Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.
ABSTRACT: Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.
Project description:Objective: We evaluated the effect on long term blood pressure (BP) of an interprofessional team-based care (TBC) intervention, involving nurses, pharmacists, and physicians, compared to usual care. Methods: We conducted a pragmatic randomized controlled study in ambulatory clinics and community pharmacies in Switzerland (ClinicalTrials.gov: NCT02511093). Uncontrolled treated hypertensive patients were randomized to TBC or usual care (UC). In the TBC group, nurses and pharmacists met patients every 6 weeks to measure BP, assess lifestyle, support medication adherence, and provide health education for 6 months. After each visit, they wrote a report to the physician who could adjust antihypertensive therapy. The outcome was the intention-to-treat difference in mean daytime ambulatory blood pressure measurement (ABPM) and control (<135/85 mmHg) at 6 and 12 months. Results: Eighty-nine patients (60 men/29 women; mean (SD) age: 61(12) year) were randomized to TBC (n = 43) or UC (n = 46). At baseline, mean (SD) BP was 144(10)/90(8) mmHg and 147(12)/87(11) mmHg in the TBC and UC groups. At 6 months, the between-groups difference in daytime systolic ABPM was−3 mmHg [95% confidence interval (CI):−10 to +4; p = 0.45]; at 12 months, this difference was−7 mmHg [95% CI:−13 to−2; p = 0.01]. At 6 months, the between-groups difference in daytime diastolic ABPM was +2 mmHg [95% CI:−1 to +6; p = 0.20]; at 12 months, this difference was−2 mmHg [95% CI:−5 to +2; 0.42]. Upon adjustment for baseline covariates including baseline BP, the between-groups differences at 6 and 12 months were maintained. At 6 months, there was no difference in BP control. At 12 months, the TBC group tended to have a better control in systolic BP (p = 0.07) but not in diastolic BP (p = 0.33). Conclusion: While there was not significant effect on BP at 6 months of follow-up, the TBC intervention can help decrease long-term systolic BP among uncontrolled hypertensive patients.
Project description:Pharmacist- or nurse-led team care decreases patient blood pressure (BP) and cardiovascular disease (CVD) risk.To evaluate whether a Web-based dietitian-led (WD) team care intervention was feasible and resulted in decreased BP, CVD risk, and weight compared to usual care (UC).Electronic health record (EHR) data identified patients aged 30-69 years with BMI >26, elevated BP, and 10%-25% 10-year Framingham CVD risk who were registered patient website users. Patients with uncontrolled BP at screening were randomized to UC or WD, which included a home BP monitor, scale, and dietitian team care. WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk. Planned follow-up occurred via secure messaging to report BP, weight, and fruit and vegetable intake and receive ongoing feedback. If needed, dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications. Primary outcomes were change in systolic BP and weight loss ?4 kg at 6 months. Feasibility outcomes included intervention utilization and satisfaction.Between 2010 and 2011, a total of 90 of 101 participants completed 6-month follow-ups. The WD group had higher rates of secure messaging utilization and patient satisfaction. The WD group lost significantly more weight than the UC group (adjusted net difference=-3.2 kg, 95% CI=-5.0, -1.5, p<0.001) and was more likely to lose ?4 kg (adjusted relative risk [RRadj]=2.96, 95% CI=1.16, 7.53). BP control and CVD risk reduction were greater in WD than UC, but differences were not statistically significant.WD intervention was feasible and resulted in decreased weight, BP, and CVD risk. A larger trial is justified.Trial Registration Number: NCT01077388.
