A scoping review of the globally available tools for assessing health research partnership outcomes and impacts.

BACKGROUND: Health research partnership approaches have grown in popularity over the past decade, but the systematic evaluation of their outcomes and impacts has not kept equal pace. Identifying partnership assessment tools and key partnership characteristics is needed to advance partnerships, partnership measurement, and the assessment of their outcomes and impacts through systematic study. OBJECTIVE: To locate and identify globally available tools for assessing the outcomes and impacts of health research partnerships. METHODS: We searched four electronic databases (Ovid MEDLINE, Embase, CINAHL + , PsychINFO) with an a priori strategy from inception to June 2021, without limits. We screened studies independently and in duplicate, keeping only those involving a health research partnership and the development, use and/or assessment of tools to evaluate partnership outcomes and impacts. Reviewer disagreements were resolved by consensus. Study, tool and partnership characteristics, and emerging research questions, gaps and key recommendations were synthesized using descriptive statistics and thematic analysis. RESULTS: We screened 36 027 de-duplicated citations, reviewed 2784 papers in full text, and kept 166 studies and three companion reports. Most studies originated in North America and were published in English after 2015. Most of the 205 tools we identified were questionnaires and surveys targeting researchers, patients and public/community members. While tools were comprehensive and usable, most were designed for single use and lacked validity or reliability evidence. Challenges associated with the interchange and definition of terms (i.e., outcomes, impacts, tool type) were common and may obscure partnership measurement and comparison. Very few of the tools identified in this study overlapped with tools identified by other, similar reviews. Partnership tool development, refinement and evaluation, including tool measurement and optimization, are key areas for future tools-related research. CONCLUSION: This large scoping review identified numerous, single-use tools that require further development and testing to improve their psychometric and scientific qualities. The review also confirmed that the health partnership research domain and its measurement tools are still nascent and actively evolving. Dedicated efforts and resources are required to better understand health research partnerships, partnership optimization and partnership measurement and evaluation using valid, reliable and practical tools that meet partners' needs.

The REDUCED trial: a cluster randomized trial for REDucing the utilization of CEsarean delivery for dystocia.

BACKGROUND: To reduce cesarean delivery rates in nulliparous women, guidelines for diagnosing nonprogressive labor have been developed by the National Institute of Child Health and Human Development, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine. These are mainly based on data from the Consortium for Safe Labor study. The guidelines have not been tested in a clinical trial, so the efficacy and safety of this new approach is uncertain. OBJECTIVE: This study aimed to assess whether adoption of new guidelines for diagnosing nonprogressing labor would reduce cesarean delivery rates. STUDY DESIGN: We conducted a cluster randomized controlled trial of a knowledge translation program of the guidelines in 26 Canadian hospitals (13 control sites and 13 intervention sites). The sites included all intrapartum care sites in Alberta that perform cesarean delivery and deliver at least 70 nulliparous women annually. The baseline period started on January 1, 2015. The intervention was initiated at the first intervention site in January 2017. The follow-up period began at the first intervention site in February 2017 and lasted till February 2020. The primary outcome was the rate of cesarean delivery in nulliparous women with vertex presentation in labor at term. The secondary outcomes included spontaneous vaginal birth and maternal and neonatal safety. The main data source for the primary and secondary outcomes was the Alberta Perinatal Health Program database. The cesarean delivery rates were assessed using repeated measures mixed effects logistic regression applied to individual births. RESULTS: The analysis was based on 45,193 deliveries at intervention sites and 43,725 deliveries at control sites. There was no evidence of a decrease in the rate of cesarean delivery in association with the intervention (baseline-adjusted odds ratio, 0.94; 95% confidence interval [0.85-1.05]; P=.259). The rate of spontaneous vaginal delivery increased slightly (baseline-adjusted odds ratio, 1.10; 95% confidence interval, [1.01-1.18]; P=.024). We did not observe any differences in adverse maternal or neonatal outcomes. CONCLUSION: Cesarean delivery rates in nulliparous women were not reduced by the application of recent guidelines for the diagnosis of nonprogressive labor. Spontaneous vaginal delivery-a secondary outcome-was increased in the intervention group. The intervention appears to be safe.

Beyond guideline knowledge: a theory-based qualitative study of low-value preoperative testing.

