Effectiveness-implementation Hybrid Design Research Articles

Study of Whole blood in Frontline Trauma (SWiFT): implementation study protocol

IntroductionUncontrolled bleeding is a major cause of death for patients with major trauma. Current transfusion practices vary, and there is uncertainty about the optimal strategy. Whole blood (WB) transfusion, which...

Study Protocol for the Healing Opioid Misuse and Pain Through Engagement Trial: Integrated Treatment for Individuals With Co-occurring Chronic Pain and Opioid Use Disorder.

Chronic pain and opioid use disorder (OUD) are public health crises and their co-occurrence has led to further complications and public health impacts. Provision of treatments for comorbid chronic pain and OUD is paramount to address these public health crises. Medications for OUD (MOUD) are gold standard treatments for OUD that have also demonstrated benefit in pain management. However, clinics that provide MOUD for chronic pain or OUD often lack behavioral treatments to address the challenges experienced by individuals with both conditions. Developing and implementing a behavioral treatment that complements MOUD may better equip clinics to provide comprehensive care to the growing proportion of clients who present with comorbid chronic pain and OUD. In the Healing Opioid misuse and Pain through Engagement (HOPE) Trial, we are using an effectiveness-implementation hybrid design to examine the benefits of an integrated behavioral treatment and to determine the feasibility of implementing the integrated treatment into clinics that provide MOUD. The treatment integrated 2 evidence-based treatments-Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention-to target the emotional, behavioral, and physiological sequelae of OUD and chronic pain. Implementation feasibility will include assessing changes in implementation readiness and identifying facilitators and barriers to implementing the integrated treatment among all personnel employed in clinics that provide MOUD. This commentary offers an overview of the study and design and details adaptations we made to our study protocol, based largely on clinic personnel time constraints and variable clinic procedures during the COVID-19 pandemic.

New Patterns for Low-income Families - A model for comprehensive and coordinated efforts.

Background: In Norway, more than one out of ten children grow up in poverty. Poverty and its consequences are often transferred across generations. Services to these families are seldom integrated and coordinated. We lack knowledge about the complexity they face and how measures should be organized to reach all family members. “New patterns” is a model for comprehensive and coordinated efforts for families with children who struggle with persistent low income and where the family experiences complex challenges.
 Aims: The aim was to develop a cross-sectoral service model to coordinate services for integrated health and social carefor poor families, to prevent transfer of low income and the accompanying social, economic, and health-related consequences across generations. 
 Methods: In New Patterns a multidisciplinary team of researchers and practitioners/social workers has searched for best practice and included findings from a pilot study where families expressed frustration and powerlessness because no one addressed the “whole picture” of their situation. Based on these findings the New patterns-model was developed. 
 We have employed a project design where evaluation and implementation function as simultaneous and reinforcing processes, inspired by the framework Effectiveness-implementation Hybrid Designs (1). The model has continuously been developed based on the experiences and feedbacks from participating families and practitioners. Dialogue with local and national policymakers and professionals has been an important part of the implementation process. 
 Results: In New Patterns a family coordinator is responsible for close follow-up of children and adults in 10 families over a period of 5 years. Follow-up includes services from different sectors, i.e., culture, education, health- and social services, and volunteer organizations. The family coordinator preforms a detailed mapping of the family`s needs, and together with the family develop a family plan enabling appropriate help and needed services. Through systematic mapping, close follow-up over time, practical and social support, and coordinator skills, the family coordinator develops trust-based relationships that provide new insight into the challenges and optimize the use of instruments in the traditional support system. 
 We have identified 10 effective elements in the family coordinator's follow-up of the participating families. These elements are illustrated in a Logic map, which shows the connection between follow-up and goal achievement, in short and long term, and the elements that must be present to succeed. The model enables integrated health care and social care to families with complex challenges. New Patterns is implemented in 10 municipalities in Norway, including 200 families.
 Conclusion: The family coordinator works with the family in the family’s everyday life, including home visits and accompanying the family members to meetings with relevant collaborating services. The intervention does not introduce new services but coordinates optimal use of existing municipal welfare services. The New Patterns model is relevant for other target groups with complex challenges and were the health and welfare systems struggle to provide integrated care to all family members.
 1.Curran GM,Bauer M,Mittman B,Pyne JM,Stetler C. Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Med Care. 2012;50(3):217-26. DOI: 10.1097/MLR.0b013e3182408812 

