Summary Background Control of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health ...professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care. Methods This randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35–85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN17585681. Findings 527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12·9 mm Hg (95% CI 10·4–15·5) from baseline to 6 months in the self-management group and by 9·2 mm Hg (6·7–11·8) in the control group (difference between groups 3·7 mm Hg, 0·8–6·6; p=0·013). From baseline to 12 months, systolic blood pressure decreased by 17·6 mm Hg (14·9–20·3) in the self-management group and by 12·2 mm Hg (9·5–14·9) in the control group (difference between groups 5·4 mm Hg, 2·4–8·5; p=0·0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients 32%; control, 55 patients 22%; p=0·022). Interpretation Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care. Funding Department of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.
IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about ...patients in high-risk groups. OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS: Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN87171227
Self-monitoring and self-titration of antihypertensives (self-management) is a novel intervention which improves blood pressure control. However, little evidence exists regarding the ...cost-effectiveness of self-monitoring of blood pressure in general and self-management in particular. This study aimed to evaluate whether self-management of hypertension was cost-effective.
A cohort Markov model-based probabilistic cost-effectiveness analysis was undertaken extrapolating to up to 35 years from cost and outcome data collected from the telemonitoring and self-management in hypertension trial (TASMINH2). Self-management of hypertension was compared with usual care in terms of lifetime costs, quality adjusted life years and cost-effectiveness using a UK Health Service perspective. Sensitivity analyses examined the effect of different time horizons and reduced effectiveness over time from self-management.
In the long-term, when compared with usual care, self-management was more effective by 0.24 and 0.12 quality adjusted life years (QALYs) gained per patient for men and women, respectively. The resultant incremental cost-effectiveness ratio for self-management was £1624 per QALY for men and £4923 per QALY for women. There was at least a 99% chance of the intervention being cost-effective for both sexes at a willingness to pay threshold of £20,000 per QALY gained. These results were robust to sensitivity analyses around the assumptions made, provided that the effects of self-management lasted at least two years for men and five years for women.
Self-monitoring with self-titration of antihypertensives and telemonitoring of blood pressure measurements not only reduces blood pressure, compared with usual care, but also represents a cost-effective use of health care resources.
Self-monitoring with self-titration of antihypertensives leads to reduced blood pressure. Patients are keen on self-monitoring but little is known about healthcare professional views.
To explore ...health professionals' views and experiences of patient self-management, particularly with respect to future implementation into routine care.
Qualitative study embedded within a randomised controlled trial of healthcare professionals participating in the TASMINH2 trial of patient self-monitoring with self-titration of antihypertensives from 24 West Midlands general practices.
Taped and transcribed semi-structured interviews with 13 GPs, two practice nurses and one healthcare assistant. Constant comparative method of analysis.
Primary care professionals were positive about self-monitoring, but procedures for ensuring patients measured blood pressure correctly were haphazard. GPs interpreted home readings variably, with many not making adjustment for lower home blood pressure. Interviewees were satisfied with patient training and arrangements for blood pressure monitoring and self-titration of medication during the trial, but less sure about future implementation into routine care. There was evidence of a need for training of both patients and professionals for successful integration of self-management.
Health professionals wanted more patient involvement in hypertension care but needed a framework to work within. Consideration of how to train patients to measure blood pressure and how home readings become part of their care is required before self-monitoring and self-titration can be implemented widely. As home monitoring becomes more widespread, the development of patient self-management, including self-titration of medication, should follow but this may take time to achieve.
New cardiac rehabilitation (CR) programmes, such as home programmes using the Heart Manual, are being introduced but little is known about patients' experiences of these.
To compare the views of ...patients who had completed a home or hospital-based CR programme and explore the benefits and problems of each programme.
16 patients from 4 hospital programmes attended one of 3 focus groups; 10 home programme patients attended one of 2 focus groups.
Some themes were common to all focus groups: loss of confidence; continuing to exercise and lifestyle changes; understanding of heart disease. Hospital programme patients particularly enjoyed exercising in a group and mixing with other people, and gained motivation and support from others. Home programme patients spoke very highly of the Heart Manual and valued the one-to-one support of the nurse facilitators. They described the home programme as a lifestyle change compared to the hospital programme which they suggested was more like a treatment.
Patients in the hospital programme enjoyed the camaraderie of group exercise and patients in the home programme valued the wealth of information and advice in the Heart Manual and this gave them a feeling of being in control of their health.
Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have ...been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care.
The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes.
The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond.
ISRCTN87171227.
Controlling blood pressure with drugs is a key aspect of cardiovascular disease prevention, but until recently has been the sole preserve of health professionals. Self-management of hypertension is ...an under researched area in which potential benefits for both patients and professionals are great.
