Clinical trial NCT02320175: Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience
Official title: Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: Family Centered Rounds
Patient Safety
Errors
Adverse Events
Patient Experience
Family Engagement
Interprofessional Communication
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-12-19
Enrollment: 6478
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. This project tests the hypothesis that rates of medical errors and adverse events (primary outcome), hospital experience, communication, and shared understanding will improve following implementation of Patient and Family Centered I-PASS, as compared with current practice.

Detailed description: We conducted an intervention study on pediatric inpatient units in seven North American hospitals. Each site was assigned to one of 3 staggered waves of implementation and data collection. The Patient and Family Centered I-PASS intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation. We measured errors and adverse events (AEs) via an established systematic surveillance methodology, family experience via pre-discharge surveys, and communication processes via direct observations.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the pediatric inpatient study units of participating hospitals
* Parents/caregivers of patients less than 18 years of age who speak English, Chinese, Arabic, Russian, or Spanish
* Nurses working on these units
* Residents working on these units
* Medical students working on these units

Exclusion Criteria:

* Parents/caregivers who do not speak a study language (decided based on the 5 most commonly spoken languages across study sites; study languages include: English, Chinese, Arabic, Russian, Spanish)
* Parents/caregivers of patients greater than 18 years of age

Primary outcomes:
measure: Rate of Medical Errors
timeFrame: 6 months (3 months pre, 3 months post) per site (7 sites total)
Secondary outcomes:
measure: Rate of Non-Preventable Adverse Events
timeFrame: 6 months (3 months pre, 3 months post) per site (7 sites total)
measure: Family Experience With Care
timeFrame: 6 months (3 months pre, 3 months post) per site (7 sites total)
measure: Quality of Communication on Rounds
timeFrame: 6 months (3 months pre, 3 months post) per site (7 sites total)
measure: Shared Understanding Between Parent, Resident, and Nurse
timeFrame: 6 months (3 months pre, 3 months post) per site (7 sites total)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital San Francisco
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Boston Children's Hospital
name: Christopher P Landrigan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starmer AJ, Spector ND, Srivastava R, West DC, Rosenbluth G, Allen AD, Noble EL, Tse LL, Dalal AK, Keohane CA, Lipsitz SR, Rothschild JM, Wien MF, Yoon CS, Zigmont KR, Wilson KM, O'Toole JK, Solan LG, Aylor M, Bismilla Z, Coffey M, Mahant S, Blankenburg RL, Destino LA, Everhart JL, Patel SJ, Bale JF Jr, Spackman JB, Stevenson AT, Calaman S, Cole FS, Balmer DF, Hepps JH, Lopreiato JO, Yu CE, Sectish TC, Landrigan CP; I-PASS Study Group. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014 Nov 6;371(19):1803-12. doi: 10.1056/NEJMsa1405556.
citation: Khan A, Coffey M, Litterer KP, Baird JD, Furtak SL, Garcia BM, Ashland MA, Calaman S, Kuzma NC, O'Toole JK, Patel A, Rosenbluth G, Destino LA, Everhart JL, Good BP, Hepps JH, Dalal AK, Lipsitz SR, Yoon CS, Zigmont KR, Srivastava R, Starmer AJ, Sectish TC, Spector ND, West DC, Landrigan CP; the Patient and Family Centered I-PASS Study Group; Allair BK, Alminde C, Alvarado-Little W, Atsatt M, Aylor ME, Bale JF Jr, Balmer D, Barton KT, Beck C, Bismilla Z, Blankenburg RL, Chandler D, Choudhary A, Christensen E, Coghlan-McDonald S, Cole FS, Corless E, Cray S, Da Silva R, Dahale D, Dreyer B, Growdon AS, Gubler L, Guiot A, Harris R, Haskell H, Kocolas I, Kruvand E, Lane MM, Langrish K, Ledford CJW, Lewis K, Lopreiato JO, Maloney CG, Mangan A, Markle P, Mendoza F, Micalizzi DA, Mittal V, Obermeyer M, O'Donnell KA, Ottolini M, Patel SJ, Pickler R, Rogers JE, Sanders LM, Sauder K, Shah SS, Sharma M, Simpkin A, Subramony A, Thompson ED Jr, Trueman L, Trujillo T, Turmelle MP, Warnick C, Welch C, White AJ, Wien MF, Winn AS, Wintch S, Wolf M, Yin HS, Yu CE. Families as Partners in Hospital Error and Adverse Event Surveillance. JAMA Pediatr. 2017 Apr 1;171(4):372-381. doi: 10.1001/jamapediatrics.2016.4812.
citation: Khan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, Garcia BM, Litterer KP, Rogers JE, Dalal AK, Lipsitz S, Yoon CS, Zigmont KR, Guiot A, O'Toole JK, Patel A, Bismilla Z, Coffey M, Langrish K, Blankenburg RL, Destino LA, Everhart JL, Good BP, Kocolas I, Srivastava R, Calaman S, Cray S, Kuzma N, Lewis K, Thompson ED, Hepps JH, Lopreiato JO, Yu CE, Haskell H, Kruvand E, Micalizzi DA, Alvarado-Little W, Dreyer BP, Yin HS, Subramony A, Patel SJ, Sectish TC, West DC, Landrigan CP. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. BMJ. 2018 Dec 5;363:k4764. doi: 10.1136/bmj.k4764.