Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial.

BACKGROUND: Home blood pressure (BP) telemonitoring combined with case management leads to BP reductions in individuals with hypertension. However, its benefits are less clear in older (age ≥ 65 years) adults. METHODS: Twelve-month, open-label, randomized trial of community-dwelling older adults comparing the combination of home BP telemonitoring (HBPM) and pharmacist-led case management, vs. enhanced usual care with HBPM alone. The primary outcome was the proportion achieving systolic BP targets on 24-h ambulatory BP monitoring (ABPM). Changes in HBPM were also examined. Logistic and linear regressions were used for analyses, adjusted for baseline BP. RESULTS: Enrollment was stopped early due to coronavirus disease 2019. Participants randomized to intervention (n = 61) and control (n = 59) groups were mostly female (77%), with mean age 79.5 years. The adjusted odds ratio for ABPM BP target achievement was 1.48 (95% confidence interval 0.87-2.52, P = 0.15). At 12 months, the mean difference in BP changes between intervention and control groups was -1.6/-1.1 for ABPM (P-value 0.26 for systolic BP and 0.10 for diastolic BP), and -4.9/-3.1 for HBPM (P-value 0.04 for systolic BP and 0.01 for diastolic BP), favoring the intervention. Intervention group participants had hypotension (systolic BP < 110) more frequently (21% vs. 5%, P = 0.009), but no differences in orthostatic symptoms, syncope, non-mechanical falls, or emergency department visits. CONCLUSIONS: Home BP telemonitoring and pharmacist case management did not improve achievement of target range ambulatory BP, but did reduce home BP. It did not result in major adverse consequences.

Telemonitoring and Case Management for Hypertensive and Remote-Dwelling Patients With Chronic Kidney Disease-The Telemonitoring for Improved Kidney Outcomes Study (TIKO): A Clinical Research Protocol.

BACKGROUND: Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. OBJECTIVE: The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed. DESIGN: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care. SETTING: Peace River region in Northern Alberta Region, Canada. PATIENTS: Primary care patients with CKD and hypertension. MEASUREMENTS: Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP [SBP]: <130 mmHg) are achieved. Once BP is controlled, (ie, to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol; however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits. LIMITATIONS: Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate. CONCLUSIONS: As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT number: NCT04098354).

CONTEXTE: L'hypertension et la pression artérielle (PA) mal contrôlée sont des facteurs de risque reconnus pour la néphropathie et la progression vers l'insuffisance rénale, en plus de poser un risque accru de morbidité et de mortalité cardiovasculaires. Plusieurs études chez des patients sans néphropathie ont démontré l'efficacité de la télésurveillance de la PA à domicile (TSPA) pour le contrôle de la PA. OBJECTIFS: Le principal objectif est d'évaluer la différence moyenne de pression artérielle systolique (PAS) après 12 mois par rapport à sa valeur initiale chez des patients atteints d'hypertension et d'insuffisance rénale chronique (IRC) habitant les communautés éloignées du nord de l'Alberta (Canada). Cet objectif sera atteint en comparant la TSPA + soins habituels à la TSPA + gestionnaire de cas. D'autres objectifs secondaires, notamment le rapport coût/efficacité de la TSPA, son acceptation et la survenue d'événements indésirables seront également évalués. TYPE D'ÉTUDE: Cette étude est conçue comme un essai randomisé contrôlé (ERC) pragmatique comparant la TSPA + prise en charge clinique des cas à la TSPA + soins habituels. CADRE: Région de Peace River dans le nord de l'Alberta (Canada). SUJETS: Patients atteints d'IRC et d'hypertension recevant des soins de santé primaires. MESURES: Les patients admissibles seront répartis 1:1 dans le groupe TSPA + prise en charge du cas d'hypertension ou dans le groupe témoin (TSPA + soins habituels). Dans le groupe d'intervention, la PA sera mesurée quatre fois par jour pendant une semaine, avec augmentation ou réduction de la médication par le gestionnaire de cas de l'étude jusqu'à ce que la cible de référence (PAS : <130 mmHg) soit atteinte. Une fois la PA contrôlée (c.-à-d. conforme aux cibles recommandées), ce protocole sur une semaine sera répété tous les trois mois pendant un an. Les patients du groupe témoin suivront le même protocole de mesure de la PA, mais sans interactions avec le gestionnaire de cas, ils transmettront plutôt leurs mesures de PA à leur médecin de soins primaires ou aux infirmières praticiennes lors de visites prévues. LIMITES: Cette étude est notamment limitée par la durée relativement courte du suivi, de possibles difficultés technologiques et la nécessité pour les participants de posséder un téléphone intelligent et d'avoir accès à l'Internet. CONCLUSION: Puisque cette étude se penchera sur une population à risque élevé et marquée par d'importantes lacunes en matière de soins, elle générera des données importantes qui aideront à mettre en œuvre des stratégies ciblées et efficaces au niveau de la population afin d'améliorer les évènements cliniques des patients hypertendus et atteints d'IRC à haut risque habitant les communautés éloignées au Canada.

