Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience

NCT02320175 | Completed Results

• 1 other identifier: CDR-1306-03556
• Study Type: interventional
• Target: 6,478
• Locations: 2 countries
• Sites: 7

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.

Conditions

Communication

Keywords

Family Centered Rounds; Patient Safety; Errors; Adverse Events; Patient Experience; Family Engagement; Interprofessional Communication

Outcome Measures

Primary Outcomes (1)

• Rate of Medical Errors

  Our primary outcome was the rate of medical errors, including harmful errors (preventable adverse events) and non-harmful errors. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable.

  6 months (3 months pre, 3 months post) per site (7 sites total)

Secondary Outcomes (4)

• Rate of Non-Preventable Adverse Events

  6 months (3 months pre, 3 months post) per site (7 sites total)

• Family Experience With Care

  6 months (3 months pre, 3 months post) per site (7 sites total)

• Quality of Communication on Rounds

  6 months (3 months pre, 3 months post) per site (7 sites total)

• Shared Understanding Between Parent, Resident, and Nurse

  6 months (3 months pre, 3 months post) per site (7 sites total)

Study Arms (2)

Pre-intervention

NO INTERVENTION

Before implementation of Patient and Family Centered I-PASS.

Post-intervention

EXPERIMENTAL

After implementation of Patient and Family Centered I-PASS.

Behavioral: Patient and Family Centered I-PASS

Interventions

Patient and Family Centered I-PASS BEHAVIORAL

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. The 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.

Post-intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (7)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

UCSF Benioff Children's Hospital San Francisco

San Francisco, California, 94158, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• 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.

  PMID: 25372088 BACKGROUND

• 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.

  PMID: 28241211 BACKGROUND

• 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.

  PMID: 30518517 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Isabella Liss, Patient and Family Centered I-PASS SCORE Study Coordinator
• Organization: Boston Children's Hospital

isabella.liss@childrens.harvard.edu

857-218-3229

Study Officials

• Christopher P Landrigan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Harvard Medical School; Research and Fellowship Director, Boston Children's Hospital Inpatient Pediatrics Service

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 19, 2014
• Study Start: December 15, 2014
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-08

Locations

CA (1); US (6)