Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

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P646Effects of personalized therapy-effect predictions on statin treatment decisions by patients and physicians: a three-armed, blinded, randomized controlled trial

European Heart Journal ◽

10.1093/eurheartj/ehz747.0253 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

N E M Jaspers ◽

F L J Visseren ◽

Y Van Der Graaf ◽

O C Damman ◽

Y M Smulders ◽

...

Keyword(s):

Decision Making ◽

Randomized Controlled Trial ◽

Life Expectancy ◽

Controlled Trial ◽

Decisional Conflict ◽

P Value ◽

Shared Decision ◽

Cvd Risk ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background Several online tools express an individual's therapy-benefit for various cardiovascular disease (CVD) prevention strategies. The benefit can be expressed in multiple formats, such as absolute 10-year CVD risk reduction or gain in CVD-free life-years. It is increasingly suggested that these estimates can be used in doctor-patient communication to support shared decision-making. However, the actual therapy-benefit to be expected from preventive therapy might be small from the perspective of patients, and it remains unclear how the estimates affect patient and physician decision-making. Purpose The primary objective was to determine whether communicating personalized predictions of prognosis and treatment-effects (compared to non-personalized standard practice) leads to lower decisional conflict among patients with stable CVD and prescribed statin medication. Methods A hypothesis-blinded, three-armed randomized controlled trial was performed in which 303 patients were randomized in a 1:1:1 ratio to either standard practice (control-group) or to one of two intervention arms. Intervention arms received personalized estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (atorvastatin 80 mg). Intervention arms differed only in the format of the treatment effect estimates: change in personal 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group). Primary outcome was patient decisional conflict score (DCS) after one-month, which varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at one or six months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomization low-density lipoprotein cholesterol levels, and physician opinion of statin therapy decisions and the intervention. Outcomes are reported as median (25th–75th percentile). Results In the iAR group, the change in 10-year absolute CVD-risk was −2.4 (−1.2 to −3.9%) from intensification and +10.2% (+7.7 to +13.5) from discontinuation. In the iLE group, the change in CVD-free life-expectancy was +0.5 years (+0.3 to +0.8) from intensification and −2.0 years (−1.3 to −2.8) from discontinuation. Decisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value versus control 0.002), and iLE-group 25 (10–31; p-value versus control 0.02). No differences in secondary outcomes were observed. Figure 1. Part of the personalized information received by iAR-group (left) and iLE-group (right). Conclusion In patients with clinically manifest CVD, providing personalized estimations of treatment-effects lowers decisional conflict associated with statin use. The results support the use of personalized predictions for patient decision making. Acknowledgement/Funding Partially funded by a Netherlands Heart Foundation grant (2016T026)

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Web-based decision aid tool for disclosure of a mental health condition in the workplace: a randomised controlled trial

Occupational and Environmental Medicine ◽

10.1136/oemed-2019-105726 ◽

2019 ◽

Vol 76 (9) ◽

pp. 595-602 ◽

Cited By ~ 3

Author(s):

Elizabeth Stratton ◽

Isabella Choi ◽

Rafael calvo ◽

Ian Hickie ◽

Claire Henderson ◽

...

Keyword(s):

Mental Health ◽

Decision Making ◽

Depressive Symptoms ◽

Randomised Controlled Trial ◽

Decision Aid ◽

Controlled Trial ◽

Decisional Conflict ◽

Web Based ◽

Randomised Controlled

ObjectivesMaking decisions about disclosing a mental illness in the workplace is complicated. Decision aid tools are designed to help an individual make a specific choice. We developed a web-based decision aid to help inform decisions about disclosure for employees. This study aimed to examine the efficacy of this tool.MethodWe conducted a randomised controlled trial with recruitment, randomisation and data collection all online. Participants had access to the intervention for 2 weeks. Assessments occurred at baseline, postintervention and 6 weeks’ follow-up. The primary outcome was decisional conflict. Secondary outcomes were stage and satisfaction of decision-making and mental health symptoms.Results107 adult employees were randomised to READY (n=53) or the control (n=54). The sample was predominantly female (83.2%). Participants using READY showed greater reduction in decisional conflict at postintervention (F(1,104)=16.8, p<0.001) (d=0.49, 95% CI 0.1 to 0.9) and follow-up (F(1,104)=23.6, p<0.001) (d=0.61, 95% CI 0.1 to 0.9). At postintervention the READY group were at a later stage of decision-making (F(1,104)=6.9, p=0.010) which was sustained, and showed a greater reduction in depressive symptoms (F(1,104)=6.5, p=0.013). Twenty-eight per cent of READY users disclosed, and reported a greater improvement in mental health than those who did not disclose.ConclusionsREADY provides a confidential, flexible and effective tool to enhance employee’s decision-making about disclosure. Its use led to a comparative improvement in depressive symptoms compared with the current information provided by a leading mental health non-governmental organisation, without apparent harm. READY seems worth evaluating in other settings and, if these results are replicated, scaling for wider use.Trial registration numberACTRN12618000229279.

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Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽

10.1136/bmjopen-2020-042101 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042101

Author(s):

Saba Aijaz ◽

Sana Sheikh ◽

Asad Pathan

Keyword(s):

Randomised Controlled Trial ◽

Radial Artery ◽

Controlled Trial ◽

Coronary Intervention ◽

Ease Of Use ◽

P Value ◽

Radial Compression ◽

Open Label ◽

Scientific Publications ◽

Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Effect of a text message intervention on alcohol-related harms and behaviours: secondary outcomes of a randomised controlled trial

BMC Research Notes ◽

10.1186/s13104-019-4308-y ◽

2019 ◽

Vol 12 (1) ◽

Cited By ~ 2

Author(s):

Sarah Sharpe ◽

Bridget Kool ◽

Robyn Whittaker ◽

Arier C. Lee ◽

Papaarangi Reid ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Text Message ◽

Secondary Outcomes ◽

Randomised Controlled ◽

Text Message Intervention

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A feasibility randomised controlled trial of the DECIDE intervention: Dementia carers making informed decisions

BJPsych Open ◽

10.1192/bjpo.bp.116.003509 ◽

2017 ◽

Vol 3 (1) ◽

pp. 12-14 ◽

Cited By ~ 3

Author(s):

Kathryn Lord ◽

Gill Livingston ◽

Claudia Cooper

Keyword(s):

Randomised Controlled Trial ◽

Family Conflict ◽

Decision Aid ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Manual Aiming ◽

Family Carers ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

SummaryFamily carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services.

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The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

10.1101/2021.09.16.21263674 ◽

2021 ◽

Author(s):

Lisa Hynes ◽

Andrew W Murphy ◽

Nigel Hart ◽

Collette Kirwan ◽

Sarah Mulligan ◽

...

Keyword(s):

Primary Care ◽

Decision Making ◽

Pilot Study ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Definitive Trial ◽

Cluster Randomised ◽

Medication Reviews ◽

Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

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