Redesigning Systems to Improve Quality for Hospitalized Patients (RESET)

January 11, 2023 updated by: Kevin O'Leary, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Conduct a multi-site mentored implementation study in which each site adapts and implements complementary interventions to improve care for medical patients.
  2. Evaluate the effect of the intervention set on teamwork climate and patient outcomes related to safety, patient experience, and efficiency.
  3. 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.

Study Type

Interventional

Enrollment (Actual)

4265

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pensacola, Florida, United States, 32501
        • Baptist Hospital
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Indiana University Ball Memorial Hospital
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Alamance Regional Medical Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I
Each study site has selected 1-2 units ideally suited for initial implementation of the Advanced and Integrated MicroSystems (AIMS) interventions (Phase I Implementation) and 1-2 units for later implementation of AIMS interventions (Phase II Implementation). During Implementation Phase I, AIMS interventions were implemented on the initial, phase I Implementation units. The phase II units serve as control units during phase I.
Behavioral: Advanced and Integrated MicroSystems (AIMS) interventions
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.
Experimental: Phase II
During Implementation Phase II, Advanced and Integrated MicroSystems (AIMS) interventions are being implemented on additional, phase II implementation units, leveraging lessons learned during phase I.
Behavioral: Advanced and Integrated MicroSystems (AIMS) interventions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered annually in years 1 through 4
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.
Medical record review of patients hospitalized in years 1 through 3.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Years 1 through 3.
Length of stay
Time Frame: Years 1 through 3
Length of hospital stay for patients admitted to study unit
Years 1 through 3
30 day readmissions
Time Frame: Years 1 through 3
30 day readmissions for patients admitted to the study units
Years 1 through 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Investigators

  • Principal Investigator: Kevin O'Leary, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • R18HS025649 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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