BACKGROUND: Choosing Wisely Canada and most major anesthesia and preoperative guidelines recommend against obtaining preoperative tests before low-risk procedures. However, these recommendations alone have not reduced low-value test ordering. In this study, the theoretical domains framework (TDF) was used to understand the drivers of preoperative electrocardiogram (ECG) and chest X-ray (CXR) ordering for patients undergoing low-risk surgery ('low-value preoperative testing') among anesthesiologists, internal medicine specialists, nurses, and surgeons. METHODS: Using snowball sampling, preoperative clinicians working in a single health system in Canada were recruited for semi-structured interviews about low-value preoperative testing. The interview guide was developed using the TDF to identify the factors that influence preoperative ECG and CXR ordering. Interview content was deductively coded using TDF domains and specific beliefs were identified by grouping similar utterances. Domain relevance was established based on belief statement frequency, presence of conflicting beliefs, and perceived influence over preoperative test ordering practices. RESULTS: Sixteen clinicians (7 anesthesiologists, 4 internists, 1 nurse, and 4 surgeons) participated. Eight of the 12 TDF domains were identified as the drivers of preoperative test ordering. While most participants agreed that the guidelines were helpful, they also expressed distrust in the evidence behind them (knowledge). Both a lack of clarity about the responsibilities of the specialties involved in the preoperative process and the ease by which any clinician could order, but not cancel tests, were drivers of low-value preoperative test ordering (social/professional role and identity, social influences, belief about capabilities). Additionally, low-value tests could also be ordered by nurses or the surgeon and may be completed before the anesthesia or internal medicine preoperative assessment appointment (environmental context and resources, beliefs about capabilities). Finally, while participants agreed that they did not intend to routinely order low-value tests and understood that these would not benefit patient outcomes, they also reported ordering tests to prevent surgery cancellations and problems during surgery (motivation and goals, beliefs about consequences, social influences). CONCLUSIONS: We identified key factors that anesthesiologists, internists, nurses, and surgeons believe influence preoperative test ordering for patients undergoing low-risk surgeries. These beliefs highlight the need to shift away from knowledge-based interventions and focus instead on understanding local drivers of behaviour and target change at the individual, team, and institutional levels.

Systematic overviews of partnership principles and strategies identified from health research about spinal cord injury and related health conditions: A scoping review.

STUDY DESIGN: Scoping review. OBJECTIVE: To identify and provide systematic overviews of partnership principles and strategies identified from health research about spinal cord injury (SCI) and related health conditions. METHODS: Four health electronic databases (Medline, Embase, CINAHL, PsycINFO) were searched from inception to March 2019. We included articles that described, reflected, and/or evaluated one or more collaborative research activities in health research about SCI, stroke, multiple sclerosis, Parkinson's disease, amputation, cerebral palsy, spina bifida, amyotrophic lateral sclerosis, acquired brain injury, or wheelchair-users. Partnership principles (i.e. norms or values) and strategies (i.e. observable actions) were extracted and analyzed using directed qualitative content analysis. RESULTS: We included 39 articles about SCI (n = 13), stroke (n = 15), multiple sclerosis (n = 5), amputation (n = 2), cerebral palsy (n = 2), Parkinson's disease (n = 1), and wheelchair users (n = 1). We extracted 110 principles and synthesized them into 13 overarching principles. Principles related to building and maintaining relationships between researchers and research users were most frequently reported. We identified 32 strategies that could be applied at various phases of the research process and 26 strategies that were specific to a research phase (planning, conduct, or dissemination). CONCLUSION: We provided systematic overviews of principles and strategies for research partnerships. These could be used by researchers and research users who want to work in partnership to plan, conduct and/or disseminate their SCI research. The findings informed the development of the new SCI Integrated Knowledge Translation Guiding Principles (www.iktprinciples.com) and will support the implementation of these Principles within the SCI research system.

How are health research partnerships assessed? A systematic review of outcomes, impacts, terminology and the use of theories, models and frameworks.

