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Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities.

ABSTRACT: Background:Women's Health Services (WHS) in the Veterans Health Administration (VA) has long partnered with VA researchers to evaluate how VA care is organized for women veterans. This partnership has yielded substantial evidence of (1) variations in women veterans' access to comprehensive healthcare services that contribute to disparities in quality and patient experience and (2) the positive impacts of gender-specific care models for women veterans' quality and satisfaction. In an effort to provide support specifically to sites that were low-performing in women's health, WHS and the VA Quality Enhancement Research Initiative co-funded an effort to roll out and evaluate evidence-based quality improvement (EBQI), an implementation strategy with demonstrated effectiveness in a prior cluster randomized trial in women's health clinics. Methods:We will identify 21 low-performing VA facilities through a combination of practice data, VA quality metrics (by gender), and other indicators. In partnership with WHS, an EBQI contractor will deliver the EBQI "package"-local consensus development and priority setting using stakeholder panels, multilevel stakeholder engagement, practice facilitation, local EBQI team training, and formative feedback-to participating sites. We propose a dynamic wait-listed design to evaluate the WHS plans for seven EBQI launches per year over 3 years. The goal is to evaluate (1) barriers and facilitators to achieving delivery of comprehensive women's health care in low-performing VA facilities; (2) effectiveness of EBQI in supporting low-performing VA facilities to achieve improved practice features (e.g., level of comprehensive services available, care coordination arrangements, Patient Aligned Care Team (PACT) features implemented, environment of care improvements), provider/staff attitudes (e.g., improved gender awareness, women's health knowledge and practice), quality of care, and patient experience; and (3) contextual factors, local implementation processes, and organizational changes over time. Discussion:Access to comprehensive women's health care reduces fragmentation of care, improves patient satisfaction, and results in better patient outcomes. We hypothesize that EBQI implementation will result in changes in leadership awareness and buy-in, multilevel engagement in problem-solving, an enhanced culture of quality improvement, structural changes in care, improved provider/staff attitudes, and better quality and patient experience. Trial registration:ClinicalTrials.gov, NCT03238417. Registered 3 August 2017. Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT03238417.

SUBMITTER: Hamilton AB

PROVIDER: S-EPMC7427959 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities.

Hamilton Alison B AB Olmos-Ochoa Tanya T TT Canelo Ismelda I Rose Danielle D Hoggatt Katherine J KJ Than Claire C Yano Elizabeth M EM

Implementation science communications 20200630

<h4>Background</h4>Women's Health Services (WHS) in the Veterans Health Administration (VA) has long partnered with VA researchers to evaluate how VA care is organized for women veterans. This partnership has yielded substantial evidence of (1) variations in women veterans' access to comprehensive healthcare services that contribute to disparities in quality and patient experience and (2) the positive impacts of gender-specific care models for women veterans' quality and satisfaction. In an effo ...[more]

PMID: 32885214

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Project description:The Veterans Health Administration (VHA) has undertaken primary care transformation based on patient-centered medical home (PCMH) tenets. VHA PCMH models are designed for the predominantly male Veteran population, and require tailoring to meet women Veterans' needs. We used evidence-based quality improvement (EBQI), a stakeholder-driven implementation strategy, in a cluster randomized controlled trial across 12 sites (eight EBQI, four control) that are members of a Practice-Based Research Network. EBQI involves engaging multilevel, inter-professional leaders and staff as stakeholders in reviewing evidence and setting QI priorities. The goal of this analysis was to examine processes of engaging stakeholders in early implementation of EBQI to tailor VHA's medical home for women. Four inter-professional regional stakeholder planning meetings were conducted; these meetings engaged stakeholders by providing regional data about gender disparities in Veterans' care experiences. Subsequent to each meeting, qualitative interviews were conducted with 87 key stakeholders (leaders and staff). Stakeholders were asked to describe QI efforts and the use of data to change aspects of care, including women's health care. Interview transcripts were summarized and coded using a hybrid deductive/inductive analytic approach. The presentation of regional-level data about gender disparities resulted in heightened awareness and stakeholder buy-in and decision-making related to women's health-focused QI. Interviews revealed that stakeholders were familiar with QI, with regional and facility leaders aware of inter-disciplinary committees and efforts to foster organizational change, including PCMH transformation. These efforts did not typically focus on women's health, though some informal efforts had been undertaken. Barriers to engaging in QI included lack of communication across clinical service lines, fluidity in staffing, and lack of protected time. Inter-professional, multilevel stakeholders need to be engaged in implementation early, with data and discussion that convey the importance and relevance of a new initiative. Stakeholder perspectives on institutional norms (e.g., gender norms) and readiness for population-specific QI are useful drivers of clinical initiatives designed to transform care for clinical subpopulations.

