Enhancing antiepileptic drug adherence: a randomized controlled trial. A randomised trial of strategies to improve patient compliance with anticonvulsant therapy. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial. The effect of staff training on agitation and use of restraint in nursing home residents with dementia: a single-blind, randomized controlled trial. Implementation strategies for a Scottish national epilepsy guideline in primary care: results of the Tayside Implementation of Guidelines in Epilepsy Randomized (TIGER) trial. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475].
Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. Fifty-three hospital outpatients with epilepsy were randomly allocated to either a control or an intervention group. Patients in the intervention group were subjected to a combination of compliance-improving strategies: patient counselling, a special medication container, self-recording of medication intake and seizures, and mailed reminders to collect prescription refills and attend clinic appointments. Compliance with anticonvulsant therapy (as measured by plasma anticonvulsant levels and prescription refill frequencies), and seizure frequency, were evaluated in each patient prior to intervention and 6 months afterwards. Patient compliance and clinical control improved significantly in the intervention group patients. Seizure frequency was, on average, halved following intervention. Compliance and seizure frequency were unaltered in the control group. Intervention failed to improve clinic appointment keeping. Poor compliance with drug therapy commonly confounds the treatment of epilepsy. This study shows that compliance can be improved and seizure frequency lessened by strategies that are easily incorporated into the routine management of epileptic patients. There is limited evidence on whether growing mobile phone availability in sub-Saharan Africa can be used to promote high adherence to antiretroviral therapy (ART). This study tested the efficacy of short message service (SMS) reminders on adherence to ART among patients attending a rural clinic in Kenya.
                A randomized controlled trial of four SMS reminder interventions with 48 weeks of follow-up.
                Four hundred and thirty-one adult patients who had initiated ART within 3 months were enrolled and randomly assigned to a control group or one of the four intervention groups. Participants in the intervention groups received SMS reminders that were either short or long and sent at a daily or weekly frequency. Adherence was measured using the medication event monitoring system. The primary outcome was whether adherence exceeded 90% during each 12-week period of analysis and the 48-week study period. The secondary outcome was whether there were treatment interruptions lasting at least 48 h.
                In intention-to-treat analysis, 53% of participants receiving weekly SMS reminders achieved adherence of at least 90% during the 48 weeks of the study, compared with 40% of participants in the control group (P = 0.03). Participants in groups receiving weekly reminders were also significantly less likely to experience treatment interruptions exceeding 48 h during the 48-week follow-up period than participants in the control group (81 vs. 90%, P = 0.03).
                These results suggest that SMS reminders may be an important tool to achieve optimal treatment response in resource-limited settings. A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.
                Prospective randomized 1-year trial.
                Collaboration of HIV university outpatient clinic and psychotherapists in private practice.
                60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml.
                Cognitive behaviour intervention in individual patients, in addition to standard of care.
                Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.
                The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.
                Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health. Agitation is common in dementia and is associated with use of restraints and use of psychotropic drugs. The aim of this study was to determine whether an education and supervision intervention could reduce agitation and the use of restraints and antipsychotic drugs in nursing homes.
                Four Norwegian nursing homes were randomly allocated to receive either treatment as usual or an intervention consisting of a 2-day educational seminar and monthly group guidance for 6 months. One hundred forty-five residents with dementia (based on medical records and corroborated with a Functional Assessment Staging score >or= 4) completed baseline and 6-month intervention assessments and were included in the analyses. The co-primary outcome measures were the proportion of residents subject to interactional restraint and the severity of agitation using the Cohen-Mansfield Agitation Inventory (CMAI). Patients were assessed at baseline, immediately after completion of the intervention at 6 months, and 12 months after baseline. Comparison of change in the 2 groups was made using repeated-measures analysis of variance (CMAI) and Mann-Whitney test (restraints). The study was conducted from 2003 to 2004.
                The proportion of residents starting new restraint was lower in the intervention than in the control group at 6-month evaluation (P = .02), but no statistically significant differences were found at 12-month assessment (P = .57). The total CMAI score declined from baseline to 6 and 12 months' follow-up in the intervention homes compared to a small increase in the control homes (F2,176 = 3.46, P = .034). There were no statistically significant differences in use of antipsychotic drugs.
                A brief 2-day staff education program followed by continued monthly guidance was able both to improve quality of care by reducing the frequency of interactional restraints and to reduce severity of agitation.
                ©Copyright 2010 Physicians Postgraduate Press, Inc. To determine the effectiveness of two dissemination and implementation strategies to implement a national guideline for epilepsy management in primary care settings.
                Three-arm cluster-randomized controlled trial. The participants were general practitioners from 68 practices in Tayside, Scotland, and 1,133 of their patients with self-reported epilepsy treated with antiepileptic medications (AEDs). Practices were randomized blind to a control, intermediate, or intensive intervention. Control: Postal dissemination of a nationally developed clinical guideline. Intermediate intervention: Postal dissemination of the guideline supported by interactive, accredited workshops, and dedicated, structured protocol documents. Intensive intervention: Intermediate intervention plus a nurse specialist who supported and educated practices in the establishment of epilepsy review clinics. The primary outcome was the SF-36 health-related quality-of-life instrument. Secondary measures were a battery of prevalidated epilepsy-specific quality-of-life instruments. These were administered at baseline and after the intervention phase. Process of care was assessed by case-note review on number of review meetings and counseling sessions for epilepsy before and after the interventions.
                None of the intervention groups showed any change in the primary or secondary outcome measures or process-of-care measures.
                None of the intervention strategies led to improvements in patient quality of life or quality of epilepsy care. Further research is needed to discover why the interventions failed, to identify barriers to adoption of guidelines, and to develop strategies that might improve implementation and uptake in the future. To evaluate the effectiveness of a training and support intervention for nursing home staff in reducing the proportion of residents with dementia who are prescribed neuroleptics.
                Cluster randomised controlled trial with blinded assessment of outcome.
                12 specialist nursing homes for people with dementia in London, Newcastle, and Oxford.
                Residents of the 12 nursing homes; numbers varied during the study period.
                Training and support intervention delivered to nursing home staff over 10 months, focusing on alternatives to drugs for the management of agitated behaviour in dementia.
                Proportion of residents in each home who were prescribed neuroleptics and mean levels of agitated and disruptive behaviour (Cohen-Mansfield agitation inventory) in each home at 12 months.
                At 12 months the proportion of residents taking neuroleptics in the intervention homes (23.0%) was significantly lower than that in the control homes (42.1%): average reduction in neuroleptic use 19.1% (95% confidence interval 0.5% to 37.7%). No significant differences were found in the levels of agitated or disruptive behaviour between intervention and control homes.
                Promotion of person centred care and good practice in the management of patients with dementia with behavioural symptoms provides an effective alternative to neuroleptics. To assess the efficacy of a behavioral intervention designed to improve HIV medication adherence and reduce alcohol consumption among HIV-positive men and women.
                A randomized controlled trial conducted between July 2002 and August 2005.
                A behavioral research center in New York City.
                HIV-positive men and women (n = 143) who were on HIV antiretroviral medication and met criteria for hazardous drinking.
                Participants were randomly assigned to an 8-session intervention based on motivational interviewing and cognitive-behavioral skills building or a time- and content-equivalent educational condition.
                Viral load, CD4 cell count, and self-reported adherence and drinking behavior were assessed at baseline and at 3- and 6-month follow-ups.
                Relative to the education condition, participants in the intervention demonstrated significant decreases in viral load and increases in CD4 cell count at the 3-month follow-up and significantly greater improvement in percent dose adherence and percent day adherence. There were no significant intervention effects for alcohol use, however, and effects on viral load, CD4 cell count, and adherence were not sustained at 6 months.
                An 8-session behavioral intervention can result in improvement in self-report and biologic markers of treatment adherence and disease progression. This type of intervention should be considered for dissemination and integration into HIV clinics providing comprehensive care for HIV-positive persons with alcohol problems. Although the effect was attenuated over time, future studies might test the added effectiveness of booster sessions or ongoing adherence counseling. The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting.
                Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use) for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis.
                Data were available from case notes at baseline (n = 897) and seven months follow-up (n = 902), 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of "as required" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69-14.50). There was no statistically significant difference between groups for the numbers of patients "at risk of stroke" on aspirin at follow-up.
                While the strategy was well received by the physicians involved, there was no change in prescribing patterns. Patient care in residential settings is complex and involves contributions from the patient's physician, family and residential care staff. The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained.
Intensive reminders and 'implementation intention' interventions appear promising in enhancing adherence to antiepileptic mediations, however we need more reliable evidence on their efficacy from carefully designed randomised controlled trials before a firm conclusion can be reached.