Determining the impact of communication based on the COMFORT model on family satisfaction of patients admitted to the intensive care unit
Design
Pilot study, quasi-experimental, non-randomized, including non-parallel control and intervention groups on 96 patients' family.
Settings and conduct
Shahid Sadoughi and Rahmonun hospitals, Yazd, and Valiasr(aj) Shahrbabak ICU units. Implementation of the study in three stages: : collecting information of the control group; implementation of communication training course for nurses; implementing the intervention and collecting information of the intervention group. The arrival time of each hospitalized patient's family starts five days after the level of consciousness decreases.
Participants/Inclusion and exclusion criteria
The family member must be fluent in Farsi, with age of 18 to 65 (the same for hospitalized patients), visit at least twice in 5 days and have consent. The patient has been hospitalized for more than 5 days and has a reduced level of consciousness.
Intervention groups
The families of patients in the control group receive the routine communication approaches of the ICU department.
Communication with the families of patients in the intervention group is established based on the principles of the COMFORT. Every day, the nurse in the shift talks for 20 minutes with one members of the patient's family about their experiences of hospitalization in the ICU , gives the necessary training and addresses the concerns. The principles of Mindful, Opening, Relating and Team are managed by the responsible nurse in order to improve communication.
Main outcome variables
Satisfaction of patients' family
General information
Reason for update
Acronym
COMFORT
IRCT registration information
IRCT registration number:IRCT20241003063250N1
Registration date:2025-01-05, 1403/10/16
Registration timing:registered_while_recruiting
Last update:2025-01-05, 1403/10/16
Update count:0
Registration date
2025-01-05, 1403/10/16
Registrant information
Name
Batool Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3413 2933
Email address
b.yazdani@stu.ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the COMFORT Model on Patients' Family Satisfaction in the Intensive Care Unit
Public title
The COMFORT Model on Patients' Family Satisfaction in the Intensive Care Unit
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's family (family member) who cooperates with the research should be fluent in Persian
The patient's family member age between 18-65
The patient's family has a close relationship with the patient or has played a role in the decision-making process for the patient (spouse, father, mother, sister, brother, children, and in the absence of the above persons, other relatives of the patient).
The patient's family has visited the patient at least twice during these five days.
The patient's family (family member) must agree to participate in the study
The age of the hospitalized patient between 18 and 65 years
The patient shows a decrease in the level of consciousness and a decrease in GCS so that he is unable to communicate with the family due to a decrease in the level of consciousness (actual decrease in consciousness) or a decrease in consciousness along with medication due to being connected to a ventilator (induced decrease in consciousness).
The patient is hospitalized in the special ward for more than five days (period considered for the implementation of the intervention).
Exclusion criteria:
The family member has a mental illness under the treatment of a psychiatrist.
The patient has been admitted to the ward due to uncommon diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadougi University of Medical Sciences
Street address
Imam Reza Complex, Research and Technical Assistant, Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.SSU.REC.1403.053
Health conditions studied
1
Description of health condition studied
Patients with reduced level of consciousness hospitalized in intensive care unit (ICU)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patients' family satisfaction
Timepoint
5 days after inclusion in the study
Method of measurement
Completing study questionnaires including demographic information questionnaire and family satisfaction questionnaire of patients hospitalized in the intensive care unit (24 FS-ICU)
Secondary outcomes
1
Description
Nursing care quality
Timepoint
Completion of the nursing care quality questionnaire by a clinical supervisor after observing the patient's care three times and communicating with the patient's family by each of the nurses in the ICU who have trained and provided the COMFORT model.
