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Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.

ABSTRACT: BACKGROUND:Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing. OBJECTIVE:Our objective was to estimate the cost effectiveness of treatment as usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN). METHODS:This was a within-trial economic evaluation of a randomised controlled trial estimating the incremental cost per 1 mmHg BP reduction and per quality-adjusted life-year (QALY) gained over a 6-month time horizon from the perspective of the UK National Health Service (NHS). RESULTS:Data were evaluable for 140 participants. Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively. No statistically significant differences in incremental costs or outcomes were detected. On average, S-MAN was dominated or extended dominated. The incremental cost per 1 mmHg BP reduction from S-MON versus TAU was £137. CONCLUSION:On average, S-MAN is an inefficient intervention. S-MON may be cost effective, depending on the willingness to pay for a 1 mmHg BP reduction, although it yielded fewer QALYs over the within-trial time horizon. Decision modelling is required to explore the longer-term costs and outcomes.

SUBMITTER: Kim LG

PROVIDER: S-EPMC7426342 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.

Kim Lois G LG Wilson Edward C F ECF Davison William J WJ Clark Allan B AB Myint Phyo K PK Potter John F JF

PharmacoEconomics - open 20200901 3

<h4>Background</h4>Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing.<h4>Objective</h4>Our ...[more]

PMID: 32056146

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Project description:BackgroundBlood pressure (BP) lowering in people who have had a stroke or transient ischaemic attack (TIA) leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life.Methods/designThis is a randomised controlled trial (RCT) in patients with a past history of stroke or TIA. Patients will be randomised to two groups and will either have their blood pressure (BP) lowered intensively to a target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg) compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months.610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be applied: systolic BP <125 mmHg at baseline, 3 or more anti-hypertensive agents, orthostatic hypotension, diabetes mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness.The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of life, adverse events and cardiovascular events.In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals understanding and views of BP management.DiscussionThe results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care, and help determine whether or not further research is required before recommending such targets for this population.Trial registrationISRCTN29062286.

Project description:We targeted stroke/transient ischemic attack (TIA) survivors to engage in self-management practices to manage secondary stroke risk factors. We conducted a randomized, regional pilot trial of a locally adapted, secondary stroke prevention program. We implemented the program at two Veterans Administration Medical Centers. Program sessions targeted stroke risk factor self-management. Specifically, we evaluated the effect of the program on the reach, implementation, and effectiveness on patient self-efficacy; stroke-specific, health-related quality of life; and medication adherence for the prevalent stroke risk factors: (1) diabetes, (2) hypertension, and (3) hyperlipidemia. Medication possession ratios were calculated to evaluate medication adherence using VA pharmacy benefits data pre (6 months prior) and post (6 months after) the stroke/TIA event. Based upon the literature standard of 80 % compliance rate, we dichotomized compliance and modeled the data using logistical regression. Final sample included 174 veterans with an acute stroke or TIA who were randomized to receive either the intervention (n?=?87) or attention control program (n?=?87). Patient self-efficacy and stroke-specific, health-related quality of life at 6 months did not significantly differ between groups. We found improvements in medication adherence within the intervention group. In the intervention group, the odds of compliance with diabetes medications post-stroke were significantly larger than the odds of compliance prior to the stroke (odds ratio?=?3.45 (95 % CI?=?1.08-10.96). For compliance to hypertension medications, the intervention group showed significantly greater odds of compliance post intervention than pre intervention (odds ratio?=?3. 68 (95 % CI?=?1.81-7.48). The control group showed no difference in compliance rates from baseline to follow-up. For adherence to hypercholesterolemia medications, both the intervention (odds ratio?=?5.98 (95 % CI?=?2.81-12.76) and control groups (odds ratio?=?3.83 (95 % CI?=?1.83-8.01), had significant increases in the odds of compliance to statin medications; however, the comparison of changes in log odds of compliance between these two groups showed that the increases were not significantly different. We observed within group improvements in medication adherence among those receiving a post-stroke risk factor self-management program suggesting that a self-management format may be feasible to enable adherence to prescribed medications to reduce secondary stroke risk after stroke in concordance with guideline care. Additional research is needed to enhance intervention components to improve effectiveness outcomes.