BE EPIC-VR: TRANSLATING AN IN-PERSON, PERSON-CENTERED COMMUNICATION TRAINING PROGRAM INTO VIRTUAL REALITY

Abstract Be EPIC is a dementia-specific, person-centered communication training program for frontline healthcare workers that uses simulations with trained actors, reflection, and feedback. Scaling Be EPIC is limited by resource and methodology demands of recruiting and training actors and consistency of delivery across sites. Virtual reality (VR) is a promising solution to the problem of scaling Be EPIC because it provides interactive, realistic, and consistent simulations. However, there is limited research on implementing VR to train frontline healthcare workers. Guided by the Consolidated Framework for Implementation Research, the current study used an effectiveness-implementation hybrid design to compare simulation experiences of Be EPIC-VR with Be EPIC-in person and real-world clinical encounters. The study also explored factors that can influence the future implementation of Be EPIC-VR in long-term care home settings during the pre-implementation period. Six frontline healthcare workers who completed the Be EPIC in-person version with trained actors also completed the same assessment simulation in VR, followed by an interview. Thematic analyses revealed two themes that contributed to the simulation’s realism: the immersive nature of the virtual environment and the accuracy of the avatar’s visual, verbal, and behavioral characteristics. Moreover, the factors influencing the successful implementation of VR simulations in long-term care home settings include sufficient technological infrastructure and workplace personnel who can assist with Be EPIC-VR implementation. The findings highlight the potential to scale Be EPIC using VR and provides insights into the iterative process involved in translating an in-person training into a VR training program.

A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol

BackgroundThe ageing population requires seamless, integrated health and social care services in the community to promote the health of older adults. However, inadequate financial resources, a lack of clear operational guidelines, and various organisational work cultures may affect the implementation quality and sustainability of these services. As a unique approach, this study seeks to examine the preliminary effects of a health-social partnership programme on the health self-management of community-dwelling older adults in Hong Kong. Additionally, the study seeks to ascertain key insights into the mechanisms and processes required to implement and sustain a self-care management programme in broader practice in community settings.MethodsThis study will use a hybrid effectiveness-implementation design. During the 3-month programme, subjects in the intervention group will receive four Zoom video conference sessions and four telephone calls conducted by a health-social service team that will include a nurse case manager, community workers, general practitioners, a Chinese medicine practitioner, and social workers. Subjects in the control group will receive a monthly social telephone call from a trained research assistant to rule out the possible social effect of the intervention. The reach, effectiveness, adoption, implementation, and maintenance framework (i.e. RE-AIM framework) will be used to evaluate the implementation and effectiveness outcomes. Of the five dimensions included in the RE-AIM framework, only effectiveness and maintenance outcomes will be collected from both the intervention and control groups. The outcomes of the other three dimensions—reach, adoption, and implementation—will only be collected from subjects in the intervention group. Data will be collected pre-intervention, immediately post-intervention, and 3 months after the intervention is completed to evaluate the maintenance effect of the programme.DiscussionThis programme will aim to enhance health-promoting self-care management behaviours in older adults dwelling in the community. This will be the first study in Hong Kong to use the hybrid effectiveness-implementation design and involve key stakeholders in the evaluation and implementation of a health self-management programme using a health-social service partnership approach. The programme, which will be rooted in the community, may be used as a model, if proven successful, for similar types of services.Trial registrationClinicaltrials.gov, NCT04442867. Submitted 19 June 2020

Effectiveness and feasibility of an interprofessional training program to improve patient safety-A cluster-randomized controlled pilot study.

