Clinical trial NCT03745677: Redesigning Systems to Improve Quality for Hospitalized Patients
Official title: Redesigning Systems to Improve Quality for Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interdisciplinary Communication
Interpersonal Relations
Adverse Event
Interprofessional Relations
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Society of Hospital Medicine
name: University of Michigan
name: University of Kentucky
name: The University of Texas Health Science Center at San Antonio
name: Alamance Regional Medical Center
name: Baptist Hospital
name: Good Samaritan Regional Medical Center, Oregon
name: Ball Memorial Hospital
name: University of Texas at Austin
First posted: 2018-11-19
Enrollment: 4265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group pretest-posttest analysis
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Teamwork climate using the Safety Attitudes Questionnaire (SAQ)
timeFrame: Administered annually in years 1 through 4
measure: Adverse events
timeFrame: Medical record review of patients hospitalized in years 1 through 3.
Secondary outcomes:
measure: Patient experience
timeFrame: Years 1 through 3.
measure: Length of stay
timeFrame: Years 1 through 3
measure: 30 day readmissions
timeFrame: Years 1 through 3
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Muncie
country: United States
facility: Indiana University Ball Memorial Hospital
state: Indiana
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital
state: Oregon
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Kevin O'Leary
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
citation: 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.