Project description:Objective To examine whether cost-free (CF) smoking cessation medication was more effective than a prescription for cessation medication in patients after transient ischaemic attack (TIA) or stroke. Design Two-site randomised trial. Setting Stroke prevention clinics (SPCs) in Ontario, Canada. Participants Smokers with TIA or stroke, willing to quit smoking. Intervention Smoking status was assessed in SPC attendees. Smokers were advised to quit smoking and received recommendations for cessation medication and counselling. Consenting participants were randomly assigned (1:1) to either a CF medication group or a prescription-only (Rx) group. CF participants immediately received a 12-week supply of cessation medication. Rx participants were given a prescription for 12 weeks of cessation medication. Follow-up counselling was provided for 26 weeks. Main outcome The primary outcome was 40-week continuous abstinence verified using a carbon monoxide breath test at 52-week follow-up. Secondary outcomes included abstinence at intermediate timepoints, medication adherence and serious adverse events. Results Hundred and ninety-four participants were randomised and 131 (67.5%) completed the trial. The 40-week continuous abstinence rate at 52-week follow-up was 15.5% in the CF group versus 14.0% in the Rx group (OR=1.13; 95% CI 0.51 to 2.53). The 14-week continuous abstinence rate at 26-week follow-up was 18.6% in the CF group versus 16.8% in the Rx group (OR=1.20; 95% CI 0.56 to 2.55). Seven-day point-prevalence abstinence at 12 weeks was 38.1% in the CF group versus 26.9% in the Rx group (OR=1.76; 95% CI 0.94 to 3.28). Medication adherence was higher in the CF group versus the Rx group (47.4%±41.2% vs 25.5±36.8%, p<0.001). Serious adverse events occurred in 11.1% of participants and were unrelated to treatment. Conclusions Our findings were inconclusive; we failed to meet our recruitment target and the effect size was smaller than anticipated. CF medication improved medication adherence. Trial registration number NCT00962988; ClinicalTrials.gov Identifier.

Project description:IntroductionMasked uncontrolled hypertension (MUCH) carries an increased risk of cardiovascular (CV) complications and can be identified through combined use of office (O) and ambulatory (A) blood pressure (BP) monitoring (M) in treated patients. However, it is still debated whether the information carried by ABPM should be considered for MUCH management. Aim of the MASked-unconTrolled hypERtension management based on OBP or on ambulatory blood pressure measurement (MASTER) Study is to assess the impact on outcome of MUCH management based on OBPM or ABPM.Methods and analysisMASTER is a 4-year prospective, randomised, open-label, blinded-endpoint investigation. A total of 1240 treated hypertensive patients from about 40 secondary care clinical centres worldwide will be included -upon confirming presence of MUCH (repeated on treatment OBP <140/90 mm Hg, and at least one of the following: daytime ABP ≥135/85 mm Hg; night-time ABP ≥120/70 mm Hg; 24 hour ABP ≥130/80 mm Hg), and will be randomised to a management strategy based on OBPM (group 1) or on ABPM (group 2). Patients in group 1 will have OBP measured at 0, 3, 6, 12, 18, 24, 30, 36, 42 and 48 months and taken as a guide for treatment; ABPM will be performed at randomisation and at 12, 24, 36 and 48 months but will not be used to take treatment decisions. Patients randomised to group 2 will have ABPM performed at randomisation and all scheduled visits as a guide to antihypertensive treatment. The effects of MUCH management strategy based on ABPM or on OBPM on CV and renal intermediate outcomes (changing left ventricular mass and microalbuminuria, coprimary outcomes) at 1 year and on CV events at 4 years and on changes in BP-related variables will be assessed.Ethics and disseminationMASTER study protocol has received approval by the ethical review board of Istituto Auxologico Italiano. The procedures set out in this protocol are in accordance with principles of Declaration of Helsinki and Good Clinical Practice guidelines. Results will be published in accordance with the CONSORT statement in a peer-reviewed scientific journal.Trial registration numberNCT02804074; Pre-results.

Dataset Information

Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.

Publications

Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.

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