A Randomized Trial of Video-based Education in Patients With Heart Failure: The Congestive Heart Failure Outreach Program of Education (COPE).

BACKGROUND: Heart failure (HF) exacerbations often relate to poor self-care. Education programs improve outcomes, but are resource-intensive. We developed a video-based educational intervention and evaluated it in patients with HF. METHODS: Congestive Heart Failure Outreach Program of Education was a pragmatic multicenter randomized trial. We included subjects with HF if they were hospitalized, seen in the emergency department (ED), or high-risk outpatients, and randomized them to intervention or control. Intervention included a 20-minute video, supplementary booklet, and 3 bimonthly newsletters focusing on salt and fluid restriction, daily weights, and medications. Subjects watched the video and were encouraged to review it at home, along with the booklet/newsletters. Control subjects received the booklet only. The primary outcome was the difference in cardiovascular hospitalizations or ED visits between groups at 6 months. Secondary outcomes included clinical events and in-hospital days. RESULTS: We recruited 539 subjects from 22 centers in Canada and the United States. Baseline characteristics were similar in both groups: 64% were male and had a mean age of 66 (± 13) years, mean ejection fraction 31% (± 13.5), and 65% New York Heart Association Functional Classification III/IV. The primary outcome occurred in 57 subjects (21%) in the intervention group compared with 61 subjects (23%) in the control group (P = 0.66). There were no significant differences in prespecified secondary outcomes; however, death occurred in 18 subjects (7%) in the intervention group and 33 subjects (12%) in the control group (P = 0.03). CONCLUSION: Video education on self-care did not reduce hospitalizations or ED visits in patients with HF. Of note, mortality was lower in the intervention group.

