Hybrid Effectiveness-implementation Type Research Articles

Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial

BackgroundDepression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, including human support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. ObjectiveThe current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. MethodsThe proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 110 patient participants, with a loss-to-follow-up rate of 30 %. DiscussionA study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services. RegistrationClinicalTrials.gov; NCT06230237.

Family cascade screening for equitable identification of familial hypercholesterolemia: study protocol for a hybrid effectiveness-implementation type III randomized controlled trial

BackgroundFamilial hypercholesterolemia (FH) is a heritable disorder affecting 1.3 million individuals in the USA. Eighty percent of people with FH are undiagnosed, particularly minoritized populations including Black or African American people, Asian or Asian American people, and women across racial groups. Family cascade screening is an evidence-based practice that can increase diagnosis and improve health outcomes but is rarely implemented in routine practice, representing an important care gap. In pilot work, we leveraged best practices from behavioral economics and implementation science—including mixed-methods contextual inquiry with clinicians, patients, and health system constituents—to co-design two patient-facing implementation strategies to address this care gap: (a) an automated health system-mediated strategy and (b) a nonprofit foundation-mediated strategy with contact from a foundation-employed care navigator. This trial will test the comparative effectiveness of these strategies on completion of cascade screening for relatives of individuals with FH, centering equitable reach.MethodsWe will conduct a hybrid effectiveness-implementation type III randomized controlled trial testing the comparative effectiveness of two strategies for implementing cascade screening with 220 individuals with FH (i.e., probands) per arm identified from a large northeastern health system. The primary implementation outcome is reach, or the proportion of probands with at least one first-degree biological relative (parent, sibling, child) in the USA who is screened for FH through the study. Our secondary implementation outcomes include the number of relatives screened and the number of relatives meeting the American Heart Association criteria for FH. Our secondary clinical effectiveness outcome is post-trial proband cholesterol level. We will also use mixed methods to identify implementation strategy mechanisms for implementation strategy effectiveness while centering equity.DiscussionWe will test two patient-facing implementation strategies harnessing insights from behavioral economics that were developed collaboratively with constituents. This trial will improve our understanding of how to implement evidence-based cascade screening for FH, which implementation strategies work, for whom, and why. Learnings from this trial can be used to equitably scale cascade screening programs for FH nationally and inform cascade screening implementation efforts for other genetic disorders.Trial registrationClinicalTrials.gov, NCT05750667. Registered 15 February 2023—retrospectively registered, https://clinicaltrials.gov/study/NCT05750667.

Impact of Implementation Facilitation on the REACH VET Clinical Program for Veterans at Risk for Suicide.

In 2017, the Veterans Health Administration (VHA) implemented a national suicide prevention program, called Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment (REACH VET), that uses a predictive algorithm to identify, attempt to reach, assess, and care for patients at the highest risk for suicide. The authors aimed to evaluate whether facilitation enhanced implementation of REACH VET at VHA facilities not meeting target completion rates. In this hybrid effectiveness-implementation type 2 program evaluation, a quasi-experimental pre-post design was used to assess changes in implementation outcome measures evaluated 6 months before and 6 months after onset of facilitation of REACH VET implementation at 23 VHA facilities. Measures included percentages of patients with documented coordinator and provider acknowledgment of receipt, care evaluation, and outreach attempt. Generalized estimating equations were used to compare differences in REACH VET outcome measures before and after facilitation. Qualitative interviews were conducted with personnel and were explored via template analysis. Time had a significant effect in all outcomes models (p<0.001). An effect of facilitation was significant only for the outcome of attempted outreach. Patients identified by REACH VET had significantly higher odds of having a documented outreach attempt after facilitation of REACH VET implementation, compared with before facilitation. Site personnel felt supported and reported that the external facilitators were helpful and responsive. Facilitation of REACH VET implementation was associated with an improvement in outreach attempts to veterans identified as being at increased risk for suicide. Outreach is critical for engaging veterans in care.

