The impact of embedding trial recruitment into a clinical care pathway

Author(s):  
Kay Por Yip ◽  
Simon Gompertz ◽  
Catherine Snelson ◽  
Jeremy Willson ◽  
Shyam Madathil ◽  
...  
2021 ◽  
Vol 8 (1) ◽  
pp. e000967
Author(s):  
Kay Por Yip ◽  
Simon Gompertz ◽  
Catherine Snelson ◽  
Jeremy Willson ◽  
Shyam Madathil ◽  
...  

IntroductionMany respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers.MethodsA respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP.ResultsOn integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence.DiscussionIntegrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.


Head & Neck ◽  
2015 ◽  
Vol 38 (S1) ◽  
pp. E1216-E1220 ◽  
Author(s):  
Jonathan F. Dautremont ◽  
Lucas R. Rudmik ◽  
Steven C. Nakoneshny ◽  
Shamir P. Chandarana ◽  
T. Wayne Matthews ◽  
...  

2020 ◽  
Vol 134 (2) ◽  
pp. 150-158 ◽  
Author(s):  
R Mhawej ◽  
B M Harmych ◽  
J J Houlton ◽  
M E Tabangin ◽  
J Meinzen-Derr ◽  
...  

AbstractObjectiveTo study the impact of a clinical care pathway and computerised order set on short-term post-operative outcomes for patients undergoing head and neck free tissue transfer.MethodsIn this retrospective cohort study, patients who underwent head and neck free tissue transfer by a single reconstructive surgeon between January 2007 and July 2009 were assigned to one of two cohorts based on the timing of their surgery: pre- or post-clinical care pathway implementation. Measured outcomes included peri-operative complications and mortality, length of hospital stay and costs, unplanned reoperations, and readmissions within 30 days of discharge.ResultsThe pre-clinical care pathway cohort included 81 patients and the post-clinical care pathway cohort comprised 46. Implementation of the clinical care pathway was associated with decreased variability in length of hospital stay (median (interquartile range) = 8 (6, 11) vs 7 (6, 9) days). The post-clinical care pathway cohort also had a significantly lower unplanned reoperation rate (15.2 vs 35.8 per cent, p = 0.01).ConclusionA clinical care pathway is a successful means of standardising and improving complex patient care. In this study, care pathway implementation in head and neck free tissue transfer patients improved efficiency and the quality of patient care.


2014 ◽  
Vol 57 (3) ◽  
pp. 194-198 ◽  
Author(s):  
Chad Ball ◽  
Elijah Dixon ◽  
Anthony MacLean ◽  
Gilaad Kaplan ◽  
Lynn Nicholson ◽  
...  

2020 ◽  
Vol 3 (2) ◽  
pp. 116-123
Author(s):  
Mathew Cherian ◽  
Pankaj Mehta ◽  
Shriram Varadharajan ◽  
Santosh Poyyamozhi ◽  
Elango Swamiappan ◽  
...  

Background: We review our initial experience of India’s and Asia’s first mobile stroke unit (MSU) following the completion of its first year of operation. We outline the clinical care pathway integrating the MSU services using a case example taking readers along our clinical care workflow while highlighting the challenges faced in organizing and optimizing such services in India. Methods: Retrospective review of data collected for all patients from March 2018 to February 2019 transported and treated within the MSU during the first year of its operation. Recent case example is reviewed highlighting complete comprehensive acute clinical care pathway from prehospital MSU services to advanced endovascular treatment with focus on challenges faced in developing nation for stroke care. Results: The MSU was dispatched and utilized for 14 patients with clinical symptoms of acute stroke. These patients were predominantly males (64%) with median age of 59 years. Ischemic stroke was seen in 7 patients, hemorrhagic in 6, and 1 patient was classified as stroke mimic. Intravenous tissue plasminogen activator was administered to 3 patients within MSU. Most of the patients’ treatment was initiated within 2 h of symptom onset and with the median time of patient contact (rendezvous) following stroke being 55 mins. Conclusion: Retrospective review of Asia’s first MSU reveals its proof of concept in India. Although the number of patients availing treatment in MSU is low as compared to elsewhere in the world, increased public awareness with active government support including subsidizing treatment costs could accelerate development of optimal prehospital acute stroke care policy in India.


Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2635
Author(s):  
Koen Huysentruyt ◽  
Kim Brunet-Wood ◽  
Robert Bandsma ◽  
Leah Gramlich ◽  
Bonnie Fleming-Carroll ◽  
...  

