scholarly journals Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

2019 ◽  
Vol 20 ◽  
Author(s):  
Iñaki Aguirrezabal ◽  
Maria Soledad Pérez de San Román ◽  
Raquel Cobos-Campos ◽  
Estibalitz Orruño ◽  
Arturo Goicoechea ◽  
...  
Keyword(s):  
Primary Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Basque Country ◽  
Intervention Group ◽  
Cost Effective ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

scholarly journals Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

2021 ◽  
Author(s):  
Stefan Morreel ◽  
Hilde Philips ◽  
Diana De Graeve ◽  
Koenraad G Monsieurs ◽  
Jarl Kampen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Predictive Values ◽  
Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

scholarly journals Triaging and referring in adjacent general and emergency departments (the TRIAGE trial): A cluster randomised controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258561
Author(s):  
Stefan Morreel ◽  
Hilde Philips ◽  
Diana De Graeve ◽  
Koenraad G. Monsieurs ◽  
Jarl K. Kampen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Triage System ◽  
Predictive Values ◽  
Randomised Controlled

Objectives To determine whether a new triage system safely diverts a proportion of emergency department (ED) patients to a general practitioner cooperative (GPC). Methods Unblinded randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was triage by a nurse using a new extension to the Manchester Triage System assigning low-risk patients to the GPC. During intervention weekends, patients were encouraged to follow this assignment; it was not communicated during control weekends (all patients remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care patients (the opinion of the treating physician was the gold standard). Results In the intervention group, 838/6294 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC, in the control group this was 431/1744 (24.7%, 95% CI 22.7 to 26.8). In total, 599/6294 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the reason for encounter, age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) were referred back to the ED, three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. Trial registration ClinicalTrials.gov Identifier: NCT03793972

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

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

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial

2021 ◽  
pp. BJGP.2021.0211
Author(s):  
Irma Bonvanie ◽  
Anouk AH Weghorst ◽  
Gea Holtman ◽  
Heleen A Russchen ◽  
Freek Fickweiler ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Acute Gastroenteritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Parental Satisfaction ◽  
Control Group ◽  
Out Of Hours ◽  
Randomised Controlled ◽  
Oral Ondansetron

Background: Acute gastroenteritis affects almost all children younger than 5 years. Due to vomiting the standard oral rehydration therapy (ORT) treatment is less effective. In secondary care, ondansetron was found to be effective in reducing vomiting. Aim: To determine the effectiveness of adding oral ondansetron to care-as-usual on vomiting in children with acute gastroenteritis attending out-of-hours primary care. Design and setting: A pragmatic randomised controlled trial with a follow-up of 7 days, at three out-of-hours primary care centres. Method: Inclusion criteria: 1) age 6 months to 6 years, 2) acute gastroenteritis diagnosed by a general practitioner, 3) at least four reported episodes of vomiting in the 24 hours before presentation, 4) at least one reported episode of vomiting in the 4 hours before presentation, and 5) written informed consent from both parents. The control group received care-as-usual (ORT). The intervention group received care-as-usual plus one dose of oral ondansetron (0.1 mg/kg). Results: In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within 4 hours from 42.9% to 19.5%, with an odds ratio of 0.37 (95% CI = 0.20–0.72, NNT 4). Ondansetron also decreased the number of vomiting episodes within 4 hours, incidence rate ratio of 0.51 (95% CI, 0.29-0.88), and improved overall parental satisfaction with treatment (p = 0.027). Conclusions: Ondansetron decreased vomiting and increased parental satisfaction in children with acute gastroenteritis. We were not able to show an increased ORT intake or decrease in referral rate.

Telementoring for improving primary care provider knowledge and competence in managing chronic pain: A randomised controlled trial

2018 ◽  
Vol 26 (1-2) ◽  
pp. 21-27 ◽  
Author(s):  
Linda H Eaton ◽  
Daniel S Godfrey ◽  
Dale J Langford ◽  
Tessa Rue ◽  
David J Tauben ◽  
...  
Keyword(s):  
Primary Care ◽  
Chronic Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Care Providers ◽  
Perceived Competence ◽  
Control Group ◽  
Care Providers ◽  
Knowledge And Attitudes ◽  
Randomised Controlled

Introduction Primary care providers are frequently unprepared to manage chronic pain adequately due in part to insufficient professional training. This study evaluated the effect of a telementoring intervention on knowledge and perceived competence related to chronic pain management. Methods The study design was a cluster randomised controlled trial. Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization. Primary care providers comprised the intervention group ( n = 23) and the control group ( n = 18). Providers in the intervention group attended telementoring sessions through the TelePain programme and presented patient cases at the beginning and end of their enrolled patients’ 12-week study period. TelePain sessions included a didactic presentation and telementoring for specific patient cases by a panel of pain specialists from the disciplines of pain medicine, internal medicine, anaesthesiology, rehabilitation medicine, psychiatry, addiction medicine, nursing and complementary and integrative pain management. Providers’ baseline and end-of-study knowledge and perceived competence in managing chronic pain were assessed by three questionnaires: Knowledge and Attitudes Survey Regarding Pain, the KnowPain-12 and the Perceived Competence Scale. Results Knowledge (Z = –0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = –0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group. These providers attended on average 12.5 sessions (range 0–31) while participating in the study. Discussion Further research is recommended to establish the effectiveness of this telementoring intervention.

