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A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

ABSTRACT: BACKGROUND:Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension. METHODS:A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the intervention between the two groups, and identification of feasible quantitative outcomes for evaluating the effect of the intervention on patient care outcomes. RESULTS:To date, the study has identified and enrolled the ten pharmacies required and initiated the intervention process. CONCLUSION:This study will be the first to examine the role of facilitation in pharmacy practice, with the goal of scalable and sustainable practice change. TRIAL REGISTRATION:Clinicaltrials.gov identifier NCT02191111.

SUBMITTER: Rosenthal MM

PROVIDER: S-EPMC5066522 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

Rosenthal Meagen M MM Tsuyuki Ross T RT Houle Sherilyn Kd SK

Pilot and feasibility studies 20150112

<h4>Background</h4>Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of th ...[more]

PMID: 27965782

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Project description:BackgroundA large proportion of the annual 3.3 million neonatal deaths could be averted if there was a high uptake of basic evidence-based practices. In order to overcome this 'know-do' gap, there is an urgent need for in-depth understanding of knowledge translation (KT). A major factor to consider in the successful translation of knowledge into practice is the influence of organizational context. A theoretical framework highlighting this process is Promoting Action on Research Implementation in Health Services (PARIHS). However, research linked to this framework has almost exclusively been conducted in high-income countries. Therefore, the objective of this study was to examine the perceived relevance of the sub-elements of the organizational context cornerstone of the PARIHS framework, and also whether other factors in the organizational context were perceived to influence KT in a specific low-income setting.MethodsThis qualitative study was conducted in a district of Uganda, where focus group discussions and semi-structured interviews were conducted with midwives (n = 18) and managers (n = 5) within the catchment area of the general hospital. The interview guide was developed based on the context sub-elements in the PARIHS framework (receptive context, culture, leadership, and evaluation). Interviews were transcribed verbatim, followed by directed content analysis of the data.ResultsThe sub-elements of organizational context in the PARIHS framework-i.e., receptive context, culture, leadership, and evaluation-also appear to be relevant in a low-income setting like Uganda, but there are additional factors to consider. Access to resources, commitment and informal payment, and community involvement were all perceived to play important roles for successful KT.ConclusionsIn further development of the context assessment tool, assessing factors for successful implementation of evidence in low-income settings-resources, community involvement, and commitment and informal payment-should be considered for inclusion. For low-income settings, resources are of significant importance, and might be considered as a separate sub-element of the PARIHS framework as a whole.

Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.

Project description:BackgroundOsteoarthritis is a leading cause of pain and disability worldwide. Despite research supporting best practice, evidence-based guidelines are often not followed. Little is known about the implementation of non-surgical models of care in routine primary care practice. From a knowledge mobilisation perspective, the aim of this study was to understand the uptake of a clinical innovation for osteoarthritis and explore the journey from a clinical trial to implementation.MethodsThis study used two methods: secondary analysis of focus groups undertaken with general practice staff from the Managing OSteoArthritis in ConsultationS research trial, which investigated the effectiveness of an enhanced osteoarthritis consultation, and interviews with stakeholders from an implementation project which started post-trial following demand from general practices. Data from three focus groups with 21 multi-disciplinary clinical professionals (5-8 participants per group), and 13 interviews with clinical and non-clinical stakeholders, were thematically analysed utilising the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, in a theoretically informative approach. Public contributors were involved in topic guide design and interpretation of results.ResultsIn operationalising implementation of an innovation for osteoarthritis following a trial, the importance of a whole practice approach, including the opportunity for reflection and planning, were identified. The end of a clinical trial provided opportune timing for facilitating implementation planning. In the context of osteoarthritis in primary care, facilitation by an inter-disciplinary knowledge brokering service, nested within an academic institution, was instrumental in supporting ongoing implementation by providing facilitation, infrastructure and resource to support the workload burden. 'Instinctive facilitation' may involve individuals who do not adopt formal brokering roles or fully recognise their role in mobilising knowledge for implementation. Public contributors and lay communities were not only recipients of healthcare innovations but also potential powerful facilitators of implementation.ConclusionThis theoretically informed knowledge mobilisation study into the uptake of a clinical innovation for osteoarthritis in primary care has enabled further characterisation of the facilitation and recipient constructs of i-PARIHS by describing optimum timing for facilitation and roles and characteristics of facilitators.

