NCT03745677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

November 15, 2018

Last Update Submit

January 11, 2023

Conditions

Interdisciplinary CommunicationInterpersonal RelationsAdverse EventInterprofessional Relations

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Patient experience

    Years 1 through 3.

  • Length of stay

    Years 1 through 3

  • 30 day readmissions

    Years 1 through 3

Study Arms (2)

Phase I

EXPERIMENTAL

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

Phase II

EXPERIMENTAL

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

Interventions

Advanced and Integrated MicroSystems (AIMS) interventionsBEHAVIORAL

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 IPhase II

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baptist Hospital

Pensacola, Florida, 32501, United States

Location

Indiana University Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

Alamance Regional Medical Center

Burlington, North Carolina, 27215, United States

Location

Legacy Good Samaritan Hospital

Portland, Oregon, 97210, United States

Location

Related Publications (13)

  • 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.

    PMID: 26628552BACKGROUND

  • 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.

    PMID: 24919598BACKGROUND

  • 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.

    PMID: 21482844BACKGROUND

  • 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.

    PMID: 19768510BACKGROUND

  • 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.

    PMID: 29056177BACKGROUND

  • 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.

    PMID: 26076428BACKGROUND

  • 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.

    PMID: 22791661BACKGROUND

  • 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.

    PMID: 18677868BACKGROUND

  • 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.

    PMID: 26286828BACKGROUND

  • 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.

    PMID: 25399928BACKGROUND

  • 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.

    PMID: 25354069BACKGROUND

  • O'Leary KJ, Johnson JK, Williams MV, Estrella R, Hanrahan K, Leykum LK, Smith GR, Goldstein JD, Kim JS, Thompson S, Terwilliger I, Song J, Lee J, Manojlovich M. Effect of Complementary Interventions to Redesign Care on Teamwork and Quality for Hospitalized Medical Patients : A Pragmatic Controlled Trial. Ann Intern Med. 2023 Nov;176(11):1456-1464. doi: 10.7326/M23-0953. Epub 2023 Oct 31.

    PMID: 37903367DERIVED

  • O'Leary KJ, Johnson JK, Manojlovich M, Goldstein JD, Lee J, Williams MV. Redesigning systems to improve teamwork and quality for hospitalized patients (RESET): study protocol evaluating the effect of mentored implementation to redesign clinical microsystems. BMC Health Serv Res. 2019 May 8;19(1):293. doi: 10.1186/s12913-019-4116-z.

    PMID: 31068161DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Kevin O'Leary

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two group pretest-posttest analysis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Hospital Medicine

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

June 5, 2018

Primary Completion

June 30, 2021

Study Completion

November 30, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)