BACKGROUND: Accurate, consistent assessment of outcomes and impacts is challenging in the health research partnerships domain. Increased focus on tool quality, including conceptual, psychometric and pragmatic characteristics, could improve the quantification, measurement and reporting partnership outcomes and impacts. This cascading review was undertaken as part of a coordinated, multicentre effort to identify, synthesize and assess a vast body of health research partnership literature. OBJECTIVE: To systematically assess the outcomes and impacts of health research partnerships, relevant terminology and the type/use of theories, models and frameworks (TMF) arising from studies using partnership assessment tools with known conceptual, psychometric and pragmatic characteristics. METHODS: Four electronic databases were searched (MEDLINE, Embase, CINAHL Plus and PsycINFO) from inception to 2 June 2021. We retained studies containing partnership evaluation tools with (1) conceptual foundations (reference to TMF), (2) empirical, quantitative psychometric evidence (evidence of validity and reliability, at minimum) and (3) one or more pragmatic characteristics. Outcomes, impacts, terminology, definitions and TMF type/use were abstracted verbatim from eligible studies using a hybrid (independent abstraction-validation) approach and synthesized using summary statistics (quantitative), inductive thematic analysis and deductive categories (qualitative). Methodological quality was assessed using the Quality Assessment Tool for Studies with Diverse Designs (QATSDD). RESULTS: Application of inclusion criteria yielded 37 eligible studies. Study quality scores were high (mean 80%, standard deviation 0.11%) but revealed needed improvements (i.e. methodological, reporting, user involvement in research design). Only 14 (38%) studies reported 48 partnership outcomes and 55 impacts; most were positive effects (43, 90% and 47, 89%, respectively). Most outcomes were positive personal, functional, structural and contextual effects; most impacts were personal, functional and contextual in nature. Most terms described outcomes (39, 89%), and 30 of 44 outcomes/impacts terms were unique, but few were explicitly defined (9, 20%). Terms were complex and mixed on one or more dimensions (e.g. type, temporality, stage, perspective). Most studies made explicit use of study-related TMF (34, 92%). There were 138 unique TMF sources, and these informed tool construct type/choice and hypothesis testing in almost all cases (36, 97%). CONCLUSION: This study synthesized partnership outcomes and impacts, deconstructed term complexities and evolved our understanding of TMF use in tool development, testing and refinement studies. Renewed attention to basic concepts is necessary to advance partnership measurement and research innovation in the field. Systematic review protocol registration: PROSPERO protocol registration: CRD42021137932 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=137932 .

A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol.

BACKGROUND: Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE. METHODS: This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5-12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks. DISCUSSION: This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices. TRIAL REGISTRATION: NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).

Optimizing COPD Acute Care Patient Outcomes Using a Standardized Transition Bundle and Care Coordinator: A Randomized Clinical Trial.

BACKGROUND: Acute exacerbations of COPD (AECOPD) are associated with high morbidity and mortality and frequent readmissions. RESEARCH QUESTION: What is the effectiveness of a COPD transition bundle, with and without a care coordinator, on rehospitalizations and ED revisits? STUDY DESIGN AND METHODS: Two patient cohorts were selected: (1) the group exposed to the transition bundle and (2) the group not exposed to the transition bundle (usual care group). Patients exposed subsequently were randomized to a care coordinator. An AECOPD transition bundle was implemented in the hospital; patients randomized to the care coordinator were contacted ≤ 72 h after discharge. Six hundred four patients (320 to the care coordinator and 284 to routine care) who met eligibility criteria from five hospitals across three cities in Alberta, Canada, were exposed to the transition bundle, whereas 3,106 patients discharged from the same hospitals received the usual care. Primary outcomes were 7-day, 30-day, and 90-day readmissions, median length of stay (LOS), and 30-day ED revisits. RESULTS: The transition bundle cohort were 83% (relative risk [RR], 0.17; 95% CI, 0.07-0.35) less likely to be readmitted within 7 days and 26% (RR, 0.74; 95% CI, 0.60-0.91) less likely to be readmitted within 30 days of discharge. Ninety-day readmissions were unchanged (RR, 1.05; 95% CI, 0.93-1.18). The transition bundle was associated with a 7.3% (RR, 1.07; 95% CI, 1.0-1.15) relative increase in LOS and a 76% (RR, 1.76; 95% CI, 1.53-2.02) greater risk of a 30-day ED revisit. The care coordinator did not influence readmission or ED revisits. INTERPRETATION: The COPD transition bundle reduced 7- and 30-day hospital readmissions while increasing LOS and ED revisits. The care coordinator did not improve outcomes. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03358771; URL: www. CLINICALTRIALS: gov.

Impact of an addiction medicine consult team intervention in a Canadian inner city hospital on acute care utilization: a pragmatic quasi-experimental study.

BACKGROUND: Inner city patients have a higher illness burden and need for care, but experience more unmet care needs. Hospital Addiction Medicine Consult Teams (AMCTs) are a promising emerging intervention. The objective of this study was to assess the impact of a Canadian AMCT-like intervention for inner city patients on reduction in high emergency department (ED) use, hospital admission, and inpatient length of stay. METHODS: Using a community-engaged, two-arm, pre-post, longitudinal quasi-experimental study design, 572 patients reporting active substance use, unstable housing, unstable income, or a combination thereof (302 at intervention site, 270 at control sites) were enrolled. Survey and administrative health service data were collected at baseline, six months post-enrolment, and 12 months post-enrolment. Multivariable regression models tested the intervention effect, adjusting for clinically important covariables (inpatient status at enrolment, medical complexity, age, gender, Indigenous identity, shelter use, opioid use). RESULTS: Initial bivariable analyses demonstrated an intervention effect on reduction in admissions and length of stay, however, this effect was no longer significant after adjusting for covariables. There was no evidence of reduction in high ED use on either bivariable or subsequent multivariable analysis. CONCLUSIONS: After adjusting for covariables, no AMCT intervention effect was detected for reduction in high ED use, inpatient admission, or hospital length of stay. Further research is recommended to assess other patient-oriented intervention outcomes.