Interprofessional healthcare teams are important actors in improving patient safety. To train these teams, an interprofessional training program (IPTP) with two interventions (eLearning and blended learning) was developed to cover key areas of patient safety using innovative adult learning methods. The aims of this study were to pilot test IPTP regarding its effectiveness and feasibility. The trial was registered with DRKS-ID: DRKS00012818. The design of our study included both a pilot investigation of the effectiveness of the two interventions (eLearning and blended learning) and testing their feasibility (effectiveness-implementation hybrid design). For testing the effectiveness, a multi-center cluster-randomized controlled study with a three-arm design [intervention group 1 (IG1): eLearning vs. intervention group 2 (IG2)]: blended learning (eLearning plus interprofessional in-person training) vs. waiting control group (WCG) and three data collection periods (pre-intervention, 12 weeks post-intervention, and 24 weeks follow-up) was conducted in 39 hospital wards. Linear mixed models were used for the data analysis. The feasibility of IPTP was examined in 10 hospital wards (IG1) and in nine hospital wards (IG2) using questionnaires (formative evaluation) and problem-focused interviews with 10% of the participants in the two intervention groups. The collected data were analyzed in a descriptive exploratory manner. Pilot testing of the effectiveness of the two interventions (eLearning and blended learning) showed no consistent differences between groups or a clear pattern in the different outcomes (safety-related behaviors in the fields of teamwork, error management, patient involvement, and subjectively perceived patient safety). Feasibility checks of the interventions showed that participants used eLearning for knowledge activation and self-reflection. However, there were many barriers to participating in eLearning, for example, lack of time or access to computers at the ward. With regard to in-person training, participants stated that the training content sensitized them to patient-safety-related issues in their everyday work, and that awareness of patient safety increased. Although the interventions were judged to be feasible, no consistent effects were observed. A possible explanation is that the duration of training and the recurrence rate may have been insufficient. Another conceivable explanation would be that participants became more sensitive to patient safety-critical situations due to their knowledge acquired through the IPTP; therefore, their assessment post-intervention was more critical than before. In addition, the participants reported high pre-measurement outcomes. Future studies should examine the evidence of the intervention within a confirmatory study after adapting it based on the results obtained.

Effectiveness and feasibility of a motivational interviewing intake (MII) intervention for increasing client engagement in outpatient addiction treatment: an effectiveness-implementation hybrid design protocol

BackgroundClient discontinuation from outpatient addiction treatment programs is common, and the initial intake is the service delivery point with the highest attrition rate. Replacing the comprehensive intake assessment with a person-centered Motivational Interviewing (MI) intervention is a potential solution to address provider and client concerns about the disengaging, time-intensive nature of the typical initial intake. It remains unclear whether the use of an alternative to the standard intake at the initial visit can fit within typical organizational reporting requirements, whether it decreases attrition, and whether implementation of person-centered intake procedures within outpatient addiction treatment programs is feasible, acceptable, and can be sustained.PurposeTo describe the methods and design of an effectiveness-implementation hybrid type 1 trial of a Motivational Interviewing at Intake (MII) intervention using the Consolidated Framework for Implementation Research (CFIR).MethodsThe study will determine the effectiveness of two intake conditions: (1) standard comprehensive intake assessment (intake-as-usual [IAU]), and (2) MII consisting of a person-centered discussion between provider and client about the client’s desire and intent to enter treatment. Although both interventions are focused on understanding client presenting complaints and needs for treatment, the delivery differs as the IAU uses a semi-structured assessment guide, while MII applies the theory of MI to have a conversation about treatment engagement. Adults seeking outpatient addiction treatment services will be randomly assigned to the MII condition (n = 75) or the IAU condition (n = 75). Primary outcomes will be client engagement (i.e., treatment entry, attendance, and completion) obtained from the electronic medical record. Secondary outcomes (client motivation and therapeutic alliance) will be putative mechanisms of client engagement assessed immediately before and after the intake. The trial also will explore determinants of effective, sustainable implementation using assessments of organizational readiness and capacity to change, as well as interviews on MII implementation feasibility.ConclusionThis trial of an MII intervention will investigate the feasibility of a motivational intervention as an initial contact with substance use treatment-seeking clients as well as indicators of intervention effectiveness within the systems where it is employed.Trial registration Clinicaltrials.gov identifier: NCT05489068

MHealth Monitoring of Treatment of Cutaneous Leishmaniasis Patients: A Community-Based Implementation Study.