INTRODUCTION: L'exacerbation de l'insuffisance cardiaque (IC) est souvent liée à une mauvaise prise en charge autonome des soins. Les programmes d'enseignement améliorent les résultats cliniques, mais exigent beaucoup de ressources. Nous avons conçu une intervention éducative par vidéo et l'avons évaluée auprès de patients atteints d'IC. MÉTHODES: Le Congestive Heart Failure Outreach Program of Education était une étude pragmatique multicentrique à répartition aléatoire. Nous avons sélectionné les sujets atteints d'IC s'ils étaient hospitalisés, vus au service des urgences (SU) ou patients en consultation externe exposés à un risque élevé, et les avons répartis de manière aléatoire au groupe d'intervention ou au groupe témoin. L'intervention a consisté en une vidéo de 20 minutes, un livret supplémentaire et 3 bulletins bimensuels portant sur la restriction du sel et des liquides, les mesures quotidiennes du poids et les médicaments. Après que les sujets eurent regardé la vidéo, nous les avons encouragés à la revoir à la maison, en plus de lire le livret et les bulletins. Les sujets témoins ont reçu seulement le livret. Le critère de jugement principal était la différence dans les hospitalisations en raison d'une maladie cardiovasculaire ou les visites au SU entre les groupes après 6 mois. Les critères de jugement secondaires étaient les événements cliniques et les jours d'hospitalisation. RÉSULTATS: Nous avons recruté 539 sujets de 22 centres au Canada et aux États-Unis. Les caractéristiques initiales étaient similaires dans les 2 groupes : 64 % étaient des hommes et avaient un âge moyen de 66 ans (± 13), une fraction d'éjection moyenne de 31 % (± 13,5), et 65 % avaient une classification fonctionnelle III/IV de la New York Heart Association. Le critère de jugement principal est survenu chez 57 sujets (21 %) dans le groupe d'intervention et chez 61 sujets (23 %) dans le groupe témoin (P = 0,66). Il n'y a eu aucune différence significative dans les critères secondaires prédéfinis. Toutefois, 18 sujets (7 %) du groupe d'intervention et 33 sujets (12 %) du groupe témoin sont morts (P = 0,03). CONCLUSION: L'enseignement sur les autosoins par vidéo n'a pas réduit les hospitalisations ou les visites au SU des patients atteints d'IC. Notamment, la mortalité a été plus faible dans le groupe d'intervention.

Usability and Acceptability of a Home Blood Pressure Telemonitoring Device Among Community-Dwelling Senior Citizens With Hypertension: Qualitative Study.

BACKGROUND: Hypertension is a major cause of cardiovascular disease in older individuals. To ensure that blood pressure (BP) levels are within the optimal range, accurate BP monitoring is required. Contemporary hypertension clinical practice guidelines strongly endorse the use of home BP measurement as a preferred method of BP monitoring for individuals with hypertension. The benefits of home BP monitoring may be optimized when measurements are telemonitored to care providers; however, this may be challenging for older individuals with less technological capabilities. OBJECTIVE: The objective of this qualitative study was to examine the usability and acceptability of a home BP telemonitoring device among senior citizens. METHODS: We conducted a qualitative descriptive study. Following a 1-week period of device use, individual, semistructured interviews were conducted. Interview audio recordings were anonymized, de-identified, and transcribed verbatim. We performed thematic analysis on interview transcripts. RESULTS: Seven senior citizens participated in the usability testing of the home BP telemonitoring device. Participants comprised females (n=4) and males (n=3) with a mean age of 86 years (range, 70-95 years). Overall, eight main themes were identified from the interviews: (1) positive features of the device; (2) difficulties or problems with the device; (3) device was simple to use; (4) comments about wireless capability and components; (5) would recommend device to someone else; (6) would use device in future; (7) suggestions for improving the device; and (8) assistance to use device. Additional subthemes were also identified. CONCLUSIONS: Overall, the home BP telemonitoring device had very good usability and acceptability among community-dwelling senior citizens with hypertension. To enhance its long-term use, few improvements were noted that may mitigate some of the relatively minor challenges encountered by the target population.

The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: principal results.

