14400 Participants Needed

PFC I-PASS Intervention for Enhanced Healthcare Communication

Recruiting at 7 trial locations
TJ
AK
AF
Overseen ByAngie Fan, BA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PFC I-PASS treatment?

Research shows that Patient and Family Centered Care (PFCC) interventions, like PFC I-PASS, improve communication between families and healthcare providers, which can enhance patient care. For example, a study found that improving communication in the ICU led to better family meetings and reduced unnecessary treatments.12345

How is the PFC I-PASS Intervention treatment different from other treatments for improving healthcare communication?

The PFC I-PASS Intervention is unique because it focuses on enhancing communication between healthcare providers and families by incorporating family-centered care principles, which emphasize the involvement and empowerment of patients and their families in the healthcare process. This approach is distinct from traditional treatments as it actively includes families in medical rounds and decision-making, aiming to improve patient satisfaction and safety.25678

Research Team

AK

Alisa Khan, MD, MPH

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Eligibility Criteria

This trial is for hospital leaders, patients aged 13+, nurses, parents/caregivers who speak one of the study languages, and medical staff at participating pediatric units. It aims to improve communication during rounds with families, especially those facing language barriers.

Inclusion Criteria

Nurses working on these units
Residents working on these units
Medical and nursing students working on these units
See 4 more

Exclusion Criteria

I or my caregiver can communicate in one of the study's specified languages.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of PFC I-PASS+ and PFC I-PASS interventions, including training and communication strategies

24 months
Regular visits for training and observation

Data Collection

Data collection on adverse events, patient/family experience, and communication quality

24 months
Ongoing data collection visits

Follow-up

Participants are monitored for safety and effectiveness after intervention implementation

4-8 weeks

Treatment Details

Interventions

  • PFC I-PASS Intervention
  • PFC I-PASS+ Intervention
Trial OverviewThe study compares PFC I-PASS+ (which includes interpreters and cultural training) with the original PFC I-PASS and usual care in hospitals. The goal is to see if these interventions can enhance how doctors and nurses communicate with patients' families.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: PFC I-PASS+ InterventionExperimental Treatment1 Intervention
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.
Group II: PFC I-PASS InterventionExperimental Treatment1 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.
Group III: Usual careActive Control1 Intervention
Unstructured communication during rounds and unstandardized interpretation at provider discretion.

PFC I-PASS Intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as PFC I-PASS for:
  • Improving communication in hospital settings
  • Reducing adverse events
  • Enhancing patient and family experience

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Pediatric Research in Inpatient Settings

Collaborator

Trials
1
Recruited
14,400+

Findings from Research

A panel of multidisciplinary stakeholders identified six essential elements for patient and family centered care (PFCC) in the ICU, including flexible visiting hours and family participation in bedside care, which received high consensus among participants.
Three key research priorities for PFCC were highlighted, with a focus on improving continuity of care after ICU discharge, although there was less consensus on the importance of family participation in bedside care and decision aids for end-of-life decisions.
A modified Delphi process to identify clinical and research priorities in patient and family centred critical care.Oczkowski, SJW., Au, S., des Ordons, AR., et al.[2018]
An initiative involving pediatric residents, medical students, and families improved physician communication in a hospital setting, achieving a significant increase in the percentage of respondents who rated physician communication as 'Always' from 72% to above the target of 75.6%.
The use of family members as standardized parents in simulation scenarios effectively enhanced the competency of medical providers in patient-family-centered communication, leading to better performance in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores.
Utilization of Family as Faculty: A Patient Directed Simulation Education to Improve Patient and Family Communication during Patient-Family Centered Rounds (PFCR).Asuncion, AM., Quintos-Alagheband, ML., Leavens-Maurer, J., et al.[2022]
Training physicians to effectively communicate with families of critically ill patients in the ICU improved the quality of family meetings, enhancing the overall experience for families during difficult times.
The intervention also resulted in a reduction in the use of nonbeneficial treatments, suggesting that better communication can lead to more appropriate care decisions for patients.
QI Intervention Reduces use of Nonbeneficial ICU Treatments.Rosenberg, K.[2022]

References

A modified Delphi process to identify clinical and research priorities in patient and family centred critical care. [2018]
Utilization of Family as Faculty: A Patient Directed Simulation Education to Improve Patient and Family Communication during Patient-Family Centered Rounds (PFCR). [2022]
QI Intervention Reduces use of Nonbeneficial ICU Treatments. [2022]
Patient, family-centred care interventions within the adult ICU setting: An integrative review. [2022]
Family-centered care in the pediatric intensive care unit. [2022]
Benchmarking patient- and family-centered care: highlights from a study of practices in 26 academic medical centers. [2010]
Incorporating patient- and family-centered care into resident education: approaches, benefits, and challenges. [2021]
Patient-Centered and Family-Centered Care in the Intensive Care Unit. [2023]