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.

A Mixed Methods Study to Implement the Synergy Tool and Evaluate Its Impact on Long-Term Care Residents.

BACKGROUND: There are ongoing workforce challenges with the delivery of long-term care (LTC), such as staffing decisions based on arbitrary standards. The Synergy tool, a resident-centered approach to staffing, provides objective, real-time acuity and dependency scores (Synergy scores) for residents. The purpose of this study was to implement and evaluate the impact of the Synergy tool on LTC delivery. METHODS: A longitudinal mixed methods study took place within two publicly funded LTC homes in British Columbia, Canada. Quantitative data included weekly Synergy scores for residents (24 weeks), monthly aggregated resident falls data (18 months) and a six-month economic evaluation. Qualitative data were gathered from family caregivers and thematically analyzed. RESULTS: Quantitative findings from Synergy scores revealed considerable variability for resident acuity/dependency needs within and across units; and falls decreased during implementation. The six-month economic evaluation demonstrated some cost savings by comparing Synergy tool training and implementation costs with savings from resident fall rate reductions. Qualitative analyses yielded three positive impact themes (improved care delivery, better communication, and improved resident-family-staff relationships), and two negative structural themes (language barrier and staff shortages). CONCLUSIONS: The Synergy tool provides useful data for enhancing a 'fit' between resident needs and available staff.

What influences decisions to donate plasma? A rapid review of the literature.

BACKGROUND AND OBJECTIVES: Plasma has become an essential ingredient for various medical treatments. Many blood collection agencies rely on voluntary non-remunerated donation when collecting plasma, but at present many do not collect sufficient plasma to meet domestic demands. This rapid review sought to explore the factors that have been found to influence people's decisions to donate plasma to inform future research. METHODS: Searches were conducted in PubMed, PsycINFO, Social Sciences Citation Index and CINAHL for peer-reviewed journal articles that discussed plasma donation and the factors associated with donor behaviour. Pertinent information from included articles was extracted and arranged in themes. RESULTS: In total, 33 articles were included in this review. Three main themes were identified by the authors. The first focused on site-level factors related to blood collection agencies' engagement with plasma donors and their influence on plasma donation experiences. The second theme considered how individual characteristics and experiences influence willingness to donate plasma. The third theme examined social and cultural-level factors, such as how social networks and community shape perceptions and experiences with donation. CONCLUSION: Our findings suggest that the current understanding of plasma donation is focused mainly on converting whole blood donors and also centres on individual-level factors to donation. Further research must examine what factors attract non-whole blood donors to become plasma donors, focusing on broader social-level influences. This review will inform policies and interventions for blood collection agencies to increase plasma donors.

"As long as that place stays open, I'll stay alive": Accessing injectable opioid agonist treatment during dual public health crises.

BACKGROUND: Since the onset of the COVID-19 pandemic, overdose rates in North America have continued to rise, with more than 100,000 drug poisoning deaths in the past year. Amidst an increasingly toxic drug supply, the pandemic disrupted essential substance use treatment and harm reduction services that reduce overdose risk for people who use drugs. In British Columbia, one such treatment is injectable opioid agonist treatment (iOAT), the supervised dispensation of injectable hydromorphone or diacetylmorphine for people with opioid use disorder. While evidence has shown iOAT to be safe and effective, it is intensive and highly regimented, characterized by daily clinic visits and provider-client interaction-treatment components made difficult by the pandemic. METHODS: Between April 2020 and February 2021, we conducted 51 interviews with 18 iOAT clients and two clinic nurses to understand how the pandemic shaped iOAT access and treatment experiences. To analyze interview data, we employed a multi-step, flexible coding strategy, an iterative and abductive approach to analysis, using NVivo software. RESULTS: Qualitative analysis revealed the ways in which the pandemic shaped clients' lives and the provision of iOAT care. First, client narratives illuminated how the pandemic reinforced existing inequities. For example, socioeconomically marginalized clients expressed concerns around their financial stability and economic impacts on their communities. Second, clients with health comorbidities recognized how the pandemic amplified health risks, through potential COVID-19 exposure or by limiting social connection and mental health supports. Third, clients described how the pandemic changed their engagement with the iOAT clinic and medication. For instance, clients noted that physical distancing guidelines and occupancy limits reduced opportunities for social connection with staff and other iOAT clients. However, pandemic policies also created opportunities to adapt treatment in ways that increased patient trust and autonomy, for example through more flexible medication regimens and take-home oral doses. CONCLUSION: Participant narratives underscored the unequal distribution of pandemic impacts for people who use drugs but also highlighted opportunities for more flexible, patient-centered treatment approaches. Across treatment settings, pandemic-era changes that increase client autonomy and ensure equitable access to care are to be continued and expanded, beyond the duration of the pandemic.

