The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

Communication Clinical Trial

Official title:

The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591066
• Other study ID #: IRB-P00042876
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: November 1, 2028

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: Alisa Khan, MD, MPH
• Phone: 617-355-2565
• Email: alisa.khan[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), 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. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14400
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted to the pediatric inpatient study units of participating hospitals

• Patients themselves who are age 13 and up (if they provide assent and their parent or guardian gives permission)

• Parents/caregivers of patients of all ages who speak English, Arabic, Armenian, Bengali, Chinese (Mandarin and Cantonese), Karen, Korean, Nepali, Quiche, Spanish, Somali, and Vietnamese (and/or other languages if resources allow)

• Nurses working on these units

• Residents working on these units

• Medical and nursing students working on these units

• Hospital leaders working at these hospitals

Exclusion Criteria:

• Patients or parents/caregivers of patients who are in state custody (lack relevant caregiver to consent or complete surveys)

Related Conditions & MeSH terms

• Communication

Intervention

Behavioral:
• PFC I-PASS Intervention
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.
• PFC I-PASS+ Intervention
PFC I-PASS+ builds on PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters during and after rounds, cultural humility training, and provider communication skills training.

Locations

Country	Name	City	State
United States	Northwest Texas Healthcare System	Amarillo	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Children's Hospital at Montefiore	Bronx	New York
United States	The Research Institute of Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	UCSF Benioff Children's Hospital of Oakland	Oakland	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Patient-Centered Outcomes Research Institute, Pediatric Research in Inpatient Settings

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Erratum In: JAMA Pediatr. 2018 Mar 1;172(3):302. — View Citation

Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831. — View Citation

Khan A, Quinones-Perez B, Castellanos A, Garcia S, MacInnes E. Promoting true meaningful access and equity for patients and clinicians through the use of certified interpreters in hospitals. J Hosp Med. 2022 Sep;17(9):772-773. doi: 10.1002/jhm.12943. Epub 2022 Aug 17. No abstract available. — View 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. — View Citation

Khan A, Yin HS, Brach C, Graham DA, Ramotar MW, Williams DN, Spector N, Landrigan CP, Dreyer BP; Patient and Family Centered I-PASS Health Literacy Subcommittee. Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children. JAMA Pediatr. 2020 Dec 1;174(12):e203215. doi: 10.1001/jamapediatrics.2020.3215. Epub 2020 Dec 7. — View Citation

Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Rates	Chart review, self-reported by staff and patients/families, and hospital incident reports	24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)
Secondary	Patient/Family Experience with Care Questionnaire	Self-reported by patients/families prior to discharge, based on a previously developed experience survey and modified Child HCAHPS items. Most items are scored on a 5-point Likert scale with higher numbers being better. Top-box (5 or 5 out of 5 scores) will be analyzed.	24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)
Secondary	Patient/Family Experience of Discrimination (Discrimination In Medical Settings Scale)	Self-reported by patients/families prior to discharge through the Discrimination in Medical Settings (DMS) Scale, which is a modified version of the Everyday Discrimination Scale (EDS) adapted to medical settings. The EDS is one of the most utilized self-reported measures of discrimination and is validated across multiple populations. The 7-item DMS Scale has excellent convergent validity and discriminant validity, internal consistency, test-retest reliability, and is used in a variety of clinical conditions. Items include whether patients are treated with less courtesy, less respect, receive poorer services; whether doctor or nurse acts as if patient is not smart, better than patient, or does not listen to patient. Responses were assessed with a 5-point Likert scale (1-never, 2-rarely, 3-sometimes, 4-most of the time, 5-always). We will evaluate top-box (topmost, ie, "never") scores for this measure.	24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)
Secondary	Safety Climate (The Children's Hospital Safety Climate Questionnaire)	Self-reported by patients/families prior to discharge. The Children's Hospital Safety Climate Questionnaire includes 14 Likert-scale (agreement on a 5 point scale from "strongly agree" to "strongly disagree") questions related to parent perceptions of safety climate during hospitalization. It was adapted from the AHRQ Hospital Survey on Patient Safety Culture for staff and validated using confirmatory factor analysis. Domains include perceptions of safety, staff communication openness, parent communication openness, and handoffs and transitions. Items of interest relate to the communication openness domain. Top-box (top-most/best) scores will be analyzed.	24 months (including usual care and intervention implementation data collection which will happen sequentially)per site (8 sites total)
Secondary	Observations of Quality and Frequency of Communications	Direct observations (by study staff) will measure the frequency of (1) overall communications between patients/families and providers, (2) language-concordant communications among patients and providers (times a provider communicates with a patient/family in a language the patient understands), and (3) interpreter-facilitated communications among patients with LEP. The type of communications and their quality will also be observed. The study team has used direct observations to measure frequency, type, and quality of communication reliably in multiple prior studies and will modify these prior measures to assess communication.	24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)