Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial
Brief Summary: In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff \[personal communication, Levin,A.\]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.


Options:
A: Arm Label: Family Integrated Care Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Family Integrated Care | Arm Label: Control Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Family Integrated Care; Assigned to Arm(s): Family Integrated Care Arm
B: Arm Label: Group Intervention: Financial support; Type: EXPERIMENTAL; Interventions: Other: Delivery of a prepaid payment card, Other: Interview with a sociologist | Arm Label: Group Control: no financial support; Type: ACTIVE_COMPARATOR; Interventions: Other: No intervention | Intervention Type: OTHER; Name: Delivery of a prepaid payment card; Assigned to Arm(s): Group Intervention: Financial support | Intervention Type: OTHER; Name: Interview with a sociologist; Assigned to Arm(s): Group Intervention: Financial support | Intervention Type: OTHER; Name: No intervention; Assigned to Arm(s): Group Control: no financial support
C: Arm Label: Low Flat Rate without Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: Low Flat Rate with Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: Low Sharp Rate without Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: Low Sharp Rate with Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: High Flat Rate without Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: High Flat Rate with Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: High Sharp Rate without Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: High Sharp Rate with Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: Easypaisa Flat Rate without Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: Easypaisa Flat Rate with Lottery; Type: EXPERIMENTAL; Interventions: Other: Conditional Cash Transfer, Other: SMS Reminder | Arm Label: SMS Reminder Only; Type: EXPERIMENTAL; Interventions: Other: SMS Reminder | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Conditional Cash Transfer; Assigned to Arm(s): Easypaisa Flat Rate with Lottery, Easypaisa Flat Rate without Lottery, High Flat Rate with Lottery, High Flat Rate without Lottery, High Sharp Rate with Lottery, High Sharp Rate without Lottery, Low Flat Rate with Lottery, Low Flat Rate without Lottery, Low Sharp Rate with Lottery, Low Sharp Rate without Lottery | Intervention Type: OTHER; Name: SMS Reminder; Assigned to Arm(s): Easypaisa Flat Rate with Lottery, Easypaisa Flat Rate without Lottery, High Flat Rate with Lottery, High Flat Rate without Lottery, High Sharp Rate with Lottery, High Sharp Rate without Lottery, Low Flat Rate with Lottery, Low Flat Rate without Lottery, Low Sharp Rate with Lottery, Low Sharp Rate without Lottery, SMS Reminder Only
D: Arm Label: Arm 1 (Pure Control Group); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 2 (Contaminated Control Group); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 3 (Intervention Group A); Type: EXPERIMENTAL; Interventions: Behavioral: Patient educational letter to engage provider in hypertension rx discussion | Arm Label: Arm 4 (Intervention Group B); Type: EXPERIMENTAL; Interventions: Behavioral: Patient educational letter to engage provider in hypertension rx discussion | Arm Label: Arm 5 (Intervention Group C); Type: EXPERIMENTAL; Interventions: Behavioral: Patient educational letter to engage provider in hypertension rx discussion, Behavioral: Financial incentive (Arms B and C) and health educator phone call (Arm C) | Intervention Type: BEHAVIORAL; Name: Patient educational letter to engage provider in hypertension rx discussion; Assigned to Arm(s): Arm 3 (Intervention Group A), Arm 4 (Intervention Group B), Arm 5 (Intervention Group C) | Intervention Type: BEHAVIORAL; Name: Financial incentive (Arms B and C) and health educator phone call (Arm C); Assigned to Arm(s): Arm 5 (Intervention Group C)

Answer: A