scholarly journals O26 Testing an intervention to reduce fatigue impact in inflammatory arthritis: design and outcomes of a single-arm feasibility study

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Susan Bridgewater ◽  
Joe Lomax ◽  
Bryan Abbott ◽  
Jo Adams ◽  
Alice Berry ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Inflammatory Arthritis ◽  
Primary Outcome ◽  
Time Frame ◽  
Secondary Outcome ◽  
Control Group ◽  
Regression To The Mean ◽  
Intervention Delivery ◽  
Cognitive Behavioural ◽  
One To One

Abstract Background/Aims  Patients with inflammatory arthritis report that fatigue can be a challenging symptom to manage, with little support available. In response, we developed a brief one-to-one cognitive-behavioural manualised intervention, delivered by rheumatology health professionals (RHPs), to help patients manage their fatigue. Methods  We designed a single-arm feasibility study called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis). Patients were eligible if they were ≥18 years, had a clinician confirmed diagnosis of inflammatory arthritis, scored ≥6/10 on the BRAF NRS Fatigue Impact with fatigue that they considered recurrent, frequent, and/or persistent, and were not accessing support for their fatigue. Following training, RHPs delivered 2-4 one-to-one sessions to participants. The initial two core sessions were delivered face-to-face in clinic; participants then had the option of up to two further sessions, either in clinic, by telephone or online. We proposed delivering sessions 1 and 2 within two weeks of each other, and sessions 3 and 4 in the following two weeks. Baseline data were collected before the first session (T0), and outcomes at six weeks (T1) and six months (T2). The primary outcome was fatigue impact (BRAF NRS Fatigue Effect), collected by telephone. Secondary outcomes included fatigue severity, fatigue coping, multi-dimensional impact of fatigue, disease impact and disability and measures of therapeutic mechanism (self-efficacy, and perceived confidence and autonomy to manage health). These outcomes were collected by post. This study allowed us to test the feasibility and acceptability of RHP training, study design and materials, intervention delivery and outcome collection, ahead of a possible RCT to determine intervention effectiveness. Results  Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Four sessions were delivered by phone and none online. Session 2 was only delivered within the two-week time frame for 37% of participants attending both core sessions. Out of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 missing primary outcome responses and 27 missing secondary outcome responses. Results indicated improvements in all measures except disability at either T1 or T2, or both, with confidence intervals supporting an interpretation of improvement. Conclusion  We were able to design and deliver FREE-IA training to RHPs, deliver FREE-IA sessions to patients, and collect outcomes at three time points with low levels of attrition. Outcomes in all measures except disability were in a direction to suggest improvement at T1, T2, or both. Study numbers were small, there was no control group and regression to the mean was a possibility. However, outcomes were in the direction to cautiously suggest benefit, and there is evidence of promise of the intervention. A definitive RCT is the next step to test clinical and cost effectiveness of the intervention. Disclosure  S. Bridgewater: None. J. Lomax: None. B. Abbott: None. J. Adams: None. A. Berry: None. S. Creanor: None. P. Ewings: None. S. Hewlett: None. L. McCracken: None. M. Ndosi: None. J. Thorn: None. M. Urban: None. E. Dures: None.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Katrin Brück ◽  
Kirsten Jacobi ◽  
Tobias Schmidt
Keyword(s):  
Neck Pain ◽  
Manual Therapy ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Control Group ◽  
Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

P–328 Dienogest significantly decreases the size of the cyst and alters Anti-Müllerian Hormone concentration in patients with endometrioma

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
E Karataş ◽  
B E Temiz ◽  
S Mumusoglu ◽  
H Yarali ◽  
G Bozdag
Keyword(s):  
Primary Outcome ◽  
Statistical Significance ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Control Group ◽  
Significant Drop ◽  
Mean Size ◽  
The Mean ◽  
Respective Figure