BACKGROUND: In Canada, demand for multidisciplinary bariatric (obesity) care far outstrips capacity. Consequently, prolonged wait times exist that contribute to substantial health impairments. A supportive, educational, self-management intervention (with in-person and web-based versions) for patients wait-listed for bariatric care has already been implemented in Northern and Central Alberta, Canada, but its effectiveness is unknown. The objective of this trial is to evaluate the clinical and economic outcomes of two self-management programs of varying intensity that are currently in use. METHODS: We conducted a pragmatic, prospective, parallel-arm, randomized controlled trial of 651 wait-listed patients from two regional bariatric programs. Patients were randomized to (1) an in-person, group-based intervention (13 sessions; n = 215) or (2) a web-based intervention (13 modules; n = 225) or (3) control group (printed educational materials; n = 211). After randomization, subjects had 3 months to review the content assigned to them (the intervention period) prior to bariatric clinic entry. The primary outcome was the proportion of patients achieving 5% weight loss at 9 months. Intention-to-treat two-way comparisons were performed and adjusted for baseline age, sex, site and body mass index. RESULTS: At baseline, mean age was 40.4 ± 9.8 years, mean weight was 134.7 ± 25.2 kg, mean body mass index was 47.7 ± 7.0 kg/m2 and 83% of participants were female. A total of 463 patients (71%) completed 9 months follow-up. At least 5% weight loss was achieved by 24.2% of those in the in-person strategy, 24.9% for the web-based strategy and 21.3% for controls (adjusted p value = 0.26 for in-person vs. controls, 0.28 for web-based vs. controls, 0.96 for in-person vs. web-based). Absolute and relative (% of baseline) mean weight reductions were 3.7 ± 7.1 kg (2.7 ± 5.4%) for in-person strategy, 2.8 ± 6.7 kg (2.0 ± 4.8%) for web-based and 2.9 ± 8.8 kg (1.9 ± 5.9%) for controls (p > 0.05 for all comparisons). No between-group differences were apparent for any clinical or humanistic secondary outcomes. Total annual costs in Canadian dollars were estimated at $477,000.00 for the in-person strategy, $9456.78 for the web-based strategy and $2270.31 for provision of printed materials. DISCUSSION: Two different self-management interventions were no more effective and were more costly than providing printed education materials to severely obese patients. Our findings underscore the need to develop more potent interventions and the importance of comprehensively evaluating self-management strategies before widespread implementation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01860131 . Registered 17 May 2013.

Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.

BACKGROUND: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. OBJECTIVE: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension. METHODS: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. RESULTS: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. CONCLUSION: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. TRIAL REGISTRATION: Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).

Medication Discrepancies Associated With a Medication Reconciliation Program and Clinical Outcomes After Hospital Discharge.

STUDY OBJECTIVE: To identify the frequency of unintended medication discrepancies 30 days postdischarge from medicine wards with interprofessional medication reconciliation processes and clinical import. METHODS: Prospective cohort study of adults discharged between October 2013 and November 2014 from two teaching hospitals in Edmonton, Canada. The Best Possible Medication Discharge Plan (BPMDP) was prepared for all patients. Patients were called 30 days postdischarge to determine the medication discrepancy rate from the BPMDP and whether this was intentional or unintentional; three clinicians used standardized criteria to determine if the discrepancy was inconsequential. Electronic health records and patient contact were used to ascertain death, hospital readmissions, and emergency department (ED) visits at 90 days. RESULTS: Of 433 patients (mean age 64 yrs, 52% female, median discharge prescriptions 6 [interquartile range 4-9]), 168 (38.8%) had at least one unintentional medication discrepancy at 30 days (325 total discrepancies; median one [interquartile range 1-2 discrepancies per patient]). Patients with unintentional medication discrepancies were older (65.9 vs 61.9 yrs, p=0.03) with more discharge medications (7 vs 6, p=0.03). Most unintentional discrepancies (91.1%) were judged inconsequential. The presence of an unintentional medication discrepancy was not associated with 90-day readmission or death (42/167 [25.1%] vs 64/263 [24.3%], adjusted odds ratio 0.96 [95% confidence interval 0.60-1.54]) or ED visits (69 [41.3%] vs 101 [38.4%], adjusted odds ratio 1.11 [95% confidence interval 0.74-1.67]. CONCLUSION: Despite the presence of an interprofessional medication reconciliation process, over one-third of patients had a medication discrepancy within 30 days of discharge, although most were inconsequential and there was no association between unintended medication discrepancies and risk of readmission, ED visit, or death 3 months after discharge.

Patient-Reported Discharge Readiness and 30-Day Risk of Readmission or Death: A Prospective Cohort Study.

