PFC I-PASS Intervention for Enhanced Healthcare Communication

Recruiting at 8 trial locations

Overseen By Elizabeth Micolisin, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

14400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving hospital communication, particularly for families who speak languages other than English. It tests the effectiveness of two communication methods, PFC I-PASS (Patient and Family Centered I-PASS) and PFC I-PASS+, against usual hospital care. PFC I-PASS+ incorporates interpreters and trains doctors in cultural sensitivity to make hospital rounds more inclusive. Patients admitted to pediatric units, especially those whose caregivers speak specified languages like Spanish or Mandarin, might be a good fit for this trial. As an unphased trial, this study provides a unique opportunity to enhance hospital communication for diverse families.

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 prior data suggests that the PFC I-PASS and PFC I-PASS+ interventions are safe for improving healthcare communication?

Research has shown that both the PFC I-PASS and PFC I-PASS+ programs are safe and improve patient care. Earlier studies found that the original PFC I-PASS program reduced unwanted medical issues in hospitals by enhancing communication between doctors, nurses, and patients and their families. This improvement led to fewer problems for patients during their hospital stay.

The PFC I-PASS+ program expands on this by including interpreters and training doctors to communicate more effectively with patients who speak different languages. Although detailed safety data for PFC I-PASS+ is not available, the emphasis on better communication and cultural understanding is generally safe and does not involve medical procedures.

Overall, both programs aim to make hospital stays safer and more welcoming for patients and their families. No reports of serious safety issues have been associated with these communication methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PFC I-PASS and PFC I-PASS+ interventions because they aim to revolutionize communication in hospitals, especially during family-centered rounds. Unlike typical practices, which can be unstructured and vary greatly depending on the healthcare provider, these interventions offer a structured communication framework that enhances information exchange between doctors, nurses, and families. The PFC I-PASS+ goes a step further by incorporating interpreters and training for cultural humility, addressing language and cultural barriers directly. This approach not only improves understanding but also actively involves families in daily decision-making, potentially leading to better patient outcomes and satisfaction.

What evidence suggests that this trial's interventions could be effective for improving healthcare communication?

Research has shown that the PFC I-PASS program, one of the interventions in this trial, enhances hospital safety and communication. In seven hospitals, it reduced harmful medical errors by 38% and improved the experience for patients and their families. The PFC I-PASS+ program, another intervention in this trial, includes interpreters and trains doctors to be more culturally aware, helping to overcome language barriers and improve communication. Early results suggest that both programs enhance information sharing and involve families more in healthcare decisions. These programs aim to make hospital visits clearer and more inclusive for everyone. ^{1 2 4 6 7}

Who Is on the Research Team?

Alisa Khan, MD, MPH

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Are You a Good Fit for This Trial?

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

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PFC I-PASS Intervention
• PFC I-PASS+ Intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: PFC I-PASS+ Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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 care Active Control 1 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

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+

Published Research Related to This Trial

A conference with 74 participants from various medical education programs identified key barriers to implementing patient- and family-centered care (PFCC) in residency training, including cultural issues, environmental factors, and time constraints.

Participants emphasized the importance of respectful communication with patients and families as a critical skill for residents, suggesting that making PFCC a core expectation in training can enhance both patient care and the learning environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating patient- and family-centered care into resident education: approaches, benefits, and challenges. Philibert, I., Patow, C., Cichon, J.[2021]

Patient-centered and family-centered care (PFCC) is increasingly recognized as beneficial in pediatric intensive care, focusing on respecting and responding to the needs of patients and their families.

Research highlights four key areas of PFCC implementation: family visitation, family-centered rounding, family presence during procedures, and family conferences, all of which contribute positively to the experiences of patients, families, and healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centered care in the pediatric intensive care unit. Meert, KL., Clark, J., Eggly, S.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QI Intervention Reduces use of Nonbeneficial ICU Treatments. Rosenberg, K.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The review analyzed 42 studies on Patient, Family-Centred Care (PFCC) in adult ICUs, revealing that while interventions are diverse, most lack a multi-dimensional approach that incorporates cultural shifts necessary for effective PFCC implementation.

Future research should focus on developing comprehensive measurement tools for PFCC that consider multiple dimensions, emphasizing the importance of partnerships among healthcare professionals, patients, and families to enhance individualized patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient, family-centred care interventions within the adult ICU setting: An integrative review. Mitchell, ML., Coyer, F., Kean, S., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Implementing patient- and family-centered care (PFCC) in hospitals leads to significant improvements in quality, safety, communication, and patient satisfaction.

Hospitals that adopted PFCC principles, as shown through surveys and ongoing analysis, have successfully created benchmarks that enhance the overall healthcare experience for patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmarking patient- and family-centered care: highlights from a study of practices in 26 academic medical centers. Vermoch, KL., Bunting, RF.[2010]

Patient-centered and family-centered care (PFCC) is essential for high-quality healthcare, especially in the challenging environment of the intensive care unit (ICU).

The article discusses various interventions to enhance PFCC in the ICU, while also addressing the limitations of current practices and suggesting future improvements to better support patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered and Family-Centered Care in the Intensive Care Unit. Secunda, KE., Kruser, JM.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9360201/

Patient and Family-Centered I-PASS SCORE Program The PFC I-PASS SCORE Program consists of three core intervention elements: (1) structured verbal communication on rounds, (2) structured written ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05591066?term=physician%20patient%20AND%20(relations%20OR%20communication)&aggFilters=status:not%20rec&rank=9

The Patient and Family Centered I-PASS LISTEN Study ... The overall goal of this project is to compare the effectiveness of PFC I-PASS+ and PFC I-PASS vs usual care (unstructured communication and unstandardized ...

3. pcori.org pcori.org/research-results/2022/comparing-three-ways-communicate-children-and-families-during-hospital-stay

Comparing Three Ways To Communicate With Children ... This study compares the clinical effectiveness of three ways to communicate with hospitalized children and their families, ...

4. publications.aap.org publications.aap.org/pediatrics/article/153/2/e2023062666/196364/Implementing-a-Family-Centered-Rounds-Intervention

Implementing a Family-Centered Rounds Intervention ... After implementing PFC I-PASS in 7 centers, harmful medical errors dropped 38% and hospital experience improved; rounds duration and teaching ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK605808/

Does a Patient- and Family-Centered Hospital ... - NCBI Implementation of a structured family-centered communication intervention was associated with improvements in patient safety, family experience, and multiple ...

6. psnet.ahrq.gov psnet.ahrq.gov/innovation/patient-and-family-centered-i-pass-family-centered-communication-program-reduce-medical

Patient and Family Centered I-PASS (Family-Centered ... This intervention sought to determine whether patient safety and communication processes could be improved via a family-centered communication ...

7. pcori.org pcori.org/research-results/2018/expanding-use-program-improve-patient-safety-children-hospitals

Expanding the Use of a Program to Improve Patient Safety ... A PCORI-funded research study found that the Patient and Family-Centered I-PASS, or PFC I-PASS, program reduced the rate of adverse events among children in the ...