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Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation.

ABSTRACT: Treatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Evidence-based clinical practice guidelines recommend timely assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring and management for these patients. This protocol article describes the project 'Monitoring and Management for Metabolic Side Effects of Antipsychotics,' which is testing an approach to implement recommendations for these practices.This project employs a cluster randomized clinical trial design to test effectiveness of an evidence-based quality improvement plus facilitation intervention. Eligible study sites were VA Medical Centers with ?300 patients started on a new antipsychotic prescription in a six-month period. A total of 12 sites, matched in pairs based on scores on an organizational practice survey, were then randomized within pairs to intervention or control conditions.Study participants include VA employees involved in metabolic monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders to facilitate tailoring of local implementation strategies to address barriers to metabolic side-effect monitoring and management. The intervention includes a Design Phase (initial site visit and subsequent development of a local implementation plan); Implementation Phase (guided by an experienced external facilitator); and a Sustainability Phase. Evaluation includes developmental, implementation-focused, progress-focused and interpretative formative evaluation components, as well as summative evaluation. Evaluation methods include surveys, qualitative data collection from provider participants, and quantitative data analysis of data for all patients prescribed a new antipsychotic medication at a study site who are due for monitoring or management of metabolic side effects during the study phases. Changes in rates of recommended monitoring and management actions at intervention and control sites will be compared using time series analyses.Improving monitoring for metabolic side effects of antipsychotics, as well as promoting timely evidence-based management when these effects emerge, will lead to improved patient safety and long-term outcomes. This article discusses key strengths and challenges of the study.NCT01875861.

SUBMITTER: Owen RR

PROVIDER: S-EPMC3852845 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation.

Owen Richard R RR Drummond Karen L KL Viverito Kristen M KM Marchant Kathy K Pope Sandra K SK Smith Jeffrey L JL Landes Reid D RD

Implementation science : IS 20131008

<h4>Background</h4>Treatment of psychotic disorders consists primarily of second generation antipsychotics, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Evidence-based clinical practice guidelines recommend timely assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring and management for these patients. This protocol article describes the project 'Monitoring and Managemen ...[more]

PMID: 24103648

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Project description:BackgroundRelatively little guidance exists on how to use virtual implementation facilitation to successfully implement evidence-based practices and innovations into clinical programs. Yet virtual methods are increasingly common. They have potentially wider reach, emergent public health situations necessitate their use, and restrictions on resources can make them more attractive. We therefore outline a set of principles for virtual external implementation facilitation and a series of recommendations based on extensive experience successfully using virtual external implementation facilitation in a national program.Model and recommendationsSuccess in virtual external implementation facilitation may be achieved by facilitators applying three overarching principles: pilot everything, incorporate a model, and prioritize metacognition. Five practical principles also help: plan in advance, communicate in real time, build relationships, engage participants, and construct a virtual room for participants. We present eight concrete suggestions for enacting the practical principles: (1) assign key facilitation roles to facilitation team members to ensure the program runs smoothly; (2) create small cohorts of participants so they can have meaningful interactions; (3) provide clarity and structure for all participant interactions; (4) structure program content to ensure key points are described, reinforced, and practiced; (5) use visuals to supplement audio content; (6) build activities into the agenda that enable participants to immediately apply knowledge at their own sites, separate from the virtual experience; (7) create backup plans whenever possible; and (8) engage all participants in the program. These principles represent a novel conceptualization of virtual external implementation facilitation, giving structure to a process that has been, to date, inadequately described. The associated actions are demonstrably useful in supporting the principles and offer teams interested in virtual external implementation facilitation concrete methods by which to ensure success. Our examples stem from experiences in healthcare. But the principles can, in theory, be applied to virtual external implementation facilitation regardless of setting, as they and the associated actions are not setting specific.

Project description:BackgroundHeart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology.ObjectiveThe goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention.ApproachThis was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions.Key resultsMany patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms.ConclusionOur qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes.Trial registrationClinicalTrials.gov Identifier: NCT02708654.