Evaluating Blinatumomab Treatment Adoption in Varied Resource Settings Using the RE-AIM Framework

Background Blinatumomab is a targeted immunotherapy for B-ALL. Widespread adoption of this evidence-based intervention in varied resource settings has been limited due to cost, commercial access, and barriers including institutional capacity and medication complexity. We used implementation science frameworks to facilitate and study the translation of blinatumomab into hospitals in lower-resource settings in partnership with a drug-donation program. After 2 years of collaboration, we applied the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) Framework to assess implementation processes and effectiveness outcomes in 2 pilot centers. Methods As a component of a larger hybrid effectiveness-implementation type 2 study, we applied RE-AIM methodology retrospectively to examine data for one hospital in India and one in Pakistan. Quantitative and qualitative data were abstracted from meeting notes, readiness assessments, a 54-question implementation survey based on validated measures, and clinical team observations. Local physicians overseeing the patient treatment with blinatumomab collected de-identified clinical data from routine care from 20 patients. Infusion and 6-month follow-up data were available for 18 and 16 patients, respectively. Patient characteristics were summarized using descriptive statistics. Clinical data were analyzed in aggregate to report real-world effectiveness, and other data were integrated to report on the five RE-AIM domains. Results Overall reach was determined by comparing proportion of annual patient requests, predicted number of eligible patients, and characteristics of patients who received blinatumomab. Reach varied by site from 48%-110%. Participants were representative with a median age of 8 years (IQR 6.23) and 55% were female. MRD-positive disease was the primary indication for receiving blinatumomab (60%, n=12). Regarding effectiveness, 73.3% of patients achieved remission after cycle 1, and 9 patients (60%) proceeded to hematopoietic stem cell transplant after receiving blinatumomab. At six months, 81.3% of patients were alive, 1 had died, and 2 were lost to follow-up. Adoption at the staff level was measured based on engagement of provider roles in training and feedback as measured by completion of a multidisciplinary implementation survey. While nursing was engaged in training at both sites, there was a notable lack of nursing-specific input to the implementation survey, identifying a key opportunity to improve engagement strategies. Early-indicator implementation outcomes were assessed by local multidisciplinary teams demonstrated high feasibility (aggregate mean 4.64/5, SD 0.35), acceptability (aggregate mean 4.71/5, SD 0.39), and appropriateness (aggregate mean 4.86/5, SD 0.24) of blinatumomab at their institution. Site-specific modifications to improve implementation included: modifications to the bag change schedule due to the lack of availability of medical supplies (bag sizes, pump cassette), and nursing ratios were temporarily reduced to provide closer monitoring for patients receiving blinatumomab. Thematic analysis revealed that maintenance is supported by the perceived relative advantage of blinatumomab vs. traditional chemotherapy, with physicians appreciating the opportunity for improved quality of life for patients and noting that also “the treating teams and the parents are happy,” highlighting a potentially positive impact on the physician and family wellbeing. One challenge for program maintenance is the cost of associated medical supplies such as medication infusion tubing and filters and the need for prolonged hospitalization due to barriers related to transportation and the availability of outpatient and emergency services. This will inform future strategies, such as implementation mapping, to determine how to address these site and resource-specific barriers. Conclusion Successful implementation and collaboration with local multidisciplinary teams is a critical predecessor to establishing effectiveness and improving future global access to complex, novel therapies such as blinatumomab. Systematic application of established implementation measures, such as RE-AIM, can improve reporting of rich implementation data and inform strategies to improve the long-term adoption and maintenance of these effective therapies in the real world.

