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A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.

ABSTRACT: Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted research is needed. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design. This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada.Community pharmacies from across the province of Saskatchewan, Canada were randomized to deliver an adherence intervention to their patients or usual care. Intervention pharmacies were trained to employ a practical adherence strategy targeted at new users of statin medications. While randomization and implementation of the intervention occurred at the community pharmacy level, the outcome analysis will occur at the level of the individual subjects. The primary outcome is the mean statin adherence among all eligible new users of statin medications. Secondary outcomes include the proportion of new statin users who exhibit adherence>or=80%, and persistence with statin use.This novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion. We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions.ClinicalTrials.gov no. NCT00971412.

SUBMITTER: Evans CD

PROVIDER: S-EPMC2912883 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature

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A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.

Evans Charity D CD Eurich Dean T DT Taylor Jeff G JG Remillard Alfred J AJ Shevchuk Yvonne M YM Blackburn David F DF

Trials 20100708

<h4>Background</h4>Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted researc ...[more]

PMID: 20615235

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Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:INTRODUCTION:With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population. METHODS AND ANALYSIS:The Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective. ETHICS AND DISSEMINATION:The protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12616001240437; Pre-results.

Project description:BackgroundMinor ailments are "self-limiting conditions which may be diagnosed and managed without a medical intervention". A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC).MethodsThe cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists' training, practice change facilitators and patients' educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals' consultation time, medication costs, pharmacists' training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences.ResultsA total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness.ConclusionsExpanding community pharmacists' scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.Trial registrationISRCTN, ISRCTN17235323 . Registered 07/05/2021 - Retrospectively registered.

Project description:The Antibiotic Guardian (AG) campaign, developed in 2014 is an online 'pledge' approach to engage health workers and the public about antimicrobial resistance. It is underpinned by models of science communication and behaviour change. Since its launch until the end of 2021, more than 140,000 individuals pledged. A service evaluation was conducted to determine the impact of the campaign upon UK pharmacy workers, in response to national training introduced in 2020. Pledged pharmacy workers were sent an online questionnaire collating demographics, self-reported behaviour and opportunity to support prudent antibiotic use. It also investigated respondents' daily practice and antimicrobial stewardship (AMS) efforts, and motivations for pledging. Capability was measured with a set of knowledge questions. Awareness of changes to the Community Pharmacy Quality Scheme in England to include incentivized training on antimicrobial resistance (AMR) was explored. Of the 5344 pharmacy workers invited to participate, 783 (14.6%) responded to the survey. There was a statistically significant difference between job roles and capability score. Pharmacists, including Academic and Hospital Pharmacists and Pharmacy Technicians reported higher confidence and capability scores than Dispensers and Pharmacy Assistants (F = 13.776, p = 0.0002). Respondents reported strong knowledge on antimicrobial resistance and high confidence in fulfilling their AG stewardship pledge within daily practices (92.7% of all respondents answered all capability questions, as measured by knowledge, correctly). Two thirds of respondents (61.6% (423/693)) agreed or strongly agreed that they had access to and were able to utilise local antibiotic prescribing guidance and a similar proportion of responding community pharmacists (60%) were aware of the content of their workplace AMS plans. No statistically significant relationships were found between motivations for pledging and subsequent behaviour; pledging due to mandatory requirements of work-place training was the most common answer in both 2019 (42%) and 2020 (54%) cohorts. This evaluation supports the value of the AG pledge-based approach to engage and educate pharmacy workers. Reflections show its impact on increasing evidence-based stewardship for pharmacy workers and their response to mandatory training requirement by employers highlights the effectiveness of the AG campaign to promote AMS within pharmacy teams.

Project description:Background: Antimicrobial stewardship programs commonly utilize infectious diseases pharmacists to guide appropriate utilization of broad-spectrum antimicrobials. Strategies should be developed to increase staff pharmacist's participation in decreasing broad-spectrum antibiotic use. Objective: The purpose of this study was to determine the effectiveness of a pharmacy-driven 72-hour antimicrobial stewardship initiative. Methods: A pharmacy-driven 72-hour antibiotic review policy was implemented at a community hospital. Targeted antibiotics included ertapenem, meropenem, and daptomycin. The hospital's infectious diseases pharmacist provided policy education to staff pharmacists. All pharmacists provided prospective audit and feedback to physicians. Preimplementation and postimplementation data were collected through a retrospective chart review to analyze the impact of the initiative. Results: There were a total of 570 targeted antibiotic orders for review, of which 155 antibiotic orders met criteria for inclusion; 97 in the preimplementation group and 58 in the postimplementation group. Targeted antibiotic orders decreased postimplementation during the study period. Days of therapy per 1000 patient days decreased between the 2 groups, although this was statistically significant neither for the pooled targeted antibiotics nor for each individual antibiotic. There was a statistically significant increase in the number of appropriately prescribed targeted antibiotics from preimplementation compared to postimplementation (from 35% to 64%, P < .01). Pharmacist interventions documented for patients receiving the targeted antibiotics increased significantly during the intervention period (P < .01). In addition, there was a total of $28 795.96 in cost avoidance based on the difference in antibiotic use between the 2 groups. Conclusion: Implementation of a pharmacy-driven 72-hour broad-spectrum antibiotic review in a large community-based hospital resulted in a reduction in utilization and hospital spending and a significant increase in appropriate use of targeted antibiotics, while also increasing pharmacist engagement with antimicrobial stewardship.

