scholarly journals Using Stories to Communicate Individual Risk for Opioid Prescriptions: Study Protocol for the Life STORRIED Multicenter Randomized Clinical Trial

2018 ◽  
Author(s):  
Zachary F Meisel ◽  
Esha Bansal ◽  
Marilyn M Schapira ◽  
Jeanmarie Perrone ◽  
Carolyn C Cannuscio ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Risk Communication ◽  
Randomized Clinical Trial ◽  
Acute Care ◽  
Acute Pain ◽  
The United States ◽  
Risk Information ◽  
Information Sheet ◽  
Health Crisis

Abstract Background: Prescription opioid abuse in the United States is a devastating public health crisis, of which many chronic opioid users were originally prescribed the medication for acute pain. Narrative enhanced risk communication may improve patient outcomes such as knowledge of opioid risk and opioid use behaviors in the setting of acute pain. Methods & Design: Patients presenting to the acute care facilities of four geographically and ethnically diverse United States hospital centers with renal colic or musculoskeletal back pain will be eligible for this multicenter randomized clinical trial. A control group of patients receiving a standardized, general risk information sheet will be compared to two intervention groups, one receiving the risk information sheet plus a probabilistic opioid risk tool and another receiving the risk information sheet plus a narrative enhanced probabilistic opioid risk tool. We will study the effect of probabilistic and narrative enhanced opioid risk communication on: 1) knowledge as measured by risk awareness and treatment preferences for fewer opioids; 2) reduced use of opioids as measured by quantity of opioids taken, functional improvement, and repeat use of unscheduled visits for pain; 3) patient-provider alignment as measured by concordance between patient preference and finalized prescription plan and the presence of shared decision making. To assess these outcomes, we will administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the ninety days after discharge. Discussion: This study seeks to assess the potential clinical role of narrative enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, stakeholder involvement, and dissemination considerations.

scholarly journals Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Zachary F Meisel ◽  
Erica B Goldberg ◽  
Abby R Dolan ◽  
Esha Bansal ◽  
Karin V Rhodes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Communication ◽  
Acute Care ◽  
Acute Pain ◽  
Kidney Stone ◽  
Controlled Trial ◽  
Risk Information ◽  
Opioid Use ◽  
Information Sheet ◽  
Randomized Controlled

BACKGROUND Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. OBJECTIVE Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. METHODS This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. RESULTS A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. CONCLUSIONS This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. CLINICALTRIAL ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19496

scholarly journals Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial

10.2196/19496 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e19496
Author(s):  
Zachary F Meisel ◽  
Erica B Goldberg ◽  
Abby R Dolan ◽  
Esha Bansal ◽  
Karin V Rhodes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Communication ◽  
Acute Care ◽  
Acute Pain ◽  
Kidney Stone ◽  
Controlled Trial ◽  
Risk Information ◽  
Opioid Use ◽  
Information Sheet ◽  
Randomized Controlled

Background Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 International Registered Report Identifier (IRRID) DERR1-10.2196/19496

Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States

2018 ◽  
Vol 22 (8) ◽  
pp. 2627-2639 ◽  
Author(s):  
Howard J. Cabral ◽  
Kendra Davis-Plourde ◽  
Mariana Sarango ◽  
Jane Fox ◽  
Joseph Palmisano ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Peer Support ◽  
The United States ◽  
Continuum Of Care ◽  
Hiv Continuum Of Care

Economic analysis of a randomized clinical trial to compare filgrastim-mobilized peripheral-blood progenitor-cell transplantation and autologous bone marrow transplantation in patients with Hodgkin's and non-Hodgkin's lymphoma.

1997 ◽  
Vol 15 (1) ◽  
pp. 5-10 ◽  
Author(s):  
T J Smith ◽  
B E Hillner ◽  
N Schmitz ◽  
D C Linch ◽  
P Dreger ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Bone Marrow ◽  
Supportive Care ◽  
Randomized Clinical Trial ◽  
Resource Utilization ◽  
Cost Savings ◽  
Autologous Bone Marrow ◽  
The United States ◽  
Short Term

PURPOSE High-dose chemotherapy (HDC) with peripheral-blood progenitor cell (PBPC) and autologous bone marrow (ABM) transplant (T) has documented survival benefits for relapsed Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL). Treatment costs associated with HDC and its supportive care have restricted its use both on and off clinical trial. In a prospective randomized clinical trial, filgrastim-mobilized PBPCT resulted in faster recovery of bone marrow function, with less hospitalization and supportive care than ABMT. This study was undertaken to analyze the costs of the two strategies using prospectively collected data from a randomized clinical trial that compared filgrastim-mobilized PBPCT versus ABMT. PATIENTS AND METHODS Clinical results and resource utilization from a randomized clinical trial that compared filgrastim-mobilized PBPCT versus ABMT following carmustine, etoposide, cytarabine, and melphalan (BEAM) HDC for HD and NHL are presented. The trial was performed in six centers in Germany, the United Kingdom, and Belgium. Resource utilization data were used to project costs and Massay Cancer Center (MCC) in the United States incurred the cost of treating the cohort. Costs were projected to the United States, because the economic implications to United States centers are significant, costs of care vary markedly among countries but resource utilization on this trial did not, and a randomized trial is unlikely to be performed in the United States. RESULTS Fifty-eight patients with relapsed HD or NHL underwent HDC with BEAM. The PBPCT and ABMT groups had similar short-term survival after BEAM. PBPCT patients had a shorter hospitalization (median, 17 v 23 days; P = .002), neutrophil recovery (11 v 14 days; P = .005), platelet recovery to > or = 20 x 10(9)/L (16 v 23 days; P = .02), and days of platelet transfusions (6 v 10; P < .001). Estimated costs were $8,531 for ABM harvest and $5,760 for PBPC collection, including filgrastim mobilization. The total estimated average cost was $59,314 for each ABMT patient versus $45,792 for each PBPCT patient. Cost savings of $13,521 (23%) were due to shorter hospitalizations with less supportive care. CONCLUSION PBPCT is as safe and more effective than ABMT for HD and NHL in the short term. PBPCT represents a significant cost savings due to lower autograft collection costs, shorter hospital stays, and less supportive care. The savings exceed the costs for filgrastim mobilization and PBPC collection. Actual savings will vary depending on local practice patterns, charges, and costs.

One-session treatment of specific phobias in youth: A randomized clinical trial in the United States and Sweden.

2009 ◽  
Vol 77 (3) ◽  
pp. 504-516 ◽  
Author(s):  
Thomas H. Ollendick ◽  
Lars-Göran Öst ◽  
Lena Reuterskiöld ◽  
Natalie Costa ◽  
Rio Cederlund ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
The United States ◽  
Specific Phobias
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