BACKGROUND: Early readmissions to hospital after discharge are common, and clinicians cannot accurately predict their occurrence. We examined whether patients who feel unready at the time of discharge have increased readmissions or death within 30 days. METHODS: This was a prospective cohort study of adult patients discharged home from 2 tertiary care hospitals in Edmonton, Alberta, Canada, between October 2013 and November 2014. Patient-reported discharge readiness was measured with an 11-point Likert response scale, with scores <7 indicating subjective unreadiness. The primary outcome was readmission or death within 30 days. Logistic regression models were adjusted for age, sex, and a validated risk prediction score for postdischarge events (LACE index). RESULTS: Of 495 patients (mean age 62 years, 51% female, mean Charlson comorbidity index 2.8), 112 (23%) reported being unready for discharge. Risk factors for being unready at discharge were cognitive impairment (mild vs none), low satisfaction with health care services, depression, lower education, previous hospital admissions (12 months), and persistent symptoms or disability. At 30 days, 85 patients (17%) had been readmitted or died, with no significant difference between patients who felt unready or ready (15% vs 18%, adjusted odds ratio 0.84, 95% confidence interval 0.46-1.54, P = .59). CONCLUSIONS: Although nearly one-quarter of hospitalized medical patients reported being unready at the time of discharge, they did not experience any higher risk of readmission or death in the first 30 days after discharge, compared with patients who felt ready for discharge.

Association between frailty and 30-day outcomes after discharge from hospital.

BACKGROUND: Readmissions after hospital discharge are common and costly, but prediction models are poor at identifying patients at high risk of readmission. We evaluated the impact of frailty on readmission or death within 30 days after discharge from general internal medicine wards. METHODS: We prospectively enrolled patients discharged from 7 medical wards at 2 teaching hospitals in Edmonton. Frailty was defined by means of the previously validated Clinical Frailty Scale. The primary outcome was the composite of readmission or death within 30 days after discharge. RESULTS: Of the 495 patients included in the study, 162 (33%) met the definition of frailty: 91 (18%) had mild, 60 (12%) had moderate, and 11 (2%) had severe frailty. Frail patients were older, had more comorbidities, lower quality of life, and higher LACE scores at discharge than those who were not frail. The composite of 30-day readmission or death was higher among frail than among nonfrail patients (39 [24.1%] v. 46 [13.8%]). Although frailty added additional prognostic information to predictive models that included age, sex and LACE score, only moderate to severe frailty (31.0% event rate) was an independent risk factor for readmission or death (adjusted odds ratio 2.19, 95% confidence interval 1.12-4.24). INTERPRETATION: Frailty was common and associated with a substantially increased risk of early readmission or death after discharge from medical wards. The Clinical Frailty Scale could be useful in identifying high-risk patients being discharged from general internal medicine wards.

Case management reduces global vascular risk after stroke: secondary results from the The preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial.

BACKGROUND: Survivors of ischemic stroke/transient ischemic attack (TIA) are at high risk for other vascular events. We evaluated the impact of 2 types of case management (hard touch with pharmacist or soft touch with nurse) added to usual care on global vascular risk. METHODS: This is a prespecified secondary analysis of a 6-month trial conducted in outpatients with recent stroke/TIA who received usual care and were randomized to additional monthly visits with either nurse case managers (who counseled patients, monitored risk factors, and communicated results to primary care physicians) or pharmacist case managers (who were also able to independently prescribe according to treatment algorithms). The Framingham Risk Score [FRS]) and the Cardiovascular Disease Life Expectancy Model (CDLEM) were used to estimate 10-year risk of any vascular event at baseline, 6 months (trial conclusion), and 12 months (6 months after last trial visit). RESULTS: Mean age of the 275 evaluable patients was 67.6 years. Both study arms were well balanced at baseline and exhibited reductions in absolute global vascular risk estimates at 6 months: median 4.8% (Interquartile range (IQR) 0.3%-11.3%) for the pharmacist arm versus 5.1% (IQR 1.9%-12.5%) for the nurse arm on the FRS (P = .44 between arms) and median 10.0% (0.1%-31.6%) versus 12.5% (2.1%-30.5%) on the CDLEM (P = .37). These reductions persisted at 12 months: median 6.4% (1.2%-11.6%) versus 5.5% (2.0%-12.0%) for the FRS (P = .83) and median 8.4% (0.1%-28.3%) versus 13.1% (1.6%-31.6%) on the CDLEM (P = .20). CONCLUSIONS: Case management by nonphysician providers is associated with improved global vascular risk in patients with recent stroke/TIA. Reductions achieved during the active phase of the trial persisted after trial conclusion.

