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Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial.

ABSTRACT: BACKGROUND:Post-stroke disability is common, costly, and projected to increase. Acute stroke treatments can substantially reduce post-stroke disability, but few patients take advantage of these cost-effective treatments. Practical, cost-efficient, and sustainable interventions to address underutilized acute stroke treatments are currently lacking. In this context, we present the Stroke Ready project, a stepped wedge design, multi-level intervention that combines implementation science and community-based participatory research approaches to increase acute stroke treatments in the predominately African American community of Flint, Michigan, USA. METHODS:Guided by the Tailored Implementation of Chronic Disease (TICD) framework, we begin with optimization of acute stroke care in emergency departments, with particular attention given to our safety-net hospital partners. Then, we move to a community-wide, multi-faceted, stroke preparedness intervention, with workshops led by peer educators, over 2 years. Measures of engagement of the safety-net hospital and the feasibility and sustainability of the implementation strategy as well as community intervention reach, dose delivered, and satisfaction will be collected. The primary outcome is acute stroke treatment rates, which includes both intravenous tissue plasminogen activator, and endovascular treatment. The co-secondary outcomes are intravenous tissue plasminogen activator treatment rates and the proportion of stroke patients who arrive by ambulance. DISCUSSION:If successful, Stroke Ready will increase acute stroke treatment rates through emergency department and community level interventions. The stepped wedge design and process evaluation will provide insight into how Stroke Ready works and where it might work best. By exploring the relative effectiveness of the emergency department optimization and the community intervention, we will inform hospitals and communities as they determine how best to use their resources to optimize acute stroke care. TRIAL REGISTRATION:ClinicalTrials.gov Trial Identifier NCT03645590 .

SUBMITTER: Skolarus LE

PROVIDER: S-EPMC6407173 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial.

Skolarus Lesli E LE Sales Anne E AE Zimmerman Marc A MA Corches Casey L CL Landis-Lewis Zach Z Robles Maria Cielito MC McBride A Camille AC Rehman Narmeen N Oliver Alina A Islam Nishat N Springer Mellanie V MV O'Brien Alison A Bailey Sarah S Morgenstern Lewis B LB Meurer William J WJ Burke James F JF

Implementation science : IS 20190307 1

<h4>Background</h4>Post-stroke disability is common, costly, and projected to increase. Acute stroke treatments can substantially reduce post-stroke disability, but few patients take advantage of these cost-effective treatments. Practical, cost-efficient, and sustainable interventions to address underutilized acute stroke treatments are currently lacking. In this context, we present the Stroke Ready project, a stepped wedge design, multi-level intervention that combines implementation science an ...[more]

PMID: 30845958

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Project description:BackgroundMost individuals with depression go unidentified and untreated. In 2016 the US Preventive Services Task Force released guidelines recommending universal screening in primary care to identify patients with depression and to link them to treatment. Feasible, acceptable, and effective strategies to implement these guidelines are needed.MethodsThis three-phased study employed rapid participatory methods to design and test strategies to increase depression screening at Penn Medicine, a large health system with 90 primary care practices. First, researchers solicited ideas and barriers from stakeholders to increase screening using an innovation tournament-a crowdsourcing method that invites stakeholders to submit ideas to address a workplace challenge. Second, a panel of stakeholders and scientists deliberated over and ranked the tournament ideas. An instant runoff election was held to select the winning idea. Third, the research team piloted the winning idea in a primary care practice using rapid prototyping, an approach that quickly refines and iterates strategy designs.ResultsThe innovation tournament yielded 31 ideas and 32 barriers from diverse stakeholders (12 primary care physicians, 10 medical assistants, 4 nurse practitioners, 2 practice managers, and 4 patient support assistants). A panel of 6 stakeholders and scientists deliberated on the ideas and voted for patient self-report (i.e., through tablet computers, text message, or an online patient portal) as the winning idea. The research team rapid prototyped tablets in one primary care practice with one physician over 5 five-hour shifts to examine the feasibility, acceptability, and effectiveness of the strategy. Most patients, the physician, and medical assistants found the tablets acceptable and feasible. However, patient support assistants struggled to incorporate them in their workflow and expressed concerns about scaling up the process. Depression screening rates were higher using tablets compared to usual care; follow-up was comparable between tablets and usual care.ConclusionsRapid participatory methods engaged and amplified the voices of diverse stakeholders in primary care. These methods helped design an acceptable and feasible implementation strategy that showed promise for increasing depression screening in a primary care setting. The next step is to evaluate the strategy in a randomized controlled trial across primary care practices.