Abstract Study question Does utilization of dienogest make any impact on the size of cyst and Anti-Müllerian Hormone (AMH) concentration in patients with endometrioma throughout 12-months? Summary answer Although dienogest makes a gradual reduction in the size of endometrioma cyst throughout 12-months, a significant drop in AMH serum concentration was also noticed. What is known already According to recent studies, pre-operative serum AMH levels might be illusively increased with parallel to the size of endometrioma which will be a misleading factor while deciding to operate the patient via cystectomy. Although dienogest is one of the medical options that might be commenced in patients with endometrioma cyst, there is limited data about its effect on the size of the endometrioma and hence serum AMH concentration throughout 12 months of follow up. Study design, size, duration The current observational cohort study was conducted among patients with endometrioma those treated with dienogest from January 2017 to January 2020. The primary outcome was alteration in diameter of endometrioma cyst at 6th and 12th months of treatment. Secondary outcome was alteration in serum AMH concentration in the same period. Of 104 patients treated with dienogest, 44 patients were excluded due to being treated with any type of surgical intervention during follow up period. Participants/materials, setting, methods A total of 60 patients were recruited for the final analysis. Of them, primary symptom was dysmenorrhea, chronic pelvic pain and menstrual irregularity in 16 (26.7%), 25 (41.7%) and 8 (13.3%) patients, respectively. Eighteen patients (30%) were asymptomatic. As 21 patients had bi-lateral endometrioma, size of the leading cyst was considered to be analyzed for the primary outcome measure. Paired-t test was used for comparison of numerical values and p ≤ 0.05 was taken as statistical significance. Main results and the role of chance The mean age was 31.5±8.0 years. In the time point when dienogest was started, the mean size of the endometrioma was 46.3±17.4 mm. The mean serum AMH concentration was 3.6±2.4 ng/ml. After 6 months of treatment, the mean size of the endometrioma decreased to 38.6±14.0 mm which corresponds to a mean difference of 7.8 mm (95% CI: 3.0 to 12.6; p: 0.003). The respective figure for AMH was 3.3±2.7 ng/ml which corresponds to a mean difference of 0.3 ng/ml (95% CI: –0.2 to 0.8; p: 0.23) at 6 months. After 12 months of treatment, the mean size of the endometrioma was 37.5±15.7 mm which corresponds to a mean difference of 8.9 mm (95% CI: 2.9 to 14.9; p: 0.005) at the end of 12 months. The respective figure for AMH was 2.7±1.9 ng/ml which corresponds to a mean difference of 0.9 ng/ml (95% CI: 0.1 to 1.7; p: 0.045) at the end of 12 months. The mean diameter of endometrioma and AMH concentration did not differ throughout the time period between 6th and 12th months of the treatment. Limitations, reasons for caution Although herein we present the largest data that depicts the alteration of endometrioma cyst and AMH concentration with the application of dienogest, the lack of control group is a limitation that avoids to perform any comparison. Wider implications of the findings: A shrinkage after commencement of treatment suggest that dienogest might present improvement in patients with endometrioma with respect to radiological findings, but further studies are required whether a decline in AMH concentration after 12 months refers to a genuine decrease in ovarian reserve or resolution of misleading high pre-treatment levels. Trial registration number not available

Abstract WP221: Very Brief Intervention Improves Stroke Response in a Randomized Trial: Stroke Ready Very Brief Intervention

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lesli E Skolarus ◽  
Maria Cielito Robles ◽  
Springer Mellanie ◽  
Chun Chieh Lin ◽  
Casey Corches ◽  
...  
Keyword(s):  
Brief Intervention ◽  
Action Plan ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Average Score ◽  
Control Group ◽  
Symptom Recognition ◽  
Stroke Symptom ◽  
One To One

Introduction: Stroke pre-hospital delay has not improved over time. Hypothesis: Stroke Ready, a very brief (5 minute), theory based, peer-led, stroke preparedness intervention, will increase stroke response compared with a control intervention. Methods: We performed a randomized, single-blind controlled trial among adults in Flint, MI. The stroke preparedness intervention group received a Stroke Ready pamphlet and action plan, while the control group received stroke prevention materials - both delivered during a one-to-one interaction with a trained peer educator. Research staff, blinded to group intervention assignment, assessed baseline and immediate post-intervention outcomes. Primary outcome was change in stroke response (behavioral intent to call 911) using a community-modified stroke action test (range 0-12). Secondary outcome was change in stroke symptom recognition (range 0-8). We conducted descriptive analyses and used a linear regression model to evaluate the effect of the intervention on stroke response after adjustment for pre-intervention intent, age, education, race, marital status, history of stroke, stroke in someone they know and psychological constructs. Results: We enrolled 129 participants (74 intervention; 55 control). Mean age was 60 years (SD 14); 61% were women, 89% were African American and 19% were not high school graduates. Intervention participants had greater improvement in stroke response than control participants (figure 1), which remained after full adjustment (improvement in average score for stroke response was 1.7 higher in intervention participants than control participants, 95% CI 0.9-2.5, p<0.0001). There was no difference in stroke symptom recognition (figure 1). Conclusion: The Stroke Ready very brief intervention increased stroke response. This new approach using a very brief, one-to-one interaction with trained peer educators is a promising, scalable, intervention to increase stroke response.

