Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design. METHODS: This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs. RESULTS: We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio, 0.78 [95% CI, 0.61 to 1.00]; P=0.047). No significant between-group changes in quality of life over time were observed (mean difference, 0.0001 [95% CI, -0.018 to 0.018]; P=0.99). The proportion of participants who were adherent to medications was not different between the 2 groups (P=0.199 for statins and P=0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; P=0.320). CONCLUSIONS: For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes. METHODS: This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs. RESULTS: A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P=0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P=0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P=0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P=0.098). CONCLUSIONS: In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Consensus Recommendations for Sick Day Medication Guidance for People With Diabetes, Kidney, or Cardiovascular Disease: A Modified Delphi Process.

RATIONALE & OBJECTIVE: Sick day medication guidance (SDMG) involves withholding or adjusting specific medications in the setting of acute illnesses that could contribute to complications such as hypotension, acute kidney injury (AKI), or hypoglycemia. We sought to achieve consensus among clinical experts on recommendations for SDMG that could be studied in future intervention studies. STUDY DESIGN: A modified Delphi process following guidelines for conducting and reporting Delphi studies. SETTING & PARTICIPANTS: An international group of clinicians with expertise relevant to SDMG was recruited through purposive and snowball sampling. A scoping review of the literature was presented, followed by 3 sequential rounds of development, refinement, and voting on recommendations. Meetings were held virtually and structured to allow the participants to provide their input and rapidly prioritize and refine ideas. OUTCOME: Opinions of participants were measured as the percentage who agreed with each recommendation, whereas consensus was defined as >75% agreement. ANALYTICAL APPROACH: Quantitative data were summarized using counts and percentages. A qualitative content analysis was performed to capture the context of the discussion around recommendations and any additional considerations brought forward by participants. RESULTS: The final panel included 26 clinician participants from 4 countries and 10 clinical disciplines. Participants reached a consensus on 42 specific recommendations: 5 regarding the signs and symptoms accompanying volume depletion that should trigger SDMG; 6 regarding signs that should prompt urgent contact with a health care provider (including a reduced level of consciousness, severe vomiting, low blood pressure, presence of ketones, tachycardia, and fever); and 14 related to scenarios and strategies for patient self-management (including frequent glucose monitoring, checking ketones, fluid intake, and consumption of food to prevent hypoglycemia). There was consensus that renin-angiotensin system inhibitors, diuretics, nonsteroidal anti-inflammatory drugs, sodium/glucose cotransporter 2 inhibitors, and metformin should be temporarily stopped. Participants recommended that insulin, sulfonylureas, and meglitinides be held only if blood glucose was low and that basal and bolus insulin be increased by 10%-20% if blood glucose was elevated. There was consensus on 6 recommendations related to the resumption of medications within 24-48 hours of the resolution of symptoms and the presence of normal patterns of eating and drinking. LIMITATIONS: Participants were from high-income countries, predominantly Canada. Findings may not be generalizable to implementation in other settings. CONCLUSIONS: A multidisciplinary panel of clinicians reached a consensus on recommendations for SDMG in the presence of signs and symptoms of volume depletion, as well as self-management strategies and medication instructions in this setting. These recommendations may inform the design of future trials of SDMG strategies.

Evaluating the impact of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial.

BACKGROUND: Multiple sclerosis (MS) is a chronic disease affecting multiple functional aspects of patients' lives. Depression and anxiety are common amongst persons with MS (PwMS). There has been an interest in utilizing patient-reported outcome measures (PROMs) to capture and systematically assess patient's perceptions of their MS experience in addition to other clinical measures, but PROMs are not usually collected in routine clinical practice. Therefore, this study aims to systematically incorporate periodic electronically administered PROMs into the care of PwMS to evaluate its effects on depression and anxiety. METHODS: A randomized controlled trial will be conducted with patients allocated 1:1 to either intervention or conservative treatment groups. Patients in the intervention group will complete PROMs at the start of the study and then every 6 months for 1 year, in addition to having their MS healthcare provider prompted to view their scores. The conservative treatment group will complete PROMs at the start of the study and again after 12 months, and their neurologist will not be able to view their scores. For both groups, pre-determined critical PROM scores will trigger an alert to the patient's MS provider. The difference in change in Hospital Anxiety and Depression Scale score between the intervention and conservative treatment groups at 12 months will be the primary outcome, along with difference in Consultation Satisfaction Questionnaire and CollaboRATE scores at 12 months, and proportion and type of healthcare provider intervention/alerts initiated by different PROMs as secondary outcomes. DISCUSSION: This study will determine the feasibility of utilizing PROMs on an interval basis and its effects on the psychological well-being of PwMS. Findings of this study will provide evidence on use of PROMs in future MS clinical practice. TRIAL REGISTRATION: This trial is registered at the National Institutes of Health United States National Library of Medicine, ClinicalTrials.gov NCT04979546 . Registered on July 28, 2021.