Cutaneous leishmaniasis (CL) remains a global health problem. Compelled by the protracted healing process, initial and final outcomes of treatment are determined at 90 and 180 days, respectively, after initiation of treatment. Loss to follow-up during these intervals is substantial. Consequently, the effectiveness of treatment is largely unknown. We conducted an effectiveness-implementation hybrid design study of a community-based mobile health (mHealth) strategy to monitor adherence to anti-leishmanial treatment, adverse drug reactions, and therapeutic response compared with standard of care in two rural communities of Colombia. Three implementation outcomes were evaluated: usability and acceptability by qualitative methods and fidelity using quantitative methods. Fifty-seven patients were prospectively included in the mHealth intervention and 48 in the standard-of-care group. In addition, 24 community health leaders (CHLs), health workers, and patients participated in qualitative evaluations. The intervention significantly increased the proportion of patients having follow-up of therapeutic outcomes 90 and 180 days after initiating treatment from 4.2% (standard of care) to 82.5% (intervention), P < 0.001. The proportion of patients having records of treatment adherence, adverse drug reactions, and therapeutic response also increased significantly (P < 0.001). Fidelity to the intervention (recording of treatment adherence, adverse drug reactions, lesion photographs, and evaluation of therapeutic response) was 70-100%. The app was highly accepted by CHLs, health workers, and patients, who perceived that the app improved case identification and follow-up and met a public health need. Although usability was high, low connectivity affected real-time transmission of data. This community-based mHealth strategy facilitated access to health care for CL in rural areas and knowledge of treatment effectiveness.

Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial

BackgroundSepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis “bundles” (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle.MethodThe primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes.DiscussionThis cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles.FundingNHLBI R01HL162954.Trial registrationClinicalTrials.gov NCT05491941. Registered on August 8, 2022.

A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial.

Suicide attempts and suicide death disproportionately affect sexual and gender minority emerging adults (age 18-24 years). However, suicide prevention strategies tailored for emerging adult sexual and gender minority (EA-SGM) groups are not widely available. The Safety Planning Intervention (SPI) has strong evidence for reducing the risk for suicide in the general population, but it is unclear how best to support EA-SGM groups in their use of a safety plan. Our intervention (Supporting Transitions to Adulthood and Reducing Suicide [STARS]) builds on content from an existing life skills mobile app for adolescent men who have sex with men (iREACH) and seeks to target core risk factors for suicide among EA-SGM groups, namely, positive affect, discrimination, and social disconnection. The mobile app is delivered to participants randomized to STARS alongside 6 peer mentoring sessions to support the use of the safety plan and other life skills from the app to ultimately reduce suicide risk. We will pilot-test the combination of peer mentoring alongside an app-based intervention (STARS) designed to reduce suicidal ideation and behaviors. STARS will include suicide prevention content and will target positive affect, discrimination, and social support. After an in-person SPI with a clinician, STARS users can access content and activities to increase their intention to use SPI and overcome obstacles to its use. EA-SGM groups will be randomized to receive either SPI alone or STARS and will be assessed for 6 months. Guided by the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework, we will recruit and enroll a racially and ethnically diverse sample of 60 EA-SGM individuals reporting past-month suicidal ideation. Using a type-1 effectiveness-implementation hybrid design, participants will be randomized to receive SPI (control arm) or to receive SPI alongside STARS (intervention arm). We will follow the participants for 6 months, with evaluations at 2, 4, and 6 months. Preliminary effectiveness outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (positive affect, coping with discrimination, and social support) will serve as our primary outcomes. Secondary outcomes include key implementation indicators, including participants' willingness and adoption of SPI and STARS and staff's experiences with delivering the program. Study activities began in September 2021 and are ongoing. The study was approved by the institutional review board of the University of Pennsylvania (protocol number 849500). Study recruitment began on October 14, 2022. This project will be among the first tailored, mobile-based interventions for EA-SGM groups at risk for suicide. This project is responsive to the documented gaps for this population: approaches that address chosen family, focus on a life-course perspective, web approaches, and focus on health equity and provision of additional services relevant to sexual and gender minority youth. ClinicalTrials.gov NCT05018143; https://classic.clinicaltrials.gov/ct2/show/NCT05018143. DERR1-10.2196/48177.

