Interdisciplinary CommunicationRESETNCT03745677
Redesigning Systems to Improve Quality for Hospitalized Patients
A study testing Advanced and Integrated MicroSystems (AIMS) interventions in people with Interdisciplinary Communication and Interpersonal Relations, run by Northwestern University at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Interdisciplinary Communication, Interpersonal Relations, Adverse Event
- What is being tested?
- Advanced and Integrated MicroSystems (AIMS) interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,265 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jun 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted, under inpatient or observation status, to study units
Who cannot join
- Patients transferred from other hospitals and those initially admitted to other units.
- Patients admitted under non-medical services on the study units.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alamance Regional Medical Center
Burlington, North Carolina, 27215
Indiana University Ball Memorial Hospital
Muncie, Indiana, 47303
Baptist Hospital
Pensacola, Florida, 32501
Legacy Good Samaritan Hospital
Portland, Oregon, 97210
About this study
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.
Read the 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:
- Conduct a multi-site mentored implementation study in which each site adapts and implements complementary interventions to improve care for medical patients.
- Evaluate the effect of the intervention set on teamwork climate and patient outcomes related to safety, patient experience, and efficiency.
- 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
- Being tested
- Advanced and Integrated MicroSystems (AIMS) interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced and Integrated MicroSystems (AIMS) interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Advanced and Integrated MicroSystems (AIMS) interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Medical record review of patients hospitalized in years 1 through 3.
Secondary outcomes (3)
Patient experience
We will use Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) global ratings of hospital care.
Measured: Years 1 through 3.
Length of stay
Length of hospital stay for patients admitted to study unit
Measured: Years 1 through 3
30 day readmissions
30 day readmissions for patients admitted to the study units
Measured: Years 1 through 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start5 Jun 2018
- Primary completion30 Jun 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Interdisciplinary CommunicationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two group pretest-posttest analysis
- Masking
- None (open label)
- Enrolment
- 4,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Hospital Medicine, University of Michigan, University of Kentucky, The University of Texas Health Science Center at San Antonio, Alamance Regional Medical Center, Baptist Hospital, Good Samaritan Regional Medical Center, Oregon, Ball Memorial Hospital, University of Texas at Austin
- Responsible party
- Principal investigator, Kevin O'Leary, Northwestern University
- Investigators
- Kevin O'Leary, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745677
- Sponsor's protocol ID
- R18HS025649
- Acronym
- RESET
- Status last verified
- Jan 2023
- First submitted
- 15 Nov 2018
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26628552O'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.
PubMed 24919598O'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.
PubMed 21482844O'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.
PubMed 19768510O'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.
PubMed 29056177Pannick 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.
PubMed 26076428Singh 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.
PubMed 22791661Nelson 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.
PubMed 18677868Kara 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.
PubMed 26286828Stein 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.
PubMed 25399928Li 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.
PubMed 25354069O'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.
PubMed 37903367O'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.
PubMed 31068161
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning Systems to Improve Quality for Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03745677
- Acronym / sponsor ID
- RESET / R18HS025649
- Conditions
- Interdisciplinary Communication, Interpersonal Relations, Adverse Event, Interprofessional Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,265 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Society of Hospital Medicine, University of Michigan, University of Kentucky, The University of Texas Health Science Center at San Antonio, Alamance Regional Medical Center, Baptist Hospital, Good Samaritan Regional Medical Center, Oregon, Ball Memorial Hospital, University of Texas at Austin
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Conduct a multi-site mentored implementation study in which each site adapts and implements complementary interventions to improve care for medical patients.
- Evaluate the effect of the intervention set on teamwork climate and patient outcomes related to safety, patient experience, and efficiency.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group pretest-posttest analysis
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Behavioral: Advanced and Integrated MicroSystems (AIMS) interventionsEach 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. |
| Phase II | Experimental | Behavioral: Advanced and Integrated MicroSystems (AIMS) interventionsDuring Implementation Phase II, Advanced and Integrated MicroSystems (AIMS) interventions are being implemented on additional, phase II implementation units, leveraging lessons learned during phase I. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted, under inpatient or observation status, to study units
Key exclusion criteria (2 listed)
- Patients transferred from other hospitals and those initially admitted to other units.
- Patients admitted under non-medical services on the study units.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced and Integrated MicroSystems (AIMS) interventionsEach 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. | Behavioural | Phase I, Phase II |
Primary outcome
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.
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.
3 secondary outcomes
Patient experience
Time frame: Years 1 through 3.
Length of stay
Time frame: Years 1 through 3
30 day readmissions
Time frame: Years 1 through 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Background: PubMed 26628552O'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.
- Background: PubMed 24919598O'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.
- Background: PubMed 21482844O'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.
- Background: PubMed 19768510O'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.
- Background: PubMed 29056177O'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.
- Background: PubMed 26076428Pannick 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.
- Background: PubMed 22791661Singh 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.
- Background: PubMed 18677868Nelson 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.
- Background: PubMed 26286828Kara 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.
- Background: PubMed 25399928Stein 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.
- Background: PubMed 25354069Li 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.
- Derived from this study: PubMed 37903367O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin O'Leary principal investigator
Northwestern University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced and Integrated MicroSystems (AIMS) interventions in people with Interdisciplinary Communication and Interpersonal Relations, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teamwork climate using the Safety Attitudes Questionnaire (SAQ) (time frame: Administered annually in years 1 through 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745677, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.