Dataset Information

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.

SUBMITTER: Santschi V

PROVIDER: S-EPMC5251291 | biostudies-other | 2017 Jan

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.

Santschi Valérie V Wuerzner Grégoire G Chiolero Arnaud A Burnand Bernard B Schaller Philippe P Cloutier Lyne L Paradis Gilles G Burnier Michel M

BMC cardiovascular disorders 20170121 1

<h4>Background</h4>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.<h4>M ...[more]

PMID: 28109266

Similar Datasets

Project description:OBJECTIVE: Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics. STUDY DESIGN: A 12-month prospective, single-blind, randomized, controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure. METHODS: As compared to usual primary care, intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocols. At baseline, there was no significant difference in blood pressure between groups. Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end. Secondary measures included blood pressure goal attainment (<140/90 mmHg), hypertension-related knowledge, medication adherence, home blood pressure monitoring, resource utilization, quality of life, and satisfaction. RESULTS: A total of 463 subjects were enrolled (n = 233 control, n = 230 intervention). Subjects receiving the intervention achieved significantly lower systolic (p = 0.007) and diastolic (p = 0.002) blood pressures compared to control (137/75 mmHg vs. 143/78 mmHg). In addition, 62% of intervention subjects achieved target blood pressure compared to 44% of control subjects (p = 0.003). The intervention group received more total office visits (7.2 vs. 4.9, p < 0.0001), however had fewer physician visits (3.2 vs. 4.7, p < 0.0001) compared to control. Intervention subjects were prescribed more antihypertensive medications (2.7 vs. 2.4, p = 0.02), but did not take more antihypertensive pills per day (2.4 vs. 2.5, p = 0.87). There were minimal differences between groups in hypertension-related knowledge, medication adherence, quality of life, or satisfaction. CONCLUSIONS: Patients randomized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction.

Project description:BackgroundThe Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT.Method/designOur study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis.DiscussionThis pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs.Trial registrationClinicalTrials.gov, ID: NCT02768922 . Registered on 11 May 2016. Last updated on 17 November 2017.

Project description:BackgroundIn Norway, a disproportionately high number of children receiving Child Welfare Services (CWS) struggle academically and drop out of school. Academic attainment is one of the strongest protective factors against societal marginalization. The present study is part of a knowledge translation project in collaboration with local CWS with the aim to develop, implement, and evaluate Enhanced Academic Support (EAS) for primary school children in CWS.Methods/designThe study is a mixed-methods hybrid type 2 randomized, controlled pragmatic trial. The participants are approximately 120 children whose families receive support measures from three child welfare agencies in and around Oslo, Norway, and practitioners from these agencies. Families are randomly assigned to either the EAS condition or "business as usual" support. Primary outcomes are math and reading skills, parental involvement in school, and intervention fidelity. Questionnaires and academic tests are administered at baseline, post-intervention (after 6 months), and at follow-up (after 12 months). Implementation drivers are assessed before and after the trial period, and intervention fidelity is monitored during the trial through checklists and structured telephone interviews. Semi-structured interviews and focus groups are conducted after the trial.DiscussionThis hybrid study has two implications. (1) The effects of providing EAS to children in child welfare will be investigated. The study also explores how each core component of the intervention and the use of specific adaptations, implementation drivers, and other important child-level covariates moderate the overall effects. The results can provide valuable knowledge about how to deliver precise and effective academic support to increase academic skills and prevent dropout. In turn, this can promote academic completion and well-being, outcomes that are beneficial for both children and society at large. (2) The study also evaluates the feasibility of applying an Integrated Knowledge Translation model designed to develop, implement, and evaluate research-supported practice in health, care, and welfare services in less time than is usually the case. If deemed successful, this model will provide an efficient collaborative approach to translate the best available evidence into effective evidence-based practice, applicable in effectiveness research and quality improvement efforts.Trial registrationISRCTN, ISRCTN38968073 . Registered on 18 September 2017. https://doi.org/10.1186/ISRCTN38968073 .

Project description:BACKGROUND:The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality. Endovascular treatment is often used aiming to improve the safety or efficacy of surgery or radiation therapy, but benefits have never been documented in a trial. A care trial context is needed to evaluate interventions at the same time they are practised. METHODS/TRIAL DESIGN:TOBAS is a pragmatic, prospective, multicenter, randomized, controlled trial and registry which offers a care trial context for brain AVM patients, including surgical resection, radiosurgery or endovascular embolization, alone or combined. The study includes two RCTs and a multimodality prospective registry. The objectives of the proposed study are to assess whether preventive interventions (surgery, embolization, radiation therapy, alone or combined), selected by the local treatment team and performed as locally practiced, randomly allocated and compared with conservative management, in unruptured brain AVM patients eligible for active or conservative management, can improve the proportion of patients having an independent outcome (modified Rankin Scale (mRS)?<?3, as assessed by a standardized questionnaire administered by non-masked care personnel) at 10 years. All patients judged ineligible for randomized allocation are to be entered in a multimodal registry. The objective of a nested trial in patients with ruptured or unruptured AVMs to be treated by surgery or radiation therapy, is to assess whether pre-surgical or pre-radiation embolization, randomly allocated and compared with no embolization, can improve the proportion of patients with complete eradication of the AVM, as locally adjudicated, combined with a good clinical outcome (mRS?<?3). The study will require up to 2000 patients in approximately 30 centers or more, followed for 10 years. TOBAS is registered at clinicaltrials.gov: NCT02098252 as of 25 March 2014.

Project description:ObjectiveTo assess the effectiveness and sustainability of a 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community chain pharmacies.DesignCluster randomized trial.Setting28 chain pharmacies (14 TEAM and 14 control) in five Wisconsin cities from December 2006 to February 2009.Participants576 black patients with hypertension.InterventionTrained pharmacist-technician teams implemented a 6-month intervention using scheduled visits, Brief Medication Questionnaires (BMQs), and novel toolkits for facilitating medication adherence and pharmacist feedback to patients and physicians. Control participants received patient information only.Main outcome measuresRefill adherence (≥80% days covered) and changes in systolic blood pressure (SBP), diastolic blood pressure, and blood pressure control using blinded assessments at 6 and 12 months.ResultsAt baseline, all patients had blood pressure of 140/90 mm Hg or more. Of those eligible, 79% activated the intervention (mean 4.25 visits). Compared with control participants at 6 months, TEAM participants achieved greater improvements in refill adherence (60% vs. 34%, P < 0.001), SBP (-12.62 vs. -5.31 mm Hg, P < 0.001), and blood pressure control (50% vs. 36%, P = 0.01). Six months after intervention discontinuation, TEAM participants showed sustained improvements in refill adherence ( P < 0.001) and SBP ( P = 0.004), though the difference in blood pressure control was not significant ( P < 0.05) compared with control participants. Analysis of intervention fidelity showed that patients who received the full intervention during months 1 through 6 achieved significantly greater 6- and 12-month improvements in refill adherence and blood pressure control compared with control participants.ConclusionA team-based intervention involving community chain pharmacists, pharmacy technicians, and novel toolkits led to significant and sustained improvements in refill adherence and SBP in black patients with hypertension.

Project description:BackgroundPolypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient's priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults.MethodsWe designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months.DiscussionOur trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient's goals and priorities for treatment.Trial registrationClinical Trials.gov NCT02942927. First registered on October 24, 2016.

Dataset Information

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.

Publications

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets