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Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods.

ABSTRACT: Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists.The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications) or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group.To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing.Clinicaltrials.gov NCT00878566.

SUBMITTER: Charrois TL

PROVIDER: S-EPMC3199859 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods.

Charrois Theresa L TL McAlister Finlay A FA Cooney Dale D Lewanczuk Richard R Kolber Michael R MR Campbell Norman Rc NR Rosenthal Meagen M Houle Sherilyn Kd SK Tsuyuki Ross T RT

Implementation science : IS 20110811

<h4>Background</h4>Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihype ...[more]

PMID: 21834970

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Project description:Exercise has favorable effects on biomarkers associated with a lower risk of breast cancer, however it is unclear if higher doses of exercise provide additional effects. No clinical trial has systematically examined how different exercise volumes influence the mechanisms underlying breast cancer etiology. The Breast Cancer and Exercise Trial in Alberta (BETA) - a follow-up study to the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial - is examining how a one-year, high versus moderate volume aerobic exercise intervention influences several biomechanisms hypothesized to influence breast cancer risk in a group of postmenopausal women. Secondary aims are to compare intervention effects on psychosocial and quality of life outcomes as well as understand exercise adherence at 12 and 24 months, and maintenance of all study outcomes at 24 months.The BETA Trial is a two-center, two-armed randomized controlled exercise intervention trial conducted in 400 previously inactive, postmenopausal women aged 50-74 years, in Alberta, Canada. Participants were randomly assigned to a one-year aerobic exercise intervention of either high volume (300 minutes/week) or moderate volume (150 minutes/week). Blood draws and accelerometry were performed at baseline, six and 12 months. Baseline and 12-month measurements were taken of adiposity (including dual energy X-ray absorptiometry and computed tomography scans), physical fitness, dietary intake, self-reported physical activity and sedentary behavior, quality of life, perceived stress, happiness, sleep, and determinants of exercise adherence. Exercise maintenance was assessed and all study measurements were repeated at 24 months. Blood will be analyzed for endogenous estrogens, insulin resistance indicators, and inflammatory markers.The BETA Trial will compare the impact of a high versus moderate volume of aerobic exercise on a variety of biological, physiological, and psychological outcomes of relevance to postmenopausal women. A tightly controlled exercise intervention and objective outcome measurements are methodological strengths. The BETA Trial will inform future prevention initiatives by assessing adherence to a high volume of exercise over 12 months by postmenopausal women, and the ability of these women to maintain activity over the longer-term. The ultimate objective is to inform public health guidelines for reducing breast cancer risk through physical activity.NCT01435005.

Project description:ObjectiveStudy objectives were to develop a questionnaire to assess factors influencing pharmacists' adoption of prescribing (i.e., continuing, adapting or initiating therapy), describe use of pre-incentive and mixed mode survey, and establish survey psychometric properties.MethodsQuestions were developed based on prior qualitative research and Diffusion of Innovation theory. Expert review, cognitive testing, survey pilot, and main survey were used to test the questionnaire. Six content experts reviewed the questionnaire to establish face and content validity. Ten pharmacists from diverse practice settings were purposefully recruited for a cognitive interview to verify question readability. Content analysis was used to analyze the results. A pre-survey introduction letter with a monetary incentive was mailed via post to 100 (i.e. pilot) and 700 (i.e., main survey) randomly selected pharmacists. This was followed by an e-mail with a personalized link to the online questionnaire, e-mail reminders, and a telephone reminder if required. The psychometric properties of scales were evaluated with an exploratory factor analysis and Cronbach's alpha. Scale responses were described.ResultsEngagement of six experts and ten pharmacists clarified definitions (e.g., prescribing), terminology, recall periods, and response options for the 34-item response scale. Fifty-six pharmacists completed the online pilot survey. Based on this data, ambiguous questions and routing issues were addressed. Three hundred and seventy-eight pharmacists completed the online main survey for a response rate of 54.6%. The factors analysis resulted in 27 questions in eight scales: (1) self-efficacy, (2) support from practice environment, (3) support from interprofessional relationship, (4) impact on professionalism, (5) impact on patient care), (6) prescribing beliefs, (7) technical use of electronic health record (EHR) and (8) patient care use of the EHR. Prescribing beliefs and technical use of the EHR scales had low reliability while the remaining six scales had strong evidence for reliability and validity.ConclusionThrough a multi-stage process, a survey instrument was developed to capture pharmacists' perceptions of prescribing influences. This questionnaire may support future research to develop interventions to enhance adoption of prescribing and enhance direct patient care by pharmacists.

Project description:ImportanceMajor gaps in the delivery of appropriate oral anticoagulation therapy (OAC) exist, leaving a large proportion of persons with atrial fibrillation (AF) unnecessarily at risk for stroke and its sequalae.ObjectiveTo investigate whether pharmacist-led OAC prescription can increase the delivery of stroke risk reduction therapy in individuals with AF.Design, setting, and participantsThis prospective, open-label, patient-level randomized clinical trial of early vs delayed pharmacist intervention from January 1, 2019, to December 31, 2022, was performed in 27 community pharmacies in Alberta, Canada. Pharmacists identified patients 65 years or older with 1 additional stroke risk factor and known, untreated AF (OAC nonprescription or OAC suboptimal dosing) or performed screening using a 30-second single-lead electrocardiogram to detect previously unrecognized AF. Patients with undertreated or newly diagnosed AF eligible for OAC therapy were considered to have actionable AF. Data were analyzed from April 3 to November 30, 2023.InterventionsIn the early intervention group, pharmacists prescribed OAC using guideline-based algorithms with follow-up visits at 1 and 3 months. In the delayed intervention group, which served as the usual care control, the primary care physician (PCP) was sent a notification of actionable AF along with a medication list (both enhancement over usual care). After 3 months, patients without OAC optimization in the control group underwent delayed pharmacist intervention.Main outcomes and measuresThe primary outcome was the difference in the rate of guideline-concordant OAC use in the 2 groups at 3-month follow-up ascertained by a research pharmacist blinded to treatment allocation.ResultsEighty patients were enrolled with actionable AF (9 [11.3%] newly diagnosed in 235 individuals screened). The mean (SD) age was 79.7 (7.4) years, and 45 patients (56.3%) were female. The median CHADS2 (congestive heart failure, hypertension, age, diabetes, and stroke or transient ischemic attack) score was 2 (IQR, 2-3). Seventy patients completed follow-up. Guideline-concordant OAC use at 3 months occurred in 36 of 39 patients (92.3%) in the early intervention group vs 23 of 41 (56.1%) in the control group (P < .001), with an absolute increase of 34% and number needed to treat of 3. Of the 23 patients who received appropriate OAC prescription in the control group, the PCP called the pharmacist for prescribing advice in 6 patients.Conclusions and relevanceThis randomized clinical trial found that pharmacist OAC prescription is a potentially high-yield opportunity to effectively close gaps in the delivery of stroke risk reduction therapy for AF. Scalability and sustainability of pharmacist OAC prescription will require larger trials demonstrating effectiveness and safety.Trial registrationClinicalTrials.gov Identifier: NCT03126214.

Project description:BackgroundResidents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification.MethodsMixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3 months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥ 65 years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident's quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants' views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed.ResultsAcross the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84 years; 61% (24) were female), and 38 participants remained at 3 months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5 L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload.ConclusionImplementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

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Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods.

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Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods.

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