was 78.4 months. The 1-year survival rate was 93.4% and the 5-year survival rate was 54.1%. Although not statistically significant, notable differences were found in the interval to death with respect to the identification of perineural invasion, lymphovascular invasion, and histopathologic features. The review of published studies suggested a difference in the histologic features and location of the disorder treated, the extent of OE undertaken, and the method of reconstruction between the ophthalmology and nonophthalmology surgical disciplines. CONCLUSIONS: Although OE results in significant disfigurement and dysfunction, it does provide good survival outcomes, given the extent of disease at presentation, evident in our group of patients. Continuation of the study, with greater numbers of patients, will serve to increase the statistical power of our observations.

Determining and broadening the definition of impact from implementing a rational priority setting approach in a healthcare organization.

Techniques to manage scarce healthcare resources continue to evolve in response to changing, growing and competing demands. Yet there is no standard definition in the priority setting literature of what might constitute the desired impact or success of resource management activities. In this 2006-09 study, using action research methodology, we determined the impact of implementing a formal priority setting model, Program Budgeting and Marginal Analysis (PBMA), in a Canadian health authority. Qualitative data were collected through post year-1 (n = 12) and year-2 (n = 9) participant interviews, meeting observation and document review. Interviews were analyzed using a constant comparison technique to identify major themes. Impact can be defined as effects at three levels: system, group, and individual. System-level impact can be seen in the actual selection of priorities and resource re-allocation. In this case, participants prioritized a list of $760,000 worth of investment proposals and $38,000 of disinvestment proposals; however, there was no clear evidence as to whether financial resources were reallocated as a result. Group and individual impacts, less frequently reported in the literature, included changes in priority setting knowledge, attitudes and practice. PBMA impacts at these three levels were found to be interrelated. This work argues in favor of attempts to expand the definition of priority setting success by including both desired system-level outcomes like resource re-allocation and individual or group level impacts like changes to priority setting knowledge, attitudes and practice. These latter impacts are worth pursuing as they appear to be intrinsic to successful system-wide priority setting. A broader definition of PBMA impact may also suggest conceptualizing PBMA as both a priority setting approach and as a tool to develop individual and group priority setting knowledge and practice. These results should be of interest to researchers and decision makers using or considering a formal priority setting approach to manage scarce healthcare resources.

Change and predictors of change in social skills of nursing home residents with dementia.

BACKGROUND: Social skills are of primary importance for those with dementia and their care providers, yet we know little about the extent to which basic social skills can be maintained over time and the predictors of change. METHODS: A total of 18 nursing homes with 149 newly admitted residents with moderate to severe dementia, 195 direct care staff, and 135 family members, in British Columbia, Canada, contributed data on change in social skills from admission to 6 months and 1 year later. RESULTS: Three-quarters of residents maintained or improved their basic social skills during both the time periods. Decline was explained primarily by cognitive status at the time of admission, notably present orientation. However, staff-to-resident communication becomes more important over time. CONCLUSIONS: Social skills appear to present an opportunity to maintain interaction with these residents. The findings also suggest that a focus on the present orientation before and following admission and on staff-to-resident communication may be beneficial.

Treatment of bleeding upper aerodigestive tract tumor-a novel approach with antifibrinolytic agent: case series and literature review.

OBJECTIVES/HYPOTHESIS: Symptomatic bleeding among patients with advanced upper aerodigestive tract tumor is a challenging problem. Given the limited options for topical treatment, embolization is often required to control the hemorrhage. There are recent reported cases of novel and successful treatment of patients with recalcitrant tracheo-bronchial bleed with tranexamic acid. We therefore described our initial experience of four consecutive cases of patients with bleeding from advanced aerodigestive tract tumor, successfully treated with oral tranexamic acid. STUDY DESIGN: Case series. METHODS: Case series of four consecutive patients with acute bleed from upper aerodigestive tract tumors, treated with oral tranexamic acid. Tranexamic acid was administered topically and systemically (1gm PO QID) for the orophayngeal and supraglottic tumor cases, where as systemic-only therapy were administered to the patients with nasal and nasopharyngeal tumors. RESULTS: None of the patients experienced further bleeding following the commencement of tranexamic acid treatment, and no adverse effect was noted. These are the first reported cases of symptomatic upper aerodigestive hemorrhage being controlled with tranexamic acid. It is increasingly being used in patients with life-threatening bleeding following trauma and major surgery. The optimum dose of tranexamic acid is undetermined. In vivo studies suggested concentrations of 10 µg/mL to 16 µg/mL for optimal anti-fibrinolytic effect, which is achievable with 1gm QID of oral administration. Large randomized controlled trials assessing the utility of tranexamic acid in various orthopedic surgeries did not show increased thromboembolic events. CONCLUSIONS: Tranexamic acid should be considered for patients with symptomatic nonarterial bleeding of the upper aerodigestive tract tumors. LEVEL OF EVIDENCE: 4.

Neurocardiogenic syncope: a rare presentation of pharyngeal lymphoma.

Syncope is a common symptom of patients attending emergency departments, yet presents significant diagnostic and therapeutic challenges. We present a rare cause of recurrent vasovagal syncope with predominant cardioinhibitory response due to lymphoma surrounding and compressing the carotid artery treated successfully with radiotherapy.

Does mother's smoking influence girls' smoking more than boys' smoking? A 20-year review of the literature using a sex- and gender-based analysis.

A systematic literature review was conducted to examine whether mother's smoking influences girls' smoking more than boys' smoking. Fifty-seven studies, published between 1989 and 2009, were analyzed using a sex and gender lens. Results indicate that mother's prenatal and postnatal smoking influences girls' smoking more than boys' smoking. Despite evidence that sex and gender are important determinants of smoking among adolescents when examined in relation to mother's smoking, the theoretical understanding of why girls are more likely to smoke if prenatally and postnatally exposed to mother's smoking remains unclear. Implications for future research are discussed.

Involuntary glottal closure during inspiration in muscle tension dysphonia.

OBJECTIVE/HYPOTHESIS: The purpose of this study was to examine respiratory function in a group of patients with muscle tension dysphonia (MTD) DESIGN: Cross-sectional analytical study. METHODS: Participants included 15 people with a diagnosis of MTD referred to speech pathology for management of their voice disorder, fiberoptic evidence of glottal or supraglottic constriction during phonation with or without posterior chink, or bowing combined and deviation in perceptual voice quality. A second group of 15 participants with no history of voice disorder served as healthy controls. Baseline pulmonary function test measures included forced expiratory volume in the first second (FEV1), FVC, FEF25 to 75, FIF50, FEV1/FVC, ratio and FEF50/FIF50 ratio. Hypertonic saline challenge test measures included FEV1 and FIF50 after provocation, dose response slope, and provocation dose. RESULTS: Compared with healthy controls, participants with MTD demonstrated a higher prevalence of glottal constriction during inspiration after provocation with nebulized hypertonic saline as demonstrated by a reduction in FIF50 after the hypertonic saline challenge. There was no significant difference between the MTD and healthy control groups in baseline pulmonary function testing. Participants with MTD demonstrated a higher prevalence than healthy controls of abnormal glottic closure during inspiration similar to paradoxical vocal fold movement (PVFM). This suggests that they either had previously undiagnosed coexisting PVFM or that the condition of MTD could be expanded to include descriptions of aberrant glottic function during respiration. This study enhances the understanding of PVFM and MTD by combining research advances made in the fields of otolaryngology and respiratory medicine.