Cholesterol end points predict outcome in patients with coronary disease: quality improvement metrics from the enhancing secondary prevention in coronary artery disease (ESP-CAD) trial.

BACKGROUND: Achievement of target low-density lipoprotein (LDL) levels for secondary prevention is endorsed in Canadian guidelines but has been de-emphasized in the 2013 American College of Cardiology/American Heart Association coronary artery disease (CAD) guidelines in favor of initiation of statins or triple therapy (antiplatelet agent, angiotensin converting enzyme inhibitor/angiotensin II receptor blocker, and statins). Our objective was to determine which of these 3 process-of-care metrics achieved within 6 months would be associated with 5-year rates of death, myocardial infarction, or stroke and thus be suitable as an end point for quality improvement studies in patients with CAD. METHODS: This was a cohort study that followed 448 participants for 5 years after their involvement in a 6-month secondary prevention trial. RESULTS: Over 5 years, 37 patients died, 23 had myocardial infarction, and 20 had stroke. Six months after randomization, 125 (27.9%) had achieved the LDL target (≤ 2.0 mmol/L), 399 (89.1%) received statins, and 256 (57.1%) received triple therapy. The 5-year composite event rate was significantly lower in patients who achieved the LDL target during the 6-month trial than in those who did not (8.8% vs 17.3%; adjusted hazard ratio [aHR], 0.52; 95% confidence interval [CI], 0.27-0.99), even accounting for statin use (adjusted P = 0.038). Conversely, 5-year event rates were not lower in patients taking statins at 6 months compared with those who were not (14.8% vs 16.3%; aHR, 1.23; 95% CI, 0.58-2.61) or in those receiving triple therapy and those who were not (14.5% vs 15.6%; aHR, 1.17; 95% CI, 0.71-1.94). CONCLUSIONS: Achievement of LDL targets at 6 months is suitable as a metric for CAD quality-improvement studies; medication use alone was not independently associated with longer term outcomes.

Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial.

BACKGROUND: Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care. METHODS: We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention). RESULTS: Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03). INTERPRETATION: Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT00931788.

The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: rationale and design.