The impact and implementation of an mHealth intervention to improve infant and young child feeding in Senegal: IIMAANJE protocol for a cluster randomized control trial.

Behavior change communication (BCC) strategies have the potential to improve infant feeding and nutrition outcomes among infants and young children in low- and middle-income countries. More recently, there has been a shift toward the adoption of mHealth interventions-the use of mobile phones to transmit health-related information or direct care-to promote recommended BCC strategies among the caregivers of infants and young children. In Senegal, most infants and young children are not fed according to recommended practices leading to a high prevalence of undernutrition and micronutrient deficiencies. The aims of this cluster randomized control trial, using an effectiveness-implementation (type 1) hybrid design, were to: (1) determine the impact of an mHealth IYCF intervention on IYCF practices and nutrition outcomes; and (2) examine the implementation, costs, and opportunities for scaling up the mHealth messaging intervention. The trial was conducted in three regions in Senegal (Thies, Fatick, Diourbel) with 488 mother, father and children (6-23 months) triads. The intervention included 8 scripted messages, that underwent cognitive testing prior to the intervention implementation, and 8 unscripted messages from positive deviants. One voice message and one text message were sent each week to members of our experimental group for a 16-week period. The impact of the intervention was assessed through a household survey, 24-h dietary recall, and hemoglobin measurements before and after the intervention implementation. The primary outcomes were minimal acceptable diet (MAD) and anemia. We also included a total of 54 participants in nine focus groups held with mothers and fathers and semi-structured interviews with Badienou Gox (i.e., community health workers) (n = 6) and national partners and program implementers (n = 6) to examine the intervention implementation process. The study was registered prior to data collection on Clinicaltrials.gov (Identifier: NCT05374837).

Study protocol of a randomized trial of STRIPES: a schoolyear, peer-delivered high school intervention for students with ADHD

BackgroundYouth with ADHD are at risk of academic impairments, dropping out of high school, and dysfunction in young adulthood. Interventions delivered early in high school could prevent these harmful outcomes, yet few high school students with ADHD receive treatment due to limited access to intervention providers. This study will test a peer-delivered intervention (STRIPES) for general education 9th grade students with impairing ADHD symptoms.MethodsA type 1 hybrid effectiveness-implementation design will be used to evaluate the effectiveness of STRIPES and explore the intervention’s implementability. Analyses will test the impact of STRIPES vs. enhanced school services control on target mechanisms and determine whether differences in basic cognitive profiles moderate intervention response. The acceptability and feasibility of STRIPES and treatment moderators will also be examined.DiscussionThis study will generate knowledge about the effectiveness and implementability of STRIPES, which will inform dissemination efforts in the future. A peer-delivered high school intervention for organization, time management, and planning skills can provide accessible and feasible treatment targeting declines in academic motivation, grades, and attendance during the ninth-grade year.Trial registrationThis study is registered on OSF Registries (10.17605/OSF.IO/Q8V6S).