Understanding integrated HPV testing and treatment of pre-cancerous cervical cancer in Burkina Faso, Cote d’Ivoire, Guatemala and Philippines: study protocol

BackgroundMany low- and-middle-income countries are disproportionately burdened by cervical cancer, resulting in high morbidity and mortality. HPV-DNA testing coupled with treatment with thermal ablation is a recommended screening and precancer treatment strategy, but not enough is known about how this can be effectively implemented in the context of integrated services. The (Scale Up Cervical Cancer Elimination by Secondary prevention Strategy, (SUCCESS) project is conducting a study to understand this approach, integrated into existing women’s health services in Burkina Faso, Cote d’Ivoire, Guatemala, and the Philippines (2020–2024).MethodsA hybrid effectiveness-implementation type III mixed-methods observational study design is used to assess feasibility, acceptability, and costs of integrated service delivery in 10 sites per country, selected considering urban/rural location, facility level, onsite/offsite laboratories, and health services type. In each country, a sample size of 2227 women aged 25–49 years will be enrolled with about 20% being women living with HIV. The primary outcome is proportion of HPV positive women completing precancer treatment, if eligible, within three months of screening. Data collection and analysis includes; facility and client exit surveys, key informant and client interviews, registries and project records extractions, and costing data analysis. Analysis includes descriptive statistics, context description, thematic analysis, and document analysis. Quantitative analyses will be stratified by participant’s HIV status.DiscussionRecruitment of study participants started in April 2022 (Burkina Faso and Côte d’Ivoire) and August 2022 (Guatemala and the Philippines). Enrolment targets for women screened, client exit, in-depth and key informant interviews conducted were reached in Burkina Faso and Cote d’Ivoire in November 2022. Guatemala and Philippines are expected to complete enrolment by June 2023. Follow-up of study Participants 12-months post-treatment is ongoing and is expected to be completed for all countries by August 2024. In LMICs, integrating cervical cancer secondary prevention services into other health services will likely require specific rather than incidental recruitment of women for screening. Reconfiguration of laboratory infrastructure and planning for sample management must be made well in advance to meet induced demand for screening.Trail Registration ClinicalTrials.Gov ID: NCT05133661 (24/11/2021).

Effectiveness and implementation of an online intervention (MINDxYOU) for reducing stress and promote mental health among healthcare workers in Spain: a study protocol for a stepped-wedge cluster randomized trial

BackgroundThe World Health Organization has formally recognized that healthcare professionals are at risk of developing mental health problems; finding ways to reduce their stress is mandatory to improve both their quality of life and, indirectly, their job performance. In recent years, particularly since the COVID-19 pandemic outbreak, there has been a proliferation of online interventions with promising results. The purpose of the present study is twofold: to test the effectiveness of an online, self-guided intervention, MINDxYOU, to reduce the stress levels of healthcare workers; and to conduct an implementation study of this intervention. Additionally, an economic evaluation of the intervention will be conducted.MethodsThe current study has a hybrid effectiveness-implementation type 2 design. A stepped wedge cluster randomized trial design will be used, with a cohort of 180 healthcare workers recruited in two Spanish provinces (Malaga and Zaragoza). The recruitment stage will commence in October 2022. Frontline health workers who provide direct care to people in a hospital, primary care center, or nursing home setting in both regions will participate. The effectiveness of the intervention will be studied, with perceived stress as the main outcome (Perceived Stress Scale), while other psychopathological symptoms and process variables (e.g., mindfulness, compassion, resilience, and psychological flexibility) will be also assessed as secondary outcomes. The implementation study will include analysis of feasibility, acceptability, adoption, appropriateness, fidelity, penetration, and sustainability. The incremental costs and benefits, in terms of quality-adjusted life years, will be examined by means of cost-utility and cost-effectiveness analyses.DiscussionMINDxYOU is designed to reduce healthcare workers’ stress levels through the practice of mindfulness, acceptance, and compassion, with a special focus on how to apply these skills to healthy habits and considering the particular stressors that these professionals face on a daily basis. The present study will show how implementation studies are useful for establishing the framework in which to address barriers to and promote facilitators for acceptability, appropriateness, adoption, feasibility, fidelity, penetration, and sustainability of online interventions. The ultimate goal is to reduce the research-to-practice gap.Trial registrationThis study was registered in ClinicalTrials.gov on 29/06/2022; registration number: NCT05436717.