scholarly journals Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019350 ◽  
Author(s):  
Susanne van de Hei ◽  
Steven McKinstry ◽  
George Bardsley ◽  
Mark Weatherall ◽  
Richard Beasley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Vitamin C ◽  
Feasibility Study ◽  
Common Cold ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pcr Analysis ◽  
Control Group ◽  
The Common ◽  
Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

Prescription for Education: Development, Evaluation, and Implementation of a Successful Interprofessional Education Program for Adults with Inflammatory Arthritis

2011 ◽  
Vol 38 (10) ◽  
pp. 2247-2257 ◽  
Author(s):  
CAROL A. KENNEDY ◽  
DORCAS E. BEATON ◽  
KELLY WARMINGTON ◽  
RACHEL SHUPAK ◽  
CAROLINE JONES ◽  
...  
Keyword(s):  
Self Efficacy ◽  
Interprofessional Education ◽  
Inflammatory Arthritis ◽  
Primary Outcome ◽  
Care Delivery ◽  
Self Report ◽  
Control Group ◽  
Patient Feedback ◽  
Main Effect ◽  
Secondary Outcomes

Objective.To assess the feasibility of recruitment and standardize care delivery for an interprofessional program for inflammatory arthritis education (Prescription for Education, or RxEd), and to explore outcomes relevant to arthritis patient education.Methods.A patient-based needs assessment and ongoing patient feedback guided program development. An interprofessional team was involved in developing program content and delivering and adapting the program to patient needs. A quasiexperimental, waitlisted control with crossover design was used to evaluate the program. Data were collected at baseline, immediately following intervention, at 6 months (when the crossover control group received intervention), and at 1 year. Self-report measures included demographics, disorder-related data, Arthritis Self-efficacy Scale, arthritis knowledge, coping efficacy, and illness intrusiveness. Analysis included baseline comparisons and longitudinal trends; direct between-group comparison at 6 months; and generalized estimating equations (GEE) analysis to evaluate the main effect of the intervention on the primary outcome (arthritis self-efficacy) and secondary outcomes.Results.Program modifications based on patient input made recruitment possible. Forty-two persons participated (including 19 controls), with 93% followup at 1 year. Comparison of change shows moderate effect sizes (standardized effect size 0.5 to 0.7). GEE analysis showed significant main effect, before to after the program, in both groups for primary outcome (arthritis self-efficacy) and most secondary outcomes.Conclusion.Program feasibility was dependent on patient feedback. Our pilot study provides evidence that the RxEd program is feasible and improves arthritis self-efficacy and other outcomes.

Low Bacterial Diet in Patients with Cytopenia after Intensive Chemotherapy for Hematological Malignancy: A Study of Efficacy and Costs.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5548-5548
Author(s):  
Harry C. Schouten ◽  
Peter Terporten ◽  
Maartje Harbers ◽  
Riette van Boxtel ◽  
Alphons Kessels ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Preventive Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Study Group ◽  
Risk Of Infection ◽  
Outcome Parameter ◽  
Societal Costs ◽  
Gram Negative ◽  
To Receive

Abstract Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. The evidence for the necessity of low bacterial diet as an infection preventive measure is weak. Therefore, in this randomized, controlled study the question whether normal hospital diet is equivalent in efficacy to low bacterial diets, given as an infection preventive measure during treatment of cytopenic patients, was addressed. Intestinal colonization by aerobic Gram negative rods and yeasts has been chosen as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care have been documented, in order to identify potential cost savings by the use of either diet. The patients were randomized into two groups: one group (Study group) to receive antimicrobial prophylaxis (AP) and low-bacterial diet, the other (Control group) to receive the same AP and normal hospital diet. The primary outcome parameter is colonization of faeces with Gram-negative rods or Candida species. Degree of colonization was calculated as [∑ 10log (CFU/g feces)] x [duration of episode] /[number of days on which feces culture were taken]. Next, an analysis of variance was performed taking several factors into account, such as the use of antibiotics. As secondary outcome parameters all infections, and therapeutic use of antibiotics were registered; moreover, total societal costs were calculated for each patient starting at first hospitalization until 28 days after the last discharge. In the study group 10 patients were included and evaluable, in the control group 10 patients were included and 9 evaluable. The number of cycles studied, defined as the period from starting antibiotic prophylaxis until leukocyte counts had recovered to 1000 /mm3 or higher, was 21 in the study group, and 18 in the control group. The median number of days per cycle was 28 (range 17–43) days for the study group, and 34 (range 19–60) days for the control group (NS). Regarding the primary outcome parameter, gut colonization by yeasts or Gram negative rods, no statistically significant differences between treatment groups were observed. With respect to infections as secondary outcome parameter, neither the number of days with fever nor the number of days, during which antibiotics were administered therapeutically, was different between the study and control group of patients. The numbers of fungal infections were no cases of invasive aspergillosis (IA) in the study group, 2 episodes of possible aspergillosis in the control group, and in both groups one episode of candidemia. Regarding the total societal costs no statistically significant differences were measured between normal diet and low-bacterial diet. The results indicate that low-bacterial diet and normal hospital diet are equivalent regarding colonization with yeasts and Gram negative rods, infections and total societal costs.