Project description:<h4>Background</h4>Team-based care is the strategy that has had the greatest effect on improving blood pressure (BP). The purpose of this systematic review was to determine the potency of interventions for BP involving nurses or pharmacists.<h4>Methods</h4>A MEDLINE search for controlled clinical trials that involved a nurse or pharmacist intervention was conducted. Mean reductions in systolic (S) and diastolic (D) BP were determined by 2 reviewers who independently abstracted data and classified the different intervention components.<h4>Results</h4>Thirty-seven articles met the inclusion criteria. Education about BP medications was significantly associated with a reduction in mean BP (-8.75/-3.60 mm Hg). Other strategies that had large effect sizes on SBP include pharmacist treatment recommendations (-9.30 mm Hg), intervention by nurses (-4.80 mm Hg), and use of a treatment algorithm (-4.00 mm Hg). The odds ratios (95% confidence intervals) for controlled BP were: nurses, 1.69 (1.48-1.93); pharmacists within primary care clinics, 2.17 (1.75-2.68); and community pharmacists, 2.89 (1.83-4.55). Mean (SD) reductions in SBP were: nursing studies, 5.84 (8.05) mm Hg; pharmacists in clinics, 7.76 (7.81) mm Hg; and community pharmacists, 9.31 (5.00) mm Hg. There were no significant differences between the nursing and pharmacy studies (P > or = .19).<h4>Conclusions</h4>Team-based care was associated with improved BP control, and individual components of the intervention appeared to predict potency. Implementation of new hypertension guidelines should consider changes in health care organizational structure to include important components of team-based care.
Project description:<h4>Background</h4>Pharmacist participation in chronic disease management benefits patients in many ambulatory settings. We explored the attitudes and perceptions among multidisciplinary members of a rheumatology team towards the skills and responsibilities of a pharmacist joining their practice.<h4>Methods</h4>The physicians, nurse, physiotherapist and staff of a rheumatology clinic were invited to participate in focus group and semistructured interviews. Practice members also completed an inventory of perceived health professional roles in the medication use process.<h4>Results</h4>Discussions with 2 physicians, a nurse, physiotherapist and 1 office administrator were conducted. Concepts related to 3 key themes included positively viewed pharmacist roles broadly related to activities that encompass provision of medication-related services for the patients, the providers and the practice. Examples of such care included educational tasks related to therapies (rheumatological and otherwise) and maintenance of accurate drug histories. These findings were reflected in high scores for perceived pharmacist roles in education and medication review responsibilities using the Medication Use Processes Matrix instrument. Most members were not comfortable with pharmacists conducting physical assessments and emphasized the need for a team member who could adapt to variations in workflow preferences across rheumatologists in the practice.<h4>Interpretation</h4>Perceived pharmacist roles expressed by existing rheumatology team members were largely consistent with the scope of pharmacist knowledge, skills and responsibilities in primary care.<h4>Conclusion</h4>Overall, existing multidisciplinary staff exhibited favourable attitudes towards a pharmacist joining their practice setting. Data from this job analysis exercise were used to inform the development of a job description for a rheumatology clinical pharmacist.
Project description:Pharmacist-physician comanagement of hypertension has been shown to improve office blood pressures (BPs). We sought to describe the effect of such a model on 24-hour ambulatory BPs.We performed a prospective, cluster-randomized, controlled clinical trial, enrolling 179 patients with uncontrolled hypertension from 5 primary care clinics in Iowa City, Iowa. Patients were randomized by clinic to receive pharmacist-physician collaborative management of hypertension (intervention) or usual care (control) for a 9-month period. In the intervention group, pharmacists helped patients to identify barriers to BP control, counseled on lifestyle and dietary modifications, and adjusted antihypertensive therapy in collaboration with the patients' primary care providers. Patients were seen by pharmacists a minimum of every 2 months. Ambulatory BP was measured at baseline and at study end.Baseline and end-of-study ambulatory BP profiles were evaluated for 175 patients. Mean (SD) ambulatory systolic BPs (SBPs), reported in millimeters of mercury, were reduced more in the intervention group than in the control group: daytime change in (?) SBP, 15.2 (11.5) vs 5.5 (13.5) (P < .001); nighttime ?SBP, 12.2 (14.8) vs 3.4 (13.3) (P < .001); and 24-hour ?SBP, 14.1 (11.3) vs 5.5 (12.5) (P < .001). More patients in the intervention group than in the control group had their BP controlled at the end of the study (75.0% vs 50.7%) (P < .001), as defined by overall 24-hour ambulatory BP monitoring.Pharmacist-physician collaborative management of hypertension achieved consistent and significantly greater reduction in 24-hour BP and a high rate of BP control. Trial Registration clinicaltrials.gov Identifier: NCT00201045.