Text4Hope: Receiving Daily Supportive Text Messages for 3 Months During the COVID-19 Pandemic Reduces Stress, Anxiety, and Depression.

BACKGROUND: This study reports on the changes in stress, anxiety, and depressive symptoms of subscribers after 3 months using Text4Hope, a supportive text messaging program designed to provide support during the pandemic. METHODS: Standardized self-report measures were used to evaluate perceived stress (measured with the Perceived Stress Scale-10 [PSS-10]), anxiety (measured with the General Anxiety Disorder Scale 7 [GAD-7]), and depressive symptoms (measured with the Patient Health Questionnaire [PHQ-9]), at baseline and 3rd month (n = 373). RESULTS: After 3 months of using Text4Hope, subscribers' self-reports revealed significant (p< 0.001) mean score reductions compared with baseline on: the GAD-7 by 22.7%, PHQ-9 by 10.3%, and PSS-10 scores by 5.7%. Reductions in inferred prevalence rates for moderate to high symptoms were also observed, with anxiety demonstrating the largest reduction (15.7%). CONCLUSIONS: Observed Text4Hope-related reductions in psychological distress during COVID-19 indicate that Text4Hope is an effective, convenient, and accessible means of implementing a population-level psychological intervention.

Trainee-led research using an integrated knowledge translation or other research partnership approaches: a scoping reviews.

BACKGROUND: There are increasing expectations for researchers and knowledge users in the health system to use a research partnership approach, such as integrated knowledge translation, to increase the relevance and use of research findings in health practice, programmes and policies. However, little is known about how health research trainees engage in research partnership approaches such as IKT. In response, the purpose of this scoping review was to map and characterize the evidence related to using an IKT or other research partnership approach from the perspective of health research trainees in thesis and/or postdoctoral work. METHODS: We conducted this scoping review following the Joanna Briggs Institute methodology and Arksey and O'Malley's framework. We searched the following databases in June 2020: MEDLINE, Embase, CINAHL and PsycINFO. We also searched sources of unpublished studies and grey literature. We reported our findings in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. RESULTS: We included 74 records that described trainees' experiences using an IKT or other research partnership approach to health research. The majority of studies involved collaboration with knowledge users in the research question development, recruitment and data collection stages of the research process. Intersecting barriers to IKT or other research partnerships at the individual, interpersonal and organizational levels were reported, including lack of skills in partnership research, competing priorities and trainees' "outsider" status. We also identified studies that evaluated their IKT approach and reported impacts on partnership formation, such as valuing different perspectives, and enhanced relevance of research. CONCLUSION: Our review provides insights for trainees interested in IKT or other research partnership approaches and offers guidance on how to apply an IKT approach to their research. The review findings can serve as a basis for future reviews and primary research focused on IKT principles, strategies and evaluation. The findings can also inform IKT training efforts such as guideline development and academic programme development.

Patients' Use of Mobile Health for Self-management of Knee Osteoarthritis: Results of a 6-Week Pilot Study.