The Stride program: Feasibility and pre-to-post program change of an exercise service for university students experiencing mental distress

Rates of mental illness are disproportionately high for young adult and higher education (e.g., university student) populations. As such, universities and tertiary institutions often devote significant efforts to services and programs that support and treat mental illness and/or mental distress. However, within that portfolio of treatment approaches, structured exercise has been relatively underutilised and greater research attention is needed to develop this evidence base. The Stride program is a structured 12-week exercise service for students experiencing mental distress. We aimed to explore the feasibility of the program and assess pre- and post-program change, through assessments of student health, lifestyle, and wellbeing outcomes. Drawing from feasibility and effectiveness-implementation hybrid design literatures, we conducted a non-randomised feasibility trial of the Stride program. Participants were recruited from the Stride program (N = 114, Mage = 24.21 years). Feasibility results indicated the program was perceived as acceptable and that participants reported positive perceptions of program components, personnel, and sessions. Participants’ pre-to-post program change in depressive symptomatology, physical activity levels, mental health-related quality of life, and various behavioural outcomes were found to be desirable. Our results provide support for the feasibility of the Stride program, and more broadly for the delivery and potential effectiveness of structured exercise programs to support university students experiencing mental distress.

Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol

BackgroundGonorrhea and chlamydia are the most common sexually transmitted diseases (STDs) among men who have sex with men (MSM) in China. Previous studies have shown pay-it-forward (PIF) interventions to be associated with a substantial increase in gonorrhea and chlamydia test uptake compared to standard-of-care. We propose a 'pay-it-forward' gonorrhea and chlamydia testing randomized controlled trial (PIONEER). The trial would evaluate the effectiveness of two pay-it-forward strategies in promoting testing uptake compared to the standard of care (in which men pay for their tests out-of-pocket) among MSM and male STD patients in China.MethodsPIONEER will be a three-armed, pragmatic cluster randomized controlled trial (RCT), conducted across 12 clinics (six MSM-led and six public STD clinics) to compare the effectiveness of three implementation strategies. Each facility will be randomized to a standard pay-it-forward intervention of gonorrhea/ chlamydia testing with minimal encouragement for testing, a community-engaged pay-it-forward arm, or a control arm where men pay for their tests out-of-pockets. The primary outcome will be dual gonorrhea/chlamydia test uptake. Secondary outcomes will include syphilis testing, amount donated in pay-it-forward, number of positive gonorrhea and chlamydia tests, and measures of antimicrobial resistance. A sequential transformative mixed methods design will be used to evaluate the implementation process in type 2 effectiveness-implementation hybrid design. Data sources will include survey on acceptability, and feelings and attitudes towards the interventions among participants; testing and treatment uptake data from clinic records, WeChat records, and qualitative data to gain insights into men's perceptions and attitudes towards the pay-it-forward, mechanisms driving uptake, and donating behaviors. Implementers and organizers will be interviewed about fidelity and adherence to protocol, sustainability of pay-it-forward intervention, and barriers and facilitators of implementing the intervention.DiscussionPIONEER will substantially increase gonorrhea/chlamydia testing among MSM in China, providing an innovative and new financial mechanism to sustain STD screening among sexual minorities in low- and middle-income countries. This study will answer compelling scientific questions about how best to implement pay-it-forward and the individual and organizational characteristics that moderate it.Trial registration: The study with identification number NCT05723263 has been registered on clinicaltrials.gov/.

The Emergency nurse Protocols Initiating Care—Sydney Triage to Admission Risk Tool (EPIC-START) trial: protocol for a stepped wedge implementation trial