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

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036799 ◽  
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.

scholarly journals Medication reconciliation knowledge among hospital pharmacists in Nigeria: A non-randomised controlled trial

2021 ◽  
pp. 528-537
Author(s):  
Akinniyi A. Aje ◽  
Segun J. Showande ◽  
Titilayo O. Fakeye
Keyword(s):  
Randomised Controlled Trial ◽  
Educational Intervention ◽  
Medication Reconciliation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
College Hospital ◽  
Tertiary Hospitals ◽  
Randomised Controlled

Background: Medication reconciliation (MR) is a patient-centred evolving role of pharmacists that improves patient’s health outcomes. Aim: To assess the effect of an educational intervention on pharmacists’ MR knowledge in two Nigerian tertiary hospitals. Methods: A two-arm parallel non-randomised controlled trial was carried out at two tertiary hospitals in Nigeria, one as intervention and the other as control site. Pharmacists’ MR knowledge was assessed pre-intervention and at one-, three- and six-month post-intervention. The intervention consisted of seminar and role-plays. Data were summarised with descriptive and inferential statistics. Results: A total of 75 pharmacists completed the study. Scores for pre-intervention out of a total of 38 was 19.31±4.76 in the intervention group and 17.50±6.86 in the control group. Post-intervention assessment scores (University College Hospital vs University of Ilorin Teaching Hospital) at one, three and six months were 29.82±5.01 vs 25.97±5.31, 31.53±4.99 vs 26.10±5.20, and 31.69±4.10 vs 23.07±3.98, respectively (p < 0.01). Conclusion: The educational intervention led to improved pharmacists’ MR knowledge.

scholarly journals Using laxatives and/or enemas to accelerate the diagnosis in children presenting with acute abdominal pain: a randomised controlled trial study protocol

2018 ◽  
Vol 2 (1) ◽  
pp. e000341
Author(s):  
Marjolijn E W Timmerman ◽  
Monika Trzpis ◽  
Paul M A Broens
Keyword(s):  
Abdominal Pain ◽  
Randomised Controlled Trial ◽  
Acute Appendicitis ◽  
Acute Abdominal Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Adequate Treatment ◽  
Randomised Controlled

IntroductionMany children with acute abdominal pain and suspicion of appendicitis are diagnosed with constipation. Nevertheless, it can be difficult to differentiate between acute constipation and acute appendicitis because of similar symptoms and lack of diagnostic criteria. Consequently, constipation is often missed despite repeated consultations at the emergency department. We hypothesise that the diagnostic process can be improved and adequate treatment accelerated by supporting faecal evacuation in children with acute abdominal pain.Methods and analysisAn unblinded randomised controlled trial including children aged between 5 years and 18 years with acute abdominal pain and suspicion of acute appendicitis. Children who do not have a definitive diagnosis after the first consultation and who need to return for a second consultation will be randomised. The intervention group will receive laxatives and enemas, while the control group will receive no medication. If, after the second consultation, still no diagnosis is established, and a third consultation is needed, then the intervention group will receive only laxatives, and the control group will again not receive medication. The primary outcome will be the differences in abdominal pain scores obtained with FACES Pain Rating Scale and the visual analogue scale at first, second and possibly third consultation. The secondary outcome will be the number of consultations needed to reach final diagnosis.Ethics and disseminationLaxatives and enemas have proven to be safe and effective treatments for constipation in children. Adverse events are therefore not expected, however, should they occur, then the child concerned shall be properly followed and treated until the event is over. The local Medical Research Ethics Committee approved of this study and waived the otherwise mandatory insurance for human test subjects.Trial registration numbersPre-results: CCMO NL44710.042.12 andEudraCT 2013-000498-56.

Self-care educational intervention to reduce hospitalisations in heart failure: A randomised controlled trial

2017 ◽  
Vol 17 (2) ◽  
pp. 178-185 ◽  
Author(s):  
M Boyde ◽  
R Peters ◽  
N New ◽  
R Hwang ◽  
T Ha ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Educational Intervention ◽  
Hospital Readmission ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Patients With Heart Failure ◽  
Randomised Controlled

Background: A variety of educational interventions have been implemented to assist patients with heart failure to maintain their own health, develop self-care behaviours and decrease readmissions. Aims: The purpose of this study was to determine the effectiveness of a multimedia educational intervention for patients with heart failure in reducing unplanned hospital readmissions. Methods: The study, a randomised controlled trial in a large tertiary referral hospital in Australia, recruited 200 patients. Patients diagnosed with heart failure were randomly allocated 1:1 to usual education or a multimedia educational intervention. The multimedia approach began with an individual needs assessment to develop an educational plan. The educational intervention included viewing a DVD, and verbal discussion supported by a written manual with a teach-back evaluation strategy. The primary outcome was all-cause unplanned hospital readmission at 28 days, three months and 12 months post-recruitment. The secondary outcomes were changes in knowledge and self-care behaviours at three months and 12 months post-recruitment. Results: At 12 months, data on 171 participants were analysed. There were 24 participants who had an unplanned hospital readmission in the intervention group compared to 44 participants in the control group ( p=0.005). The self-care educational intervention reduced the risk of readmission at 12 months by 30% (relative risk: 0.703; 95% confidence interval: 0.548–0.903). Conclusion: A targeted multimedia educational intervention can be effective in reducing all-cause unplanned readmissions for people with heart failure.

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