JMIR Publications

ABSTRACT

Background:

Postoperative complications and readmissions to hospital are factors known to negatively influence short- and long-term quality of life (QoL) of oncological gastrointestinal patients. Active family involvement in activities, such as fundamental care activities, has the potential to improve quality of healthcare. However, there is a lack of evidence on the relationship between active family involvement and outcomes in oncological gastrointestinal patients after surgery.

Objective:

This protocol describes a study that aims to evaluate the effect of a family involvement program (FIP) for adult patients undergoing surgery for malignant gastrointestinal tumors on unplanned readmissions. Additionally, the study aims to evaluate the effect of the FIP on family caregiver burden and their well-being and the fidelity of the FIP.

Methods:

This multicenter prospective cohort study will be undertaken in two large academic hospitals in the Netherlands. The FIP will be offered to adult patients and their family caregivers scheduled for oncological gastrointestinal surgery and who have an expected hospital stay of at least five days postoperatively. Family caregivers have to be willing to participate in fundamental care activities during hospitalization and after discharge. Consenting patients and their families will choose if they will participate in the FIP or not. If not, they will be the usual care group. According to the power calculation, we will continue recruiting until we have at least 150 patients/families in the FIP group and 150 in the usual care group. The intervention group receives the FIP that consists of: (1) information; (2) shared goal setting; (3) task-oriented training; (4) participation in fundamental care, focusing on mobilization, breathing exercises, oral intake, cognitive activities and oral hygiene; (5) presence of family caregivers during ward rounds; and (6) rooming-in for at least 8 hours a day. Patients in the comparison group receive usual postoperative care. The primary outcome measure is the number of unplanned readmissions up to 30 days after surgery. Several secondary outcomes will be collected: i.e. total number of complications (sensitive to fundamental care activities) 30 days and 90 days after surgery, emergency department visits, Intensive Care Unit (ICU) admissions up to 30 and 90 days after surgery, hospital length of stay (LOS), patients’ quality of life, and the amount of home care needed after discharge. Family caregiver outcomes are caregiver burden and well-being up to 90 days after participating in the FIP. For fidelity, we will check whether the FIP was executed as intended. Univariable regression and multivariable regression analyses will be conducted.

Results:

This study is ongoing. The first participant was enrolled in April 2019.

Conclusions:

The study will provide evidence on outcomes from a FIP and will give healthcare professionals practical tools for family involvement in the oncological surgical care setting.