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

Studies

Study First Submitted Date 2022-10-17
Study First Posted Date 2022-10-24
Last Update Posted Date 2023-04-14
Start Month Year February 1, 2024
Primary Completion Month Year November 1, 2028
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-14

Facilities

Sequence: 200938155 Sequence: 200938156 Sequence: 200938157 Sequence: 200938158 Sequence: 200938159 Sequence: 200938160 Sequence: 200938161 Sequence: 200938162
Name University of Alabama at Birmingham Name Children's Hospital Los Angeles Name UCSF Benioff Children's Hospital of Oakland Name University of Nebraska Medical Center Name Children's Hospital at Montefiore Name The Research Institute of Nationwide Children's Hospital Name UPMC Children's Hospital of Pittsburgh Name Northwest Texas Healthcare System
City Birmingham City Los Angeles City Oakland City Omaha City Bronx City Columbus City Pittsburgh City Amarillo
State Alabama State California State California State Nebraska State New York State Ohio State Pennsylvania State Texas
Zip 35233 Zip 90027 Zip 94609 Zip 68198 Zip 10467 Zip 43205 Zip 15224 Zip 79106
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Facility Contacts

Sequence: 28245557 Sequence: 28245554 Sequence: 28245555 Sequence: 28245556 Sequence: 28245558 Sequence: 28245559 Sequence: 28245560 Sequence: 28245561 Sequence: 28245562 Sequence: 28245563 Sequence: 28245564 Sequence: 28245565 Sequence: 28245566 Sequence: 28245567 Sequence: 28245568
Facility Id 200938156 Facility Id 200938155 Facility Id 200938155 Facility Id 200938156 Facility Id 200938157 Facility Id 200938157 Facility Id 200938158 Facility Id 200938158 Facility Id 200938159 Facility Id 200938159 Facility Id 200938160 Facility Id 200938160 Facility Id 200938161 Facility Id 200938162 Facility Id 200938162
Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup
Name Susan Wu, MD Name Erin Shaughnessy, MD, MSHCM Name Lauren Nassetta, MD Name Angela Choe, MD Name Dorea Martin, MD Name Suzy Chen, MD Name Aleisha Nabower, MD Name Christopher Edwards, MD Name Theresa Serra, MD Name Courtney McNamara, MD Name Cara Harasaki, MD, MPH Name Shauna Schord, MD Name Andrew Buchert, MD Name Tetyana L Vasylyeva, MD, PhD, DSc Name Skye McLaurin-Jiang, MD
Email suwu@chla.usc.edu Email eshaughnessy@uabmc.edu Email lkbrewer@uab.edu Email anchoe@chla.usc.edu Email dorea.martin@ucsf.edu Email Suzy.Chen@ucsf.edu Email aleisha.nabower@unmc.edu Email tserra@montefiore.org Email comcnama@montefiore.org Email cara.harasaki@nationwidechildrens.org Email Shauna.Schord@nationwidechildrens.org Email andrew.buchert@chp.edu Email tetyana.vasylyeva@ttuhsc.edu Email Skyler.McLaurin@ttuhsc.edu
Phone 323-361-6177 Phone 205-638-9922 Phone 323-361-6177 Phone 510-428-3885 Phone 510428-3331 Phone 402-955-4140 Phone 718-741-2470 Phone 718-741-2470 Phone 614-722-0417 Phone 614-722-4998 Phone 412-692-7288 Phone 806-414-9800

Facility Investigators

Sequence: 18418803
Facility Id 200938159
Role Sub-Investigator
Name Patricia Hametz, MD

Conditions

Sequence: 52417672
Name Communication
Downcase Name communication

Id Information

Sequence: 40333082
Id Source org_study_id
Id Value P00042876

Countries

Sequence: 42759468
Name United States
Removed False

Design Groups

Sequence: 55866444 Sequence: 55866445 Sequence: 55866446
Group Type No Intervention Group Type Experimental Group Type Experimental
Title Usual care Title PFC I-PASS Intervention Title PFC I-PASS+ Intervention
Description Unstructured communication during rounds and unstandardized interpretation at provider discretion. Description 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. Description 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.