Results from an effectiveness-implementation evaluation of a postpartum depression prevention intervention delivered in home visiting programs

BackgroundBuilding on growing research examining lay health professionals delivering postpartum depression preventive interventions, we conducted a hybrid effectiveness-implementation Type 2 trial to examine implementation metrics and determine whether pregnant women receiving Mothers and Babies 1-on-1 delivered by lay home visitors exhibit greater reductions in depressive symptoms and perceived stress than women receiving usual home visiting. Methods1229 (672 control, 557 intervention) pregnant women were enrolled, with intervention participants receiving Mothers and Babies 1-on-1 delivered by a lay home visitor and control participants receiving usual home visiting services. Baseline and six-month follow-up assessments measured client mental health outcomes, with management information system data collected to assess intervention dosage. Surveys were administered nine months post-training to agency managers as well as home visitors who delivered any intervention content. ResultsIntent-to-treat analyses indicated a significant reduction in perceived stress among intervention participants compared to controls, while as-treated analyses showed significant reductions in perceived stress and depressive symptoms. Although all study sites adopted the intervention, <50 % of eligible women received the intervention. Over two-thirds of home visitors made at least one fidelity-consistent adaptation, with client recruitment and retention in home visiting highlighted as challenges to delivery. LimitationsUnmeasured historical events may have affected study outcomes and caution should be used generalizing to perinatal women from different racial/ethnic groups and home visiting models. ConclusionMothers and Babies 1-on-1 delivered by lay home visitors leads to reductions in perceived stress and depressive symptoms, suggesting task shifting to non-mental health professionals is viable when appropriate training and supervision is provided.

Determining feasibility of incorporating consumer engagement into implementation activities: study protocol of a hybrid effectiveness-implementation type II pilot

IntroductionImplementation researchers could draw from participatory research to engage patients (consumers of healthcare) in implementation processes and possibly reduce healthcare disparities. There is a little consumer involvement in healthcare implementation,...

Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model

BackgroundThe treatment of suicidal patients often suffers owing to a lack of integrated care and standardized approaches for identifying and reducing risk. The National Strategy for Suicide Prevention endorsed the Zero Suicide (ZS) model, a multi-component, system-wide approach to identify, engage, and treat suicidal patients. The ZS model is a framework for suicide prevention in healthcare systems with the aspirational goal of eliminating suicide in healthcare. While the approach is widely endorsed, it has yet to be evaluated in a systematic manner. This trial evaluates two ZS implementation strategies statewide in specialty mental health clinics. Methods/study designThis trial is the first large-scale implementation of the ZS model in mental health clinics using the Assess, Intervene, and Monitor for Suicide Prevention (A-I-M) clinical model. Using a hybrid effectiveness-implementation type 1 design, we are testing the effectiveness of ZS implementation in 186 mental health clinics in 95 agencies in New York State. Agencies are randomly assigned to either: “Basic Implementation” (BI; a large group didactic learning collaboratives) or “Enhanced Implementation” (EI; participatory small group learning collaboratives; enhanced consultation for site champions). Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation. DiscussionThis project has the potential to have a significant public health impact by determining the effectiveness of the ZS model in mental health clinics, a setting where suicide attempts and suicides occur at a higher rate than any other healthcare setting. It will also provide guidance on the implementation level required to achieve uptake and sustainability of ZS.Trial registration: N/A.

Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial

IntroductionMobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and...

A cluster randomized controlled trial on a multifaceted implementation strategy to promote integrated palliative care in COPD: study protocol of the COMPASSION study

