Pragmatic Research

Pragmatic
Research

HiLo is a new type of study called pragmatic. Taking place in dialysis units where patients are receiving their care, HiLo is designed to reflect the real world and answer a question that is important to patients, families, clinicians, dietitians, dialysis providers, payers, and other healthcare decision-makers.

Generating Evidence into Clinical Practice

“By embedding rigorous research into clinical care delivery, HiLo addresses a question of great importance to patients and clinicians.”

Laura Dember, MD
HiLo Steering Committee Meeting
University of Pennsylvania

Innovating Clinical Research

HiLo provides a pragmatic model to innovate the clinical research process. Clinical research studies are the foundation for how medical professionals learn which treatments work best in taking care of patients. Traditional research studies are typically expensive, slow, limit participation, and burdensome to study participants and medical staff.

Pragmatic studies such as HiLo are performed in settings where patients are receiving care. In addition, pragmatic studies have broad eligibility criteria and aim to generate actionable clinical evidence at a fraction of the typical cost and time needed to conduct a traditional study.

Below we explore the pragmatic elements of HiLo.

 

Results from HiLo have the potential to rapidly influence the care of kidney patients receiving dialysis.

Evidence into Practice

HiLo will take place in dialysis facilities where patients are receiving care. There will be no extra study visits or responsibilities for participants and minimal extra responsibilities for the dialysis care team. Results from HiLo have the potential to rapidly influence the care of kidney patients receiving dialysis.

Multicenter

More than 100 outpatient hemodialysis facilities across U.S. will be involved in HiLo.

Large

Approximately 4000 patients will be enrolled in HiLo and followed for up to four years.

 

Outcomes that matter

Outcomes are events or endpoints that are monitored in a study to measure the impact of the research intervention on the health of a given population. In HiLo, researchers will compare how people feel, how they are managing daily activities, how often they are hospitalized, and how long they live based on the level of phosphate in their blood.

Electronic Health Record Data Collection

HiLo will be collecting real world data obtained as part of routine clinical care. All study data will be captured from the electronic health record.

 

Broad Eligibility Criteria

All adult kidney patients on standard in-center maintenance dialysis are welcome to consider participation in HiLo.

 

Cluster-randomization

Participating dialysis facilities will be randomized instead of individual patients. This approach will ease operational logistics since all study participants will have the same phosphate treatment goal.

Open-label

The dialysis care team and study participants will know their assigned phosphate treatment goal. This will streamline operations and eliminate uncertainty on behalf of participants and staff.

 

Electronic Informed Consent

Informed consent will be obtained using a novel electronic consent using a smart phone, tablet, or computer.