ARTIS: Activating Relatives To get Involved in care after Surgery

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.

A family involvement program will reduce the number of unplanned readmissions in adult patients undergoing major abdominal surgery.

T0= baseline

T1= at discharge

T2= date of surgery + 30 days

T3= discharge + 90 days

T5= end of trial

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.