Project description:To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes.Engaging and Motivating Patients Online With Enhanced Resources for Diabetes was a 12-month parallel randomized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin (A1C) values ?7.5% from primary care sites sharing an electronic health record. The intervention included: (1) wirelessly uploaded home glucometer readings with graphical feedback; (2) comprehensive patient-specific diabetes summary status report; (3) nutrition and exercise logs; (4) insulin record; (5) online messaging with the patient's health team; (6) nurse care manager and dietitian providing advice and medication management; and (7) personalized text and video educational 'nuggets' dispensed electronically by the care team. A1C was the primary outcome variable.Compared with usual care (UC, n=189), patients in the intervention (INT, n=193) group had significantly reduced A1C at 6 months (-1.32% INT vs -0.66% UC; p<0.001). At 12 months, the differences were not significant (-1.14% INT vs -0.95% UC; p=0.133). In post hoc analysis, significantly more INT patients had improved diabetes control (>0.5% reduction in A1C) than UC patients at 12 months (69.9 (95% CI 63.2 to 76.5) vs 55.4 (95% CI 48.4 to 62.5); p=0.006).A nurse-led, multidisciplinary health team can manage a population of diabetic patients in an online disease management program. INT patients achieved greater decreases in A1C at 6 months than UC patients, but the differences were not sustained at 12 months. More INT than UC patients achieved improvement in A1C (>0.5% decrease). Trial registered in clinical trials.gov: #NCT00542204.
Project description:UK, home-based patients with COPD receive specialist care from respiratory physicians, nurses, and general practitioners (GPs), but increasing complexity of therapeutic options and a GP/Nurse workforce crisis suggests merit in testing the role of home visits by a clinical pharmacist. We conducted a non-randomised intervention study with a contemporaneous comparator group, in Glasgow (Scotland). A clinical pharmacist (working closely with a consultant respiratory physician) visited patients with COPD living at home, assessing respiratory and other co-morbid conditions, and medicines then, with patient approval, agreed treatment modifications with a consultant physician. Comparator group-patients were drawn from another hospital out-patient clinic. Main outcomes were exacerbations during 4-months of follow-up and respiratory hospitalisations (number and duration) after 1 year. In the intervention group, 86 patients received a median of three home visits; 87 received usual care (UC). At baseline, patients in the intervention group were similar to those in UC in terms of respiratory hospitalisations although slightly younger, more likely to receive specific maintenance antibiotics/Prednisolone and to have had exacerbations. Sixty-two (72.1%) of the intervention group received dose changes; 45 (52.3%) had medicines stopped/started and 21 (24.4%) received an expedited review at the specialist respiratory consultant clinic; 46 (53.5%) were referred to other healthcare services. Over one-third were referred for bone scans and 11% received additional investigations. At follow-up, 54 (63.5%) of intervention group participants had an exacerbation compared with 75 (86.2%) in the UC group (p?=?0.001); fewer had respiratory hospitalisations (39 (45.3%) vs. 66 (76.7%); p?<?0.001). Hospitalisations were shorter in the intervention group. Pharmacist-consultant care for community dwelling patients with COPD, changed clinical management and improved outcomes. A randomised controlled trial would establish causality.