BACKGROUND: In a previous study, a prototype mobile health (mHealth) app was co-designed with patients, family physicians, and researchers to enhance self-management and optimize conservative management for patients with mild to moderate knee osteoarthritis (OA). OBJECTIVE: This study aims to evaluate the overall usability, quality, and effectiveness of the mHealth app prototype for aiding knee OA self-management from the perspectives of patients with OA and health care providers (HCPs). METHODS: Using methods triangulation of qualitative and quantitative data, we conducted a pilot evaluation of an mHealth app prototype that was codeveloped with patients and HCPs. We recruited adult patients aged ≥20 years with early knee OA (n=18) who experienced knee pain on most days of the month at any time in the past and HCPs (n=7) to participate. In the qualitative assessment, patient and HCP perspectives were elicited on the likeability and usefulness of app features and functionalities and the perceived impact of the app on patient-HCP communication. The quantitative assessment involved evaluating the app using usability, quality, and effectiveness metrics. Patient baseline assessments included a semistructured interview and survey to gather demographics and assess the quality of life (European Quality-of-Life 5-Dimension 5-Level Questionnaire [EQ-5D-5L]) and patient activation (patient activation measure [PAM]). Following the 6-week usability trial period, a follow-up survey assessed patients' perceptions of app usability and quality and longitudinal changes in quality of life and patient activation. Semistructured interviews and surveys were also conducted with HCPs (n=7) at baseline to evaluate the usability and quality of the app prototype. RESULTS: Interviews with patients and HCPs revealed overall positive impressions of the app prototype features and functionalities related to likeability and usefulness. Between the baseline and follow-up patient assessments, the mean EQ-5D-5L scores improved from 0.77 to 0.67 (P=.04), and PAM scores increased from 80.4 to 87.9 (P=.01). Following the 6-week evaluation, patients reported a mean System Usability Scale (SUS) score of 57.8, indicating marginal acceptability according to SUS cutoffs. The mean number of goals set during the usability period was 2.47 (SD 3.08), and the mean number of activities completed for knee OA self-management during the study period was 22.2 (SD 17.8). Spearman rank correlation (rs) calculations revealed that the follow-up PAM scores were weakly correlated (rs=-0.32) with the number of goals achieved and the number (rs=0.19) of activities performed during the 6-week usability period. HCPs reported a mean SUS score of 39.1, indicating unacceptable usability. CONCLUSIONS: This evidence-based and patient-centered app prototype represents a potential use of mHealth for improving outcomes and enhancing conservative care by promoting patient activation and patient-HCP communication regarding OA management. However, future iterations of the app prototype are required to address the limitations related to usability and quality.

Contextual factors and mechanisms that influence sustainability: a realist evaluation of two scaled, multi-component interventions.

BACKGROUND: In 2012, Alberta Health Services created Strategic Clinical NetworksTM (SCNs) to develop and implement evidence-informed, clinician-led and team-delivered health system improvement in Alberta, Canada. SCNs have had several provincial successes in improving health outcomes. Little research has been done on the sustainability of these evidence-based implementation efforts. METHODS: We conducted a qualitative realist evaluation using a case study approach to identify and explain the contextual factors and mechanisms perceived to influence the sustainability of two provincial SCN evidence-based interventions, a delirium intervention for Critical Care and an Appropriate Use of Antipsychotics (AUA) intervention for Senior's Health. The context (C) + mechanism (M) = outcome (O) configurations (CMOcs) heuristic guided our research. RESULTS: We conducted thirty realist interviews in two cases and found four important strategies that facilitated sustainability: Learning collaboratives, audit & feedback, the informal leadership role, and patient stories. These strategies triggered certain mechanisms such as sense-making, understanding value and impact of the intervention, empowerment, and motivation that increased the likelihood of sustainability. For example, informal leaders were often hands-on and influential to front-line staff. Learning collaboratives broke down professional and organizational silos and encouraged collective sharing and learning, motivating participants to continue with the intervention. Continual audit-feedback interventions motivated participants to want to perform and improve on a long-term basis, increasing the likelihood of sustainability of the two multi-component interventions. Patient stories demonstrated the interventions' impact on patient outcomes, motivating staff to want to continue doing the intervention, and increasing the likelihood of its sustainability. CONCLUSIONS: This research contributes to the field of implementation science, providing evidence on key strategies for sustainability and the underlying causal mechanisms of these strategies that increases the likelihood of sustainability. Identifying causal mechanisms provides evidence on the processes by which implementation strategies operate and lead to sustainability. Future work is needed to evaluate the impact of informal leadership, learning collaboratives, audit-feedback, and patient stories as strategies for sustainability, to generate better guidance on planning sustainable improvements with long term impact.

Facilitators and barriers to implementation of Alberta family integrated care (FICare) in level II neonatal intensive care units: a qualitative process evaluation substudy of a multicentre cluster-randomised controlled trial using the consolidated framework for implementation research.