Acute kidney injury during cisplatin therapy and associations with kidney outcomes 2 to 6 months post-cisplatin in children: a multi-centre, prospective observational study.

BACKGROUND: Few studies describe acute kidney injury (AKI) burden during paediatric cisplatin therapy and post-cisplatin kidney outcomes. We determined risk factors for and rate of (1) AKI during cisplatin therapy, (2) chronic kidney disease (CKD) and hypertension 2-6 months post-cisplatin, and (3) whether AKI is associated with 2-6-month outcomes. METHODS: This prospective cohort study enrolled children (aged < 18 years at cancer diagnosis) treated with cisplatin from twelve Canadian hospitals. AKI during cisplatin therapy (primary exposure) was defined based on Kidney Disease: Improving Global Outcomes (KDIGO) serum creatinine criteria (≥ stage one). Severe electrolyte abnormalities (secondary exposure) included ≥ grade three hypophosphatemia, hypokalemia, or hypomagnesemia (National Cancer Institute Common Terminology Criteria for Adverse Events v4.0). CKD was albuminuria or decreased kidney function for age (KDIGO guidelines). Hypertension was defined based on the 2017 American Academy of Pediatrics guidelines. RESULTS: Of 159 children (median [interquartile range [IQR]] age: 6 [2-12] years), 73/159 (46%) participants developed AKI and 55/159 (35%) experienced severe electrolyte abnormalities during cisplatin therapy. At median [IQR] 90 [76-110] days post-cisplatin, 53/119 (45%) had CKD and 18/128 (14%) developed hypertension. In multivariable analyses, AKI was not associated with 2-6-month CKD or hypertension. Severe electrolyte abnormalities during cisplatin were associated with having 2-6-month CKD or hypertension (adjusted odds ratio (AdjOR) [95% CI]: 2.65 [1.04-6.74]). Having both AKI and severe electrolyte abnormalities was associated with 2-6-month hypertension (AdjOR [95% CI]: 3.64 [1.05-12.62]). CONCLUSIONS: Severe electrolyte abnormalities were associated with kidney outcomes. Cisplatin dose optimization to reduce toxicity and clear post-cisplatin kidney follow-up guidelines are needed. A higher resolution version of the Graphical abstract is available as Supplementary information.

Barriers to Surgical Intervention and Factors Influencing Motor Outcomes in Patients with Severe Peripheral Nerve Injury: A Province Wide Cohort Study.

INTRODUCTION: Despite the importance of timing of nerve surgery after peripheral nerve injury, optimal timing of intervention has not been clearly delineated. The goal of this study is to explore factors that may have a significant impact on clinical outcomes of severe peripheral nerve injury that requires reconstruction with nerve transfer or graft. MATERIALS AND METHODS: Adult patients who underwent peripheral nerve transfer or grafting in Alberta were reviewed. Clustered multivariable logistic regression analysis was used to examine the association of time to surgery, type of nerve repair, and patient characteristics on strength outcomes. Cox proportional hazard regression analysis model was used to examine factors correlated with increased time to surgery. RESULTS: Of the 163 patients identified, the median time to surgery was 212 days. For every week of delay, the adjusted odds of achieving Medical Research Council strength grade ≥ 3 decreases by 3%. An increase in preinjury comorbidities was associated with longer overall time to surgery (aHR 0.84, 95% CI 0.74-0.95). Referrals made by surgeons were associated with a shorter time to surgery compared to general practitioners (aHR 1.87, 95% CI 1.14-3.06). In patients treated with nerve transfer, the adjusted odds of achieving antigravity strength was 388% compared to nerve grafting; while the adjusted odds decreased by 65% if the injury sustained had a pre-ganglionic injury component. CONCLUSION: Mitigating delays in surgical intervention is crucial to optimizing outcomes. The nature of initial nerve injury and surgical reconstructive techniques are additional important factors that impact postoperative outcomes.