scholarly journals Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye

2018 ◽  
Vol 103 (5) ◽  
pp. 648-653 ◽  
Author(s):  
Marcel Y Avila ◽  
Angela M Igua ◽  
Amparo M Mora
Keyword(s):  
Hyaluronic Acid ◽  
Outcome Measures ◽  
Dry Eye ◽  
Primary Outcome ◽  
Platelet Rich Plasma ◽  
Intervention Group ◽  
Treatment Compliance ◽  
Secondary Outcome ◽  
Control Group ◽  
Corneal Staining

BackgroundTo evaluate the effectiveness of platelet-rich plasma (PRP) injections in the treatment of severe dry eye.MethodsThis prospective, intervention study included patients with severe dry eye who had been diagnosed with Sjogren syndrome. Patients were divided into two groups. The intervention group received PRP (n=15) injections on days 0, 30, 60 and 90, as well as hyaluronic acid five times per day. The comparison group received hyaluronic acid (n=15) five times per day. Subjects were measured at baseline and at 30, 60 and 90 days. The primary outcome measures were changes in corneal staining according to the Oxford classification, results of the Schirmer test and tear break-up time (TBUT). The secondary outcome measures were changes in the Ocular Surface Disease Index (OSDI) and treatment compliance.ResultsAll subjects completed the study. The intervention group showed improvements in all primary outcome measures when compared with the control group, including a reduction in corneal staining (p<0.001), increase in the mean Schirmer value from 5.6±0.7 to 9.0±1.1 mm, and an increase in TBUT from 4.0±0.4 to 6.4±0.4 s at day 90. An improvement in subjective OSDI values was also found.ConclusionPRP injection is safe and effective in improving tear parameters as well as subjective parameters, and was found to be superior to hyaluronic acid alone in the management of patients with severe dry eye. This represent a novel alternative treatment for severe dry eye.Trial registration numberNCT02257957.

Safety of Infliximab Treatment in Patients with Rheumatoid Arthritis in a Real-world Clinical Setting: Description and Evaluation of Infusion Reactions

2012 ◽  
Vol 39 (8) ◽  
pp. 1539-1545 ◽  
Author(s):  
JOHN KELSALL ◽  
PAMELA ROGERS ◽  
GRISELDA GALINDO ◽  
MARY A. De VERA
Keyword(s):  
Inflammatory Arthritis ◽  
Reaction Rate ◽  
Chart Review ◽  
Primary Outcome ◽  
Retrospective Chart Review ◽  
Infusion Reaction ◽  
Secondary Outcome ◽  
Infliximab Treatment ◽  
Infusion Reactions ◽  
Acute Reaction

Objective.To describe acute and delayed infusion reactions in a large cohort of patients with inflammatory arthritis, treated with infliximab (IFX).Methods.We conducted a retrospective chart review of patients treated with IFX at the Mary Pack Arthritis Centre between 2000 and 2008. The primary outcome was the occurrence of acute infusion reactions during infusions or 1–2 hours after each infusion, and secondary outcome was the occurrence of delayed infusion reactions 1–14 days after an infusion. Descriptive analyses were conducted to summarize study outcomes and identify trends over followup.Results.Since 2000, 376 patients were referred to the Mary Pack IFX clinic and 200 received 4399 IFX infusions over a mean 140 ± 132 weeks of followup. Of these, 135 were patients with RA who received 2977 IFX infusions over mean followup of 138 ± 132 weeks. In total 258 episodes of acute reactions were observed for an overall acute reaction rate of 5.8%. Acute infusion reactions were mostly mild (42.6%) and moderate (43.8%) and commonly affected sites were head and neck (31.5%) and cutaneous (21.1%). A total of 37 delayed infusion reaction episodes were observed (0.9% rate); reactions were also mostly mild (16.2%) and moderate (64.9%).Conclusion.These clinical data from 200 patients treated with IFX demonstrate that acute and delayed infusion reactions occur infrequently and are mostly mild to moderate in presentation.

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)

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