NCT05449990

Brief Summary

Family presence on patient care rounds in adult intensive care units remains the least studied area of family-centered care. Despite support from professional organizations and critical care experts, very few critical care units in the United States have written policies allowing family presence (Davidson, 2013). This multidisciplinary prospective, quasi-experimental design study examined 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 and determined the nurses' and health care professionals' attitudes toward family presence during multidisciplinary patient care rounds in the ICU of two hospitals. The sample was 150 patients and family members (75 per hospital) and a convenience sampling of 90 healthcare professionals from the two sites. This investigation will have a potential impact on nursing practice and research. Findings obtained from this study may provide further concrete information on the effect of family presence during multidisciplinary patient care rounds, and patient and family satisfaction that will develop policies and standardized approaches to rounding processes that are innovative in diverse critical care settings as well as other non-critical care settings. Data obtained from this research will be used to create patient and family-centered care plans, add new knowledge and educational programs for healthcare professionals

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

March 28, 2022

Last Update Submit

November 1, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing Patient Satisfaction Change after Inclusion in patient-and-family-centered rounds using the Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) scale

    Patient satisfaction with ICU stay was assessed using the Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) scale. The instrument is a 19-item questionnaire. Cronbach's reliability estimates of 0.97. Participants' responses are provided using a 5-point Likert-type scale. Total possible scores range from 19-95. Lower total scores indicate greater satisfaction with nursing care. The scoring of the scale was: 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor

    Baseline (day 1 when in the study) and post-intervention (4 days after the patient leave the ICU)

  • Assessing Family Satisfaction Change after Inclusion in patient-and-family-centered rounds using the Critical Care Family Satisfaction Survey (CCFSS) scale

    The 5 subscales of the CCFSS are assurance, proximity, support, comfort, and information. The Cronbach alpha for the total scale was 0.96 and 0.74 - 0.92 for the subscales (Roberti \& Fitzpatrick, 2010). When administering the CCFSS, the respondent endorses one of five choices from 1 (very dissatisfied) to 5 (very satisfied) for each of the 20 items. A mean subscale score is calculated for each subscale (range 1 to 5), and a total satisfaction score (range 5 to 25) is computed by summing the five subscale scores. Higher scores for the subscale and total satisfaction scores indicate a greater satisfaction as perceived by a patient's family member (Wasser \& Matchett, 2001; Wasser et al., 2001, 2004)

    Baseline (day 1 when in the study) and post-intervention(4 days after the patient leave the ICU)

  • Assessing attitudes of healthcare professionals using the Families' Importance in Nursing Care-Nurse's Attitudes" (FINC-NA),

    The instrument consists of 26 items and four subscales: families as a resource in nursing care (10 items; score range 10 to 50), family as a conversational partner (8 items, score range 8 to 40), family as a burden ((four items, score range 4 to 20), and family as its own resource ((4 items, score range 4 to 20). Item scores are summed to create a total score that ranges from 26 to 130. After reverse coding negatively worded items from the Fam-B subscale, higher scores indicated more positive attitudes.

    one time at any point during the study: through study completion, an average of 1 year

Study Arms (2)

CONTROL GROUP: survey and Standard Care (SC)

NO INTERVENTION

150 (75 patients and 75 family members)

EXPERIMENTAL GROUP: participation in patient-and-family-centered interdisciplinary rounds (PFCC-IR)

EXPERIMENTAL

150 (75 patients and 75 family members)

Other: Participation in PFCC-IR

Interventions

Patient-and-family-centered-care interdisciplinary rounds (PFCC-IR) with the critical care team are standard practice in the ICU but it doesn't usually include family members. The intervention for this study is PFCC-IR that include one family member of the patient.

EXPERIMENTAL GROUP: participation in patient-and-family-centered interdisciplinary rounds (PFCC-IR)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inspira Health Network

Mullica Hill, New Jersey, 08062, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brigitte S Cypress

    Rutgers University School of Nursing Camden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: control group: 150 patients and one family member experimental group: 150 patients and one family member; 90 healthcare professionals (no intervention, convenience sampling. cross-sectional data collection)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

July 8, 2022

Study Start

July 26, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results that are and will be reported in published articles based on this study will be available after deidentification (texts, tables, figures, and appendices)

Shared Documents
SAP
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: brigitte.cypress@rutgers.edu

Locations