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An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

ABSTRACT: This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age.This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants received either usual care or the educational handout. The 10-question test assessed increased knowledge of which AEDs affected efficacy of certain hormonal contraceptives and was assessed by calculating the improvement in score between the pretest and posttest. The educational handout included the names of AEDs that have drug interactions with certain contraceptives and the efficacy of the contraceptives.A total of 42 epilepsy patients participated in this study. Fourteen participants were taking AEDs that are enzyme p450 inducers and 13 participants were taking Lamotrigine. Twenty women were randomized to receive the educational handout and 22 women were randomized to usual care. We found no statistical difference in the groups with regard to age, ethnicity or level of education. We found a significantly higher improvement in quiz scores in the educational handout group (3.65 point increase) compared to the usual care group (0.68 point increase) as calculated by the Student's two-sample t test (p<.001).An educational handout on drug interactions and contraceptives resulted in increased short-term information retention on this topic among reproductive-age female epilepsy patients.This pilot study highlights the need for further larger studies to evaluate the impact of educational interventions on improving patient knowledge about the drug interaction of AEDs and hormonal contraceptives.

SUBMITTER: Mody SK

PROVIDER: S-EPMC4852845 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

Mody Sheila K SK Haunschild Carolyn C Farala John Paul JP Honerkamp-Smith Gordon G Hur Vivian V Kansal Leena L

Contraception 20150718 1

<h4>Objective</h4>This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age.<h4>Study design</h4>This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants ...[more]

PMID: 26197260

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Project description:ObjectiveTo compare the Centers for Disease Control and Prevention's (CDC) contraceptive effectiveness poster with a more patient-centered poster on factors affecting the likelihood of using effective contraceptives.MethodsThe posters were tested in a randomized controlled trial. Women were eligible if they were aged 18-44 years, could speak and read English, were not pregnant or trying to conceive, and had engaged in vaginal intercourse in the past 3 months. An online survey administered through Amazon Mechanical Turk was used to collect baseline and immediate follow-up data on three primary outcomes: contraceptive knowledge (measured using the Contraceptive Knowledge Assessment), perceived pregnancy risk, and the effectiveness of the contraceptive the woman intended to use in the next year. Subgroup analyses were conducted in women with prior pregnancy scares, low numeracy, and no current contraceptive. Within- and between-group differences were compared for the two randomized groups.ResultsFrom January 26 to February 13, 2018, 2,930 people were screened and 990 randomized. For the primary outcomes, the only significant result was that the patient-centered poster produced a greater improvement in contraceptive knowledge than the CDC poster (P<.001). Relative to baseline, both posters significantly improved contraceptive knowledge (CDC +3.6, patient-centered +6.4 percentage points, P<.001) and a constructed score measuring the effectiveness of the contraceptive that women intended to use in the next year (CDC and patient-centered +3 percentage points, P<.01). This is equivalent to 1-17 of every 100 women who viewed a poster changing their intentions in favor of a more effective contraceptive.ConclusionThis study suggests that both posters educate women about contraception and may reduce unplanned pregnancy risk by improving contraceptive intentions. Of the three primary outcomes, the patient-centered poster performs significantly better than the CDC poster at increasing contraceptive knowledge.Clinical trial registrationClinicalTrials.gov, NCT03372369.

Project description:BackgroundPublic stigma against depression contributes to low employment rates among individuals with depression. Contact-based educational (CBE) interventions have been shown to reduce this public stigma.ObjectiveWe investigated the ability of our Virtual Reality Antistigma (VRAS) app developed for CBE interventions to reduce the stigma of depression.MethodsSixteen medical students were recruited and randomized 1:1 to the intervention group, who used the VRAS app (VRAS group), and the control group, who watched a video on depression. The depression stigma score was assessed using the Depression Stigma Scale (DSS) and Attitudinal Social Distance (ASD) questionnaire at pre- and postintervention. Feasibility was assessed in both groups and usability was assessed only in the VRAS group after the intervention. A qualitative study was performed on the acquisition of knowledge about stigma in both groups based on participants' answers to open-ended questions and interviews after the intervention.ResultsThe feasibility score was significantly higher in the VRAS group (mean 5.63, SD 0.74) than in the control group (mean 3.88, SD 1.73; P=.03). However, no significant differences were apparent between the VRAS and control groups for the DSS (VRAS: mean 35.13, SD 5.30; control: mean 35.38, SD 4.50; P=.92) or ASD (VRAS: mean 12.25, SD 3.33; control: mean 11.25, SD 1.91; P=.92). Stigma scores tended to decrease; however, the stigma-reducing effects of the VRAS app were not significant for the DSS (pre: mean 33.00, SD 4.44; post: mean 35.13, SD 5.30; P=.12) or ASD (pre: mean 13.25, SD 3.92; post: mean 12.25, SD 3.33; P=.12). Qualitative analysis suggested that the VRAS app facilitated perspective-taking and promoted empathy toward the patient.ConclusionsThe CBE intervention using virtual reality technology (VRAS app) was as effective as the video intervention. The results of the qualitative study suggested that the virtual reality intervention was able to promote perspective-taking and empathy toward patients.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000043020; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049109.

