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.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
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,
anxiety, depression, satisfaction of patients with care, social isolation,
unplanned readmissions caused by complications sensible to basic care
activities, healthcare costs, amount of home care after discharge, hospital
length of stay, and sleep quality.
Background summary
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.
Study objective
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 and the UMCG.
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
Study burden and risks
Included patients will undergo major elective surgery. If patients are
allocated to the intervention group, family caregivers will be asked to deliver
basic care during hospitalization and after discharge (if needed). Furthermore,
we expect that they will be present for a minimum of 8 hours per day during the
first 5 days on the nursing ward. This may instigate family caregiver burden.
However, based on the results of our pilot study, it seems that the family
involvement program is feasible for family caregivers, patients and healthcare
professionals. Our results indicate that this program may lead to an absolute
reduction of hospital readmissions of 15%; the incidence of postoperative
pneumonia was slightly higher in the control group compared to the intervention
group. We therefore hypothesize that the family involvement program can lead to
a reduction of the number of first unplanned readmissions, and considered a 10%
reduction as clinical relevant.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
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 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 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 themselves.
Design
Recruitment
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 |
|---|---|
| CCMO | NL66712.018.18 |