Project description:Collaborative-care management is an evidence-based practice for improving depression outcomes in primary care. The Department of Veterans Affairs (VA) has mandated the implementation of collaborative-care management in its satellite clinics, known as Community Based Outpatient Clinics (CBOCs). However, the organizational characteristics of CBOCs present added challenges to implementation. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI) as a strategy to facilitate the adoption of collaborative-care management in CBOCs.This nonrandomized, small-scale, multisite evaluation of EBQI was conducted at three VA Medical Centers and 11 of their affiliated CBOCs. The Plan phase of the EBQI process involved the localized tailoring of the collaborative-care management program to each CBOC. Researchers ensured that the adaptations were evidence based. Clinical and administrative staff were responsible for adapting the collaborative-care management program for local needs, priorities, preferences and resources. Plan-Do-Study-Act cycles were used to refine the program over time. The evaluation was based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) Framework and used data from multiple sources: administrative records, web-based decision-support systems, surveys, and key-informant interviews.Adoption: 69.0% (58/84) of primary care providers referred patients to the program. Reach: 9.0% (298/3,296) of primary care patients diagnosed with depression who were not already receiving specialty care were enrolled in the program. Fidelity: During baseline care manager encounters, education/activation was provided to 100% (298/298) of patients, barriers were assessed and addressed for 100% (298/298) of patients, and depression severity was monitored for 100% (298/298) of patients. Less than half (42.5%, 681/1603) of follow-up encounters during the acute stage were completed within the timeframe specified. During the acute phase of treatment for all trials, the Patient Health Questionnaire (PHQ9) symptom-monitoring tool was used at 100% (681/681) of completed follow-up encounters, and self-management goals were discussed during 15.3% (104/681) of completed follow-up encounters. During the acute phase of treatment for pharmacotherapy and combination trials, medication adherence was assessed at 99.1% (575/580) of completed follow-up encounters, and side effects were assessed at 92.4% (536/580) of completed follow-up encounters. During the acute phase of treatment for psychotherapy and combination trials, counseling session adherence was assessed at 83.3% (239/287) of completed follow-up encounters. Effectiveness: 18.8% (56/298) of enrolled patients remitted (symptom free) and another 22.1% (66/298) responded to treatment (50% reduction in symptom severity). Maintenance: 91.9% (10/11) of the CBOCs chose to sustain the program after research funds were withdrawn.Provider adoption was good, although reach into the target population was relatively low. Fidelity and maintenance were excellent, and clinical outcomes were comparable to those in randomized controlled trials. Despite the organizational barriers, these findings suggest that EBQI is an effective facilitation strategy for CBOCs.Clinical trial # NCT00317018.

Project description:Foodborne pathogens can cause acute and chronic diseases and produce a wide range of symptoms. Since the consumption of ground beef is a risk factor for infections with some bacterial pathogens, we performed a comprehensive evaluation of butcher shops, implemented improvement actions for both butcher shops and consumers, and verified the impact of those actions implemented. A comprehensive evaluation was made and risk was quantified on a 1-100 scale as high-risk (1-40), moderate-risk (41-70) or low-risk (71-100). A total of 172 raw ground beef and 672 environmental samples were collected from 86 butcher shops during the evaluation (2010-2011) and verification (2013) stages of the study. Ground beef samples were analyzed for mesophilic aerobic organisms, Escherichia coli and coagulase-positive Staphylococcus aureus enumeration. Salmonella spp., E. coli O157:H7, non-O157 Shiga toxin-producing E. coli (STEC), and Listeria monocytogenes were detected and isolated from all samples. Risk quantification resulted in 43 (50.0%) high-risk, 34 (39.5%) moderate-risk, and nine (10.5%) low-risk butcher shops. Training sessions for 498 handlers and 4,506 consumers were held. Re-evaluation by risk quantification and microbiological analyses resulted in 19 (22.1%) high-risk, 42 (48.8%) moderate-risk and 25 (29.1%) low-risk butcher shops. The count of indicator microorganisms decreased with respect to the 2010-2011 period. After the implementation of improvement actions, the presence of L. monocytogenes, E. coli O157:H7 and stx genes in ground beef decreased. Salmonella spp. was isolated from 10 (11.6%) ground beef samples, without detecting statistically significant differences between both study periods (evaluation and verification). The percentage of pathogens in environmental samples was reduced in the verification period (Salmonella spp., 1.5%; L. monocytogenes, 10.7%; E. coli O157:H7, 0.6%; non-O157 STEC, 6.8%). Risk quantification was useful to identify those relevant facts in butcher shops. The reduction of contamination in ground beef and the environment was possible after training handlers based on the problems identified in their own butcher shops. Our results confirm the feasibility of implementing a comprehensive risk management program in butcher shops, and the importance of information campaigns targeting consumers. Further collaborative efforts would be necessary to improve foodstuffs safety at retail level and at home.