Managing 'sick days' in patients with chronic conditions: An exploration of patient and healthcare provider experiences.

INTRODUCTION: People with chronic medical conditions often take medications that improve long-term outcomes but which can be harmful during acute illness. Guidelines recommend that healthcare providers offer instructions to temporarily stop these medications when patients are sick (i.e., sick days). We describe the experiences of patients managing sick days and of healthcare providers providing sick day guidance to their patients. METHODS: We undertook a qualitative descriptive study. We purposively sampled patients and healthcare providers from across Canada. Adult patients were eligible if they took at least two medications for diabetes, heart disease, high blood pressure and/or kidney disease. Healthcare providers were eligible if they were practising in a community setting with at least 1 year of experience. Data were collected using virtual focus groups and individual phone interviews conducted in English. Team members analyzed transcripts using conventional content analysis. RESULTS: We interviewed 48 participants (20 patients and 28 healthcare providers). Most patients were between 50 and 64 years of age and identified their health status as 'good'. Most healthcare providers were between 45 and 54 years of age and the majority practised as pharmacists in urban areas. We identified three overarching themes that summarize the experiences of patients and healthcare providers, largely suggesting a broad spectrum in approaches to managing sick days: Individualized Communication, Tailored Sick Day Practices, and Variation in Knowledge of Sick Day Practices and Relevant Resources. CONCLUSION: It is important to understand the perspectives of both patients and healthcare providers with respect to the management of sick days. This understanding can be used to improve care and outcomes for people living with chronic conditions during sick days. PATIENT OR PUBLIC CONTRIBUTION: Two patient partners were involved from proposal development to the dissemination of our findings, including manuscript development. Both patient partners took part in team meetings and contributed to team decision-making. Patient partners also participated in data analysis by reviewing codes and theme development. Furthermore, patients living with various chronic conditions and healthcare providers participated in focus groups and individual interviews.

The effect of nurse practitioner (NP-led) care on health-related quality of life in people with multiple sclerosis - a randomized trial.

BACKGROUND: Care for People with Multiple Sclerosis (PwMS) is increasingly complex, requiring innovations in care. Canada has high rates of MS; it is challenging for general neurologists to optimally care for PwMS with busy office practices. The aim of this study was to evaluate the effects of add-on Nurse Practitioner (NP)-led care for PwMS on depression and anxiety (Hospital Anxiety and Depression Scale, HADS), compared to usual care (community neurologist, family physician). METHODS: PwMS followed by community neurologists were randomized to add-on NP-led or Usual care for 6 months. Primary outcome was the change in HADS at 3 months. Secondary outcomes were HADS (6 months), EQ5D, MSIF, CAREQOL-MS, at 3 and 6 months, and Consultant Satisfaction Survey (6 months). RESULTS: We recruited 248 participants; 228 completed the trial (NP-led care arm n = 120, Usual care arm n = 108). There were no significant baseline differences between groups. Study subjects were highly educated (71.05%), working full-time (41.23%), living independently (68.86%), with mean age of 47.32 (11.09), mean EDSS 2.53 (SD 2.06), mean duration since MS diagnosis 12.18 years (SD 8.82) and 85% had relapsing remitting MS. Mean change in HADS depression (3 months) was: -0.41 (SD 2.81) NP-led care group vs 1.11 (2.98) Usual care group p = 0.001, sustained at 6 months; for anxiety, - 0.32 (2.73) NP-led care group vs 0.42 (2.82) Usual care group, p = 0.059. Other secondary outcomes were not significantly different. There was no difference in satisfaction of care in the NP-led care arm (63.83 (5.63)) vs Usual care (62.82 (5.45)), p = 0.194). CONCLUSION: Add-on NP-led care improved depression compared to usual neurologist care and 3 and 6 months in PwMS, and there was no difference in satisfaction with care. Further research is needed to explore how NPs could enrich care provided for PwMS in healthcare settings. TRIAL REGISTRATION: Retrospectively registered on clinicaltrials.gov ( ClinicalTrials.gov Identifier: NCT04388592 , 14/05/2020).

Retroactive application of the EPIS framework to promote future implementation success in community pharmacy clinical interventions.