Background: Disease-associated malnutrition (DAM) is common in hospitalized children. This survey aimed to assess current in-hospital practices for clinical care of pediatric DAM in Canada. Methods: An electronic survey was sent to all 15 tertiary pediatric hospitals in Canada and addressed all pillars of malnutrition care: screening, assessment, treatment, monitoring and follow-up. Results: Responses of 120 health care professionals were used from all 15 hospitals; 57.5% were medical doctors (MDs), 26.7% registered dietitians (RDs) and 15.8% nurses (RNs). An overarching protocol for prevention, detection and intervention of pediatric malnutrition was present or “a work in progress”, according to 9.6% of respondents. Routine nutritional screening on admission was sometimes or always performed, according to 58.8%, although the modality differed among hospitals and profession. For children with poor nutritional status, lack of nutritional follow-up after discharge was reported by 48.5%. Conclusions: The presence of a standardized protocol for the clinical assessment and management of DAM is uncommon in pediatric tertiary care hospitals in Canada. Routine nutritional screening upon admission has not been widely adopted. Moreover, ongoing nutritional care of malnourished children after discharge seems cumbersome. These findings call for the adoption and implementation of a uniform clinical care pathway for malnutrition among pediatric hospitals.


2021 ◽  
pp. 105566562110174
Author(s):  
Thomas R. Cawthorn ◽  
Anna R. Todd ◽  
Nina Hardcastle ◽  
Adam O. Spencer ◽  
A. Robertson Harrop ◽  
...  

Objective: To evaluate the development process and clinical impact of implementing a standardized perioperative clinical care pathway for cleft palate repair. Design: Medical records of patients undergoing primary cleft palate repair prior to pathway implementation were retrospectively reviewed as a historical control group (N = 40). The historical cohort was compared to a prospectively collected group of patients who were treated according to the pathway (N = 40). Patients: Healthy, nonsyndromic infants undergoing primary cleft palate repair at a tertiary care pediatric hospital. Interventions: A novel, standardized pathway was created through an iterative process, combining literature review with expert opinion and discussions with institutional stakeholders. The pathway integrated multimodal analgesia throughout the perioperative course and included intraoperative bilateral maxillary nerve blocks. Perioperative protocols for preoperative fasting, case timing, antiemetics, intravenous fluid management, and postoperative diet advancement were standardized. Main Outcome Measures: Primary outcomes include: (1) length of hospital stay, (2) cumulative opioid consumption, (3) oral intake postoperatively. Results: Patients treated according to the pathway had shorter mean length of stay (31 vs 57 hours, P < .001), decreased cumulative morphine consumption (77 vs 727 μg/kg, P < .001), shorter time to initiate oral intake (9.3 vs 22 hours, P = .01), and greater volume of oral intake in first 24 hours postoperatively (379 vs 171 mL, P < .001). There were no differences in total anesthesia time, total surgical time, or complication rates between the control and treatment groups. Conclusions: Implementation of a standardized perioperative clinical care pathway for primary cleft palate repair is safe, feasible, and associated with reduced length of stay, reduced opioid consumption, and improved oral intake postoperatively.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Matthew Budoff ◽  
Robert Karwasky ◽  
Naser Ahmadi MD Ahmadi ◽  
Cyrus A Nasserian ◽  
William W Chang ◽  
...  

To identify CAD among patients who fail treadmill tests, the traditional clinical care pathway is MPI, then invasive coronary angiography (ICA). In a retrospective cohort study, we compared the direct costs for detecting CAD using the traditional clinical care pathway and an alternative that incorporates MDCT, with coronary calcium score (CCS) followed by computed tomographic angiography (CTA) and ICA. Over a 2-year period, 3,950 Los Angeles, CA Firefighters underwent wellness/fitness exams at 6 contracted medical facilities. A total of 495 cases had abnormal treadmill tests and were referred for follow-up cardiology evaluation. All cases received CCS, followed by CTA for calcium scores >10, and ICA for abnormal CTA (>50% obstruction in at least one vessel). MPI results were estimated based on the prior year’s experience, with abnormal MPI receiving ICA. Costs to detect CAD were calculated for both the MPI and MDCT pathways based on results for the cohort and current Medicare reimbursement costs. Sensitivity analyses were performed by varying each of the clinical and cost components of the model to “low” and “high” levels and computing net costs. Most model inputs were varied by ±50% of baseline values to gauge the robustness of the results. Among 495 cases with abnormal treadmill tests, 146 (29.5%) would have required ICA due to abnormal MPI tests; 131 (26.9%) had abnormal CCS (>10) and went to CTA; 40 (8.1%) had abnormal CTA (>50% stenosis) and went to ICA. ICA showed 38 (7.7%) cases of CAD. The computed cost to detect CAD was $1,376 per case for the traditional route with MPI as gatekeeper and $503 per case for CCS as gatekeeper. All sensitivity analyses showed lower costs for the MDCT compared to MPI pathways. The net cost to ICA-confirmed diagnosis of CAD is substantially lower with MDCT compared to MPI as gatekeeper to ICA.


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