Interventions

Sequence: 52726141 Sequence: 52726142
Intervention Type Behavioral Intervention Type Behavioral
Name PFC I-PASS Intervention Name PFC I-PASS+ Intervention
Description 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. Description 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.

Keywords

Sequence: 80201350 Sequence: 80201351 Sequence: 80201352 Sequence: 80201353 Sequence: 80201354 Sequence: 80201355 Sequence: 80201356 Sequence: 80201357 Sequence: 80201358 Sequence: 80201359
Name Family Centered Rounds Name Patient Safety Name Errors Name Limited English Proficiency Name Health Disparities Name Adverse Events Name Patient Experience Name Family Engagement Name Interprofessional Communication Name Language Barriers
Downcase Name family centered rounds Downcase Name patient safety Downcase Name errors Downcase Name limited english proficiency Downcase Name health disparities Downcase Name adverse events Downcase Name patient experience Downcase Name family engagement Downcase Name interprofessional communication Downcase Name language barriers

Design Outcomes

Sequence: 178297900 Sequence: 178297901 Sequence: 178297902 Sequence: 178297903 Sequence: 178297904
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Adverse Event Rates Measure Patient/Family Experience with Care Questionnaire Measure Patient/Family Experience of Discrimination (Discrimination In Medical Settings Scale) Measure Safety Climate (The Children's Hospital Safety Climate Questionnaire) Measure Observations of Quality and Frequency of Communications
Time Frame 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total) Time Frame 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total) Time Frame 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total) Time Frame 24 months (including usual care and intervention implementation data collection which will happen sequentially)per site (8 sites total) Time Frame 24 months (including usual care and intervention implementation data collection which will happen sequentially) per site (8 sites total)
Description Chart review, self-reported by staff and patients/families, and hospital incident reports Description 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. Description 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. Description Self-reported by patients/families throughout hospitalization. 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. Description 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.

Sponsors

Sequence: 48548102 Sequence: 48548103 Sequence: 48548104
Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Boston Children's Hospital Name Patient-Centered Outcomes Research Institute Name Pediatric Research in Inpatient Settings

Overall Officials

Sequence: 29413199
Role Principal Investigator
Name Alisa Khan, MD, MPH
Affiliation Boston Children's Hospital/Harvard Medical School

Central Contacts

Sequence: 12073872 Sequence: 12073873
Contact Type primary Contact Type backup
Name Alisa Khan, MD, MPH Name Tyler Johnson, BA
Phone 617-355-2565 Phone 857-218-4970
Email alisa.khan@childrens.harvard.edu Email tyler.johnson@childrens.harvard.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68483908 Sequence: 68483909
Design Group Id 55866445 Design Group Id 55866446
Intervention Id 52726141 Intervention Id 52726142

Eligibilities

Sequence: 30907030
Gender All
Minimum Age 0 Years
Maximum Age N/A
Healthy Volunteers No
Criteria 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, Chinese (Mandarin and Cantonese), Karen, 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: Parents/caregivers who do not speak a study language (decided based on the 10 most commonly spoken languages across study sites; study languages include: English, Arabic, Armenian, Chinese (Mandarin and Cantonese), Karen, Nepali, Quiche, Spanish, Somali, and Vietnamese and/or other languages if resources allow)
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254165681
Number Of Facilities 8
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 0
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30652745
Allocation Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking Single
Outcomes Assessor Masked True

Responsible Parties

Sequence: 29019398
Responsible Party Type Principal Investigator
Name Alisa Khan
Title Pediatric Hospitalist/Assistant Professor of Pediatrics
Affiliation Boston Children's Hospital

Study References

Sequence: 52328457 Sequence: 52328458 Sequence: 52328459 Sequence: 52328460 Sequence: 52328461 Sequence: 52328462 Sequence: 52328463
Pmid 25372088 Pmid 28241211 Pmid 30518517 Pmid 33074313 Pmid 35411380 Pmid 35977037 Pmid 35696195
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
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. Erratum In: JAMA Pediatr. 2018 Mar 1;172(3):302. 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. 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. 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. 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. 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.