Project description:BackgroundCanadian funding agencies are no longer content to support research that solely advances scientific knowledge, and key directives are now in place to promote research transfer to policy- and decision-makers. Therefore, it is necessary to improve our understanding of how researchers are trained and supported to facilitate knowledge translation activities. In this study, we investigated differences in health researcher characteristics and knowledge translation activities.MethodsOur sample consisted of 240 health researchers from three Alberta universities. Respondents were classified by research domain [basic (n = 72) or applied (n = 168)] and faculty [medical school (n = 128) or other health science (n = 112)]. We examined our findings using Mode I and Mode II archetypes of knowledge production, which allowed us to consider the scholarly and social contexts of knowledge production and translation.ResultsDifferences among health researcher professional characteristics were not statistically significant. There was a significant gender difference in the applied researcher faculty group, which was predominantly female (p < .05). Research domain was linked to translation activities. Applied researchers reported engaging in significantly more Mode II activities than basic researchers (p < .001), and scored higher than basic researchers regarding the perceived importance of translation activities (Mode I, p = .01; Mode II, p < .001). Main effects of faculty were limited to engaged dissemination (medical school < other faculties; p = .025) and number of publications (medical school > other faculties; p = .004). There was an interaction effect for research domain and faculty group for number of publications (p = .01), in that applied researchers in medical faculties published more than their peers in other faculty groups.ConclusionOur findings illustrate important differences between health researchers and provide beginning insights into their professional characteristics and engagement in Mode I and Mode II activities. A future study designed to examine these dimensions in greater detail, including potential covariates across more varied institutions, would yield richer insights and enable an examination of relative influences, needs and costs of each mode of activity.

Project description:BackgroundSome older people who find standard exercise programmes too strenuous may be encouraged to exercise while remaining seated - chair based exercises (CBE). We previously developed a consensus CBE programme (CCBE) following a modified Delphi process. We firstly needed to test the feasibility and acceptability of this treatment approach and explore how best to evaluate it before undertaking a definitive trial.MethodsA feasibility study with a cluster randomised controlled trial component was undertaken to 1. Examine the acceptability, feasibility and tolerability of the intervention and 2. Assess the feasibility of running a trial across 12 community settings (4 day centres, 4 care homes, 4 community groups). Centres were randomised to either CCBE, group reminiscence or usual care. Outcomes were collected to assess the feasibility of the trial parameters: level of recruitment interest and eligibility, randomisation, adverse events, retention, completion of health outcomes, missing data and delivery of the CCBE. Semi- structured interviews were conducted with participants and care staff following the intervention to explore acceptability.Results48% (89 out of 184 contacted) of eligible centres were interested in participating with 12 recruited purposively. 73% (94) of the 128 older people screened consented to take part with 83 older people then randomised following mobility testing. Recruitment required greater staffing levels and resources due to 49% of participants requiring a consultee declaration. There was a high dropout rate (40%) primarily due to participants no longer attending the centres. The CCBE intervention was delivered once a week in day centres and community groups and twice a week in care homes. Older people and care staff found the CCBE intervention largely acceptable.ConclusionThere was a good level of interest from centres and older people and the CCBE intervention was largely welcomed. The trial design and governance procedures would need to be revised to maximise recruitment and retention. If the motivation for a future trial is physical health then this study has identified that further work to develop the CCBE delivery model is warranted to ensure it can be delivered at a frequency to elicit physiological change. If the motivation for a future trial is psychological outcomes then this study has identified that the current delivery model is feasible.Trial registrationISRCTN27271501 . Date registered: 30/01/2018.

