Dataset Information

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

ABSTRACT:

Background

The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.

Methods

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.

Conclusions

IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.

SUBMITTER: Mills KT

PROVIDER: S-EPMC7437489 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

Mills Katherine T KT Peacock Erin E Chen Jing J Zimmerman Amanda A Brooks Kenya K He Hua H Cyprian Alecia A Davis Gerrelda G Fuqua Sonja R SR Greer Angelique A Gray-Winfrey Lea L Williams Shondra S Wiltz Gary M GM Winfrey Keith L KL Whelton Paul K PK Krousel-Wood Marie M He Jiang J

American heart journal 20200819

<h4>Background</h4>The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment a ...[more]

PMID: 32827458

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Project description:ImportanceFew primary care patients complete guideline-recommended out-of-office blood pressure (BP) monitoring prior to having hypertension diagnosed.ObjectiveTo evaluate the effectiveness of a behavioral theory-informed, multifaceted implementation strategy on out-of-office BP monitoring (ambulatory BP monitoring [ABPM] or home BP monitoring [HBPM]) among patients with new hypertension.Design, setting, and participantsThis 2-group, pre-post cluster randomized trial was conducted within a primary care network of 8 practices (4 intervention practices with 99 clinicians; 4 control practices with 55 clinicians) and 1186 patients (857 intervention; 329 control) with at least 1 visit with elevated office BP and no prior hypertension diagnosis between October 2016 and September 2017 (preimplementation period) or between April 2018 and March 2019 (postimplementation period). Data were analyzed from February to July 2023.InterventionsUsual care (control group) or a multifaceted implementation strategy consisting of an accessible ABPM service; electronic health record (EHR) tools to facilitate test ordering; clinician education, reminders, and feedback relevant to out-of-office BP monitoring; nurse training on HBPM; and patient information handouts.Main outcomes and measuresThe primary outcome was patient completion of out-of-office BP monitoring within 6 months of an eligible visit. Secondary outcomes included clinician ordering of out-of-office BP monitoring. Blinded assessors extracted outcomes from the EHR.ResultsA total of 1186 patients (857 intervention; 329 control) were included, with a mean (SD) age of 54 (16) years; 808 (68%) were female, and 549 (48%) were Spanish speaking; among those with race and ethnicity documented, 123 (10%) were Black or African American, and 368 (31%) were Hispanic. Among intervention practices, the percentage of visits resulting in completed out-of-office BP monitoring increased from 0.6% (0% ABPM; 0.6% HBPM) to 5.7% (3.7% ABPM; 2.0% HBPM) between the preimplementation and postimplementation periods (P = .009). Among control practices, the percentage of visits resulting in completed out-of-office BP monitoring changed from 5.4% (0% ABPM; 5.4% HBPM) to 4.3% (0% ABPM; 4.3% HBPM) during the corresponding period (P = .94). The ratio of relative risks (RRs) of out-of-office BP monitoring in the postimplementation vs preimplementation periods for intervention vs control practices was 10.5 (95% CI, 1.9-58.0; P = .01). The ratio of RRs of out-of-office BP monitoring being ordered was 2.2 (95% CI, 0.8-6.3; P = .12).Conclusions and relevanceThis study found that a theory-informed implementation strategy that included access to ABPM modestly increased out-of-office BP monitoring among patients with elevated office BP but no hypertension diagnosis.Trial registrationClinicalTrials.gov Identifier: NCT03480217.

Project description:BackgroundAttempting to implement evidence-based practices in contexts for which they are not well suited may compromise their fidelity and effectiveness or burden users (e.g., patients, providers, healthcare organizations) with elaborate strategies intended to force implementation. To improve the fit between evidence-based practices and contexts, implementation science experts have called for methods for adapting evidence-based practices and contexts and tailoring implementation strategies; yet, methods for considering the dynamic interplay among evidence-based practices, contexts, and implementation strategies remain lacking. We argue that harmonizing the three can be facilitated by user-centered design, an iterative and highly stakeholder-engaged set of principles and methods.MethodsThis paper presents a case example in which we used a three-phase user-centered design process to design and plan to implement a care coordination intervention for young adults with cancer. Specifically, we used usability testing to redesign and augment an existing patient-reported outcome measure that served as the basis for our intervention to optimize its usability and usefulness, ethnographic contextual inquiry to prepare the context (i.e., a comprehensive cancer center) to promote receptivity to implementation, and iterative prototyping workshops with a multidisciplinary design team to design the care coordination intervention and anticipate implementation strategies needed to enhance contextual fit.ResultsOur user-centered design process resulted in the Young Adult Needs Assessment and Service Bridge (NA-SB), including a patient-reported outcome measure and a collection of referral pathways that are triggered by the needs young adults report, as well as implementation guidance. By ensuring NA-SB directly responded to features of users and context, we designed NA-SB for implementation, potentially minimizing the strategies needed to address misalignment that may have otherwise existed. Furthermore, we designed NA-SB for scale-up; by engaging users from other cancer programs across the country to identify points of contextual variation which would require flexibility in delivery, we created a tool intended to accommodate diverse contexts.ConclusionsUser-centered design can help maximize usability and usefulness when designing evidence-based practices, preparing contexts, and informing implementation strategies-in effect, harmonizing evidence-based practices, contexts, and implementation strategies to promote implementation and effectiveness.