Project description:BackgroundOver 1100 veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs)-those with formal training who support other veterans with similar diagnoses. A White House Executive Action mandated the pilot reassignment of VHA PSs from their usual placement in mental health to 25 primary care Patient Aligned Care Teams (PACTs) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PSs in PACTs, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in new settings.MethodsThis study was a cluster-randomized hybrid II effectiveness-implementation trial to test the impact of minimal implementation support vs. facilitated implementation on the deployment of VHA PSs in PACT over 2 years. Twenty-five Veterans Affairs Medical Centers (VAMCs) were recruited to reassign mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 7, 10, 8) over 6-month blocks were matched and randomized to each study condition. In facilitated implementation, an outside expert worked with site stakeholders through a site visit and regular calls, and provided performance data to guide the planning and address challenges. Minimal implementation sites received a webinar and access to the VHA Office of Mental Health Services work group. The two conditions were compared on PS workload data and veteran measures of activation, satisfaction, and functioning. Qualitative interviews collected information on perceived usefulness of the PS services.ResultsIn the first year, sites that received facilitation had higher numbers of unique veterans served and a higher number of PS visits, although the groups did not differ after the second year. Also, sites receiving external facilitation started delivering PS services more quickly than minimal support sites. All sites in the external facilitation condition continued in the pilot into the second year, whereas two of the sites in the minimal assistance condition dropped out after the first year. There were no differences between groups on veterans' outcomes-activation, satisfaction, and functioning. Most veterans were very positive about the help they received as evidenced in the qualitative interviews.DiscussionThese findings demonstrate that external facilitation can be effective in supporting the implementation of PSs in primary care settings. The lack of significant differences across conditions after the second year highlights the positive outcomes associated with active facilitation, while also raising the important question of whether longer-term success may require some level of ongoing facilitation and implementation support.Trial registrationThis project is registered at ClinicalTrials.gov with number NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 ).

Project description:BackgroundThe Veterans Health Administration (VHA) is invested in expanding access to medication treatment for opioid use disorder (MOUD) to save lives. Access varies across VHA facilities and, thus, requires implementation strategies to promote system-wide adoption of MOUD. We conducted a 12-month study employing external facilitation that targeted MOUD treatment among low-adopting VHA facilities. In this study, we sought to evaluate the patterns of perceived barriers over 1 year of external implementation facilitation using the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework.MethodsWe randomly selected eight VHA facilities from the bottom quartile of the proportion of Veterans with an OUD diagnosis receiving MOUD (< 21%). The 1-year external implementation intervention included developmental evaluation to tailor the facilitation, an on-site visit, and monthly facilitation calls. Facilitators recorded detailed notes for each call on a structured template. Qualitative data was analyzed by coding and mapping barriers to the constructs in the i-PARIHS framework (Innovation, Recipients, Context). We identified emerging themes within each construct by month.ResultsBarriers related to the Innovation, such as provider perception of the need for MOUD in their setting, were minimal throughout the 12-month study. Barriers related to Recipients were predominant and fluctuated over time. Recipient barriers were common during the initial months when providers did not have the training and waivers necessary to prescribe MOUD. Once additional providers (Recipients) were trained and waivered to prescribe MOUD, Recipient barriers dropped and then resurfaced as the facilities worked to expand MOUD prescribing to other clinics. Context barriers, such as restrictions on which clinics could prescribe MOUD and fragmented communication across clinics regarding the management of patients receiving MOUD, emerged more prominently in the middle of the study.ConclusionsVHA facilities participating in 12-month external facilitation interventions experienced fluctuations in barriers to MOUD prescribing with contextual barriers emerging after a facilitated reduction in recipient- level barriers. Adoption of MOUD prescribing in low-adopting VHA facilities requires continual reassessment, monitoring, and readjustment of implementation strategies over time to meet challenges. Although i-PARIHS was useful in categorizing most barriers, the lack of conceptual clarity was a concern for some constructs.

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Dataset Information

Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation.

Publications

Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation.

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