BACKGROUND: In Canada, demand for multidisciplinary bariatric (obesity) care far outstrips capacity. Consequently, prolonged wait times exist and contribute to substantial health impairments.A supportive, educational intervention (with in-person and web-based versions) designed to enhance the self-management skills of patients wait-listed for multidisciplinary bariatric medical and surgical care has been variably implemented across Alberta, Canada. However, its effectiveness has not been evaluated. Our objectives were: 1. To determine if this program improves clinical and humanistic outcomes and is cost-effective compared to a control intervention; and 2. To compare the effectiveness and cost-effectiveness of in-person group-based versus web-based care. We hypothesize that both the web-based and in-person programs will reduce body weight and improve outcomes compared to the control group. Furthermore, we hypothesize that the in-person version will be more effective but more costly than the web-based version. METHODS/DESIGN: This pragmatic, prospective controlled trial will enrol 660 wait-listed subjects (220 per study arm) from regional bariatric programs in Alberta and randomly assign them to: 1. an in-person, group-based intervention (9 modules delivered over 10 sessions); 2. a web-based intervention (13 modules); and 3. controls who will receive mailed literature. Subjects will have three months to review the content assigned to them (the intervention period) after which they will immediately enter the weight management clinic. Data will be collected at baseline and every 3 months for 9 months (study end), including: 1. Clinical [5% weight loss responders (primary outcome), absolute and % weight losses, changes in obesity-related comorbidities]; 2. Humanistic (health related quality of life, patient satisfaction, depression, and self-efficacy); and 3. Economic (incremental costs and utilities and cost per change in BMI assessed from the third party health care payor perspective) outcomes. Covariate-adjusted baseline-to-nine-month change-scores will be compared between groups for each outcome using linear regression for continuous outcomes and logistic regression for dichotomous ones. DISCUSSION: Our findings will determine whether this intervention is effective and cost-effective compared to controls and if online or in-person care delivery is preferred. This information will be useful for clinicians, health-service providers and policy makers and should be generalizable to similar publically-funded bariatric care programs. TRIAL REGISTRATION: Trial Identifier: NCT01860131.

The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788].

BACKGROUND: Survivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes. METHODS: We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP) > 140 mm Hg) or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L) and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L) at six months compared to baseline; 12-month data will also be collected for analyses of sustainability of any effects. A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected. CONCLUSIONS: Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial) implications will be enormous.

The Enhancing Secondary Prevention in Coronary Artery Disease trial.

BACKGROUND: Proven efficacious therapies are sometimes underused in patients with chronic cardiac conditions, resulting in suboptimal outcomes. We evaluated whether evidence summaries, which were either unsigned or signed by local opinion leaders, improved the quality of secondary prevention care delivered by primary care physicians of patients with coronary artery disease. METHODS: We performed a randomized trial, clustered at the level of the primary care physician, with 3 study arms: control, unsigned statements or opinion leader statements. The statements were faxed to primary care physicians of adults with coronary artery disease at the time of elective cardiac catheterization. The primary outcome was improvement in statin management (initiation or dose increase) 6 months after catheterization. RESULTS: We enrolled 480 adults from 252 practices. Although statin use was high at baseline (n=316 [66%]), most patients were taking a low dose (mean 32% of the guideline-recommended dose), and their low-density lipoprotein (LDL) cholesterol levels were elevated (mean 3.09 mmol/L). Six months after catheterization, statin management had improved in 79 of 157 patients (50%) in the control arm, 85 of 158 (54%) patients in the unsigned statement group (adjusted odds ratio [OR] 1.18, 95% CI 0.71-1.94, p=0.52) and 99 of 165 (60%) patients in the opinion leader statement group (adjusted OR 1.51, 95% CI 0.94-2.42, p=0.09). The mean fasting LDL cholesterol levels after 6 months were similar in all 3 study arms: 2.35 (standard deviation [SD] 0.86) mmol/L in the control arm compared with 2.24 (SD 0.73) among those in the opinion leader group (p=0.48) and 2.19 (SD 0.68) in the unsigned statement group (p=0.32). INTERPRETATION: Faxed evidence reminders for primary care physicians, even when endorsed by local opinion leaders, were insufficient to optimize the quality of care for adults with coronary artery disease. ClinicalTrials.gov trial register no. NCT00175240.

A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240].

