Family Inclusion and Engagement on Patient-and-Family-Centered Care Interdisciplinary Rounds (PFCC-IR)
Primary Purpose
Critical Illness
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participation in PFCC-IR
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to the adult ICU over the age of 20 who are awake and alert with a score of above 25 on the Mini-Mental Status (MMS) examination, able to provide informed consent, fill-out the questionnaires and who has a family member or significant other who will be willing to participate in the study.
- Family members who are in the patient's primary support system and or caregiver, significant other, or those whom the patient considered or identified as the family who are over the age of 20, able to provide informed consent and will be willing to attend the multidisciplinary rounds while their patient is in the ICU and fill-out the questionnaires.
- All ICU nurses and other health care professionals such as the physicians, respiratory therapists, social workers, and dietitians over the age of 25, male and female nurses, working full time in the ICUs, and willing to provide informed consent will be surveyed.
Exclusion Criteria:
- Any patient with an MMS score below 25 will not be included in the study.
- Patients who are admitted in cardiogenic shock or who are hemodynamically unstable, who are 'intubated' and on mechanical ventilation will be excluded from the study, and with an MMS score of below 20 will be excluded in the study.
- Family members and nurses who are unwilling or will refuse to participate in multidisciplinary rounds will be excluded.
Sites / Locations
- Inspira Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL GROUP: SURVEY ONLY
EXPERIMENTAL GROUP: SURVEY AND ROUNDS
Arm Description
75 patients and 75 family member - total of 150 plus 90 healthcare professionals: survey only Grand total: 240
75 patients and 75 family member - total of 150
Outcomes
Primary Outcome Measures
Assessing Patient Satisfaction Change after Inclusion in PFCC-IR
Will there be a difference in in patient and family satisfaction between rounding in the presence of family compared to patient rounding without family members in the adult ICU using the PSNCQQ?
Assessing Family Satisfaction Change after Inclusion in PFCC-IR
Will there be a difference in in patient and family satisfaction between rounding in the presence of family compared to patient rounding without family members in the adult ICU using the CCFSS?
Secondary Outcome Measures
Full Information
NCT ID
NCT05449990
First Posted
March 28, 2022
Last Updated
July 7, 2022
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05449990
Brief Title
Family Inclusion and Engagement on Patient-and-Family-Centered Care Interdisciplinary Rounds (PFCC-IR)
Official Title
Family Inclusion and Engagement on Patient-and-Family-Centered Care Interdisciplinary Rounds (PFCC-IR)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose/Specific Aims The overall goal of this multidisciplinary, multisite experimental study was to determine whether family presence and engagement during patient-and-family-centered interdisciplinary rounds (PFCC-IR) impacts nurses' and health care professionals' attitudes and patient and family satisfaction with their intensive care unit (ICU) stay.
A. Objectives
(1) To examine if there is a difference in patient and family satisfaction between rounding in the presence of family compared to patient rounding without family members in the adult intensive care unit (ICU) using the Patient Satisfaction with Nursing Care Quality Questionnaire ([PSNCQQ], and the Critical Care Family Satisfaction Survey ([CCFSS]; and, (2) To determine ICU nurses' and health care professionals' attitudes toward family presence during PFCC-IR using the Families' Importance in Nursing Care-Nurse's Attitudes ([FINC-NA] scale
B. Hypotheses / Research Question(s) The present study hypothesized that: H1: There will be greater patient satisfaction when rounding with family present compared to without family present. H2: There will be differences in attitudes towards family presence during PFCC-IR.
Detailed Description
Research Design and Methods: This multisite experimental study was conducted in an adult ICU of two hospitals in southern New Jersey. Approval from the Institutional Review Board (IRB) was obtained before the initiation of the study. Informed consent was obtained from the patients, family members, nurses, and health care professionals. The sample consists of 150 patients and family members (75 dyads per hospital) and 90 healthcare professionals (n = 390 total) that included the ICU Attendings/Intensivists, Fellows, medical residents, respiratory therapists, physical therapists, pharmacists, dietitians and a social worker. Three instruments were used: the FINC-NA, the PSNCQQ, and the CCFSS. The PFCC-IR were led by the ICU Attending or Intensivist.
Duration for Study and Each Subject: The patient and family members' participation in the study took 30 minutes to one hour for the rounds, and another 20-30 minutes to complete the survey for an overall total participation time of 2.5 hours.
Sample Size Justification: A sample of 75 dyads or 150 patients and family members was the projected target sample size for this study. Power analysis for the study was calculated based on 80% power to detect a difference, with a significance level of 0.05 (2-tailed), in means of 0.4 with a standard error of 0.8.