Exploring nursing home resident and their care partner priorities for care using the Action-Project Method.

BACKGROUND: Nursing home (NH) residents' experiences are embedded within their relationships to others. Our objectives were to describe how residents and care partners (family or staff members) jointly construct, discuss, and act on care priorities. METHODS: We used Action-Project Method, a qualitative method focused on action within social context. We recruited 15 residents and 12 care partners (5 family and 7 staff members) from 3 urban NHs in Alberta, Canada. Residents and care partners participated in a video-recorded conversation about their experiences in the NH, then individually reviewed the video-recording to add context to the conversation. Following transcription, preliminary narrative construction, and participant feedback, the research team conducted in-depth analysis to identify participant actions, goals, and projects, including those jointly shared by dyad members. RESULTS: All participants' intentions could be broadly described as "making time in the NH as good as possible" and projects were grouped into five categories: resident identity, relationships (both presence and absence), advocacy, positivity, and respectful care. Participants often raised issues of short-staffing as a significant barrier to respectful care. Care partners, especially staff, used positivity to redirect residents from difficult topics. Joint projects could be identified in some, but not all, cases. CONCLUSIONS: We found that maintaining a sense of identity, fostering relationships, and receiving respectful care were important to residents but that short-staffing created barriers. Methods to capture these aspects of the resident experience are needed but should not be influenced by care partners' tendency towards positivity in resident interactions.

Influences of post-implementation factors on the sustainability, sustainment, and intra-organizational spread of complex interventions.

BACKGROUND: Complex interventions are increasingly applied to healthcare problems. Understanding of post-implementation sustainment, sustainability, and spread of interventions is limited. We examine these phenomena for a complex quality improvement initiative led by care aides in 7 care homes (long-term care homes) in Manitoba, Canada. We report on factors influencing these phenomena two years after implementation. METHODS: Data were collected in 2019 via small group interviews with unit- and care home-level managers (n = 11) from 6 of the 7 homes using the intervention. Interview participants discussed post-implementation factors that influenced continuing or abandoning core intervention elements (processes, behaviors) and key intervention benefits (outcomes, impact). Interviews were audio-recorded, transcribed verbatim, and analyzed with thematic analysis. RESULTS: Sustainment of core elements and sustainability of key benefits were observed in 5 of the 6 participating care homes. Intra-unit intervention spread occurred in 3 of 6 homes. Factors influencing sustainment, sustainability, and spread related to intervention teams, unit and care home, and the long-term care system. CONCLUSIONS: Our findings contribute understanding on the importance of micro-, meso-, and macro-level factors to sustainability of key benefits and sustainment of some core processes. Inter-unit spread relates exclusively to meso-level factors of observability and practice change institutionalization. Interventions should be developed with post-implementation sustainability in mind and measures taken to protect against influences such as workforce instability and competing internal and external demands. Design should anticipate need to adapt interventions to strengthen post-implementation traction.

Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions.

