Impact Of Nurse Navigation Program on Outcomes in Patients With GI Cancers

Not Applicable

Completed

Conditions: Gastrointestinal Cancer

Interventions: Other: Oncology Nurse Navigation

Registration Number: NCT04602611

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 228

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncology Nurse Navigation	Oncology Nurse Navigation	Standard of Care + Oncology Nurse Navigation

Primary Outcome Measures

Name	Time	Method
Annualized Count of Acute Care Visits	From the date of randomization until subject discontinued the intervention, assessed up to 34 months	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.
Proportion of Participants Surviving at 6 Months	From the date of randomization to death or 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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Surviving at 12 Months	From the date of randomization up until 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.
Hospital Length of Stay	From the date of randomization until subject discontinued the intervention, assessed up to 34 months	Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention.
Time From Hospice Referral to Death for Participants Referred to Hospice	From the date of hospice referral to death or last follow-up, assessed over 7 months.	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.
Total Number of 30-day Readmissions	From the date of randomization until subject discontinued the intervention, assessed up to 34 months	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.
Proportion of Participants Referred to Supportive Care Services	From the date of randomization until subject discontinued the intervention, assessed up to 34 months	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.
Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months	This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type.
Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33	From the date of randomization up until 14 weeks	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).