Evaluating the impact of pharmaceutical care services on the clinical outcomes of epilepsy: a randomised controlled trial

BackgroundConcerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health.AimsTo examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living.MethodIn a multicentre, single-blind, randomised controlled trial, 443 patients in four general practices were randomised to screening for suicidal ideation or control questions on health and lifestyle (trial registration: ISRCTN84692657). The primary outcome was thinking that life is not worth living measured 10–14 days after randomisation. Secondary outcome measures comprised other aspects of suicidal ideation and behaviour.ResultsA total of 443 participants were randomised to early (n = 230) or delayed screening (n = 213). Their mean age was 48.5 years (s.d. = 18.4, range 16–92) and 137 (30.9%) were male. The adjusted odds of experiencing thoughts that life was not worth living at follow-up among those randomised to early compared with delayed screening was 0.88 (95% CI 0.66–1.18). Differences in secondary outcomes between the two groups were not seen. Among those randomised to early screening, 37 people (22.3%) reported thinking about taking their life at baseline and 24 (14.6%) that they had this thought 2 weeks later.ConclusionsScreening for suicidal ideation in primary care among people who have signs of depression does not appear to induce feelings that life is not worth living.

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Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes in Hospitalised Patients. A Feasibility Randomised Controlled Trial Protocol.

10.21203/rs.3.rs-1191653/v1 ◽

2022 ◽

Author(s):

Carlos Areia ◽

Sarah Vollam ◽

Cristian Roman ◽

Mauro Santos ◽

Louise Young ◽

...

Keyword(s):

Blood Pressure ◽

Randomised Controlled Trial ◽

Clinical Outcomes ◽

Monitoring System ◽

Standard Care ◽

Controlled Trial ◽

Ambulatory Monitoring ◽

Hospitalised Patients ◽

Randomised Controlled ◽

The Impact

Abstract BackgroundDespite the exponential growth of wearable technology, previous research indicates a lack of statistically significant evidence to support the hypothesis that implementation of wearable ambulatory vital sign monitoring systems impact early patient deterioration detection and clinical outcomes. This highlights the need for large, rigorous studies to address this gap. The objective of this feasibility trial is to assess the impact of an ambulatory monitoring system (AMS) on deterioration detection and clinical outcomes in hospitalised patients, compared to standard care. As a secondary objective we will assess the feasibility of conducting a full randomised controlled trial (RCT).MethodsBetween 120 and 240 patients will be recruited and randomised equally to either an AMS or standard care group. Wearable devices will include a pulse oximeter (monitoring pulse rate and oxygen saturation), a chest patch (monitoring heart rate, respiratory rate and temperature) and a wireless blood pressure cuff (monitoring systolic and diastolic blood pressure). Both groups will wear the devices during their ward length of stay, however only data and alerts from the AMS group will be visible to clinical staff.DiscussionRecruitment of participants is expected to start in January 2022, with an anticipated completion date of December 2022. This feasibility RCT will test the early impact of our AMS implementation in a non-intensive care ward and provide data to support the design and deployment of a full RCT which will provide much-needed evidence of the impact of AMS on early deterioration detection and clinical outcomes.

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