Current SORCE Projects

Comparative-Effectiveness of Pretreatment Lung Cancer Nodal Staging
Funder: National Institute of Health, National Cancer Institute

The goal of this study is to reduce diagnostic and treatment errors, improve survival, and increase the value of care for lung cancer patients by improving the ability to select patients who benefit from a lymph node biopsy prior to starting treatment. This study determines the effectiveness of guideline recommended selection criteria for a pretreatment lymph node biopsy, and it tests whether a novel approach to selecting patients for lymph node biopsy is equivalent to guideline recommended strategy in terms of survival but superior in terms of lower biopsy-related severe adverse events and health expenditures. Findings from this study will lead to (1) developing and testing implementation strategies designed to increase guideline-concordant lymph node evaluation, (2) alternative guideline recommendations for lymph node evaluation, and/or (3) justifying trials comparing outcomes between different lymph node evaluation strategies.

 

The Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID)
Funder: Patient-Centered Outcomes Research Institute (PCORI)

COSMID is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL)-limiting diverticulitis. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticulitis, is elective colectomy more effective than best medical management? The study will aim to investigate and complete the following objectives: Compare patient-reported outcomes such as quality of life in patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management; compare clinical outcomes such as number of subsequent episodes of diverticulitis between patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management; and compare healthcare utilization between patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management.

 

Drug-ELuting REGistry: ReAl-World Treatment of LesioNs in the Peripheral VasCulaturE (ELEGANCE)
Funder:  Boston Scientific Co.

ELEGANCE is a medical device study for patients with Peripheral Vascular Disease (PVD) to support the use of Boston Scientific drug-eluting devices for the treatment of lesions located in the peripheral vasculature. This study focuses on including populations previously not represented in Peripheral Vascular Disease (PVD) trials. ELEGANCE is a national multi-center registry to collect Real-World Data, including health economic data, to support the use of commercially available PVD devices.

Devices being investigated are:

• ELUVIA™ Drug-Eluting Vascular Stent System and the
• Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter.

 

Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial
Funder: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Studies have proven that diet, exercise, and other healthy behaviors may decrease the risk of a first episode of diverticulitis. However, there have not been studies on how these behaviors may or may not keep diverticulitis from coming back. The Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial is comparing how two eating patterns affect quality of life for people with diverticulitis, as well as how markers in the blood related to inflammation change. The two eating patterns are increasing the amount of fiber eaten and a Mediterranean-style diet and education program, called Medi For All. Medi For All includes education and support on eating a Mediterranean-style diet, and is designed to support everyone, regardless of food budget or cultural eating preferences.

The IMPEDE trial will 1) compare the Medi For All education and support program to usual advice to increase the amount of fiber eaten among an initial group of 75 patients with diverticulitis, and 2) examine markers in blood and stool related to inflammation to determine the effects that each eating pattern has on the inflammatory markers.

 

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON)
Funder: Medtronic

A multi-center, non-randomized trial to evaluate the safety and effectiveness of the Model 400 bovine pericardial stented aortic bioprosthesis in a patient population undergoing surgical aortic valve replacement for their aortic valve disease. The collected data will be used to support regulatory applications in seeking market approval for the valve in Europe (CE Mark), the United States, Canada and other geographies. For each participant, data will be collected preoperatively, intra-operatively, at hospital discharge up to 30 days, between 3 and 6 months post-operative, 1 year, 18 months, 2 years, 30 months, 3 years, and annually thereafter through 5 years, or until trial closure.

The trial will be conducted at up to 40 sites worldwide with approximately 14 in Europe, 4 in Canada and up to 22 in the United States. A maximum of 1300 subjects will be implanted in the trial.

 

Pharmacy Integrated Transition Study (PIT)
Funder: Agency for Healthcare Research and Quality (AHRQ)

This project was developed to focus on improving the standard transition process to target key gaps contributing to medication errors and evaluate its impact on medication-related problems and patient and caregiver measures of transition quality. The program will (1) compare the effectiveness of the PIT program with the Joint Commissions transition process on medication related problems, and 2) compare patient and provider reported measures of quality of communication and care coordination.

 

Pharmacy Transitional Team: Evaluating the Value for Patients with Limited English Proficiency
Funder: The Patrick and Catherine Weldon Donaghue Medical Research Foundation

This project aims to characterize the experiences, barriers, and facilitators related to providing effective care transitions from hospital to post-acute care settings to elucidate the failures that drive disparate outcomes using qualitative methodology, and to ultimately adapt standardized processes to close the equity gap.

 

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms (PMEG)
Funder: University of Washington

PMEG is led by Dr. Benjamin Starnes at the Harborview Medical Center. The study is an investigator-initiated, consecutively enrolling, non- randomized single institution clinical evaluation of the safety and efficacy of physician modification of currently FDA-approved off the shelf aortic stent grafts to preserve branch vessels when used in the treatment of patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms with limited or no other options for repair. Treatment will have follow up intervals at 1, 6, and 12 months following the initial implant procedure, annually through 5 years, and then followed by chart review collection from years 6 throughout lifespan.

The primary objectives of this study are to determine whether physician modified endovascular grafts are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.

 

RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection/Traumatic Injury of the Descending Thoracic Aorta (Relay Pro D/T)
Funder: Bolton Medical Inc.

Bolton has two ongoing device trials: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta and a study of the RelayPro in Subjects with an Acute, Complicated Type B Aortic Dissection. The purpose of these studies is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts when used on study participants in the abdominal aorta. Treatment will have follow up intervals at 1, 6, and 12 months following the initial implant procedure, and then annually through 5 years.