BACKGROUND: The assessment of the implementation process of a clinical intervention in a community pharmacy setting can reveal useful insights for future implementation efforts. OBJECTIVE: We aimed to examine the implementation of a community pharmacist-led prospective registry and practice tool (RxING, Epidemiology Research Coordinating Center and the University of Alberta) designed to reduce cardiovascular risk among patients with diabetes and to assess how the participating pharmacists could be supported at each of these stages. METHODS: Semistructured interviews were conducted developed using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. The EPIS framework was used to evaluate the implementation of an online, guideline-driven tool (RxING tool) designed to help pharmacists implement and document the care of patients with diabetes by a group of community pharmacies located in Alberta, Canada. RESULTS: In relation to the preparation phase, responses focused more on suitability of the work environments and less on workflow adjustment. With regard to the implementation stage, participants mentioned that often the pharmacy manager or owner received the training to operate the RxING tool, complicating their ability to engage in regular patient recruitment and follow-up. Most pharmacies did not have specific goals relating to patient recruitment and retention. Concerns hindering sustainability of the evidence-based practice centered around the time-consuming online documentation process and patient retention. Finally, innovation factors identified from the pharmacists' responses were related to patient recruitment and streamlining the documentation process. CONCLUSIONS: This study identified 17 key recommendations that should be considered when designing and implementing future community pharmacy-led projects. In particular, providing assistance and training to pharmacies on-site, specific planning for program roll-out, identifying participating staff who have the time to engage with the program, and troubleshooting how to best integrate programs in normal workflow processes are some key recommendations.

Ups and downs of hypertension control in Canada: critical factors and lessons learned.

As the leading risk for death, population control of increased blood pressure represents a major challenge for all countries of the Americas. In the early 1990's, Canada had a hypertension control rate of 13%. The control rate increased to 68% in 2010, accompanied by a sharp decline in cardiovascular disease. The unprecedented improvement in hypertension control started around the year 2000 when a comprehensive program to implement annually updated hypertension treatment recommendations started. The program included a comprehensive monitoring system for hypertension control. After 2011, there was a marked decrease in emphasis on implementation and evaluation and the hypertension control rate declined, driven by a reduction in control in women from 69% to 49%. A coalition of health and scientific organizations formed in 2011 with a priority to develop advocacy positions for dietary policies to prevent and control hypertension. By 2015, the positions were adopted by most federal political parties, but implementation has been slow. This manuscript reviews key success factors and learnings. Some key success factors included having broad representation on the program steering committee, multidisciplinary engagement with substantive primary care involvement, unbiased up to date credible recommendations, development and active adaptation of education resources based on field experience, extensive implementation of primary care resources, annual review of the program and hypertension indicators and developing and emphasizing the few interventions important for hypertension control. Learnings included the need for having strong national and provincial government engagement and support, and retaining primary care organizations and clinicians in the implementation and evaluation.

La hipertensión arterial representa el principal riesgo de muerte; controlarla a nivel de la población constituye un desafío importante para todos los países de la Región de las Américas. A principios de la década de 1990, Canadá presentaba una tasa de control de la hipertensión del 13%. La tasa de control aumentó al 68% en el 2010, lo que vino acompañado por una disminución importante de las enfermedades cardiovasculares. Esta mejora sin precedentes en el control de la hipertensión empezó alrededor del año 2000 cuando se inició un programa integral para aplicar las recomendaciones sobre el tratamiento de la hipertensión, actualizadas anualmente. El programa incluyó un sistema de monitoreo integral para el control de la hipertensión. Después del 2011, hubo una marcada disminución del énfasis en la implementación y la evaluación, y la tasa de control de la hipertensión disminuyó, impulsada por una reducción en el control en las mujeres, que pasó del 69% al 49%. En el 2011, se formó una coalición de organizaciones científicas y de salud con la prioridad de elaborar una campaña de defensa y promoción de las políticas alimentarias para prevenir y controlar la hipertensión. Para el año 2015, esta postura fue adoptada por la mayoría de los partidos políticos federales, aunque la implementación ha sido lenta.En este artículo se revisan los factores clave de éxito y las lecciones aprendidas. Algunos factores clave de éxito fueron tener una amplia representación en el comité directivo del programa; el compromiso multidisciplinario con la participación sustantiva del sector de la atención primaria; unas recomendaciones creíbles, imparciales y actualizadas; el desarrollo y la adaptación activa de recursos educativos basados en la experiencia en el terreno; la amplia implementación de los recursos de la atención primaria; la revisión anual del programa y de los indicadores de hipertensión; y el desarrollo y el énfasis en unas pocas intervenciones importantes para el control de la hipertensión. Entre las lecciones aprendidas se encontró la necesidad de contar con un fuerte compromiso y apoyo del gobierno nacional y provincial, y de mantener a las organizaciones de atención primaria y al personal médico en la implementación y la evaluación.

