A Randomised Controlled Trial of Pharmacist Medication Histories and Supplementary Prescribing on Medication Errors in Postoperative Medications

Errors in the management of regular medications at the time of hospital admission are common. This randomised controlled three-arm parallel-group trial examined the impact of pharmacist medication history taking and pharmacist supplementary prescribing on unintentional omissions of postoperative medications in a large perioperative service. Participants included elective surgical patients taking regular medications with a postoperative hospital stay of one night or more. Patients were randomly assigned, on admission, to usual care (n=120), a pharmacist medication history only (n=120) or pharmacist medication history and supplementary prescribing (n=120). A medication history involved the pharmacist interviewing the patient preoperatively and documenting a medication history in the medical record. In the supplementary prescribing group the patients’ regular medicines were also prescribed on the inpatient medication chart by the pharmacist, so that dosing could proceed as soon as possible after surgery without the need to wait for medical review. The estimate marginal mean number of missed doses during a patients hospital stay was 1.07 in the pharmacist supplementary prescribing group, which was significantly less than both the pharmacist history group (3.30) and the control group (3.21) (P <0.001). The number of medications charted at an incorrect dose or frequency was significantly reduced in the pharmacist history group and further reduced in the prescribing group (P <0.001). We conclude that many patients miss doses of regular medication during their hospital stay and preoperative medication history taking and supplementary prescribing by a pharmacist can reduce this.

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Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2020-000376 ◽

2020 ◽

Vol 7 (1) ◽

pp. e000376

Author(s):

Sivakami Janahiraman ◽

Chan Yen Tay ◽

Jie Min Lee ◽

Wen Ling Lim ◽

Chun Hoe Khiew ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

Tertiary Hospital ◽

Educational Programme ◽

Control Group ◽

Randomised Controlled ◽

The Impact ◽

Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

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A randomised controlled trial of the impact of increased therapy levels on duration of hospital stay in a rehabilitation medicine unit.

http://isrctn.org/> ◽

10.1186/isrctn80381661 ◽

2012 ◽

Author(s):

M Anne Chamberlain

Keyword(s):

Randomised Controlled Trial ◽

Hospital Stay ◽

Controlled Trial ◽

Rehabilitation Medicine ◽

Duration Of Hospital Stay ◽

Randomised Controlled ◽

The Impact

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Cluster randomised controlled trial of an online intervention to prevent ecstasy and new psychoactive substance use among adolescents: final results and implications for implementation

BMJ Open ◽

10.1136/bmjopen-2017-020433 ◽

2018 ◽

Vol 8 (11) ◽

pp. e020433 ◽

Cited By ~ 1

Author(s):

Katrina E Champion ◽

Nicola Clare Newton ◽

Lexine Stapinski ◽

Maree Teesson

Keyword(s):

Randomised Controlled Trial ◽

Health Education ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Online Intervention ◽

