Redesigning Systems to Improve Quality for Hospitalized Patients

NCT ID: NCT03745677

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2022-11-30

Brief Summary

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.

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.

Conditions

Interdisciplinary Communication; Interpersonal Relations; Adverse Event; Interprofessional Relations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Advanced and Integrated MicroSystems (AIMS) interventions

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Advanced and Integrated MicroSystems (AIMS) interventions

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Hospital Medicine

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Alamance Regional Medical Center

UNKNOWN

Sponsor Role: collaborator

Baptist Hospital

UNKNOWN

Sponsor Role: collaborator

Good Samaritan Regional Medical Center, Oregon

OTHER

Sponsor Role: collaborator

Ball Memorial Hospital

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Kevin O'Leary

Chief, Division of Hospital Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin O'Leary

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Baptist Hospital

Pensacola, Florida, United States

Indiana University Ball Memorial Hospital

Muncie, Indiana, United States

Alamance Regional Medical Center

Burlington, North Carolina, United States

Legacy Good Samaritan Hospital

Portland, Oregon, United States

Countries

United States

References

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Other Identifiers

R18HS025649

Identifier Type: AHRQ

Identifier Source: org_study_id

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