IntroductionEmergency department (ED) overcrowding is a global problem and a threat to the quality and safety of emergency care. Providing timely and safe emergency care therein is challenging. To address this in New South Wales (NSW), Australia, the Emergency nurse Protocol Initiating Care—Sydney Triage to Admission Risk Tool (EPIC-START) was developed. EPIC-START is a model of care incorporating EPIC protocols, the START patient admission prediction tool, and a clinical deterioration tool to support ED flow, timely care, and patient safety. The aim of this study is to evaluate the impact of EPIC-START implementation across 30 EDs on patient, implementation, and health service outcomes.Methods and analysisThis study protocol adopts an effectiveness-implementation hybrid design (Med Care 50: 217-226, 2012) and uses a stepped–wedge cluster randomised control trial of EPIC-START, including uptake and sustainability, within 30 EDs across four NSW local health districts spanning rural, regional, and metropolitan settings. Each cluster will be randomised independently of the research team to 1 of 4 dates until all EDs have been exposed to the intervention. Quantitative and qualitative evaluations will be conducted on data from medical records and routinely collected data, and patient, nursing, and medical staff pre- and post-surveys.Ethics and disseminationEthical approval for the research was received from the Sydney Local Health District Research Ethics Committee (Reference Number 2022/ETH01940) on 14 December 2022.Trial registrationAustralian and New Zealand Clinical trial, ACTRN12622001480774p. Registered on 27 October 2022.

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial

BackgroundThe safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. MethodsThis 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11–14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. DiscussionWe expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers.Trial registration: ClinicalTrials.govNCT04587167. Registered on October 14, 2020.

Weaving Evidence into Action for Veterans with Dementia (WEAVE): Evaluation of implementation into long-term care practice.

Veterans living with dementia in long-term care have complex needs, with variable manifestation of symptoms of dementia that interact with their lived experience. Best practice dementia care prioritises nonpharmacological interventions; of which few have strong evidence. Implementation of evidence is complex, with evaluation of outcomes and processes necessary. This paper details the evaluation of implementation, at veteran and organisational level, of the Weaving Evidence into Action for Veterans with Dementia (WEAVE) programme. A Type 2 hybrid effectiveness-implementation design was used, underpinned by the Implementation Framework for Aged Care (IFAC). Programme intervention incorporated music therapy, exercise, reminiscence therapy and/or sensory modulation, offered over a 24-week period. Evaluation components included: (1) programme effectiveness for veterans with dementia for responsive behaviour, physical wellbeing, cognitive status, emotional state, medications and falls (at baseline, 8-week, 16-week and 24-week); and (2) implementation outcomes of reach and adoption, feasibility and acceptability, fidelity (via interviews) and a preliminary cost analysis. Thirty-eight veterans participated in the 24-week programme, with high levels of engagement in interventions of their choice. Statistically significant improvements were seen across all veteran-level outcome measures, for functional capacity and reduced neuro-psychiatric and depressive symptoms. Ten staff members were interviewed, highlighting co-designed core elements were feasible and acceptable, and the momentum generated by resident and staff enthusiasm. Cost analysis included costs of programme set-up and running the 24-week intervention. Key components of programme success were the therapeutic leaders, adherence to core elements of programme design, and veterans' choice in meaningful activity. Cost analysis supports deliberations for upscale across further care homes.

Implementation of inclisiran in United Kingdom primary care for patients with atherosclerotic cardiovascular disease or its-risk equivalents: rationale and design of Victorion-spirit, a pragmatic phase IIIb, randomised controlled study

Background: Translational gaps exist in implementing health innovations rapidly in clinical practice. Pragmatic effectiveness and implementation studies, therefore, play a pivotal role in understanding how high-value health innovations could be deployed and delivered in healthcare systems to reduce barriers to adoption and provide more rapid patient benefit. Victorion-spirit is an ongoing pragmatic, 9-month, phase IIIb, open-label, multicentre, randomised controlled study evaluating the implementation, patient experience, and delivery of the subcutaneous lipid-lowering therapy, inclisiran sodium 300 mg, in participants with elevated low-density lipoprotein cholesterol (LDL-C) who are on established lipid-lowering medication, or have been recommended lipid-lowering therapy, but are unable to tolerate treatment. Methods: Victorion-spirit utilises a type 1 hybrid effectiveness-implementation design, where the primary objective is to demonstrate superiority of inclisiran with or without (±) behavioural support versus standard of care (SOC; e.g., statin and/or other lipid-lowering therapies) + behavioural support in terms of percentage reduction in LDL-C from baseline to Day 270 in a primary care setting. Secondary objectives will evaluate implementation of inclisiran ± behavioural support versus SOC + behavioural support through assessment of patient satisfaction and patient activation/empowerment after treatment at Day 90; adherence to cardiovascular disease self-management; and serious adverse event profile. Additionally, a process evaluation ascertaining the views of patients, providers and national health service (NHS) commissioners will explore barriers and enablers to integrating inclisiran within primary care. Conclusions: The results of Victorion-spirit have potential to change our approach to lipid management and inform further implementation efforts in healthcare systems, such as the NHS. Trial registration: ClinicalTrials.gov NCT04087400.

