scholarly journals Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK

BJGP Open ◽  
2019 ◽  
Vol 3 (4) ◽  
pp. bjgpopen19X101666 ◽  
Author(s):  
Hind Khalifeh ◽  
Emma Molyneaux ◽  
Ruth Brauer ◽  
Simone Vigod ◽  
Louise M Howard

BackgroundDecision-making regarding antidepressant use in pregnancy is challenging, given the uncertain evidence base on the benefits and risks for women and their children. Patient decision aids (PDAs) can improve shared decision-making for complex health decisions but no evidence-based PDAs exist for antidepressant use in pregnancy.AimTo assess the feasibility of a full-scale randomised controlled trial (RCT) to evaluate the efficacy of an electronic PDA on antidepressant use in pregnancy.Design & settingA UK-based pilot parallel-group RCT.MethodThe study recruited women whose clinicians recommended an antidepressant for depression in a current or planned pregnancy, and who were uncertain about antidepressant use while pregnant. Women were recruited via clinician or self-referral, and randomised to online access to the PDA or online access to standard resource list, with primary follow-up at 4 weeks and longer-term follow-up. The primary outcome was protocol feasibility (recruitment target of 50 women and follow-up rate of 80%). Outcome measures for a future full-scale RCT included the decisional conflict scale (DCS).ResultsFifty-one women were recruited with a follow-up rate of 90.2% at 4 weeks. The PDA received good overall satisfaction ratings (mean 4.2/5). Analysis of covariance (ANCOVA) indicated a small improvement in decisional conflict at 4 weeks, accounting for baseline scores (DCS regression coefficient = -3.5, 95% confidence intervals [CI = -12.6 to 5.6]).ConclusionThis pilot RCT for an electronic PDA on antidepressant use in pregnancy showed that the study protocol was feasible, with high rates of participant satisfaction among those randomised to the PDA.

2019 ◽  
Vol 76 (9) ◽  
pp. 595-602 ◽  
Author(s):  
Elizabeth Stratton ◽  
Isabella Choi ◽  
Rafael calvo ◽  
Ian Hickie ◽  
Claire Henderson ◽  
...  

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  

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.


2019 ◽  
Vol 7 (12) ◽  
pp. 574-574

A trial weighing up the risk and benefits of antidepressant use in pregnancy has shown that patient decision aids were feasible with high patient satisfaction


Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Simone Vigod ◽  
Neesha Hussain-Shamsy ◽  
Sophie Grigoriadis ◽  
Louise M. Howard ◽  
Kelly Metcalfe ◽  
...  

2013 ◽  
Vol 203 (5) ◽  
pp. 350-357 ◽  
Author(s):  
Claire Henderson ◽  
Elaine Brohan ◽  
Sarah Clement ◽  
Paul Williams ◽  
Francesca Lassman ◽  
...  

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.


2021 ◽  
Author(s):  
Jenny Rogojanski

Decision aids communicate the best available evidence on treatment options to patients in order to facilitate informed decision-making. Research suggests that decision aids improve patients’ treatment knowledge, reduce decisional conflict, and promote more active decision-making. Despite evidence of the utility of decision aids in physical health conditions, they are both understudied and rarely used for mental health problems. The present study evaluated the acceptability and utility of a decision aid for the treatment of depression and its relationship to participants' knowledge and decision-making. Undergraduate students ( Participants completed a follow-up knowledge test, along with a series of questionnaires assessing acceptability of the decision aid and other variables of interest (e.g., decisional conflict, preparation for decision-making). One month later, participants completed the knowledge test for the third time. Overall, a majority of participants rated the decision aid as highly acceptable and useful. There was a significant increase in participants’ knowledge of depression treatment from prior to reading to after reading the decision aid. Although participants’ knowledge scores decreased slightly at the 1-month follow-up, they were still significantly higher than their baseline scores. The hypothesis that participants’ treatment choice would be influenced by the order in which treatment options were presented to them within the decision aid was partially supported. However, this effect was eliminated when the few participants who selected the “no treatment” option were excluded, as well as when participants were given the additional option of selecting a combined treatment (i.e., medication and psychotherapy). This is one of the few studies aimed at expanding the use of decision aids to mental health conditions. Future research should evaluate the utility of this decision aid with a clinical sample. Additionally, the methodology used in this study can be translated to the evaluation of other decision aids.


2019 ◽  
Vol 251 ◽  
pp. 91-99 ◽  
Author(s):  
Simone N. Vigod ◽  
Neesha Hussain-Shamsy ◽  
Donna E. Stewart ◽  
Sophie Grigoriadis ◽  
Kelly Metcalfe ◽  
...  

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