FamilyLink Family-Centered Rounds

Study Overview
=================
Brief Summary
-----------------
This study will be a pilot test of using FamilyLink software to bring parents of patients in the neonatal intensive care unit (NICU) virtually to the bedside during Family Centered Rounds.

Official Title
-----------------
FamilyLink Family-Centered Rounds Pilot Study

Conditions
-----------------
Family Centered Rounds

Intervention / Treatment
-----------------
* Other: Telemedicine FCR
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the Blue Team in the NICU aged 0-365 days Parents/guardians of patients admitted to the Blue Team in the NICU aged ≥ 18 years Medical team members (physicians, nurse practitioners, fellows, residents, medical students, nurses) of patients admitted to the Blue Team in the NICU aged ≥ 18 years Exclusion Criteria: Patients who are not discharged home from the NICU (e.g., transferred to another inpatient unit or another hospital) Parents/guardians of patients admitted to the Blue Team in the NICU who do not speak English, as a translator will not reliability be available to participate in rounds when the parent/guardian is not physically present Patients who have more than one admission to the Blue Team during our study period will only be included on their first admission
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine FCR<br>These patients will be eligible to use telemedicine for Family Centered Rounds | Other: Telemedicine FCR<br>* Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)<br>|
| Placebo Comparator: Control<br>These patients will not be eligible to use telemedicine for Family Centered Rounds (standard of care) | Other: Standard of care<br>* Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAHPS Communication with Parent Subscale | 19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum) | Through study completion, approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adverse events | Rates of adverse events reported by parents, providers, or nurses | Up to 6 months | 
| Hospital Length of Stay | Hospital length of stay of the patient measured in days | Through study completion, approximately 3 months | 
| Breastmilk at discharge | If the patient was receiving all, some or no breastmilk | Through study completion, approximately 3 months |