Method of measurement
QUALPAC nursing care and quality questionnaire
Intervention groups
1
Description
Intervention group: The intervention is a daily 20-minute face-to-face communication intervention for the families of patients admitted to the ICU. Based on the daily intervention, the nurse in the morning shift first examines all the nursing reports and measures taken for the patient during the previous day and actively participates in the patient delivery process to obtain the necessary information about the patient's condition and events. Earn yesterday. Then, for 20 minutes, with one or two members of the patient's first-degree family (meetings are planned by the researcher and take place at the meeting time), he asks about their experiences of hospitalization in the ICU (principle Connect). Based on the family's level of knowledge, their health literacy, and the existing ambiguities, he explains in simple language the ambiguous points in the ICU department. He provides the necessary training (Options principle). Continuing the discussion process, more focus is placed on the family, their concerns, supporting them, and helping them accept new conditions (family principle). During the five days of the intervention, only one nurse is responsible for communicating with the target family. Since the nurse in charge may not be present in the hospital every five days, the researcher introduced himself to the patient's family on the same day of the start of the study and the arrival of the participants, and based on coordination with the nurse in charge, the intervention was carried out at the required times. It helps. Also, the researcher provides a direct contact number to answer the important questions of the patient's family by specifying the allowed contact times. The researcher does not answer the family's specific questions about the patient to prevent the contradiction between the statements of the patient and the responsible nurse. It only provides important explanations and conveys what is needed. The principles of Mindful communication, Opening, Relating, and Team are managed by the responsible nurse based on the progress of communication and based on the issues that arise. A COMFORT implementation checklist has also been prepared for nurses to specify the actions taken based on each principle. Communication meetings are held in a quiet part of the department during the meeting. For the period when the nurse is not in charge at the patient's bedside, to prevent the occurrence of problems, the researcher is present at the patient's bedside and provides the necessary care. colleagues (2023) was used. The educational content has been prepared using related books and articles in PowerPoint format as well as 9 educational clips in the field of COMFORT skill curriculum. For all seven COMFORT principles, seven scenarios and seven educational clips have been prepared. Seven scenarios related to each of the comfort sections were selected from the medical professional commitment book. The scenarios will be answered in the last session. Also, seven related educational clips from YouTube are searched and subtitled in Farsi and placed at the end of the presentation of each comfort component. Scenarios and clips are presented to create reasoning and thinking and to challenge the level of knowledge and skills of nurses. The training course is conducted in 10 sessions in person and over 10 weeks with repetition twice a week for the attendance of all nurses of the department.
Category
N/A
2
Description
Control group: The families of the patients in the control group receive the routine communication approaches of the ICU department, including the usual telephone and face-to-face communication with the nurses based on the usual procedure in the hospital.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadouqi Hospital
Full name of responsible person
Ali Dehghani
Street address
Yazd, Shahid Kandi Blvd., Ibn Sina St., Shahid Sadouqi Hospital
City
Yazd
Province
Yazd
Postal code
8115887857
Phone
+98 35 3822 4000
Email
sadoghi-Hospital@ssu.ac.ir
Web page address
https://yssh.ssu.ac.ir/
2
Recruitment center
Name of recruitment center
Shahid rahnamoon hospital
Full name of responsible person
Ali Zare Harooki
Street address
Shahid beheshti.sq.Farrokhi Av.Rahnommon hospital
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0002
Fax
+98 35 3132 3005
Email
rahnamoon@ssu.ac.ir
Web page address
https://rahnemoon.ssu.ac.ir/
3
Recruitment center
Name of recruitment center
Valiasr(aj)Hospital
Full name of responsible person
Reza Amin
Street address
Jahad Blvd.valiasr Hospital
City
Shahr-e-babak
Province
Kerman
Postal code
۷۷۵۱۶۵۱۱۵۲
Phone
+98 34 3411 2186
Fax
+98 34 3411 5003
Email
hbalinie@yahoo.com
Web page address
https://kmu.ac.ir/fa/shahrbabakhcn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Imam Reza Complex, Research and Technical Assistant, Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3733 3726
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Buali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 1751 3824
Email
fateme.bakhshii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Bakhshi
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Buali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
fateme.bakhshii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Bakhshi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Buali St
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
fateme.bakhshii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after de-identification. Data sharing is done in the form of uploading in official data sharing databases or following the request of the applicant in the form of an email to the responsible author's email.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
The data will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For scientific application and use for systematic review studies
From where data/document is obtainable
Fateme Bakhshi, Yazd, Bu Ali St., Safaiyeh, Shahid Sadouqi College of Nursing and Midwifery, Yazd Nursing and Midwifery Care Research Center Postal code: 8916877443 Phone: 0098 9139684626 Email address: Fateme.bakhshii@gmail.com f.bakhshi@ssu.
What processes are involved for a request to access data/document