The telemonitoring and self-management in hypertension trial (TASMINH2) will be a primary care based randomised controlled trial with embedded economic and qualitative analyses in order to evaluate the costs and effects of increasing patient involvement in blood pressure management, specifically with respect to home monitoring and self titration of antihypertensive medication compared to usual care. Provision of remote monitoring results to participating practices will ensure that practice staff are able to engage with self management and provide assistance where required. 478 patients will be recruited from general practices in the West Midlands, which is sufficient to detect clinically significant differences in systolic blood pressure between self-management and usual care of 5 mmHg with 90% power. Patients will be excluded if they demonstrate an inability to self monitor, their blood pressure is below 140/90 or above 200/100, they are on three or more antihypertensive medications, have a terminal disease or their blood pressure is not managed by their general practitioner. The primary end point is change in mean systolic blood pressure (mmHg) between baseline and each follow up point (6 months and 12 months). Secondary outcomes will include change in mean diastolic blood pressure, costs, adverse events, health behaviours, illness perceptions, beliefs about medication, medication compliance and anxiety. Modelling will evaluate the impact of costs and effects on a system wide basis. The qualitative analysis will draw upon the views of users, informal carers and professionals regarding the acceptability of self-management and prerequisites for future widespread implementation should the trial show this approach to be efficacious.
The TASMINH2 trial will provide important new evidence regarding the costs and effects of self monitoring with telemonitoring in a representative primary care hypertensive population.
Self-management of hypertension, comprising self-monitoring of blood pressure with self-titration of medication, improves blood pressure control, but little is known regarding the views of patients ...undertaking it.
To explore patients' views of self-monitoring blood pressure and self-titration of antihypertensive medication.
Qualitative study embedded within the randomised controlled trial TASMINH2 (Telemonitoirng and Self Management in the Control of Hypertension) trial of patient self-management of hypertension from 24 general practices in the West Midlands.
Taped and transcribed semi-structured interviews with 23 intervention patients were used. Six family members were also interviewed. Analysis was by a constant comparative method.
Patients were confident about self-monitoring and many felt their multiple home readings were more valid than single office readings taken by their GP. Although many patients self-titrated medication when required, others lacked the confidence to increase medication without reconsulting with their GP. Patients were more comfortable with titrating medication if their blood pressure readings were substantially above target, but were reluctant to implement such a change if readings were borderline. Many planned to continue self-monitoring after the study finished and report home readings to their GP, but few wished to continue with a self-management plan.
Participants valued the additional information and many felt confident in both self-monitoring blood pressure and self-titrating medication. The reluctance to change medication for borderline readings suggests behaviour similar to the clinical inertia seen for physicians in analogous circumstances. Additional support for those lacking in confidence to implement prearranged medication changes may allow more patients to undertake self-management.
Background. There has been a rapid increase in proton pump inhibitor (PPI) prescribing in recent years, and controlling the cost and improving the quality of prescribing is an issue of concern to ...many GPs. Objective. Our aim was to compare GPs' usage of different PPIs and explore how GPs' PPI prescribing changes following the introduction of a cheaper competitor. Methods. PPI prescribing data (PACT) for 53 GPs, who were selected as regular users of a teaching hospital, were monitored from January 1995 to December 1997. The GPs were located in two adjoining health districts and had been interviewed about influences on their decisions to begin prescribing lansoprazole. The PPI prescribing data were collected for the teaching hospital and the general hospital in the adjoining district. Results. Complete prescribing data were available for 50 GPs. Total PPI prescribing increased throughout the study due mainly to increasing use of the new PPIs. Use of the new PPIs increased from 6 to 24% over 3 years. The proportion of maintenance doses prescribed increased from 3 to 12%. There was a 23-fold difference in total PPI prescribing and an 87-fold difference in lansoprazole prescribing between the highest and lowest prescribers. The uptake of pantoprazole was slower than that of lansoprazole. A rapid increase in the use of lansoprazole by the GPs followed an increase in use in the teaching hospital. Conclusion. Hospital prescribing was an important influence on the choice of PPI used by GPs. The wide variation in PPI prescribing suggests that there is scope for improvement in the quality and cost of PPI prescribing.
Abstract Objective: To explore consultants' and general practitioners' perceptions of the factors that influence their decisions to introduce new drugs into their clinical practice. Design: ...Qualitative study using semistructured interviews. Monitoring of hospital and general practice prescribing data for eight new drugs. Setting: Teaching hospital and nearby general hospital plus general practices in Birmingham. Participants: 38 consultants and 56 general practitioners who regularly referred to the teaching hospital. Main outcome measures: Reasons for prescribing a new drug; sources of information used for new drugs; extent of contact between consultants and general practitioners; and amount of study drugs used in hospitals and by general practitioners. Results: Consultants usually prescribed new drugs only in their specialty, used few new drugs, and used scientific evidence to inform their decisions. General practitioners generally prescribed more new drugs and for a wider range of conditions, but their approach varied considerably both between general practitioners and between drugs for the same general practitioner. Drug company representatives were an important source of information for general practitioners. Prescribing data were consistent with statements made by respondents. Conclusions: The factors influencing the introduction of new drugs, particularly in primary care, are more multiple and complex than suggested by early theories of drug innovation. Early experience of using a new drug seems to strongly influence future use. What is already known on this topic UK studies show that use of new drugs by general practitioners is influenced by consultants, the nature of the drug, and perceived risk What this study adds Consultants generally introduced fewer drugs than general practitioners, usually within their specialty Decisions were said to be based mainly on the evidence from the scientific literature and meetings General practitioners prescribed more new drugs and the basis of decisions was more varied Doctors' interpretations of using a new drug were not consistent
PDF