O controle populacional da hipertensão arterial ­ o maior fator de risco de morte ­ representa um grande desafio para todos os países das Américas. No início da década de 1990, o Canadá tinha uma taxa de controle de hipertensão de 13%. Esse índice aumentou para 68% em 2010, acompanhado por um declínio acentuado das doenças cardiovasculares. A melhoria sem precedentes no controle da hipertensão começou por volta do ano 2000, quando teve início um programa abrangente para implementar recomendações de tratamento de hipertensão atualizadas anualmente. O programa incluía um sistema integral de monitoramento do controle da hipertensão. Após 2011, houve uma acentuada redução da ênfase na implementação e avaliação, e a taxa de controle de hipertensão caiu, principalmente às custas de uma redução deste controle em mulheres (de 69% para 49%). Uma coalizão de organizações científicas e de saúde formou-se em 2011 com a prioridade de desenvolver posições de defesa de políticas alimentares para prevenir e controlar a hipertensão. Até 2015, essas posições haviam sido adotadas pela maioria dos partidos políticos federais, mas a implementação tem sido lenta.Este manuscrito examina fatores-chave de sucesso e aprendizados. Alguns fatores-chave de sucesso incluíram uma ampla representatividade no comitê diretor do programa, engajamento multidisciplinar (com envolvimento significativo da atenção primária), recomendações imparciais e confiáveis, elaboração e adaptação ativa de recursos didáticos com base na experiência de campo, ampla implementação dos recursos da atenção primária, revisão anual do programa e dos indicadores de hipertensão e desenvolvimento e ênfase das poucas intervenções realmente importantes para o controle da hipertensão. As lições aprendidas incluíram a necessidade de ter forte envolvimento e apoio dos governos nacional e subnacionais e manter organizações e médicos da atenção primária engajados na implementação e avaliação.

A Twitter analysis of World Pharmacists Day 2020 images: Sending the wrong messages.

BACKGROUND: Pharmacists are often depicted as dispensers of medication as opposed to health professionals who provide patient care. Our objective was to identify how pharmacists' roles were portrayed in images on Twitter for World Pharmacists Day (WPD) 2020. METHODS: A qualitative content analysis was undertaken to evaluate the images of pharmacists on WPD. Tweets were included that had a photo or image, used 1 of 5 WPD hashtags and were posted between September 24 and 26, 2020. Thematic analysis was performed independently by 2 investigators. Tweets were categorized into 5 groups: 1) drug distribution roles, 2) patient care roles, 3) no described roles, 4) not professional/unprofessional roles and 5) not relevant. Subgroup analysis was performed for the users who posted the tweets. RESULTS: Of the 970 tweets analyzed, only 11% of the overall tweets portrayed the patient care roles of pharmacists, whereas 51% portrayed drug distribution roles and 29% did not describe any particular roles of pharmacists. These proportions were similar between subgroups of tweeters. DISCUSSION: WPD is intended to promote and advocate for the pharmacy profession. The results of our study show poor messaging of pharmacists' roles and reflect a missed opportunity to showcase the full scope of pharmacy practice. CONCLUSION: Based on the images tweeted on WPD 2020, the diversity of pharmacists' practice as skilled health care practitioners was lost in a sea of tweets portraying pharmacists' roles in drug distribution. We hope that pharmacists and pharmacy organizations will awaken to this self-induced problem for WPD 2021. Can Pharm J (Ott) 2021;154(5):xx-xx.

Exploring the impact of pharmacist comprehensive annual care plans on perceived quality of chronic illness care by patients in Alberta, Canada.