BACKGROUND: Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg's popular Treatment Fidelity model, this paper aims to increase understanding of how to practically and comprehensively assess fidelity in complex, group-level, interventions. APPROACH AND LESSONS LEARNED: Drawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data-INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity 'failures' and 'deviations' and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn't threaten internal validity. RECOMMENDATIONS AND CONCLUSIONS: Six guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02695836. Registered on February 24, 2016.

Examining fidelity in the INFORM trial: a complex team-based behavioral intervention.

BACKGROUND: Fidelity in complex behavioral interventions is underexplored. This study examines the fidelity of the INFORM trial and explores the relationship between fidelity, study arm, and the trial's primary outcome-care aide involvement in formal team communications about resident care. METHODS: A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial. RESULTS: Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042). CONCLUSIONS: Overall fidelity enactment was associated with improvements in formal team communications, but the study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.

Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes-the INFORM cluster-randomized controlled trial.

BACKGROUND: Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on goal-setting theory on improving formal staff communication in NHs. METHODS: This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up. RESULTS: Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035). We found no difference in this outcome between the two higher intensity groups. CONCLUSIONS: Theoretically informed feedback was superior to simple feedback in improving care aides' involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02695836 ), registered on March 1, 2016.

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.

Motor skills, cognition, and work performance of people with severe mental illness.

PURPOSE: Employment offers many benefits to people with mental illness, yet their employment rate is much lower than that of the general population. We investigated the effect of work-related motor skills, neurocognition, and job attitudes on the work performance of people with mental illness, comparing those working in sheltered workshops, with controls working in similar jobs. METHODS: Twenty-nine adults with severe mental illness and 27 controls matched by gender and age were enrolled into the study using convenience sampling. They were assessed for gross and fine motor hand functioning, job attitudes, work performance, and cognition. RESULTS: People with mental illness scored lower on work performance, cognitive functioning, and hand dexterity while sitting and working with tools. They were assigned lower job loads than were controls, and perceived the physical environment at work as more constraining than did controls. Assembling motor skills significantly explained the work performance of people with mental illness. CONCLUSIONS: The results expand our understanding of the complexities involved in the employment of people with severe mental illness, and point to new paths for improving vocational outcomes of people with severe mental illness, taking into account their motor skills and job attitudes. Implications for rehabilitation Therapists should be aware that employed people with severe mental illness may have various unmet needs, affecting their work performance and experience of stress. This study results demonstrate importance of motor skills and perception of the work environment for the promotion of vocational outcomes among individuals with severe mental illness. Employment of people with severe mental illness should be viewed from holistic perspective as with general population, rather than focused on traditionally illness-related factors.

Implementing Frontline Worker-Led Quality Improvement in Nursing Homes: Getting to "How".

BACKGROUND: Despite emerging frameworks for quality improvement (QI) implementation, little is known about how the implementation process works, particularly in nursing home settings. A study was conducted to describe "how"' a complex frontline worker-led QI program was implemented in nursing homes. METHODS: Six focus groups were conducted in February 2017 with participants of a year-long, multicomponent, unit-level QI intervention in seven nursing homes in the Canadian province of Manitoba. Constant comparative analysis was used to examine perspectives of different groups of QI program participants-35 health care aides, health professionals, and managers. RESULTS: Five themes important to the implementation process were identified: (1) "supportive elements of the QI program structure," (2) "navigating the workplace," (3) "negotiating relationships," (4) "developing individual skills," and (5) "observable program impact." Data on theme integration suggest that "supportive elements of the QI program structure" (Theme 1), "developing individual skills" (Theme 4), and "observable program impact" (on residents, health care aides, and leaders; Theme 5) operated as part of a reinforcing feedback loop that boosted team members' ability to navigate the workplace, negotiate relationships, and implement the QI program. CONCLUSION: Health care aide-led QI teams are feasible. However, a leadership paradox exists whereby worker-led QI programs also must incorporate concrete mechanisms to promote strong leadership and sponsor support to teams. The findings also point to the underexplored impact of interpersonal relationships between health care aides and professional staff on QI implementation.