The results of clinician-focused implementation strategies on uptake and outcomes of Measurement-Based Care (MBC) in general mental health care

BackgroundMeasurement-Based Care (MBC) is the routine administration of measures, clinicians’ review of the feedback and discussion of the feedback with their clients, and collaborative evaluation of the treatment plan. Although MBC is a promising way to improve outcomes in clinical practice, the implementation of MBC faces many barriers, and its uptake by clinicians is low. The purpose of this study was to investigate whether implementation strategies that were developed with clinicians and aimed at clinicians had an effect on (a) clinicians’ uptake of MBC and (b) clients’ outcomes of MBC.MethodsWe used an effectiveness-implementation hybrid design based on Grol and Wensing’s implementation framework to assess the impact of clinician-focused implementation strategies on both clinicians’ uptake of MBC and outcomes obtained with MBC for clients in general mental health care. We hereby focused on the first and second parts of MBC, i.e., the administration of measures and use of feedback. Primary outcome measures were questionnaire completion rate and discussion of the feedback with clients. Secondary outcomes were treatment outcome, treatment length, and satisfaction with treatment.ResultsThere was a significant effect of the MBC implementation strategies on questionnaire completion rate (one part of clinicians’ uptake), but no significant effect on the amount of discussion of the feedback (the other part of clinicians’ uptake). Neither was there a significant effect on clients’ outcomes (treatment outcome, treatment length, and satisfaction with treatment). Due to various study limitations, the results should be viewed as exploratory.ConclusionsEstablishing and sustaining MBC in real-world general mental health care is complex. This study helps to disentangle the effects of MBC implementation strategies on differential clinician uptake, but the effects of MBC implementation strategies on client outcomes need further examination.

Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss.

Lower limb loss (LLL) is a distressing experience with psychological, physical, and social challenges. Education is needed to enhance the coping skills and confidence of patients to improve LLL outcomes. However, access to rehabilitation services and education is limited outside of urban centers. To address this service gap, we co-created an eHealth platform, called Self-Management for Amputee Rehabilitation using Technology (SMART). First, we will test the effect of SMART and usual care compared with usual care only on walking capacity and confidence among individuals with LLL. Second, we will describe key implementation factors for program delivery and adoption at the person- and provider-level. This is a Type 1 Effectiveness-Implementation Hybrid Design, mixed-methods, multi-site (British Columbia and Ontario, Canada), parallel, assessor-blinded randomized controlled trial. Participants will include adults with unilateral LLL, during early prosthetic fitting (<2 years after casting for initial prosthesis). Participants in both groups will receive usual care. The experimental group will receive SMART with weekly support sessions from a trained peer mentor for goal setting and action planning for six weeks. Participants will be encouraged to continue using SMART for an additional four weeks. The control group will receive usual care, and weekly social contacts for six weeks. The primary outcome measure is walking capacity operationalized as the performance based Timed Up and Go test. The secondary outcome is walking confidence using the Ambulatory Self-Confidence Questionnaire. Outcome measures will be assessed at baseline, immediately post-intervention, and four weeks follow-up. We will describe key implementation factors (such as, participant experience, intervention adoption, fidelity) throughout the study using questionnaires, semi-structured interviews, and direct observation. No participants have been enrolled. SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL. NCT04953364 in Clinical Trial Registry (https://clinicaltrials.gov/).