Data Collection: All data were collected by the PI after having all subjects signed the informed consent. Family members or significant others attended one to two PFCC-IR on the first week of admission while the patient is in the ICU. The patient questionnaire was given to the patient by the PI to be completed at the time of discharge or within 24 hours of discharge from the ICU. The family member and/or significant other questionnaires were administered on the day of the patient's discharge from the ICU or within 48 hours of discharge from the ICU. All eligible ICU nurses and health care professionals were given a survey packet by the PI at the beginning and end of the study. Completed questionnaires was returned in a drop box in the ICU.
Consent Procedures: The consent process took place in a private room in the ICU of the hospital. The PI followed-up and scheduled a bedside contact to explain the study fully to the patient during visiting hours or over the telephone. All questions from subjects were answered by the PI. The patient and family members were given enough time that they need to read and understand the content of informed consent. Informed consents were obtained from all the 390 subjects in this study.
Economic Burden and/or Compensation for Subjects: Subjects did not incur any expenses by participating in this study. No remuneration was given to the subjects.
Risks and Benefits to Subjects: Patients and family members who gave consent participated in the PFCC-IR. No untoward events occurred when the intervention was administered for the whole duration of the study. There are no withdrawal or attrition of subjects.
Current guidelines recommend for families of ICU patients to participate PFCC-IR to facilitate patient-family-centered-care. However, there has been relatively little research to inform best practices. Findings obtained from this study may provide further new knowledge on the effect of family presence during PFCC-IR, and patient and family satisfaction that will help establish policies and a standardized approach to rounding processes that can be applied, further developed and implemented in different critical care settings as well as other non-critical care settings. Further, it may decrease the ambivalence expressed by diverse health care providers and limit practice variation.
Data Analysis: Data analysis for this study is in progress using the latest version of the SPSS software.
Data Security: Subjects were made aware that they have the right to privacy and that their identities will not be revealed, and the confidentiality of information will be ensured. Identity protection and confidentiality were fully expressed in the consent form. All the data that were collected are stored in a password protected computer located in the researcher's office. Hard copies of transcripts and narratives are stored in a locked cabinet in the researcher's office in the university, to assure safety and preserve the privacy and confidentiality of all participants.
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL GROUP: SURVEY ONLY
Arm Type
No Intervention
Arm Description
75 patients and 75 family member - total of 150 plus 90 healthcare professionals: survey only Grand total: 240
Arm Title
EXPERIMENTAL GROUP: SURVEY AND ROUNDS
Arm Type
Experimental
Arm Description
75 patients and 75 family member - total of 150
Intervention Type
Other
Intervention Name(s)
Participation in PFCC-IR
Intervention Description
PFCC-IR with the critical care team is standard practice in ICU but it doesn't usually include family members. The intervention for this study is multidisciplinary patient care rounds that include one family member of the patient.
Primary Outcome Measure Information:
Title
Assessing Patient Satisfaction Change after Inclusion in PFCC-IR
Description
Will there be a difference in in patient and family satisfaction between rounding in the presence of family compared to patient rounding without family members in the adult ICU using the PSNCQQ?
Time Frame
The PSNCQQ questionnaire will be given to the patient and family members to be completed up to 4 days after discharge from ICU.A 5-point Likert scale ranging from poor to excellent is used for each item of the PSNCQQ
Title
Assessing Family Satisfaction Change after Inclusion in PFCC-IR
Description
Will there be a difference in in patient and family satisfaction between rounding in the presence of family compared to patient rounding without family members in the adult ICU using the CCFSS?
Time Frame
The CCSFSS questionnaire will be given to the family members to be completed up to 4 days after discharge from ICU. The instrument has a Likert scale one of five choices from 1 (very dissatisfied) to 5 (very satisfied) for each of the 20 items.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients admitted to the adult ICU over the age of 20 who are awake and alert with a score of above 25 on the Mini-Mental Status (MMS) examination, able to provide informed consent, fill-out the questionnaires and who has a family member or significant other who will be willing to participate in the study.
Family members who are in the patient's primary support system and or caregiver, significant other, or those whom the patient considered or identified as the family who are over the age of 20, able to provide informed consent and will be willing to attend the multidisciplinary rounds while their patient is in the ICU and fill-out the questionnaires.
All ICU nurses and other health care professionals such as the physicians, respiratory therapists, social workers, and dietitians over the age of 25, male and female nurses, working full time in the ICUs, and willing to provide informed consent will be surveyed.
Exclusion Criteria:
Any patient with an MMS score below 25 will not be included in the study.
Patients who are admitted in cardiogenic shock or who are hemodynamically unstable, who are 'intubated' and on mechanical ventilation will be excluded from the study, and with an MMS score of below 20 will be excluded in the study.
Family members and nurses who are unwilling or will refuse to participate in multidisciplinary rounds will be excluded.
Facility Information:
Facility Name
Inspira Medical Center
City
Elmer
State/Province
New Jersey
ZIP/Postal Code
08318
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family Inclusion and Engagement on Patient-and-Family-Centered Care Interdisciplinary Rounds (PFCC-IR)
We'll reach out to this number within 24 hrs