OBJECTIVE: To evaluate the barriers and facilitators to implementing Alberta Family Integrated Care (AB-FICare [2019 Benzies]), a model of care for integrating parents into level II neonatal intensive care units (NICUs) care teams, from the perspective of healthcare providers (HCP) and hospital administrators. DESIGN: Qualitative process evaluation substudy. SETTING: Ten level II NICUs in six cities across Alberta, Canada. PARTICIPANTS: HCP and hospital administrators (n=32) who were involved in the cluster-randomised controlled trial of AB-FICare in level II NICUs. METHODS: Post-implementation semi-structured interviews were conducted via phone or in-person. The Consolidated Framework for Implementation Research was used to develop interview guides, code transcripts and analyse data. RESULTS: Key facilitators to implementation of AB-FICare included (1) a receptive implementation climate, (2) compatibility of the intervention with individual and organisational practices, (3) available resources and access to knowledge and information for HCP and hospital administrators, (4) engagement of key stakeholders across the organisation, (5) engagement of and outcomes for intervention participants, and (6) reflecting and evaluating on implementation progress and patient and family outcomes. Barriers were (1) design quality and packaging of the intervention, (2) relative priority of AB-FICare in relation to other initiatives, and (3) learning climate within the organisation. Mixed influences on implementation depending on contextual factors were coded to eight constructs: intervention source, cost, peer pressure, external policy and incentives, staff needs and resources, structural characteristics, organisational incentives and rewards, and knowledge, beliefs and attitudes. CONCLUSIONS: The characteristics of an organisation and the implementation process had largely positive influences, which can be leveraged for implementation of AB-FICare in the NICU. We recommend site-specific consultations to mitigate barriers and assess how swing factors might impact implementation given the local context, with the goal that strategies can be put in place to manage their influence on implementation. TRIAL REGISTRATION NUMBER: NCT02879799.

Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women.

BACKGROUND: Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). METHODS: A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12-28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). DISCUSSION: CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. TRIAL REGISTRATION: ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

Gender Differences in Satisfaction With a Text Messaging Program (Text4Hope) and Anticipated Receptivity to Technology-Based Health Support During the COVID-19 Pandemic: Cross-sectional Survey Study.

BACKGROUND: In March 2020, Text4Hope-a community health service-was provided to Alberta residents. This free service aims to promote psychological resilience and alleviate pandemic-associated stress, anxiety, and depression symptoms during the COVID-19 pandemic. OBJECTIVE: This study aimed to evaluate the feedback, satisfaction, experience, and perceptions of Text4Hope subscribers and to examine any differences based on gender after subscribers received 6 weeks of daily supportive text messages. Additionally, this study examined subscribers' anticipated receptivity to technology-based medical services that could be offered during major crises, emergencies, or pandemics. METHODS: Individuals self-subscribed to Text4Hope to receive daily supportive text messages for 3 months. Subscribers were invited to complete a web-based survey at 6 weeks postintervention to provide service satisfaction-related information. Overall satisfaction was assessed on a scale of 0-10, and satisfaction scores were analyzed using a related-measures t test. Likert scale satisfaction responses were used to assess various aspects of the Text4Hope program. Gender differences were analyzed using one-way analysis of variance (ANOVA) and Chi-square analyses. RESULTS: A total of 2032 subscribers completed the baseline and 6-week surveys; 1788 (88%) were female, 219 (10.8%) were male, and 25 (1.2%) were other gender. The mean age of study participants was 44.58 years (SD 13.45 years). The mean overall satisfaction score was 8.55 (SD 1.78), suggesting high overall satisfaction with Text4Hope. The ANOVA analysis, which was conducted using the Welch test (n=1716), demonstrated that females had significantly higher mean satisfaction scores than males (8.65 vs 8.11, respectively; mean difference=0.546; 95% CI 0.19 to 0.91; P<.001) and nonsignificantly lower satisfaction scores than other gender respondents (mean difference=-0.938; 95% CI -0.37 to 2.25; P=.15). More than 70% of subscribers agreed that Text4Hope helped them cope with stress (1334/1731, 77.1%) and anxiety (1309/1728, 75.8%), feel connected to a support system (1400/1729, 81%), manage COVID-19-related issues (1279/1728, 74%), and improve mental well-being (1308/1731, 75.6%). Similarly, subscribers agreed that messages were positive, affirmative, and succinct. Messages were always or often read by 97.9% (1681/1716) of respondents, and more than 20% (401/1716, 23.4%) always or often returned to messages. The majority of subscribers (1471/1666, 88.3%) read the messages and either reflected upon them or took a positive action. Subscribers welcomed almost all technology-based services as part of their health care during crisis or emergency situations. Text4Hope was perceived to be effective by many female subscribers, who reported higher satisfaction and improved coping after receiving text messages for 6 weeks. CONCLUSIONS: Respondents affirmed the high quality of the text messages with their positive feedback. Technology-based services can provide remotely accessible and population-level interventions that align with the recommended physical distancing practices for pandemics. Text4Hope subscriber feedback revealed high satisfaction and acceptance at 6 weeks postintervention. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.

Mental Health Outreach via Supportive Text Messages during the COVID-19 Pandemic: Improved Mental Health and Reduced Suicidal Ideation after Six Weeks in Subscribers of Text4Hope Compared to a Control Population.