BACKGROUND: In 2012, the Government of Alberta introduced a funding program to remunerate pharmacists to develop a comprehensive annual care plan (CACP) for patients with complex needs. The objective of this study is to explore patients' perceptions of the care they received through the pharmacist CACP program in Alberta. METHODS: We invited 3442 patients who received a pharmacist-billed CACP within the previous 3 months and 6888 matched controls across Alberta to complete an online questionnaire. The questionnaire consisted of the short version Patient Assessment of Chronic Illness Care (PACIC-11), with 3 additional pharmacy-specific assessment questions added. Additional questions related to health status and demographics were also included. RESULTS: Overall, most patients indicated a low level of chronic illness care by pharmacists, with few differences noted between CACP patients and non-CACP controls. Of note, controls reported higher quality of care for 5 domains within the adapted PACIC-like tool compared with CACP patients (p < 0.05 for all). Interestingly, only 79 (44%) of CACP patients reported that they had received a CACP, whereas only 192 (66%) of control patients reported that they did not receive a care plan. In a sensitivity analysis including only these respondents, individuals who received a CACP perceived a significantly higher quality of chronic illness care across all PACIC domains. CONCLUSION: Overall, chronic illness care incentivized by the pharmacist CACP program in Alberta is perceived to be moderate to low. When limited to respondents who explicitly recognized receiving the service or not, the perceptions of quality of care were more positive. This suggests that better implementation of CACP by pharmacists may be associated with improved quality of care and that some redesign is needed to engage patients more. Can Pharm J (Ott) 2021;154:xx-xx.

Impact of a "Pharmacist First" innovative workflow plan in patients with hypertension and/or diabetes.

Usual community pharmacy workflow, whereby patients might see a pharmacist at the end of the dispensing process, is not conducive to proactive patient-centred care. The objective of this study was to evaluate the impact of the "Pharmacist First" (P1st) workflow model on blood pressure and glycemic control in patients with hypertension and/or diabetes. This retrospective review was set in 2 community pharmacies that use the P1st model in the Greater Edmonton Region. The population entailed patients with hypertension and/or type 1 or 2 diabetes who received care via the P1st workflow model. The P1st workflow model places the patient in immediate contact with the pharmacist. The pharmacist first assesses prescription appropriateness, reviews relevant laboratory tests, discusses chronic disease control and addresses any questions or concerns the patient has before passing the prescription to be filled by a technician. This allows issues or concerns to be identified and addressed up front, rather than waiting until the prescription is filled and the patient is ready to leave the pharmacy. The primary outcome assessed in this study was change in blood pressure and/or A1C from baseline to the last follow-up visit. We reviewed 215 patient records. The mean age was 69.4 years (standard deviation 12.5), 51.2% of patients were male, 57.7% had hypertension, 5.6% had diabetes, and 36.7% had both. Median follow-up time was 4.2 months (interquartile range 2.5-9.3). In 203 patients with hypertension, systolic blood pressure was reduced from 139.83 mmHg to 131.26 mmHg (p < 0.001) and diastolic blood pressure from 80.26 mmHg to 76.86 mmHg (p < 0.001). In 87 patients with diabetes, A1C changed from 7.4% to 7.2% (p = ns). The P1st workflow model demonstrated significant improvements in blood pressure. Further investigation is needed to evaluate the effectiveness of this model with a control group, longer follow-up and evaluation of the patient experience.

Assessment of the educational competencies for the Hypertension Canada Professional Certification Program (HC-PCP) designed for implementation of hypertension guidelines into primary care.

BACKGROUND: The uptake of clinical practice guidelines into practice is limited for many chronic conditions, including hypertension. The aim of this study was to ascertain the importance of the educational competencies for the development of the Hypertension Canada Professional Certification Program (HC-PCP) among frontline, primary care professionals (e.g., pharmacists, physicians, nurses). METHODS: A group of hypertension experts developed 15 competencies believed to be important for primary care professionals to master when providing hypertension management. These competencies were surveyed for consensus by frontline clinicians through the Hypertension Canada e-newsletter in 2018. Clinicians were asked to rank the importance of each competency for a primary care provider to acquire when undertaking a certification in hypertension management, using a Likert scale from 1 (not important) to 5 (very important). RESULTS: A total of 121 clinicians responded to the survey. Of these, 38% were pharmacists, 31.4% were registered nurses, 10.7% were physicians and 7% were nurse practitioners. There was at least 1 respondent from each Canadian province and territory, except for the Northwest Territories. All 15 competencies received a mean rank of at least 4. The competency with the highest ranking was Competency 6: Ability to screen and identify hypertension (mean 4.83 [0.04]). The competencies with the lowest average ranks were Competency 1: Demonstrates a sound knowledge of the epidemiology of hypertension (mean 4.07 [0.85]) and Competency 5: Demonstrates an understanding of the validation process for blood pressure devices (mean 4.15 [0.08]). CONCLUSIONS: Clinicians generally ranked all 15 competencies to be of high importance for a provider who is certified in hypertension management to possess. These competencies and the current Hypertension Canada guidelines were used as the foundation for the development of an education program called the Hypertension Canada Professional Certification Program. Can Pharm J (Ott) 2021;154:xx-xx.

Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

BACKGROUND: Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. METHODS: Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. RESULTS: Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. CONCLUSIONS: We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. TRIAL REGISTRATION: Trial Registration Number: NCT02579655 - initially registered Oct 19, 2015.

The effect of a pharmacist consultation on pregnant women's quality of life with a special focus on nausea and vomiting: an intervention study.

BACKGROUND: Maternal wellbeing and quality of life (QOL) are increasingly being recognized as important for healthy pregnancies. The aim of this study was to investigate the impact of a pharmacist consultation on pregnant women's QOL focusing on nausea and vomiting in pregnancy (NVP), and patient satisfaction. METHODS: For this intervention study in 14 community pharmacies, women in early pregnancy were recruited and assigned to a pharmacist consultation (intervention) or standard care (control). The consultation aimed to address each woman's concerns regarding medications and pregnancy-related ailments. Data were collected through online questionnaires at baseline (Q1) and during the second trimester (Q2). The intervention group completed an additional satisfaction questionnaire after the consultation was completed. The primary outcome was the impact of the intervention on the Quality of Life Scale (QOLS) scores between the first and second trimesters. The impact of the intervention was assessed by linear regression, and secondary analyses were performed to assess effect modification by NVP. RESULTS: Of the 340 women enrolled in the study, we analyzed data for 245. Half (170/340) of the original participants were allocated to the intervention group, of whom 131 received the pharmacist consultation. Most women (75%, 78/96) reported that the consultation was useful to a large/very large extent. The consultation had no overall impact on QOLS scores between the first and the second trimesters compared with standard care (adjusted ß: 0.7, 95% CI: -2.1, 3.4). The impact of the intervention on QOLS was greater amongst women with moderate/severe NVP (adjusted ß: 3.6, 95% CI: -0.6, 7.7) compared to those with no/mild NVP (adjusted ß: -1.4, 95% CI: -5.1, 2.2) (interaction term study group*NVP severity, p = 0.048). CONCLUSIONS: The pregnant women highly appreciated the pharmacist consultation, but the intervention did not affect their QOL scores compared with standard care. Future studies should further explore the effect of a pharmacist consultation specifically for NVP and on other outcomes such as use of health care services and medication use in pregnancy. TRIAL REGISTRATION: Retrospectively registered in ClinicalTrials.gov (identifier: NCT04182750 , registration date: December 2, 2019).

Exploring patient and pharmacist perspectives on complex interventions for cardiovascular prevention: A qualitative descriptive process evaluation.

BACKGROUND: The Assessing outcomes of enhanced Chronic disease Care through patient Education and a value-baSed formulary Study (ACCESS) is a randomized controlled trial evaluating two interventions targeting barriers to care among those at high risk of cardiovascular disease: copayment elimination for cardioprotective medications, and a tailored self-management support programme. We designed a process evaluation to better understand participant perspectives on the interventions. DESIGN: We used a qualitative descriptive study design, collecting patient and pharmacist feedback via individual semi-structured telephone interviews and in-person focus groups. Data were analysed inductively using thematic analysis. RESULTS: Fifty-three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated. Copayment elimination provided quality of life benefits: minimizing the need to 'cut-back', allowing 'peace of mind' and providing emotional support. Health-related benefits included: improving adherence to covered medications, and helping to afford non-covered goods. The only criticism was that not all medications and testing supplies were covered. Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication. Some participants felt that the educational materials were repetitive, overly medication-focused and not tailored enough. Pharmacists felt that their patients benefitted from both interventions, which improved patient adherence and communication with their patients. CONCLUSION: The success of interventions intended to change behaviour is largely dependent upon participant's feelings that the intervention is helpful. This process evaluation provided insights into participants' perceptions on these interventions. Reception of both was largely positive with a few criticisms noted.