Project description:Introduction:Integrated team-based primary healthcare is well positioned to support opioid tapering for patients experiencing chronic pain. This paper describes the development, implementation and acceptability of a primary healthcare opioid tapering intervention 'Assess Inform Manage Monitor' (AIMM) at two sites. Methods:AIMM involved GP advice; nurse monitoring and potential engagement with: community pharmacist; psychologist; dietitian and exercise physiologist. Individuals receiving 90 days or more of prescription opioids were eligible. Patient and provider surveys and qualitative interviews were completed. Results:Of 140 eligible patients, 37 attended during the study period and were invited to participate. Patient post-intervention surveys (n = 8) and interviews (n = 6) indicated the intervention was acceptable, although the perceived value of some of the integrated team was low. GP and practice nurse support was valued. Providers (n = 4) valued team integration. Low weaning readiness was a barrier to engagement by patients and providers. Key lessons and conclusions:The intervention, whilst conceptually acceptable, was not feasible in its current form. Future efforts to transition patients towards integrated care should retain the practice nurse and place more focus on understanding and reinforcing patients' readiness to wean. Greater inter-professional collaboration may also be needed. Such refinements may advance the cause of opioid reduction in primary care.
Project description:OBJECTIVE:The objective of this study was to assess the potential health and budgetary impacts of implementing a pharmacist-involved team-based hypertension management model in the United States. RESEARCH DESIGN:In 2017, we evaluated a pharmacist-involved team-based care intervention among 3 targeted groups using a microsimulation model designed to estimate cardiovascular event incidence and associated health care spending in a cross-section of individuals representative of the US population: implementing it among patients with: (1) newly diagnosed hypertension; (2) persistently (?1 year) uncontrolled blood pressure (BP); or (3) treated, yet persistently uncontrolled BP-and report outcomes over 5 and 20 years. We describe the spending thresholds for each intervention strategy to achieve budget neutrality in 5 years from a payer's perspective. RESULTS:Offering this intervention could prevent 22.9-36.8 million person-years of uncontrolled BP and 77,200-230,900 heart attacks and strokes in 5 years (83.8-174.8 million and 393,200-922,900 in 20?years, respectively). Health and economic benefits strongly favored groups 2 and 3. Assuming an intervention cost of $525 per enrollee, the intervention generates 5-year budgetary cost-savings only for Medicare among groups 2 and 3. To achieve budget neutrality in 5 years across all groups, intervention costs per person need to be around $35 for Medicaid, $180 for private insurance, and $335 for Medicare enrollees. CONCLUSIONS:Adopting a pharmacist-involved team-based hypertension model could substantially improve BP control and cardiovascular outcomes in the United States. Net cost-savings among groups 2 and 3 make a compelling case for Medicare, but favorable economics may also be possible for private insurers, particularly if innovations could moderately lower the cost of delivering an effective intervention.
Project description:This systematic review and meta-analysis of randomized controlled trials (RCTs) assesses the effect of pharmacist care on cardiovascular disease (CVD) risk factors among outpatients with diabetes.MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials were searched. Pharmacist interventions were classified, and a meta-analysis of mean changes of blood pressure (BP), total cholesterol (TC), LDL cholesterol, HDL cholesterol, and BMI was performed using random-effects models.The meta-analysis included 15 RCTs (9,111 outpatients) in which interventions were conducted exclusively by pharmacists in 8 studies and in collaboration with physicians, nurses, dietitians, or physical therapists in 7 studies. Pharmacist interventions included medication management, educational interventions, feedback to physicians, measurement of CVD risk factors, or patient-reminder systems. Compared with usual care, pharmacist care was associated with significant reductions for systolic BP (12 studies with 1,894 patients; -6.2 mmHg [95% CI -7.8 to -4.6]); diastolic BP (9 studies with 1,496 patients; -4.5 mmHg [-6.2 to -2.8]); TC (8 studies with 1,280 patients; -15.2 mg/dL [-24.7 to -5.7]); LDL cholesterol (9 studies with 8,084 patients; -11.7 mg/dL [-15.8 to -7.6]); and BMI (5 studies with 751 patients; -0.9 kg/m(2) [-1.7 to -0.1]). Pharmacist care was not associated with a significant change in HDL cholesterol (6 studies with 826 patients; 0.2 mg/dL [-1.9 to 2.4]).This meta-analysis supports pharmacist interventions-alone or in collaboration with other health care professionals-to improve major CVD risk factors among outpatients with diabetes.