Control Group ◽

Full Dose ◽

Cluster Randomised ◽

Randomised Controlled ◽

The Impact

ObjectivesTo evaluate the effectiveness of the onlineClimate Schools: Ecstasy and Emerging Drugs moduleover 2 years, and examine the impact of intervention dose on outcomes.DesignCluster randomised controlled trial.SettingSecondary schools in Australia.Participants1126 students (aged 14.9 years) from 11 schools.InterventionFive schools were randomly allocated to the four-lesson internet-basedClimate Schools: Ecstasy and Emerging Drugsmodule. This universal intervention uses cartoon storylines to deliver harm-minimisation information about ecstasy and new psychoactive substances (NPS). It was delivered during health education classes over 4 weeks. Six schools were randomised to the control group (health education as usual). Participants were not blinded to intervention allocation.Outcomes measuresStudents completed self-report surveys at baseline, post-test, 6, 12 and 24 months post-baseline. Intentions to use ecstasy and NPS (including synthetic cannabis and synthetic stimulants), knowledge about ecstasy and NPS and lifetime use of ecstasy and NPS were assessed. This paper reports the results at 24 months post-baseline.AnalysisMixed effects regressions were conducted to analyse intervention effects from baseline to 24 months. Post hoc analyses using Inverse Probability of Treatment Weighting compared controls with students who: i) completed all four lessons (‘full dose’) and ii) partially completed the intervention (≤three lessons, ‘incomplete dose’).ResultsPrimary analyses found that controls were significantly more likely to intend on using synthetic cannabis compared with intervention group students (OR=3.56, p=0.01). Results from the weighted analyses indicated that controls reported significantly lower knowledge about ecstasy (p=0.001) and NPS (p=0.04) compared with the full-dose group. No significant differences were observed between the incomplete dose and control groups.ConclusionsThe online intervention was effective in modifying students’ intentions to use synthetic cannabis up to 24 months; however, this study highlights the importance of delivering prevention programmes in full to maximise student outcomes.Trial registration numberACTRN12613000708752.

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Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037251 ◽

2020 ◽

Vol 10 (3) ◽

pp. e037251

Author(s):

Lindsay Jibb ◽

Paul C Nathan ◽

Vicky Breakey ◽

Conrad Fernandez ◽

Donna Johnston ◽

...

Keyword(s):

Real Time ◽

Pain Treatment ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Trial ◽

Control Group ◽

Management Support ◽

Scientific Meetings ◽

Randomised Controlled ◽

The Impact

IntroductionPain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.Methods and analysisThis will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.Ethics and disseminationThis trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.Trial registration numberNCT03632343(ClinicalTrials.gov).

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Impact of convex ostomy appliances on leakage frequency, peristomal skin health and stomal protrusion

Gastrointestinal Nursing ◽

10.12968/gasn.2021.19.sup9.s30 ◽

2021 ◽

Vol 19 (Sup9) ◽

pp. S30-S37

Author(s):

Eugenia Rodriguez González ◽

Carmen del Pino Zurita ◽

Gemma Arrontes Caballero ◽

Araceli Hoyo Rodríguez ◽

Eugenia Zapatero Rodríguez ◽

...

Keyword(s):

Patient Satisfaction ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Anova Analysis ◽

Independent Variables ◽

Peristomal Skin ◽

Randomised Controlled ◽

The Impact

Aim: The Convexity in Ostomy (ECOS) study measured the impact of soft convex ostomy appliances on leakage frequency, peristomal skin health, and patient satisfaction, as well as stomal protrusion and body profile. Methods: This prospective non-randomised controlled trial included people with a stoma, divided into a control group using a convex appliance throughout (Alterna Confort Convex or Easiflex Confort Convex Light, Coloplast A/S, Humlebæk, Denmark), and an intervention group who were using a flat appliance at baseline before switching to a convex appliance for the rest of the study. Leakage frequency was counted within the past 2 weeks; peristomal skin health was assessed using the discolouration, erosion and tissue overgrowth (DET) Ostomy Skin Tool; and patient satisfaction was measured with a 0-10 Likert scale of self-reported satisfaction with the appliance. Measurements were taken at three visits: baseline (V1), 2-8 weeks (V2) and 6 months (V3). The Kruskal-Wallis and analysis of variance (ANOVA) tests were used for comparison. Multiple regression analysis was used to evaluate the effect of independent variables on the change in leakage frequency and DET score between baseline and 6 months. Findings: Of 253 participants screened, 245 completed the follow-up, with 151 in the intervention group and 94 in the control group. Mean leakage frequency period went from 5.85 ± 5.55 (V1) to 0.63 ± 1.42 (V2) and 0.23 ± 0.75 (V3) (p<.0001). Mean DET score changed from 4.8 ± 3.47 (V1) to 1.41 ± 2.17 (V2) and 0.54 ± 1.57 (V3) (p<.0001). Mean satisfaction changed from 6.0 ± 2.25 (V1) to 8.6 ± 1.14 (V2) and 9.17 ± 0.93 (V3) (p<.0001). From V1 to V3, the proportion of patients with a depressed peristomal area went from 45.7% to 31.4%, a normal peristomal area went from 45.3% to 65.3%, stoma protrusion went from 31.4% to 47.3% and stoma retraction went from 28.6% to 15.5%. By group, mean leakage frequency decreased in the intervention group by 7.65, from 7.57 to 0.11, and in the control group by 2.37, from 2.94 to 0.46 (p<0.0001). Multiple ANOVA analysis confirmed independent variables in reducing leakage to be initiating convexity and appliance coupling. By group, mean DET score decreased in the intervention group by 4.82, from 5.24 to 0.42, and in the control group by 3.52, from 4.34 to 0.76. Multiple ANOVA analysis showed independent variables for DET score to be initiating convexity, emergency surgery and stoma siting. Conclusion: People with a stoma experiencing repeated leakage benefitted from shifting from a flat to a soft convex appliance in terms of leakage frequency, peristomal skin health, stomal protrusion and body profile.

