Feasibility of modifying the hospital environment to reduce the length of amnesia after traumatic brain injury: a pilot randomized controlled trial

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Natasha A Lannin ◽  
Claire Galea ◽  
Megan Coulter ◽  
Russell Gruen ◽  
Laura Jolliffe ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Usual Care ◽  
Acute Care ◽  
Controlled Trial ◽  
Hospital Environment ◽  
Control Group ◽  
Care Hospital ◽  
Randomized Controlled

Abstract Background Reorientation programmes have been an important component of neurotrauma rehabilitation for adults who suffer from post-traumatic amnesia (PTA) after traumatic brain injury (TBI); however, research testing the efficacy of acute programmes is limited. Objective This study aimed to determine if it is feasible to provide a standardized environmental reorientation programme to adults suffering from PTA after TBI in an acute care hospital setting, and whether it is likely to be beneficial. Methods We conducted a randomized controlled trial with concealed allocation and intention-to-treat analysis. A total of 40 participants suffering from PTA after TBI were included. The control group received usual care; the experimental group received usual care plus a standardized orientation programme inclusive of environmental cues. The primary outcome measure was time to emergence from PTA measured by the Westmead PTA Scale, assessed daily from hospital admission or on regaining consciousness. Results Adherence to the orientation programme was high, and there were no study-related adverse responses to the environmental orientation programme. Although there were no statistically significant between-group differences in time to emergence, the median time to emergence was shorter for those who received the standardized reorientation programme (9.0 (6.4–11.6) versus 13.0 (4.5–21.5) days). Multivariate analysis showed that the Glasgow Coma Scale (GCS) at scene (P = 0.041) and GCS at arrival at hospital (P = 0.0001) were significant factors contributing to the longer length of PTA. Conclusion Providing an orientation programme in acute care is feasible for adults suffering from PTA after TBI. A future efficacy trial would require 216 participants to detect a between-group difference of 5 days with an alpha of 0.05 and a power of 80%.

scholarly journals PL04: A randomized controlled trial comparing prescribed light exercise to standard management for emergency department patients with acute mild traumatic brain injury

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S6-S6
Author(s):  
C. Varner ◽  
C. Thompson ◽  
K. de Wit ◽  
B. Borgundvaag ◽  
R. Houston ◽  
...  
Keyword(s):  
Health Care ◽  
Traumatic Brain Injury ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Median Number ◽  
Control Group ◽  
Discharge Instructions ◽  
Randomized Controlled

Introduction: The emergency department (ED) is often the first point of health care contact for patients with mild traumatic brain injury (MTBI). Spontaneous resolution occurs in most patients within 7 days, yet 15-30% will develop post-concussion syndrome (PCS). Given the paucity of effective management strategies to prevent PCS and emerging evidence supporting exercise, the objective of this study was to evaluate the impact of prescribed early light exercise compared to standard discharge instructions for acute MTBI patients in the ED. Methods: This was a randomized controlled trial conducted in three Canadian EDs. Consecutive, adult (18-64 years) ED patients with a MTBI sustained within the preceding 48 hours were eligible for enrollment. The intervention group received discharge instructions prescribing 30 minutes of daily light exercise (e.g., walking), and the control group was given standard MTBI instructions advising gradual return to exercise following symptom resolution. Participants documented their daily physical activities and completed follow-up questionnaires at 7, 14, and 30 days. The primary outcome was the proportion of patients with PCS at 30 days, defined as the presence of ≥ 3 symptoms on the Rivermead Post-concussion Symptoms Questionnaire (RPQ) at 30 days. Results: 367 patients were enrolled (control n = 184; intervention n = 183). Median age was 32 years and 201 (57.6%) were female. There was no difference in the proportion of patients with PCS at 30 days (control 13.4 vs intervention 14.6; Δ1.2, 95% CI: -6.2 to 8.5). There were no differences in median change of RPQ scores (control 14 vs intervention 13; Δ1, 95% CI: -1 to 4), median number of return health care provider visits (control 1 vs intervention 1; Δ0, 95% CI: 0 to 0), or median number of missed school or work days (control 2 vs intervention 2; Δ0, 95% CI: 0 to 1) at 30 days. There was a nonsignificant difference in unplanned return ED visits within 30 days (control 9.9% vs intervention 5.6%; Δ1, 95% CI: -1.4 to 10.3). Participants in the control group reported fewer minutes of light exercise at 7 days (30 vs 35; Δ5, 95% CI: 2 to 15). Conclusion: To our knowledge, this is the first randomized trial of prescribed early light exercise for adults with acute MTBI. There were no differences in recovery or healthcare utilization outcomes. Results suggest prescribed early light exercise should be encouraged as tolerated at ED discharge following MTBI, but exercise prescription alone is not sufficient to prevent PCS.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial

Brain Injury ◽  
2021 ◽  
pp. 1-9
Author(s):  
Kathleen R. Bell ◽  
Donald Fogelberg ◽  
Jason Barber ◽  
Risa Nakase-Richardson ◽  
Jennifer M. Zumsteg ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Acute Rehabilitation

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

scholarly journals Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury

2019 ◽  
Vol 100 (8) ◽  
pp. 1409-1416 ◽  
Author(s):  
Candace Tefertiller ◽  
Kaitlin Hays ◽  
Audrey Natale ◽  
Denise O’Dell ◽  
Jessica Ketchum ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Balance Deficits

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

Sign in / Sign up

Export Citation Format

Share Document