Project description:BackgroundSchools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)).Methods/designThe aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors.DiscussionThis study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the adoption of EBPs.Trial registrationClinicalTrials.gov, NCT02651402.

Project description:BackgroundInnovative approaches are needed to maximize fit between the characteristics of evidence-based practices (EBPs), implementation strategies that support EBP use, and contexts in which EBPs are implemented. Standard approaches to implementation offer few ways to address such issues of fit. We characterized the potential for collaboration with experts from a relevant complementary approach, user-centered design (UCD), to increase successful implementation.MethodUsing purposive and snowball sampling, we recruited 56 experts in implementation (n = 34) or UCD (n = 22). Participants had 5+ years of professional experience (M = 10.31), worked across many settings (e.g., healthcare, education, human services), and were mostly female (59%) and white (73%). Each participant completed a web-based concept mapping structured conceptualization task. They sorted strategies from established compilations for implementation (36 strategies) and UCD (30 strategies) into distinct clusters, then rated the importance and feasibility of each strategy.ResultsWe used multidimensional scaling techniques to examine patterns in the sorting of strategies. Based on conceptual clarity and fit with established implementation frameworks, we selected a final set of 10 clusters (i.e., groups of strategies), with five implementation-only clusters, two UCD-only clusters, and three trans-discipline clusters. The highest-priority activities (i.e., above-average importance and feasibility) were the trans-discipline clusters plus facilitate change and monitor change. Implementation and UCD experts sorted strategies into similar clusters, but each gave higher importance and feasibility ratings to strategies/clusters from their own discipline.ConclusionsIn this concept mapping study, experts in implementation and UCD had perspectives that both converged (e.g., trans-discipline clusters, which were all rated as high-priority) and diverged (e.g., in importance/feasibility ratings). The results provide a shared understanding of the alignment between implementation science and UCD, which can increase the impact and sustainability of EBP implementation efforts. Implications for improved collaboration among implementation and UCD experts are discussed.

Project description:BACKGROUND:Given today's high prevalence of common mental disorders and related sick leave among teachers, an urgent need exists for a more systematic approach to the management of social and organizational risk factors within schools. In 2015, we launched the first Swedish occupational health guideline to support a structured prevention of these risks at the workplace. The existence of guidelines does however not guarantee their usage, as studies show that guidelines are often underused. Knowledge is therefore needed on effective implementation strategies that can facilitate the translation of guidelines into practice. The primary aim of the randomized waiting list-controlled trial described in this study protocol is to compare the effectiveness of a multifaceted implementation strategy versus a single implementation strategy for implementing the Guideline for the prevention of mental ill-health at the workplace within schools. The effectiveness will be compared regarding the extent to which the recommendations are implemented (implementation effectiveness) and with regard to social and organisational risk factors for mental ill-health, absenteeism and presenteeism (intervention effectiveness). METHODS:The trial is conducted among primary schools of two municipalities in Sweden. The single implementation strategy is an educational strategy (an educational meeting). The multifaceted strategy consists of the educational meeting, an implementation team and a series of workshops. The outcome measure of implementation effectiveness is guideline adherence. The primary outcome of intervention effectiveness is exhaustion. Secondary outcomes include demands at work, work organization and job contents, interpersonal relations and leadership, presenteeism, work performance, recovery, work-life balance, work-engagement, self-reported stress, self-perceived health, sickness absence and psychosocial safety climate. Process outcomes as well as barriers and facilitators influencing the implementation process are assessed. Data will be collected at baseline, 6, 12, 18 and 24?months by mixed methods (i.e. survey, focus-group interviews, observation). DISCUSSION:The study described in this protocol will provide valuable knowledge on the effectiveness of implementation strategies for implementing a guideline for the prevention of common mental disorders within schools. We hypothesize that successful implementation will result in reductions in school personnel's perceived social and organizational risk factors, mental ill-health and sick-leave. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03322839 (trial registration: 09/19/2017).

Project description:To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs).8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis.Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period.The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured.Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed.The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing.NCT01634451.

Dataset Information

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

Background

Methods

Conclusions

Publications

Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.

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