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Financial disincentives? A three-armed randomised controlled trial of the effect of financial Incentives in Diabetic Eye Assessment by Screening (IDEAS) trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-311778 ◽

2018 ◽

Vol 102 (8) ◽

pp. 1014-1020 ◽

Cited By ~ 4

Author(s):

Gaby Judah ◽

Ara Darzi ◽

Ivo Vlaev ◽

Laura Gunn ◽

Derek King ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Financial Incentives ◽

Controlled Trial ◽

Control Group ◽

Attendance Rates ◽

Incentive Group ◽

Eye Screening ◽

Diabetic Eye Screening ◽

Randomised Controlled ◽

The Impact

ObjectiveConflicting evidence exists regarding the impact of financial incentives on encouraging attendance at medical screening appointments. The primary aim was to determine whether financial incentives increase attendance at diabetic eye screening in persistent non-attenders.Methods and analysisA three-armed randomised controlled trial was conducted in London in 2015. 1051 participants aged over 16 years, who had not attended eye screening appointments for 2 years or more, were randomised (1.4:1:1 randomisation ratio) to receive the usual invitation letter (control), an offer of £10 cash for attending screening (fixed incentive) or a 1 in 100 chance of winning £1000 (lottery incentive) if they attend. The primary outcome was the proportion of invitees attending screening, and a comparative analysis was performed to assess group differences. Pairwise comparisons of attendance rates were performed, using a conservative Bonferroni correction for independent comparisons.Results34/435 (7.8%) of control, 17/312 (5.5%) of fixed incentive and 10/304 (3.3%) of lottery incentive groups attended. Participants who received any incentive were significantly less likely to attend their appointment compared with controls (risk ratio (RR)=0.56; 95% CI 0.34 to 0.92). Those in the probabilistic incentive group (RR=0.42; 95% CI 0.18 to 0.98), but not the fixed incentive group (RR=1.66; 95% CI 0.65 to 4.21), were significantly less likely to attend than those in the control group.ConclusionFinancial incentives, particularly lottery-based incentives, attract fewer patients to diabetic eye screening than standard invites in this population. Financial incentives should not be used to promote screening unless tested in context, as they may negatively affect attendance rates.

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Clinical Pathways Based on Integrative Medicine in Chinese Hospitals Improve Treatment Outcomes for Patients with Acute Myocardial Infarction: A Multicentre, Nonrandomized Historically Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/821641 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 7

Author(s):