Project description:Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N?=?119 intervention/N?=?241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

Project description:BackgroundCommunity pharmacy represents an important setting to identify patients who may benefit from an adherence intervention, however it remains unclear whether it would be feasible to monitor antihypertensive adherence within the workflow of community pharmacy. The aim of this study was to identify facilitators and barriers to monitoring antihypertensive medication adherence of older adults at the point of repeat dispensing.MethodsWe undertook a factorial survey of Irish community pharmacists, guided by a conceptual model adapted from the Theory of Planned Behaviour (TPB). Respondents completed four sections, 1) five factorial vignettes (clinical scenario of repeat dispensing), 2) a medication monitoring attitude measure, 3) subjective norms and self-efficacy questions, and 4) demographic and workplace questions. Barriers and facilitators to adherence monitoring behaviour were identified in factorial vignette analysis using multivariate multilevel linear modelling, testing the effect of both contextual factors embedded within the vignettes (section 1), and respondent-level factors (sections 2-4) on likelihood to perform three adherence monitoring behaviours in response to the vignettes.ResultsSurvey invites (n = 1543) were sent via email and 258 completed online survey responses were received; two-thirds of respondents were women, and one-third were qualified pharmacists for at least 15 years. In factorial vignette analysis, pharmacists were more inclined to monitor antihypertensive medication adherence by examining refill-patterns from pharmacy records than asking patients questions about their adherence or medication beliefs. Pharmacists with more positive attitudes towards medication monitoring and normative beliefs that other pharmacists monitored adherence, were more likely to monitor adherence. Contextual factors also influenced pharmacists' likelihood to perform the three adherence monitoring behaviours, including time-pressures and the number of days late the patient collected their repeat prescription. Pharmacists' normative beliefs and the number of days late the patient collected their repeat prescription had the largest quantitative influence on responses.ConclusionsThis survey identified that positive pharmacist attitudes and normative beliefs can facilitate adherence monitoring within the current workflow; however contextual time-barriers may prevent adherence monitoring. Future research should consider these findings when designing a pharmacist-led adherence intervention to be integrated within current pharmacy workflow.

Project description:BackgroundDespite US naloxone access laws, community pharmacists lack training and confidence in providing naloxone.ObjectiveTo assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as naloxone prescriptions dispensed.MethodsA 3-month pragmatic randomized controlled trial was conducted from December 2018 to March 2019. Alabama community pharmacists were recruited by mail, email, phone, and fax and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly reminders only). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3), including naloxone knowledge (%correct); perceived barriers, attitudes, confidence, and intention regarding naloxone services implementation (7-point Likert-type scale; 1 = strongly disagree, 7 = strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention from T1 to T3 were assessed using 2-way mixed analysis of variance and adjusted analyses were conducted using generalized estimating equations with negative binomial distribution to assess associations between variables.ResultsOf 55 participants (n = 27 intervention, n = 28 control), most were female (80.3%), white (80.6%), in independently owned pharmacies (39.1%). Increases in mean [SD] confidence (5.52 [1.03]-6.16 [0.74], P < 0.0005) and intention (5.35 [1.51]-6.10 [0.96], P = 0.023) occurred from pre- to post-program within the intervention group and were statistically significant compared with control (confidence P = 0.016, intention P = 0.014). Confidence (exp(β) = 1.46, P = 0.031) and perceived barriers (exp(β) = 0.75, P = 0.022) were associated with number of naloxone prescriptions dispensed.Conclusion and relevanceThe Empowering Community Pharmacists program improved community pharmacists' confidence and intention regarding naloxone services implementation. Other states can adapt program elements according to their laws.Clinicaltrials.gov identifierNCT05093309.

Dataset Information

A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.

Publications

A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.

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