BackgroundDespite the urgent need for palliative care for patients with advanced chronic obstructive pulmonary disease (COPD), it is not yet daily practice. Important factors influencing the provision of palliative care are adequate communication skills, knowing when to start palliative care and continuity of care. In the COMPASSION study, we address these factors by implementing an integrated palliative care approach for patients with COPD and their informal caregivers.MethodsAn integrated palliative care intervention was developed based on existing guidelines, a literature review, and input from patient and professional organizations. To facilitate uptake of the intervention, a multifaceted implementation strategy was developed, comprising a toolbox, (communication) training, collaboration support, action planning and monitoring. Using a hybrid effectiveness-implementation type 2 design, this study aims to simultaneously evaluate the implementation process and effects on patient, informal caregiver and professional outcomes. In a cluster randomized controlled trial, eight hospital regions will be randomized to receive the integrated palliative care approach or to provide care as usual. Eligible patients are identified during hospitalization for an exacerbation using the Propal-COPD tool. The primary outcome is quality of life (FACIT-Pal) at 6 months. Secondary outcome measures include spiritual well-being, anxiety and depression, unplanned healthcare use, informal caregiver burden and healthcare professional’s self-efficacy to provide palliative care. The implementation process will be investigated by a comprehensive mixed-methods evaluation assessing the following implementation constructs: context, reach, dose delivered, dose received, fidelity, implementation level, recruitment, maintenance and acceptability. Furthermore, determinants to implementation will be investigated using the Consolidated Framework for Implementation Research.DiscussionThe COMPASSION study will broaden knowledge on the effectiveness and process of palliative care integration into COPD-care. Furthermore, it will improve our understanding of which strategies may optimize the implementation of integrated palliative care.Trial registrationNetherlands Trial Register (NTR): NL7644. Registration date: April 7, 2019.

Implementation and evaluation of nonclinical interventions for appropriate use of cesarean section in low- and middle-income countries: protocol for a multisite hybrid effectiveness-implementation type III trial

BackgroundWhile cesarean sections (CSs) are a life-saving intervention, an increasing number are performed without medical reasons in low- and middle-income countries (LMICs). Unnecessary CS diverts scarce resources and thereby reduces access to healthcare for women in need. Argentina, Burkina Faso, Thailand, and Vietnam are committed to reducing unnecessary CS, but many individual and organizational factors in healthcare facilities obstruct this aim. Nonclinical interventions can overcome these barriers by helping providers improve their practices and supporting women’s decision-making regarding childbirth. Existing evidence has shown only a modest effect of single interventions on reducing CS rates, arguably because of the failure to design multifaceted interventions effectively tailored to the context. The aim of this study is to design, adapt, and test a multifaceted intervention for the appropriate use of CS in Argentina, Burkina Faso, Thailand, and Vietnam.MethodsWe designed an intervention (QUALIty DECision-making—QUALI-DEC) with four components: (1) opinion leaders at heathcare facilities to improve adherence to best practices among clinicians, (2) CS audits and feedback to help providers identify potentially avoidable CS, (3) a decision analysis tool to help women make an informed decision on the mode of birth, and (4) companionship to support women during labor. QUALI-DEC will be implemented and evaluated in 32 hospitals (8 sites per country) using a pragmatic hybrid effectiveness-implementation design to test our implementation strategy, and information regarding its impact on relevant maternal and perinatal outcomes will be gathered. The implementation strategy will involve the participation of women, healthcare professionals, and organizations and account for the local environment, needs, resources, and social factors in each country.DiscussionThere is urgent need for interventions and implementation strategies to optimize the use of CS while improving health outcomes and satisfaction in LMICs. This can only be achieved by engaging all stakeholders involved in the decision-making process surrounding birth and addressing their needs and concerns. The study will generate robust evidence about the effectiveness and the impact of this multifaceted intervention. It will also assess the acceptability and scalability of the intervention and the capacity for empowerment among women and providers alike.Trial registrationISRCTN67214403

Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults

IntroductionWhile early psychosis intervention (EPI) has proliferated in recent years amid evidence of its effectiveness, programmes often struggle to deliver consistent, recovery-based care. NAVIGATE is a manualised model of EPI...

Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial

BackgroundThe Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10–20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective.Methods/DesignThis partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE! program. Mediation analyses will be conducted to identify whether program design differences impact outcomes.DiscussionFindings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0250-0) contains supplementary material, which is available to authorized users.