No registrations found.
ID
Source
Brief title
Health condition
Family-centered care, fundamentals of care, surgery, oncology
Familiegecentreerde zorg, basiszorg, chirurgie, oncologie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the number of first unplanned readmissions within 30
days after discharge.
Secondary outcome
Secondary outcomes are postoperative complications, patients¡¯ quality of life,
satisfaction of patients with care, unplanned readmissions caused by complications sensible to basic care activities, healthcare costs, amount of
home care after discharge, hospital length of stay, sleep quality, anxiety and depression .
Background summary
The trial has been stopped prematurely, as we changed the design to a cohort study.
Background of the study:
In surgery, active involvement of family caregivers has the potential to improve outcomes by the prevention of unplanned readmissions and surgical complications. Some complications are believed to be potentially preventable
and are sensitive to basic care. Basic care reflects a diverse range of care processes that combine the physical, psychosocial and relational dimensions of care, traditionally delivered by nursing staff. Although basic care activities
seems to be simple, they are prone to be missed care. Since family caregivers are often the primary caregivers after discharge, they could be trained to deliver basic care. The period of hospitalization can be seen as an optimum
environment to actively stimulate family caregivers to collaborate in care.
Objective of the study:
To evaluate whether a family involvement program comprising a set of evidence-based basic care activities reduces the number of unplanned readmissions and postoperative complications after major abdominal surgery.
Study design:
A randomized controlled, pragmatic superiority trial in the Amsterdam University Medical Center, location AMC.
Study population:
Adults (¡Ý 18 years), undergoing major surgery with an expected hospital stay of at least 5 days for one of the following indications: premalignant and malignant pancreatic, esophageal or colorectal tumor. We will include 244
patients per group, 488 patients in total.
Intervention:
A family involvement program to support the active involvement family caregivers in basic care activities for patients in post-surgical patient care. This program consists of six main components: (1) information about basic care
activities; (2) goal setting with the patient, family caregiver and nurse; (3)
task-oriented training; (4) hands-on participation in basic care focusing on early mobilization, oral intake, breathing exercises, oral care and active
orientation; (5) presence of family caregivers during medical ward rounds; (6) rooming-in (at least 8 hours a day). This intervention is added on top of usual postoperative care.
Control:
Usual postoperative care
Primary study outcome:
Primary outcome measure is the number of first unplanned readmissions within 30 days after discharge.
Secundary study outcomes:
Secondary outcomes are postoperative complications, patients¡¯ quality of life, satisfaction of patients with care, unplanned readmissions caused by complications sensible to basic care activities, healthcare costs, amount of home care after discharge, hospital length of stay, sleep quality, anxiety and depression.
Study objective
A family involvement program will reduce the number of unplanned readmissions in adult patients undergoing major abdominal surgery.
Study design
T0= baseline
T1= at discharge
T2= date of surgery + 30 days
T3= discharge + 90 days
T5= end of trial
Intervention
A family involvement program to support the active involvement family
caregivers in basic care activities for patients in post-surgical patient care.
This program consists of six main components: (1) information about basic care
activities; (2) goal setting with the patient, family caregiver and nurse; (3)
task-oriented training; (4) hands-on participation in basic care focusing on
early mobilization, oral intake, breathing exercises, oral care and active
orientation; (5) presence of family caregivers during medical ward rounds; (6)
rooming-in (at least 8 hours a day). This intervention is added on top of usual
postoperative care.
Inclusion criteria
• Age equal or above 18 years;
• Scheduled for major surgery as treatment for the following indications: premalignant or malignant pancreatic, esophageal or colorectal tumor
• An expected hospital stay of at least 5 days postoperatively;
• Presence of a suitable family caregiver who is up to deliver basic care during hospitalization and after discharge (if needed)
• Presence of a suitable family caregiver who is able to be present during hospitalization (minimum of 8 hours per day) during the first 5 days on the nursing ward.
Exclusion criteria
Patients:
• Patients who are expected to remain in the intensive care unit (ICU) for over 72 hours after surgery
• Patients who will be operated in another hospital not participating in this study
• Patients unable to provide informed consent
• Patients who are unable to communicate in Dutch
Family caregivers:
• Family caregivers with an age equal or below 17 years
• Family caregivers who are not able to be present during hospitalization (minimum of 8 hours per day) during the first 5 postoperative days on the nursing ward
• Family caregivers who are not nominated as appointed family caregiver by patient
• Family caregivers who receive support from healthcare professionals to carry out self-care activities by
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7346 |
| NTR-old | NTR7611 |
| Other | Medical Ethics Committee Amsterdam UMC : ABR ID: NL66712.018.18 |