Project description:BackgroundMitigating the risks of adverse outcomes from opioids is critical. Thus, the Veterans Affairs (VA) Healthcare System developed the Stratification Tool for Opioid Risk Management (STORM), a dashboard to assist clinicians with opioid risk evaluation and mitigation. Updated daily, STORM calculates a "risk score" of adverse outcomes (e.g., suicide-related events, overdoses, overdose death) from variables in the VA medical record for all patients with an opioid prescription and displays this information along with documentation of recommended risk mitigation strategies and non-opioid pain treatments. In March 2018, the VA issued a policy notice requiring VA Medical Centers (VAMCs) to complete case reviews for patients whom STORM identifies as very high-risk (i.e., top 1% of STORM risk scores). Half of VAMCs were randomly assigned notices that also stated that additional support and oversight would be required for VAMCs that failed to meet an established percentage of case reviews. Using a stepped-wedge cluster randomized design, VAMCs will be further randomized to conduct case reviews for an expanded pool of patients (top 5% of STORM risk scores vs. 1%) starting either 9 or 15 months after the notice was released, creating four natural arms. VA commissioned an evaluation to understand the implementation strategies and factors associated with case review completion rates, whose protocol is described in this report.MethodsThis mixed-method study will include an online survey of all VAMCs to identify implementation strategies and interviews at a subset of facilities to identify implementation barriers and facilitators. The survey is based on the Expert Recommendations for Implementing Change (ERIC) project, which engaged experts to create consensus on 73 implementation strategies. We will use regression models to compare the number and types of implementation strategies across arms and their association with case review completion rates. Using questions from the Consolidated Framework for Implementation Research, we will interview stakeholders at 40 VAMCs with the highest and lowest adherence to opioid therapy guidelines.DiscussionBy identifying which implementation strategies, barriers, and facilitators influence case reviews to reduce opioid-related adverse outcomes, this unique implementation evaluation will enable the VA to improve the design of future opioid safety initiatives.Trial registrationThis project is registered at the ISRCTN Registry with number ISRCTN16012111 . The trial was first registered on 5/3/2017.

Project description:BackgroundAvailable resources within an organization can determine the implementation success of an intervention. However, few studies have investigated how the required resources change over the phases of implementation. Using stakeholder interviews, we examined the changes in and interactions between available resources and implementation climate in the implementation and sustainment phases of a national implementation effort for a population health tool.MethodsWe conducted a secondary analysis of the interviews with 20 anticoagulation professionals at 17 clinical sites in the Veterans Health Administration health system about their experiences with a population health dashboard for anticoagulant management. Interview transcripts were coded using constructs from the Consolidated Framework for Implementation Research (CFIR) and according to the phase of implementation (pre-implementation, implementation, and sustainment) as defined by the VA Quality Enhancement Research Initiative (QUERI) Roadmap. We analyzed the factors that may determine successful implementation by examining the co-occurrence patterns between available resources and implementation climate across different implementation phases. To illustrate the variations in these determinants across phases, we aggregated and scored coded statements using a previously published CFIR scoring system (- 2 to + 2). Key relationships between available resources and implementation climate were identified and summarized using thematic analysis.ResultsThe resources necessary to support the successful implementation of an intervention are not static; both the quantity and types of resources shift based on the phases of the intervention. Furthermore, increased resource availability does not guarantee the sustainment of intervention success. Users need different types of support beyond the technical aspects of an intervention, and this support varies over time. Specifically, available resources in the form of technological support and social/emotional support help users establish trust in a new technological-based intervention during the implementation phase. Resources that foster and maintain collaboration between users and other stakeholders help them stay motivated during sustainment.ConclusionsOur findings highlight the dynamic nature of available resources and their impacts on the implementation climate across different phases of implementation. A better understanding of the dynamics of available resources over time from the users' perspectives will allow the adaptation of resources to better meet the needs of the intervention stakeholders.

Dataset Information

Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities.

Publications

Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities.

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