Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-inferiority Clinical Trial

2022 ◽  
Author(s):  
Alison Salloum ◽  
Yuanyuan Lu ◽  
Henian Chen ◽  
Troy Quast ◽  
Judith A. Cohen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Care ◽  
Stepped Care

Telemedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions of the TELE-IBD Intervention (Preprint)

2019 ◽  
Author(s):  
Charlene C Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J. Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Standard Care ◽  
Disease Process ◽  
The United States ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Treatment Groups ◽  
Inflammatory Bowel

BACKGROUND Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of the parent study, TELE-IBD, was to compare disease activity and quality of life (QoL) in a one-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL but there was not significant differences between groups. Study adherence to the text-based intervention was less than the 80% of the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants’ perceptions of the TELE-IBD system, including their recommendations for future TELE-IBD monitoring. METHODS In the parent study, patients attending three tertiary referral centers with worsening IBD symptoms in the previous two years were eligible for randomization to remote monitoring via texts every other week (EOW), weekly (W) or standard care. Participants (n=348) were evenly enrolled in the treatment groups and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and non-adherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% or more of the W or EOW self-assessments. Semi-structured interviews conducted by phone surveyed 1) the strengths and benefits of TELE-IBD; 2) challenges associated with using TELE-IBD; and 3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti qualitative data analysis software. RESULTS Participants' discussions centered on three elements of the intervention: 1) self-assessment questions, 2) action plans, and 3) educational messages. Participants also commented on: text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and non-adherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive TELE-IBD as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD. CLINICALTRIAL NCT01692743

scholarly journals Randomized clinical trial of postoperative chewing gum versus standard care after colorectal resection

2016 ◽  
Vol 103 (8) ◽  
pp. 962-970 ◽  
Author(s):  
C. Atkinson ◽  
C. M. Penfold ◽  
A. R. Ness ◽  
R. J. Longman ◽  
S. J. Thomas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Standard Care ◽  
Colorectal Resection ◽  
Chewing Gum

The Effect of Patient Navigators on Laboratory Parameters of Hydroxyurea Adherence in Sickle Cell Anemia: The SHIP-HU Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2309-2309
Author(s):  
Wally R Smith ◽  
Donna k McClish ◽  
Richard Lottenberg ◽  
India Sisler ◽  
Daniel Sop ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Case Management ◽  
Sickle Cell ◽  
Mean Corpuscular Volume ◽  
Standard Care ◽  
Health Workers ◽  
Patient Navigators ◽  
Total Hemoglobin ◽  
Baseline Values

Background: Hydroxyurea (HU) therapy in adults with sickle cell anemia (SCA) increases total hemoglobin (Hb) and percent fetal hemoglobin (HbF) levels, reduces total white cell (WBC) and neutrophil (ANC) count, and increases the mean corpuscular volume (MCV). Case management and community health workers are both evidence-based health management strategies. Patient navigators (PN) are community health workers trained specifically in case management for patients with SCA. We therefore hypothesized that HU-eligible patients exposed to patient navigators (PN) would have improved laboratory characteristics reflecting improved uptake and adherence to HU. Methods: We enrolled 224 adult patients eligible for HU into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Randomized Controlled Trial. All patients received care from trained physicians who implemented use of a standardized HU prescribing protocol using NIH guidelines. Pateints were randomized to either PN intervention (which included case management and education through home, telephone, and/or other visits from PNs) plus standard care by their treating physician (Experimental, E), or standard care by their physician alone (Control, C). Study physicians were blinded to study arm. At baseline, 6 months and 12 months we assessed: Complete Blood Count including WBC, ANC, total hemoglobin (Hb), platelet count (plt), mean corpuscular volume (MCV), and; HbF via HPLC and electrophoresis. Main analyses consisted of comparisons of the hematological variables between arms. Mixed model analysis of variance was used to analyze follow-up visits, controlling for site and baseline value of outcome variable. Any missing baseline values for subjects were imputed. Results: 206 of 224 patients had at least one lab value at follow-up. Patients had mean age 30.1, 45.6% were male, 82.5% had been prescribed HU at baseline. HbF was higher at the 6 month visit for group E vs. group C when controlled for baseline values. Neither WBC, ANC, Hb, Hb F, Plt, nor MCV were different between groups E and C at any other time point (Table). Conclusions: In our sample, there were no differences in hematological variables among patients who were exposed to PNs vs those who weren't. Several factors may have impacted these outcomes. HU was prescribed to 82.5% of enrolled patients at baseline, with higher % HbF than anticipated in study design. The intention to study change in % HbF as a singular marker for HU uptake and adherence did not assume high utilization of HU at baseline. We are currently analyzing data to enable comparisons between patients who were on HU at baseline and those who were not, which we believe will be able to speak to the true impact of the PN intervention. Future analyses will examine these and other factors influencing outcomes. Table Disclosures Smith: Novartis: Consultancy, Honoraria. Villella:Pfizer: Other: Site PI for the Rivipansel Clinical Trial; Emmaus: Membership on an entity's Board of Directors or advisory committees. Liles:Novartis: Other: PI on clinical trial Sickle cell ; Shire: Other: PI on clinical trial Sickle cell ; Imara: Other: PI on Clinical trial- Sickle cell.

Cost analysis of a randomized trial of early palliative care (PC) in patients with metastatic non-small cell lung cancer (NSCLC).

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 4-4 ◽  
Author(s):  
Joseph A. Greer ◽  
Angela Tramontano ◽  
Pamela M McMahon ◽  
Areej El-Jawahri ◽  
Ravi Bharat Parikh ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Health Care Costs ◽  
Standard Care ◽  
Secondary Analysis ◽  
Cost Of Care ◽  
Average Total Cost ◽  
Total Cost ◽  
Metastatic Nsclc ◽  
Care Costs

4 Background: Several randomized, controlled trials have shown that early, integrated palliative and oncology care improves quality of life, mood, and symptom burden in patients with advanced cancers. However, the degree to which early involvement of specialty PC in the ambulatory care setting impacts the cost of care remains unknown. We investigated the health care costs for patients with metastatic NSCLC enrolled in a clinical trial of early PC. Methods: For this secondary analysis, we examined data from a randomized trial of 151 patients with newly-diagnosed metastatic NSCLC from 06/2006 to 07/2009. Patients received either early PC integrated with standard care or standard care (SC) alone. We abstracted costs for emergency and inpatient care, outpatient visits, intravenous chemotherapy, and physician services from the hospital’s accounting system. Oral chemotherapy costs were estimated based on actual drug charges for patients. To estimate hospice costs, we used Medicare reimbursement rates. For each participant, we calculated the average total cost of care per day for the entire study period as well as the total cost of care for the final 30 days prior to death. Costs differences between groups were examined with the Wilcoxon Rank-Sum Test. Results: We analyzed health care costs of the 138 patients who died by 07/15/2013 (early PC N=68; SC N=70). The mean number of days on study was longer for patients assigned to early PC (M=397, SD=360) versus SC (M=299, SD=266). Over the study period, early PC was associated with a lower average total cost per day of $117 (SD=$436) compared to SC (p=.09). In the final 30 days of life, patients in the early PC group incurred higher total costs for hospice care (Mean difference=$1,053, SD=$3,162, p=.11), while expenses for chemotherapy were less (Mean difference=$757, SD=$2,143, p=.06). No cost differences between groups met the threshold for statistical significance. Conclusions: Although this secondary analysis was inconclusive due to the lack of statistical power to examine differences in cost outcomes, the delivery of early PC for patients with metastatic NSCLC does not appear to increase health care expenses over the course of disease or at the end of life. Clinical trial information: NCT01038271.

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