The cirrhosis care Alberta (CCAB) protocol: implementing an evidence-based best practice order set for the management of liver cirrhosis - a hybrid type I effectiveness-implementation trial.

BACKGROUND: Liver cirrhosis is a leading cause of morbidity, premature mortality and acute care utilization in patients with digestive disease. In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, multiple care gaps exist, the most notable stemming from i) the lack of a structured approach to best practice care for cirrhosis complications, ii) the lack of a structured approach to broader health needs and iii) suboptimal preparation for transition of care into the community. Cirrhosis Care Alberta (CCAB) is a 4-year multi-component pragmatic trial which aims to address these gaps. The proposed intervention is initiated at the time of hospitalization through implementation of a clinical information system embedded electronic order set for delivering evidence-based best practices under real-world conditions. The overarching objective of the CCAB trial is to demonstrate effectiveness and implementation feasibility for use of the order set in routine patient care within eight hospital sites in Alberta. METHODS: A mixed methods hybrid type I effectiveness-implementation design will be used to evaluate the effectiveness of the order set intervention. The primary outcome is a reduction in 90-day cumulative length of stay. Implementation outcomes such as reach, adoption, fidelity and maintenance will also be evaluated alongside other patient and service outcomes such as readmission rates, quality of care and cost-effectiveness. This theory-based trial will be guided by Normalization Process Theory, Consolidated Framework on Implementation Research (CFIR) and the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Framework. DISCUSSION: The CCAB project is unique in its breadth, both in the comprehensiveness of the multi-component order set and also for the breadth of its roll-out. Lessons learned will ultimately inform the feasibility and effectiveness of this approach in "real-world" conditions as well as adoption and adaptation of these best practices within the rest of Alberta, other provinces in Canada, and beyond. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04149223, November 4, 2019.

Outcomes of nurse practitioner-led care in patients with cardiovascular disease: A systematic review and meta-analysis.

AIM: To assess randomized controlled trials evaluating the impact of nurse practitioner-led cardiovascular care. BACKGROUND: Systematic review of nurse practitioner-led care in patients with cardiovascular disease has not been completed. DESIGN: Systematic review and meta-analysis. DATA SOURCES: The Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, CINAHL, Web of Science, Scopus and ProQuest were systematically searched for studies published between January 2007 - June 2017. REVIEW METHODS: Cochrane methodology was used for risk of bias, data extraction and meta-analysis. The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Out of 605 articles, five articles met the inclusion criteria. There was no statistical difference between nurse practitioner-led care and usual care for 30-day readmissions, health-related quality of life and length of stay. A 12% reduction in Framingham risk score was identified. CONCLUSION: There are a few randomized control trials assessing nurse practitioner-led cardiovascular care. IMPACT: Low to moderate quality evidence was identified with no statistically significant associated outcomes of care. Nurse practitioner roles need to be supported to conduct and publish high-quality research.

Evaluation of comprehensive annual care plans by pharmacists in Alberta for patients with complex conditions.

OBJECTIVES: To characterize the population of patients who received a pharmacist-billed comprehensive annual care plan (CACP) in Alberta and to evaluate any changes in health care use for such patients, including physician visits, hospitalizations, and emergency department (ED) visits. METHODS: We used administrative data from Alberta Health to identify all individuals in Alberta who received a pharmacist CACP between July 1, 2012, and March 31, 2015. Two control patients were identified for each CACP patient, matched on age, sex, provider, date of service, and qualifying conditions. Controlled interrupted time series analyses were used to evaluate changes in physician visits, all-cause and ambulatory care-sensitive condition (ACSC)-related hospitalizations, and ED visits in the 12 months before and after the CACP index date. RESULTS: Between July 1, 2012, and March 31, 2015, 188,640 pharmacy CACPs were billed in Alberta. Of these, 137,178 CACP patients were matched to 241,658 control patients. Those who received a CACP were associated with an overall decrease in all-cause hospitalizations, ACSC-related ED visits, and physician visits (181, 144, and 1206 events per 10,000 people, respectively, P < 0.05) compared with controls. However, among those who received a CACP, all-cause ED visits and ACSC-related hospitalizations increased by 40.1 and 8 visits per 10,000, respectively (P < 0.05), compared with controls. CONCLUSION: The uptake of the pharmacy CACP remuneration model has been substantial since 2012. Overall, the CACP philosophy of a single yearly assessment has demonstrated limited impact on major health care use.