scholarly journals Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. m4858
Author(s):  
Richard J McManus ◽  
Paul Little ◽  
Beth Stuart ◽  
Katherine Morton ◽  
James Raftery ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Systolic Blood Pressure ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Monitoring ◽  
Digital Intervention ◽  
Online Management ◽  
One Year ◽  
Randomised Controlled

Abstract Objective The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint. Setting 76 general practices in the United Kingdom. Participants 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. Interventions Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. Main outcome measures The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. Results After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of −3.4 mm Hg (95% confidence interval −6.1 to −0.8 mm Hg) and a mean difference in diastolic blood pressure of −0.5 mm Hg (−1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. Conclusions The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. Trial registration ISRCTN13790648 .

scholarly journals Effect of free distribution of medicines on the process of care for adult patients with type 1 and type 2 diabetes and hypertension: post hoc analysis of randomised controlled trial findings

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042046
Author(s):  
Onella Charles ◽  
Hannah Woods ◽  
Muhamad Ally ◽  
Braden Manns ◽  
Baiju R Shah ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Access To Medicines ◽  
Free Access ◽  
Process Of Care ◽  
Self Monitoring ◽  
Free Distribution ◽  
Randomised Controlled

ObjectivesThe Carefully Selected and Easily Accessible at No charge Medicines randomised controlled trial showed that patients receiving free access to medicines had improved diabetes and hypertension outcomes compared with patients who had usual access to medicines. In this study, we aimed to test the impact of providing free access to medicine to people with diabetes and hypertension on process of care indicators.DesignIn this post hoc analysis of randomised controlled trial findings, we identified process of care indicators for the management of diabetes and hypertension using relevant guidelines. The following process of care indicators were identified for diabetes management: encounters with healthcare professionals, blood pressure measurements, self-monitoring of blood glucose, annual eye and foot examination, annual administration of the influenza vaccine, and laboratory testing for glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol, serum creatinine and urine albumin to creatinine ratio. We identified the following process of care indicators for hypertension: encounters with healthcare professionals, blood pressure measurements, self-measuring of blood pressure, and serum tests for electrolytes, HbA1c, lipids and creatinine. Chart extractions were performed for all patients and the indicators for diabetes and hypertension were recorded. We compared the indicators for patients in each arm of the trial.ResultsThe study included 268 primary care patients. Free distribution of medicines may improve self-monitoring behaviours (adjusted rate ratio (aRR) 1.30; 95% CI 0.66 to 2.57) and reduce missed primary care appointments for patients with diabetes (aRR 0.80; 95% CI 0.48 to 1.33) or hypertension (aRR 0.41; 95% CI 0.18 to 0.90). Free distribution may also reduce primary care and consultant appointments and laboratory testing in patients with hypertension.ConclusionsImproving medicine accessibility for patients with diabetes and hypertension not only improves surrogate health outcomes but also improves the patient experience and may also reduce healthcare costs by encouraging self-monitoring.Trial registration numberThe randomised controlled trial mentioned is clinicaltrials.gov identifier: NCT02744963.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial

2021 ◽  
Author(s):  
Steven Lubitz ◽  
Steven J. Atlas ◽  
Jeffrey M. Ashburner ◽  
Ana Lipsanopoulos ◽  
Leila Borowsky ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Care Practice ◽  
Control Group ◽  
Newly Diagnosed ◽  
One Year ◽  
And Control

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥ 65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16,0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18,3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01,0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5,10.4). Conclusions: Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation.

scholarly journals OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022930 ◽  
Author(s):  
James P Sheppard ◽  
Jenni Burt ◽  
Mark Lown ◽  
Eleanor Temple ◽  
John Benson ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Usual Care ◽  
Antihypertensive Medication ◽  
Clinical Care ◽  
Economic Modelling ◽  
Host Institution ◽  
South Central ◽  
Randomised Controlled

IntroductionRecent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.Methods and analysisThis trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life.Ethics and disseminationThe protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberEudraCT 2016-004236-38;ISRCTN97503221; Pre-results.

scholarly journals Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial

2020 ◽  
Vol 2 (7) ◽  
pp. e401-e411 ◽  
Author(s):  
Kika Konstantinou ◽  
Martyn Lewis ◽  
Kate M Dunn ◽  
Reuben Ogollah ◽  
Majid Artus ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Stratified Care ◽  
Randomised Controlled

scholarly journals Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial

2019 ◽  
Vol 53 (4) ◽  
pp. 1801530 ◽  
Author(s):  
Jenifer Liang ◽  
Michael J. Abramson ◽  
Grant Russell ◽  
Anne E. Holland ◽  
Nicholas A. Zwar ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Lung Function ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Smoking Abstinence ◽  
Model Of Care ◽  
Cluster Randomised ◽  
Randomised Controlled

We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI –0.89–5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19–10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.

scholarly journals Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial

2019 ◽  
Vol 69 (686) ◽  
pp. e612-e620 ◽  
Author(s):  
Sabrina Grant ◽  
James Hodgkinson ◽  
Claire Schwartz ◽  
Peter Bradburn ◽  
Marloes Franssen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Home Monitoring ◽  
Data Communication ◽  
Free Text ◽  
Self Monitoring ◽  
Structured Care ◽  
Randomised Controlled

BackgroundSelf-monitoring of blood pressure is common but how telemonitoring with a mobile healthcare (mHealth) solution in the management of hypertension can be implemented by patients and healthcare professionals (HCPs) is currently unclear.AimEvaluation of facilitators and barriers to self- and telemonitoring interventions for hypertension within the Telemonitoring and Self-monitoring in Hypertension (TASMINH4) trial.Design and settingAn embedded process evaluation of the TASMINH4 randomised controlled trial (RCT), in the West Midlands, in UK primary care, conducted between March 2015 and September 2016.MethodA total of 40 participants comprising 23 patients were randomised to one of two arms: mHealth (self-monitoring by free text/short message service [SMS]) and self-monitoring without mHealth (self-monitoring using paper diaries). There were also15 healthcare professionals (HCPs) and two patient caregivers.ResultsFour key implementation priority areas concerned: acceptability of self- and telemonitoring to patients and HCPs; managing data; communication; and integrating self-monitoring into hypertension management (structured care). Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients. Paper-based recording integrated better into current workflows but required additional staff input.ConclusionAlthough telemonitoring by mHealth facilitates easier communication and convenience, the realities of current UK general practice meant that a paper-based approach to self-monitoring could be integrated into existing workflows with greater ease. Self-monitoring should be offered to all patients with hypertension. Telemonitoring appears to give additional benefits to practices over and above self-monitoring but both need to be offered to ensure generalisability.

Sign in / Sign up

Export Citation Format

Share Document