Lei Wang ◽

Minzhou Zhang ◽

Liheng Guo ◽

Jianyong Qi ◽

Haiming Luo ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Hospital Stay ◽

Integrative Medicine ◽

Clinical Pathways ◽

Controlled Trial ◽

Length Of Hospital Stay ◽

Control Group ◽

Hospitalization Period ◽

The Impact

Objective. To determine the impact of an integrative medicine clinical pathways (CPs) on the length of in-hospital stay and on outcomes for patients with acute myocardial infarction (AMI).Methods. A multicenter nonrandomized controlled trial enrolling 197 consecutive patients with AMI at eight urban TCM hospitals was conducted between 1 January 2010 and 31 October 2010. These patients were enrolled in the interventional group after the CPs had been implemented. The control group included 405 patients with AMI from eight hospitals; these patients were treated between 1 January 2008 and 31 December 2009, before the CPs were implemented. Outcome measures were the length of hospital stay costs of medical care, and major cardiovascular events (MACEs) during hospitalization.Results. Compared with the control group, the patients in intervention group had a shorter length of hospital stay (9.2±4.2days versus12.7±8.6days,P<0.05), and reduced healthcare costs in hospital (46365.7±18266.9versus52866.0±35404.4,P<0.05). There were statistically significant differences in MACE between the two groups during the hospitalization period (2.5% versus 6.9%,P=0.03).Conclusion. These data suggest that the development and implementation of the clinical pathways based in Integrative Medicine could further improve quality of care and outcome for patients with AMI.

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Improving admission medication reconciliation with pharmacists or pharmacy technicians in the emergency department: a randomised controlled trial

BMJ Quality & Safety ◽

10.1136/bmjqs-2017-006761 ◽

2017 ◽

Vol 27 (7) ◽

pp. 512-520 ◽

Cited By ~ 18

Author(s):

Joshua M Pevnick ◽

Caroline Nguyen ◽

Cynthia A Jackevicius ◽

Katherine A Palmer ◽

Rita Shane ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Future Research ◽

Control Group ◽

Reference Standard ◽

Multiple Sources ◽

Medication History ◽

Pharmacy Staff ◽

Pharmacy Technicians ◽

Randomised Controlled

BackgroundAdmission medication history (AMH) errors frequently cause medication order errors and patient harm.ObjectiveTo quantify AMH error reduction achieved when pharmacy staff obtain AMHs before admission medication orders (AMO) are placed.MethodsThis was a three-arm randomised controlled trial of 306 inpatients. In one intervention arm, pharmacists, and in the second intervention arm, pharmacy technicians, obtained initial AMHs prior to admission. They obtained and reconciled medication information from multiple sources. All arms, including the control arm, received usual AMH care, which included variation in several common processes. The primary outcome was severity-weighted mean AMH error score. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life threatening. Each error was assigned 1, 4 or 9 points, respectively, to calculate severity-weighted AMH and AMO error scores for each patient.ResultsPatient characteristics were similar across arms (mean±SD age 72±16 years, number of medications 15±7). Analysis was limited to 278 patients (91%) with reference standard AMHs. Mean±SD AMH errors per patient in the usual care, pharmacist and technician arms were 8.0±5.6, 1.4±1.9 and 1.5±2.1, respectively (p<0.0001). Mean±SD severity-weighted AMH error scores were 23.0±16.1, 4.1±6.8 and 4.1±7.0 per patient, respectively (p<0.0001). These AMH errors led to a mean±SD of 3.2±2.9, 0.6±1.1 and 0.6±1.1 AMO errors per patient, and mean severity-weighted AMO error scores of 6.9±7.2, 1.5±2.9 and 1.2±2.5 per patient, respectively (both p<0.0001).ConclusionsPharmacists and technicians reduced AMH errors and resultant AMO errors by over 80%. Future research should examine other sites and patient-centred outcomes.Trial registration numberNCT02026453.

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Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-036799 ◽

2020 ◽

Vol 10 (5) ◽

pp. e036799 ◽

Cited By ~ 1

Author(s):

David Blanco ◽

Sara Schroter ◽

Adrian Aldcroft ◽

David Moher ◽

Isabelle Boutron ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Peer Review ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Randomised Trials ◽

Randomised Controlled ◽

The Impact ◽

Completeness Of Reporting

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.

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