The purpose of this study is to learn about the impact of the Oncology Nurse Navigation program on the frequency of Emergency Department, urgent care visits and inpatient hospital admissions; and overall survival rate at 6 months. The investigators aim to understand if prompt and effective coordination of care provided by Oncology Nurse Navigation (ONN) service will reduce the number of avoidable, unplanned ED visits and hospitalizations, as well as adding measurable value to cancer care, and improve patient overall survival.
A randomized controlled prospective trial evaluating the effectiveness of a nurse navigation program for gastrointestinal cancer patients undergoing oncological treatment. Upon accrual, patients will be randomized 1:1 to receive standard of care plus ONN service (n = 107) or standard of care only (without ONN service; n = 107). Patients in both arms will be assessed for acute care utilization and overall survival (OS) rate at 6 months. Anticipated accrual period will be 30 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
228
Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse.
Levine Cancer Institute
Charlotte, North Carolina, United States
Annualized Count of Acute Care Visits
The annualized count of acute care visits, where acute care visits included all unplanned inpatient admissions, emergency room encounters, and/or urgent care visits, was calculated for each subject as the total number of acute care visits normalized to an annual basis.
Time frame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportion of Participants Surviving at 6 Months
The proportion of participants surviving at 6 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 6 months after study enrollment. Failure occurred if the subject died from any cause within 6 months of study enrollment. The proportions were compared between the arms.
Time frame: From the date of randomization to death or 6 months
Proportion of Participants Surviving at 12 Months
The proportion of participants surviving at 12 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months after study enrollment. Failure occurred if the subject died from any cause within 12 months of study enrollment. The proportions were compared between the arms.
Time frame: From the date of randomization up until 12 months
Hospital Length of Stay
Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention.
Time frame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Time From Hospice Referral to Death for Participants Referred to Hospice
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Time from hospice referral to death was a time-to-event endpoint defined as the time from hospice referral to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. This endpoint was only calculated for subjects referred to hospice.
Time frame: From the date of hospice referral to death or last follow-up, assessed over 7 months.
Total Number of 30-day Readmissions
The number of readmissions within 30 days of in-patient admission discharges was calculated for each participant. This outcome was derived for each subject with at least one in-patient admission.
Time frame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportion of Participants Referred to Supportive Care Services
Referral to Supportive Care Services was derived for each participant as a binary variable indicating if there was at least one documented referral to Palliative Care, Nutrition Services, and/or Social Work Services.
Time frame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.
This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type.
Time frame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33
Subject satisfaction was assessed by a modified European Organization for Research and Treatment of Cancer Patient Satisfaction with cancer care questionnaire #33 (EORTC PATSAT C33) 10-14 weeks after randomization. Subjects completed the questionnaire assessing thirty-four elements of their experience with regards to hospital environment, hospital personnel, and treatment. Each question was assessed on a Likert-type scale ranging Poor to Excellent (mapped numerically to 1-5), where the higher scores indicated a better experience. The average score was calculated for each subject as the sum of the non-missing standardized scores divided by the number of measures contributing to the sum. The average score could range from 1 (the minimum) to 5 (the maximum).
Time frame: From the date of randomization up until 14 weeks