Participation in daily life of people with schizophrenia in comparison to the general population.

BACKGROUND: Participation in occupations is a basic human right. Although people with schizophrenia commonly experience restrictions in participation, there is a paucity of research in this area. PURPOSE: This study aimed to compare the participation patterns of people with schizophrenia to people without mental illness (control group). METHOD: A total of 140 people of similar age and sex completed the Adults Subjective Assessment of Participation and provided demographic and health-related data. FINDINGS: People with schizophrenia tend to participate in fewer activities and to participate alone. However, they participate with similar intensity as those in the control group. IMPLICATIONS: The participation patterns of people with schizophrenia are both unique and similar to those of the general population. The differences in participation raise concerns due to signs of restriction and social exclusion. However, it appears that people with schizophrenia benefit from occupation and community-based services that promote and support participation with others in diverse activities.

From hospital admission to independent living: is prediction possible?

An integral component of recovery from mental illness is being able to engage in everyday activities. This ability is often restricted among people with schizophrenia. Although functional deficits are addressed during hospitalization, the ability to predict daily functioning based on information gathered during hospitalization has not been well established. This study examines whether measurements completed during hospitalization can be useful for predicting independent living within the community. Inpatients with schizophrenia (N=104) were enrolled in the study and assessed for cognitive functioning, functional capacity and symptoms. They were approached again 6 months after discharge to evaluate their functioning with respect to everyday life Instrumental Activities of Daily Living (IADL) and Activities of Daily Living (ADL). Functional capacity during hospitalization predicted 26.8% of ADL functioning and 38.8% of IADL functioning. ADL was best predicted by the severity of negative symptoms, cognitive functioning, and the number of hospitalizations (51.2%), while IADL was best predicted by functional capacity, cognition, and number of hospitalizations (60.1%). This study provides evidence that evaluations during hospitalization can be effective, and demonstrates the advantage of a holistic approach in predicting daily functioning. When a holistic approach is not practical, a functional capacity measurement may serve as an effective predictor.

Sex and the community: the implications of neighbourhoods and social networks for sexual risk behaviours among urban gay men.

Gay neighbourhoods have historically served as vital places for gay socialising, and gay social networks are important sources of social support. Yet, few studies have examined the influence of these forms of community on sexual health. Informed by theoretical frameworks on neighbourhoods and networks, we employ multi-level modelling to test hypotheses concerning whether gay neighbourhoods and social network factors are associated with five sexual risk behaviours: receptive and insertive unprotected anal intercourse (UAI), barebacking identity, recent internet use for finding sexual partners, and 'Party and Play' (PnP). Our analyses of a community-based sample of gay men in New York City reveal little evidence for the direct effect of gay enclaves on sexual risk with the exception of PnP, which was more likely among gay enclave residents. Having a network composed predominantly of other gay men was associated with insertive UAI, PnP, and internet use for meeting sexual partners. This network type also mediated the association between gay neighbourhoods and higher odds of insertive UAI as well as PnP. Our findings highlight the sexual health implications of two important facets of gay community and, in doing so, indicate the need to better contextualise the sexual health risks faced by gay men.

Community and drug use among gay men: the role of neighborhoods and networks.

Gay neighborhoods serve as vital places for gay men's socializing, yet few studies have examined their contributions to gay men's health-either directly or indirectly via residents' social networks. Drawing from theoretical perspectives on community and networks, we test hypotheses concerning whether gay neighborhoods and social network factors are associated with patterns of recent illicit drug use among a sample of 740 urban gay men from New York City. Higher odds of drug use were observed among individuals who resided in gay neighborhoods, had networks composed predominantly of other gay men, and had increased socialization with gay men. Network factors did not mediate associations between gay neighborhoods and drug use. These findings highlight the need to better contextualize the health risks faced by gay men by accounting for both neighborhood and network structures.