Redesigning Systems to Improve Quality for Hospitalized Patients

Adverse Event Clinical Trial

— RESET  

Official title:

Redesigning Systems to Improve Quality for Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745677
• Other study ID #: R18HS025649
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4265
• Est. completion date: November 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Event
• Interdisciplinary Communication
• Interpersonal Relations
• Interprofessional Relations

Intervention

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.

Locations

Country	Name	City	State
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	Indiana University Ball Memorial Hospital	Muncie	Indiana
United States	Baptist Hospital	Pensacola	Florida
United States	Legacy Good Samaritan Hospital	Portland	Oregon

Sponsors (10)

Lead Sponsor	Collaborator
Northwestern University	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

Country where clinical trial is conducted

United States, 

References & Publications (11)

Kara A, Johnson CS, Nicley A, Niemeier MR, Hui SL. Redesigning inpatient care: Testing the effectiveness of an accountable care team model. J Hosp Med. 2015 Dec;10(12):773-9. doi: 10.1002/jhm.2432. Epub 2015 Aug 19. — View Citation

Li J, Hinami K, Hansen LO, Maynard G, Budnitz T, Williams MV. The physician mentored implementation model: a promising quality improvement framework for health care change. Acad Med. 2015 Mar;90(3):303-10. doi: 10.1097/ACM.0000000000000547. — View Citation

Nelson EC, Godfrey MM, Batalden PB, Berry SA, Bothe AE Jr, McKinley KE, Melin CN, Muething SE, Moore LG, Wasson JH, Nolan TW. Clinical microsystems, part 1. The building blocks of health systems. Jt Comm J Qual Patient Saf. 2008 Jul;34(7):367-78. doi: 10.1016/s1553-7250(08)34047-1. — View Citation

O'Leary KJ, Buck R, Fligiel HM, Haviley C, Slade ME, Landler MP, Kulkarni N, Hinami K, Lee J, Cohen SE, Williams MV, Wayne DB. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011 Apr 11;171(7):678-84. doi: 10.1001/archinternmed.2011.128. — View Citation

O'Leary KJ, Creden AJ, Slade ME, Landler MP, Kulkarni N, Lee J, Vozenilek JA, Pfeifer P, Eller S, Wayne DB, Williams MV. Implementation of unit-based interventions to improve teamwork and patient safety on a medical service. Am J Med Qual. 2015 Sep-Oct;30(5):409-16. doi: 10.1177/1062860614538093. Epub 2014 Jun 11. — View Citation

O'Leary KJ, Johnson JK, Manojlovich M, Astik GJ, Williams MV. Use of Unit-Based Interventions to Improve the Quality of Care for Hospitalized Medical Patients: A National Survey. Jt Comm J Qual Patient Saf. 2017 Nov;43(11):573-579. doi: 10.1016/j.jcjq.2017.05.008. Epub 2017 Jul 21. — View Citation

O'Leary KJ, Killarney A, Hansen LO, Jones S, Malladi M, Marks K, M Shah H. Effect of patient-centred bedside rounds on hospitalised patients' decision control, activation and satisfaction with care. BMJ Qual Saf. 2016 Dec;25(12):921-928. doi: 10.1136/bmjqs-2015-004561. Epub 2015 Dec 1. — View Citation

O'Leary KJ, Wayne DB, Landler MP, Kulkarni N, Haviley C, Hahn KJ, Jeon J, Englert KM, Williams MV. Impact of localizing physicians to hospital units on nurse-physician communication and agreement on the plan of care. J Gen Intern Med. 2009 Nov;24(11):1223-7. doi: 10.1007/s11606-009-1113-7. Epub 2009 Sep 19. — View Citation

Pannick S, Davis R, Ashrafian H, Byrne BE, Beveridge I, Athanasiou T, Wachter RM, Sevdalis N. Effects of Interdisciplinary Team Care Interventions on General Medical Wards: A Systematic Review. JAMA Intern Med. 2015 Aug;175(8):1288-98. doi: 10.1001/jamainternmed.2015.2421. — View Citation

Singh S, Tarima S, Rana V, Marks DS, Conti M, Idstein K, Biblo LA, Fletcher KE. Impact of localizing general medical teams to a single nursing unit. J Hosp Med. 2012 Sep;7(7):551-6. doi: 10.1002/jhm.1948. Epub 2012 Jul 12. — View Citation

Stein J, Payne C, Methvin A, Bonsall JM, Chadwick L, Clark D, Castle BW, Tong D, Dressler DD. Reorganizing a hospital ward as an accountable care unit. J Hosp Med. 2015 Jan;10(1):36-40. doi: 10.1002/jhm.2284. Epub 2014 Nov 17. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Teamwork climate using the Safety Attitudes Questionnaire (SAQ)	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
Primary	Adverse events	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	Patient experience	We will use Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) global ratings of hospital care.	Years 1 through 3.
Secondary	Length of stay	Length of hospital stay for patients admitted to study unit	Years 1 through 3
Secondary	30 day readmissions	30 day readmissions for patients admitted to the study units	Years 1 through 3