Project description:BACKGROUND:This study assessed whether a theoretically conceptualised tailored intervention centred on multidisciplinary teams (MDTs) increased clinician referral behaviours in line with clinical practice guideline recommendations. METHODS:Nine hospital Sites in New South Wales (NSW), Australia with a urological MDT and involvement in a state-wide urological clinical network participated in this pragmatic stepped wedge, cluster randomised implementation trial. Intervention strategies included flagging of high-risk patients by pathologists, clinical leadership, education, and audit and feedback of individuals' and study Sites' practices. The primary outcome was the proportion of patients referred to radiation oncology within 4 months after prostatectomy. Secondary outcomes were proportion of patients discussed at a MDT meeting within 4 months after surgery; proportion of patients who consulted a radiation oncologist within 6 months; and the proportion who commenced radiotherapy within 6 months. Urologists' attitudes towards adjuvant radiotherapy were surveyed pre- and post-intervention. A process evaluation measured intervention fidelity, response to intervention components and contextual factors that impacted on implementation and sustainability. RESULTS:Records for 1071 high-risk post-RP patients operated on by 37 urologists were reviewed: 505 control-phase; and 407 intervention-phase. The proportion of patients discussed at a MDT meeting increased from 17% in the control-phase to 59% in the intervention-phase (adjusted RR = 4.32; 95% CI [2.40 to 7.75]; p < 0·001). After adjustment, there was no significant difference in referral to radiation oncology (intervention 32% vs control 30%; adjusted RR = 1.06; 95% CI [0.74 to 1.51]; p = 0.879). Sites with the largest relative increases in the percentage of patients discussed also tended to have greater increases in referral (p = 0·001). In the intervention phase, urologists failed to provide referrals to more than half of patients whom the MDT had recommended for referral (78 of 140; 56%). CONCLUSIONS:The intervention resulted in significantly more patients being discussed by a MDT. However, the recommendations from MDTs were not uniformly recorded or followed. Although practice varied markedly between MDTs, the intervention did not result in a significant overall change in referral rates, probably reflecting a lack of change in urologists' attitudes. Our results suggest that interventions focused on structures and processes that enable health system-level change, rather than those focused on individual-level change, are likely to have the greatest effect. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611001251910 ). Registered 6 December 2011.

Project description:BACKGROUND:Controlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial. METHODS:The trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes. RESULTS:From 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99. CONCLUSIONS:Sequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding. TRIAL REGISTRATION:Registered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.

Project description:BACKGROUND:Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs. METHODS:Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals. RESULTS:Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3?months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled). CONCLUSIONS:Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out. TRIAL REGISTRATION:ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

Project description:RationaleClinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n = 75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality-of-life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care.AimsWhat is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to the standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life.Methods and sample size estimatesThis national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12, or 16 months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to either Usual Care or Walk 'n Watch. The trial will enroll a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take five steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30 min of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increase in intensity informed by activity trackers measuring heart rate and step number.Study outcome(s)The primary outcome will be the change in walking endurance, measured by the 6-Minute Walk Test, from baseline (T1) to 4 weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12 months post-stroke (T3) by a blinded assessor.DiscussionThe implementation of stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial and for the many participants with stroke admitted after the trial ends.

Project description:BACKGROUND:Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. METHODS:This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ??18?years, and requiring a PIVC for >?24?h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. RESULTS:Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n?=?306, intervention n?=?313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference -?8%, 95% CI -?14 to -?1, p?=?0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. CONCLUSIONS:This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. TRIAL REGISTRATION:Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415 .

Project description:ImportanceAcute stroke treatment rates in the US lag behind those in other high-income nations.ObjectiveTo assess whether a hospital emergency department (ED) and community intervention was associated with an increased proportion of patients with stroke receiving thrombolysis.Design, setting, and participantsThis nonrandomized controlled trial of the Stroke Ready intervention took place in Flint, Michigan, from October 2017 to March 2020. Participants included adults living in the community. Data analysis was completed from July 2022 to May 2023.InterventionStroke Ready combined implementation science and community-based participatory research approaches. Acute stroke care was optimized in a safety-net ED, and then a community-wide, theory-based health behavior intervention, including peer-led workshops, mailers, and social media, was conducted.Main outcomes and measuresThe prespecified primary outcome was the proportion of patients hospitalized with ischemic stroke or transient ischemic attack from Flint who received thrombolysis before and after the intervention. The association between thrombolysis and the Stroke Ready combined intervention, including the ED and community components, was estimated using logistic regression models, clustering at the hospital level and adjusting for time and stroke type. In prespecified secondary analyses, the ED and community intervention were explored separately, adjusting for hospital, time, and stroke type.ResultsIn total, 5970 people received in-person stroke preparedness workshops, corresponding to 9.7% of the adult population in Flint. There were 3327 ischemic stroke and TIA visits (1848 women [55.6%]; 1747 Black individuals [52.5%]; mean [SD] age, 67.8 [14.5] years) among patients from Flint seen in the relevant EDs, including 2305 in the preintervention period from July 2010 to September 2017 and 1022 in the postintervention period from October 2017 to March 2020. The proportion of thrombolysis usage increased from 4% in 2010 to 14% in 2020. The combined Stroke Ready intervention was not associated with thrombolysis use (adjusted odds ratio [OR], 1.13; 95% CI, 0.74-1.70; P = .58). The ED component was associated with an increase in thrombolysis use (adjusted OR, 1.63; 95% CI, 1.04-2.56; P = .03), but the community component was not (adjusted OR, 0.99; 95% CI, 0.96-1.01; P = .30).Conclusions and relevanceThis nonrandomized controlled trial found that a multilevel ED and community stroke preparedness intervention was not associated with increased thrombolysis treatments. The ED intervention was associated with increased thrombolysis usage, suggesting that implementation strategies in partnership with safety-net hospitals may increase thrombolysis usage.Trial registrationClinicalTrials.gov Identifier: NCT036455900.