Background: In March 2020, Alberta Health Services launched Text4Hope, a free mental health text-message service. The service aimed to alleviate pandemic-associated stress, generalized anxiety disorder (GAD), major depressive disorder (MDD), and suicidal propensity. The effectiveness of Text4Hope was evaluated by comparing psychiatric parameters between two subscriber groups. Methods: A comparative cross-sectional study with two arms: Text4Hope subscribers who received daily texts for six weeks, the intervention group (IG); and new Text4Hope subscribers who were yet to receive messages, the control group (CG). Logistic regression models were used in the analysis. Results: Participants in the IG had lower prevalence rates for moderate/high stress (78.8% vs. 88.0%), likely GAD (31.4% vs. 46.5%), and likely MDD (36.8% vs. 52.1%), respectively, compared to respondents in the CG. After controlling for demographic variables, the IG remained less likely to self-report symptoms of moderate/high stress (OR = 0.56; 95% CI = 0.41-0.75), likely GAD (OR = 0.55; 95% CI = 0.44-0.68), and likely MDD (OR = 0.50; 95% CI = 0.47-0.73). The mean Composite Mental Health score, the sum of mean scores on the PSS, GAD-7, and PHQ-9 was 20.9% higher in the CG. Conclusions: Text4Hope is an effective population-level intervention that helps reduce stress, anxiety, depression, and suicidal thoughts during the COVID-19 pandemic. Similar texting services should be implemented during global crises.

COVID-19 Pandemic: Demographic Predictors of Self-Isolation or Self-Quarantine and Impact of Isolation and Quarantine on Perceived Stress, Anxiety, and Depression.

Introduction: With the sudden onset and global dispersal of the SARS-CoV-2 virus, many nations including Canada attempted to reduce spread of the resultant COVID-19 syndrome with self-isolation and quarantine, while seeking a cure or vaccine for this disease. Understanding impacts of self-isolation and self-quarantine on stress, anxiety, and depression will help us to mitigate these issues through appropriate development of mental health services. Methods: The sample was drawn from individuals who self-subscribed to Text4Hope, a service that delivers text messages based on a cognitive behavioral therapy framework. Text4Hope was developed to support Albertans during the COVID-19 pandemic. Subscribers were asked for demographic information and if they had to self-isolate or self-quarantine during the pandemic via a survey link. Mental health was assessed using the validated instruments: Perceived Stress Scale (PSS), Generalized Anxiety Disorder-7 item scale (GAD-7), and the Patient Health Questionnaire-9 (PHQ-9). Descriptive statistics and Chi-Square test results were derived using Statistical Package for Social Sciences (SPSS) version-26. Results: 6,041 of 32,805 Text4Hope subscribers (18.4%) completed the survey. Of these respondents, 19.2% had self-isolated or self-quarantined in Alberta as of March 31, 2020 during the COVID-19 pandemic. Post-hoc analysis using adjusted residuals suggested that individuals aged 60 years of age or older, and retirees had a higher likelihood of self-isolation or self-quarantine, compared to respondents with other age or employment characteristics. One-week prevalence rates for self-reported measures of moderate to high stress, likely Generalized Anxiety Disorder (GAD), and likely Major Depressive Disorder (MDD) were 84.9, 46.7, and 41.4%, respectively. Respondents who had to self-isolate or self-quarantine during the COVID-19 pandemic were significantly more likely to present with moderate to high stress, significant anxiety symptomatology, and significant depressive symptomatology. Conclusions: Older age and employment status were significantly associated with the likelihood of self-isolation or self-quarantine. We found elevated self-reported levels of anxiety and depression associated with self-reported COVID-19 pandemic-related self-isolation and self-quarantine activity. These findings have mental health implications both during and after the pandemic and demonstrate the need for greater focus on psychological complications of self-isolation and self-quarantine, and development of optimal ways to manage these pandemic consequences.

Changes in Stress, Anxiety, and Depression Levels of Subscribers to a Daily Supportive Text Message Program (Text4Hope) During the COVID-19 Pandemic: Cross-Sectional Survey Study.

