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OpenTrials
Completed

NCT Number: NCT03745677

Redesigning Systems to Improve Quality for Hospitalized Patients

Despite recent improvements, healthcare systems are still a long way from consistently delivering high quality care to hospitalized patients. In this study, the research team is assisting hospitals in implementing a set of complementary, mutually reinforcing interventions to redesign care for hospitalized medical patients. The investigators anticipate the interventions will improve teamwork and patient outcomes and that identifiable factors and strategies will be associated with successful implementation.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Hospital, Pensacola, Florida, United States

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About this study

Most adults requiring hospitalization are admitted for medical conditions, yet the optimal model of care for these patients is yet to be established. Current care delivery models lack the ability to optimally coordinate care on a daily basis and improve performance over time. A growing body of research has tested interventions to redesign aspects of care delivery for hospitalized medical patients. These interventions improve processes and culture, but the evidence that patient outcomes have improved is equivocal. Importantly, most studies have examined the effect of single interventions in isolation, yet these interventions are better conceptualized as complementary and mutually reinforcing components of a redesigned clinical microsystem. Clinical microsystems are the front line care giving units where patients, families, and care teams meet. Our research team developed a set of complementary, mutually reinforcing interventions based on available evidence and anchored in a clinical microsystem framework. The 5 Advanced and Integrated MicroSystems (AIMS) interventions include: 1) Unit-based Physician Teams, 2) Unit Nurse-Physician Co-leadership, 3) Enhanced Interdisciplinary Rounds, 4) Unit-level Performance Reports, 5) Patient Engagement Activities. Our long term goal is to discover and disseminate the optimal model of care to improve outcomes for hospitalized patients. Our specific objective for this proposal is to implement a set of evidence-based complementary interventions across a range of clinical microsystems, identify factors and strategies associated with successful implementation, and evaluate the impact on quality. Our research team is using mentored implementation, i.e., coaching by external professionals who are experts in the area of focus, to help facilitate change. The research team has enrolled 4 hospitals in this quality improvement mentored implementation study. Our hypothesis is that uptake of the complementary components of the intervention set will result in improvements in teamwork climate and patient outcomes.

Specific Aims of the Redesigning Systems to Improve Quality for Hospitalized Patients (RESET) study include:

  • Conduct a multi-site mentored implementation study in which each site adapts and implements complementary interventions to improve care for medical patients.
  • Evaluate the effect of the intervention set on teamwork climate and patient outcomes related to safety, patient experience, and efficiency.
  • Assess how site-specific contextual factors interact with the variation in the intensity and fidelity of implementation to effect teamwork and patient outcomes.

The findings generated from this study will be directly applicable to hospitals throughout the U.S. and our partnership with the Society of Hospital Medicine, the American Nurses Association, and the Institute for Patient- and Family-Centered Care will ensure effective dissemination and impact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients admitted, under inpatient or observation status, to study units

Exclusion criteria

  • Patients transferred from other hospitals and those initially admitted to other units.
  • Patients admitted under non-medical services on the study units.

Treatment and study plan

Advanced and Integrated MicroSystems (AIMS) interventions

Behavioral

Each of 4 sites is receiving mentorship from nurse and physician with expertise in implementing similar interventions. The AIMS interventions consist of 1) unit-based physician teams, 2) unit nurse-physician co-leadership, 3) enhanced interprofessional rounds, 4) unit-level performance reports, and 5) patient engagement activities.

Primary outcomes

  1. Teamwork climate using the Safety Attitudes Questionnaire (SAQ)

    Time frame: Administered annually in years 1 through 4

    14 item validated survey tool to assess teamwork climate in clinical settings. The survey will be administered via REDcap to all nurses, physicians, pharmacists, social workers, and case managers on study units.

  2. Adverse events

    Time frame: Medical record review of patients hospitalized in years 1 through 3.

    We will use the Medicare Patient Safety Monitoring System (MPSMS) methodology to detect adverse events. MPSMS is a medical record-based national patient safety surveillance system that provides rates for specific inpatient adverse event measures.

Secondary outcomes

  1. Patient experience

    Time frame: Years 1 through 3.

    We will use Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) global ratings of hospital care.

  2. Length of stay

    Time frame: Years 1 through 3

    Length of hospital stay for patients admitted to study unit

  3. 30 day readmissions

    Time frame: Years 1 through 3

    30 day readmissions for patients admitted to the study units

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Alamance Regional Medical Center
  • Ball Memorial Hospital
  • Baptist Hospital
  • Good Samaritan Regional Medical Center, Oregon
  • Society of Hospital Medicine
  • The University of Texas Health Science Center at San Antonio
  • University of Kentucky
  • University of Michigan
  • University of Texas at Austin

Registry information

Acronym: RESET

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 19, 2018
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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