Project description:ObjectivesThis study aimed to develop an evidence-based community pharmacist-delivered screening model for diabetes and cardiovascular disease (CVD), and assess its feasibility to identify and refer patients with elevated risk.DesignA feasibility study.SettingA purposive sample of 12 community pharmacies in three cities in the United Arab Emirates (UAE).ParticipantsAdults 40 years of age and above who have not been previously diagnosed with either diabetes or CVD.InterventionPharmacist screening of adults visiting pharmacies involved history, demographics, anthropometric measurements, blood pressure and point-of-care testing including glycated haemoglobin (HbA1c) levels and lipid panel. Participants with a 10-year CVD risk ≥7.5%, HbA1c level ≥5.7% or American Diabetes Association (ADA) risk score ≥5 points were advised to visit their physician.Primary and secondary outcome measuresThe primary outcomes were (1) development of UAE pharmacist-delivered screening model, (2) the proportion of screened participants identified as having high CVD risk (atherosclerotic CVD 10-year risk defined as ≥7.5%) and (3) the proportion of participants identified as having elevated blood glucose (high HbA1c level ≥5.7% (38.8 mmol/mol)) or high self-reported diabetes risk (ADA risk score ≥5 points). Secondary outcome is participants' satisfaction with the screening.ResultsThe first UAE pharmacist-delivered screening model was developed and implemented. A total of 115 participants were screened, and 92.3% of the entire screening process was completed during a single visit to pharmacy. The mean duration of the complete screening process was 27 min. At-risk individuals (57.4%) were referred to their physicians for further testing, while 94.5% of participants were at least satisfied with their screening experience.ConclusionsThe community pharmacist-delivered screening of diabetes and CVD risk is feasible in the UAE. The model offers a platform to increase screening capacity within primary care and provides an opportunity for early detection and treatment. However, pathways for the integration of the pharmacist-delivered screening service with physicians in primary care are yet to be explored.

Project description:BackgroundNegative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada.MethodsIn a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student's choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™.ResultsNine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation.ConclusionWhile most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations.Trial registrationThe trial is registered at ClinicalTrials.gov ( NCT03948633 ); Submitted April 24, 2019.

Project description:ObjectivesDetermine the feasibility of using a diabetes risk assessment tool followed by HbA1c-measurement in a community-pharmacy setting in Norway.MethodsIn this longitudinal study two pharmacists in each of three community pharmacies were trained to perform risk assessments, HbA1c-measurements and counselling. Pharmacy customers who were > 18 years old and could understand and speak Norwegian or English were recruited in the pharmacies during a two-months-period. Information about the service was presented in local newspapers, social media, leaflets and posters at the pharmacy. Customers wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. A HbA1c measurement was performed for individuals with a moderate to high risk of developing diabetes. If HbA1c ≥ 6.5% they were recommended to visit their general practitioner for follow-up. The pharmacies performed internal and external quality control of the HbA1c instrument.ResultsOf the 211 included participants 97 (46%) were > 50 years old. HbA1c was measured for the 47 participants (22%) with high risk. Thirty-two (15%) had HbA1c values < 5.7%, twelve (5.4%) had values between 5.7%-6.4%, and three (1.4%) had an HbA1c ≥ 6.5%. Two participants with HbA1 ≥ 6.5% were diagnosed with diabetes by their general practitioner. The third was lost to follow-up. Results from internal and external quality control for HbA1c were within set limits.ConclusionThe pharmacists were able to perform the risk assessment and measurement of HbA1c, and pharmacy customers were willing to participate. The HbA1c measurements fulfilled the requirements for analytical quality. Thus, it is feasible to implement this service in community pharmacies in Norway. In a large-scale study the inclusion criteria should be increased to 45 years in accordance with the population the risk test has been validated for.

Dataset Information

A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

Publications

A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

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