BACKGROUND: In addition to the obvious physical medical impact of COVID-19, the disease poses evident threats to people's mental health, psychological safety, and well-being. Provision of support for these challenges is complicated by the high number of people requiring support and the need to maintain physical distancing. Text4Hope, a daily supportive SMS text messaging program, was launched in Canada to mitigate the negative mental health impacts of the pandemic among Canadians. OBJECTIVE: This paper describes the changes in the stress, anxiety, and depression levels of subscribers to the Text4Hope program after 6 weeks of exposure to daily supportive SMS text messages. METHODS: We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of Text4Hope subscribers. Perceived stress, anxiety, and depression were measured with the 10-Item Perceived Stress Scale (PSS-10), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the Patient Health Questionnaire-9 (PHQ-9) scale at baseline and sixth week time points. Moderate or high perceived stress, likely generalized anxiety disorder, and likely major depressive disorder were assessed using cutoff scores of ≥14 for the PSS-10, ≥10 for the GAD-7, and ≥10 for the PHQ-9, respectively. At 6 weeks into the program, 766 participants had completed the questionnaires at both time points. RESULTS: At the 6-week time point, there were statistically significant reductions in mean scores on the PSS-10 and GAD-7 scales but not on the PHQ-9 scale. Effect sizes were small overall. There were statistically significant reductions in the prevalence rates of moderate or high stress and likely generalized anxiety disorder but not likely major depressive disorder for the group that completed both the baseline and 6-week assessments. The largest reductions in mean scores and prevalence rates were for anxiety (18.7% and 13.5%, respectively). CONCLUSIONS: Text4Hope is a convenient, cost-effective, and accessible means of implementing a population-level psychological intervention. This service demonstrated significant reductions in anxiety and stress levels during the COVID-19 pandemic and could be used as a population-level mental health intervention during natural disasters and other emergencies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.

Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial.

BACKGROUND: Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS: In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS: We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. CONCLUSIONS: Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

Prevalence of Perceived Stress, Anxiety, Depression, and Obsessive-Compulsive Symptoms in Health Care Workers and Other Workers in Alberta During the COVID-19 Pandemic: Cross-Sectional Survey.

BACKGROUND: During pandemics, effective containment and mitigation measures may also negatively influence psychological stability. As knowledge about COVID-19 rapidly evolves, global implementation of containment and mitigation measures has varied greatly, with impacts to mental wellness. Assessing the impact of COVID-19 on the mental health needs of health care workers and other workers may help mitigate mental health impacts and secure sustained delivery of health care and other essential goods and services. OBJECTIVE: This study assessed the self-reported prevalence of stress, anxiety, depression, and obsessive-compulsive symptoms in health care workers and other workers seeking support through Text4Hope, an evidence-based SMS text messaging service supporting the mental health of residents of Alberta, Canada, during the COVID-19 pandemic. METHODS: An online cross-sectional survey gathered demographic (age, gender, ethnicity, education, relationship, housing and employment status, employment type, and isolation status) and clinical characteristics using validated tools (self-reported stress, anxiety, depression, and contamination/hand hygiene obsessive-compulsive symptoms). Descriptive statistics and chi-square analysis were used to compare the clinical characteristics of health care workers and other workers. Post hoc analysis was conducted on variables with >3 response categories using adjusted residuals. Logistic regression determined associations between worker type and likelihood of self-reported symptoms of moderate or high stress, generalized anxiety disorder, and major depressive disorder, while controlling for other variables. RESULTS: Overall, 8267 surveys were submitted by 44,992 Text4Hope subscribers (19.39%). Of these, 5990 respondents were employed (72.5%), 958 (11.6%) were unemployed, 454 (5.5%) were students, 559 (6.8%) were retired, 234 (2.8%) selected "other," and 72 (0.9%) did not indicate their employment status. Most employed survey respondents were female (n=4621, 86.2%). In the general sample, the 6-week prevalence rates for moderate or high stress, anxiety, and depression symptoms were 85.6%, 47.0%, and 44.0%, respectively. Self-reported symptoms of moderate or high stress, anxiety, and depression were all statistically significantly higher in other workers than in health care workers (P<.001). Other workers reported higher obsessive-compulsive symptoms (worry about contamination and compulsive handwashing behavior) after the onset of the pandemic (P<.001), while health care worker symptoms were statistically significantly higher before and during the COVID-19 pandemic (P<.001). This finding should be interpreted with caution, as it is unclear the extent to which the adaptive behavior of health care workers or the other workers might be misclassified by validated tools during a pandemic. CONCLUSIONS: Assessing symptoms of prevalent stress, anxiety, depression, and obsessive-compulsive behavior in health care workers and other workers may enhance our understanding of COVID-19 mental health needs. Research is needed to understand more fully the relationship between worker type, outbreak phase, and mental health changes over time, as well as the utility of validated tools in health care workers and other workers during pandemics. Our findings underscore the importance of anticipating and mitigating the mental health effects of pandemics using integrated implementation strategies. Finally, we demonstrate the ease of safely and rapidly assessing mental health needs using an SMS text messaging platform during a pandemic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.