Project description:The Researching Effective Approaches to Cleaning in Hospitals (REACH) study will generate evidence about the effectiveness and cost-effectiveness of a novel cleaning initiative that aims to improve the environmental cleanliness of hospitals. The initiative is an environmental cleaning bundle, with five interdependent, evidence-based components (training, technique, product, audit and communication) implemented with environmental services staff to enhance hospital cleaning practices.The REACH study will use a stepped-wedge randomised controlled design to test the study intervention, an environmental cleaning bundle, in 11 Australian hospitals. All trial hospitals will receive the intervention and act as their own control, with analysis undertaken of the change within each hospital based on data collected in the control and intervention periods. Each site will be randomised to one of the 11 intervention timings with staggered commencement dates in 2016 and an intervention period between 20 and 50 weeks. All sites complete the trial at the same time in 2017. The inclusion criteria allow for a purposive sample of both public and private hospitals that have higher-risk patient populations for healthcare-associated infections (HAIs). The primary outcome (objective one) is the monthly number of Staphylococcus aureus bacteraemias (SABs), Clostridium difficile infections (CDIs) and vancomycin resistant enterococci (VRE) infections, per 10,000 bed days. Secondary outcomes for objective one include the thoroughness of hospital cleaning assessed using fluorescent marker technology, the bio-burden of frequent touch surfaces post cleaning and changes in staff knowledge and attitudes about environmental cleaning. A cost-effectiveness analysis will determine the second key outcome (objective two): the incremental cost-effectiveness ratio from implementation of the cleaning bundle. The study uses the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to support the tailored implementation of the environmental cleaning bundle in each hospital.Evidence from the REACH trial will contribute to future policy and practice guidelines about hospital environmental cleaning. It will be used by healthcare leaders and clinicians to inform decision-making and implementation of best-practice infection prevention strategies to reduce HAIs in hospitals.Australia New Zealand Clinical Trial Registry ACTRN12615000325505.

Project description:BackgroundIncreased breast density augments breast cancer risk and reduces mammography sensitivity. Supplemental breast MRI screening can significantly increase cancer detection among women with dense breasts. However, few women undergo this exam, and screening is consistently lower among racially minoritized populations. Implementation strategies informed by behavioral economics ("nudges") can promote evidence-based practices by improving clinician decision-making under conditions of uncertainty. Nudges directed toward clinicians and patients may facilitate the implementation of supplemental breast MRI.MethodsApproximately 1600 patients identified as having extremely dense breasts after non-actionable mammograms, along with about 1100 clinicians involved with their care at 32 primary care or OB/GYN clinics across a racially diverse academically based health system, will be enrolled. A 2 × 2 randomized pragmatic trial will test nudges to patients, clinicians, both, or neither to promote supplemental breast MRI screening. Before implementation, rapid cycle approaches informed by clinician and patient experiences and behavioral economics and health equity frameworks guided nudge design. Clinicians will be clustered into clinic groups based on existing administrative departments and care patterns, and these clinic groups will be randomized to have the nudge activated at different times per a stepped wedge design. Clinicians will receive nudges integrated into the routine mammographic report or sent through electronic health record (EHR) in-basket messaging once their clinic group (i.e., wedge) is randomized to receive the intervention. Independently, patients will be randomized to receive text message nudges or not. The primary outcome will be defined as ordering or scheduling supplemental breast MRI. Secondary outcomes include MRI completion, cancer detection rates, and false-positive rates. Patient sociodemographic information and clinic-level variables will be examined as moderators of nudge effectiveness. Qualitative interviews conducted at the trial's conclusion will examine barriers and facilitators to implementation.DiscussionThis study will add to the growing literature on the effectiveness of behavioral economics-informed implementation strategies to promote evidence-based interventions. The design will facilitate testing the relative effects of nudges to patients and clinicians and the effects of moderators of nudge effectiveness, including key indicators of health disparities. The results may inform the introduction of low-cost, scalable implementation strategies to promote early breast cancer detection.Trial registrationClinicalTrials.gov NCT05787249. Registered on March 28, 2023.

Dataset Information

Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial.

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Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial.

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