BACKGROUND: Although numerous therapies have been shown to be beneficial in the prevention of myocardial infarction and/or death in patients with coronary disease, these therapies are under-used and this gap contributes to sub-optimal patient outcomes. To increase the uptake of proven efficacious therapies in patients with coronary disease, we designed a multifaceted quality improvement intervention employing patient-specific reminders delivered at the point-of-care, with one-page treatment guidelines endorsed by local opinion leaders ("Local Opinion Leader Statement"). This trial is designed to evaluate the impact of these Local Opinion Leader Statements on the practices of primary care physicians caring for patients with coronary disease. In order to isolate the effects of the messenger (the local opinion leader) from the message, we will also test an identical quality improvement intervention that is not signed by a local opinion leader ("Unsigned Evidence Statement") in this trial. METHODS: Randomized trial testing three different interventions in patients with coronary disease: (1) usual care versus (2) Local Opinion Leader Statement versus (3) Unsigned Evidence Statement. Patients diagnosed with coronary artery disease after cardiac catheterization (but without acute coronary syndromes) will be randomly allocated to one of the three interventions by cluster randomization (at the level of their primary care physician), if they are not on optimal statin therapy at baseline. The primary outcome is the proportion of patients demonstrating improvement in their statin management in the first six months post-catheterization. Secondary outcomes include examinations of the use of ACE inhibitors, anti-platelet agents, beta-blockers, non-statin lipid lowering drugs, and provision of smoking cessation advice in the first six months post-catheterization in the three treatment arms. Although randomization will be clustered at the level of the primary care physician, the design effect is anticipated to be negligible and the unit of analysis will be the patient. DISCUSSION: If either the Local Opinion Leader Statement or the Unsigned Evidence Statement improves secondary prevention in patients with coronary disease, they can be easily modified and applied in other communities and for other target conditions.

Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial.

BACKGROUND: Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF. METHODS: We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations. RESULTS: The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months). INTERPRETATION: There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist.

A multicenter disease management program for hospitalized patients with heart failure.

BACKGROUND: Despite the availability of proven therapies, outcomes in patients with heart failure (HF) remain poor. In this 2-stage, multicenter trial, we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF. METHODS AND RESULTS: In Stage 1, a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme (ACE) inhibitors and other HF medications. Before discharge (Stage 2), patients were randomized to a patient support program (PSP) (education about HF, self-monitoring, adherence aids, newsletters, telephone hotline, and follow-up at 2 weeks, then monthly for 6 months after discharge) or usual care. In Stage 1 (766 patients) ACE inhibitor use increased from 58% on admission to 83% at discharge (P < .0001), and the daily dose (in enalapril equivalents) increased from 11.3 +/- 8.8 mg to 14.5 +/- 8.8 mg (P < .0001). In Stage 2 (276 patients) there was no difference in ACE inhibitor adherence, but a reduction in cardiovascular-related emergency room visits (49 versus 20, P = .030), hospitalization days (812 versus 341, P = .003), and cost of care (2,531 Canadian dollars less per patient) in favor of the PSP. CONCLUSION: Simple interventions can improve ACE inhibitor use and patient outcomes.

A randomized trial to assess the impact of an antithrombotic decision aid in patients with nonvalvular atrial fibrillation: the DAAFI trial protocol [ISRCTN14429643].

BACKGROUND: Decision aids are often advocated as a means to assist patient and health care provider decision making when faced with complicated treatment or screening decisions. Despite an exponential growth in the availability of decision aids in recent years, their impact on long-term treatment decisions and patient adherence is uncertain due to a paucity of rigorous studies. The choice of antithrombotic therapy for nonvalvular atrial fibrillation (NVAF) is one condition for which a trade-off exists between the potential risks and benefits of competing therapies, and the need to involve patients in decision making has been clearly identified. This study will evaluate whether an evidence-based patient decision aid for patients with NVAF can improve the appropriateness of antithrombotic therapy use by patients and their family physicians. DESIGN: A multi-center, two-armed cluster randomized trial based in community family practices in which patients with NVAF will be randomized to decision aid or usual care. Patients will receive one of four decision aids depending on their baseline stroke risk. The primary outcome is the provision of "appropriate antithrombotic therapy" at 3 months to study participants (appropriateness defined as per the 2001 American College of Chest Physicians recommendations for NVAF). In addition, the impact of this decision aid on patient knowledge, decisional conflict, well-being, and adherence will be assessed after 3 months, 6 months, and 12 months.