Project description:Poor patient knowledge about transplantation is a significant problem following kidney transplant. A video-based educational intervention was developed to supplement standard education provided by transplant teams.MethodsA multicenter randomized controlled trial tested the intervention delivered to patients undergoing assessment or waitlisted for kidney transplant. Adult participants were randomized to the control (standard education) or the intervention group, consisting of electronic access to the videos (or digital video disks if no internet) plus standard education. Differences between groups in changes in transplant knowledge (measured by the Kidney Transplant Understanding Tool), education satisfaction, self-efficacy, and quality of life (secondary outcomes) were evaluated by a preintervention and postintervention survey. Video viewing habits were tracked and described for patients in the intervention group.ResultsOne hundred sixty-two patients were enrolled, with 132 completing both questionnaires (n = 64 intervention and n = 68 control), with similar enrollment from 3 Canadian sites. Video viewing statistics in the complete cases indicated that 78% (50/64) watched the videos, with 70% (45/64) viewing them electronically, while 8% (5/64) received digital video disks and self-reported participation. Baseline knowledge scores in the intent-to-treat population were 55.4 ± 6.5 and 55.7 ± 7.1 in the intervention and control, respectively. The mean knowledge change in the intervention (2.1 ± 3.6) was significantly higher than in the control group (0.8 ± 3.4, P < 0.02). In the per-protocol analysis (patients with objective evidence of watching at least 80% of the videos), the knowledge improvements were 3.4 ± 3.8. Video group participants reported higher satisfaction with education (P < 0.02) and expressed positive comments in open-ended feedback.ConclusionsElectronic video education in the pretransplant setting improved knowledge and satisfaction.

Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).

Project description:BackgroundThe Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.SettingThe University Health Network, a tertiary care cancer center in Toronto, Canada.ParticipantsAdult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.InterventionWe designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.ControlUsual care includes access to an informational booklet, website, and patient volunteer if desired.OutcomesExpected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DiscussionOur pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.Trial registrationNCT01857882.

Project description:ObjectiveTo explore the safety and efficacy of external trigeminal nerve stimulation (eTNS) in patients with drug-resistant epilepsy (DRE) using a double-blind randomized controlled trial design, and to test the suitability of treatment and control parameters in preparation for a phase III multicenter clinical trial.MethodsThis is a double-blind randomized active-control trial in DRE. Fifty subjects with 2 or more partial onset seizures per month (complex partial or tonic-clonic) entered a 6-week baseline period, and then were evaluated at 6, 12, and 18 weeks during the acute treatment period. Subjects were randomized to treatment (eTNS 120 Hz) or control (eTNS 2 Hz) parameters.ResultsAt entry, subjects were highly drug-resistant, averaging 8.7 seizures per month (treatment group) and 4.8 seizures per month (active controls). On average, subjects failed 3.35 antiepileptic drugs prior to enrollment, with an average duration of epilepsy of 21.5 years (treatment group) and 23.7 years (active control group), respectively. eTNS was well-tolerated. Side effects included anxiety (4%), headache (4%), and skin irritation (14%). The responder rate, defined as >50% reduction in seizure frequency, was 30.2% for the treatment group vs 21.1% for the active control group for the 18-week treatment period (not significant, p = 0.31, generalized estimating equation [GEE] model). The treatment group experienced a significant within-group improvement in responder rate over the 18-week treatment period (from 17.8% at 6 weeks to 40.5% at 18 weeks, p = 0.01, GEE). Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59-0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio (p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory (p = 0.02, ANOVA).ConclusionsThis study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial.Classification of evidenceThis phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.

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An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

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An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

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