Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635150
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-11-12
Brief Title:
National Evaluation of the Close Collaboration With Parents Training
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
National Evaluation of the Close Collaboration With Parents Training Enhancing Parents Presence and Participation During Neonatal Intensive Care
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VVME5
Brief Summary:
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infants stay in the Neonatal Intensive Care Unit NICU and parents and staff perception on family centered care in the unit This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018 Data was collected by using daily parental diaries daily text message questions to parents and an audit interview for the staff
Detailed Description:
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infants stay in the Neonatal Intensive Care Unit NICU and parents and staff perception on family centered care FCC in the unit We hypothesized that parents spend more time in the unit and have more skin-to skin contact with their infant after the intervention compared to the time before the intervention We also hypothesized that care culture becomes more family centered after the intervention both from parent and staff perspectives
Study NICUs and participants This study was an intervention study comparing the situation before and after the intervention It was carried out in nine NICUs in Finland including two level III hospitals and seven level II hospitals The study progressed stepwise between May 2012 and September 2018 two or three hospitals participated in the study simultaneously The study permission was granted by the Hospital District of Southwest Finland T572012 and separately by each study site
The study participants were recruited during three-month periods before and after the Close Collaboration with Parents training program which lasted for 18 months Every parent of an infant estimated to stay in the NICU longer than three days was approached Other inclusion criteria were 1 the infant had no major congenital anomalies or syndromes 2 the parents spoke Finnish or Swedish 3 the family lived in the catchment area of the hospital A log including infants gestational age birth weight the length of hospital period and the distance to home was kept for all admissions of infants with a length of stay longer than 3 days to identify eligible parents and evaluate drop-out rate
The staff introduced the study protocol to parents and gave them at least one day to consider their participation After the parents signed the informed consent form they were given instructions for use of the closeness diaries and text messages The parents provided infant characteristics including gestational age birthweight birth head circumference sex mode of delivery and whether the infant was a singletonmultiple or had siblings and family characteristics including parents age education socio-economic status and the distance from the hospital to home
Closeness diary The duration of parents presence in the NICU and skin-to-skin contact SSC was reported with closeness diaries Presence in the unit was defined by being inside the unit not necessarily all the time in the room of the baby SSC was defined as the baby lying on the parents bare chest dressed only in a diaper and a cap if necessary On the diary there were four different timelines where parents filled in the time spent in NICU and SSC with their infant mother present mother SSC father present and father SSC Parents were asked to fill in the diaries from the time of recruitment until discharge During data collection the diaries were stored in a folder at the bedside so that other families or nurses did not see the diaries
Intervention The Close Collaboration with Parents intervention was developed based on theoretical evidence from infant neurobehavioral and attachment theories The training is based on a multi-method learning philosophy using theoretical teaching hands-on teaching at bedside and reflective discussions supporting simultaneous implementation of practice change The intervention teaches new skills to the entire staff of a unit to collaborate with parents in order to support parents presence and involvement in infants care The original intervention was condensed to a structured 18-month-long training including four phases A facilitator network model was used including local mentors trained by the trainer mentors and a supervisor
BLISS Audit tool The data from staff were collected using the Bliss Baby Charter Audit Tool with permission of Bliss organization The audit tool is a self-assessment instrument identifying areas of improvement in the quality of FCC in NICUs The tool has 141 statements divided into seven core principles which summarize the care respect and support that infants and their parents should receive All seven principles contain different categories of family-centered care as defined by Bliss The categories are 1 Active care by parent and staff 18 criteria 2 Parent and family support 17 criteria 3 Communication 6 criteria 4 Developmental care 9 criteria 5 Empowered decision making 10 criteria 6 Facilities 17 criteria 7 Guidelines and policies 17 criteria 8 Staff skills and training 12 criteria 9 Information provision 27 criteria and 10 Service improvement and parent involvement 8 criteria
DigiFCC Parents evaluated the quality of FCC with DigiFCC-P tool by answering to the text-message questions delivered by mobile phones The tool was developed for the evaluation of the Close Collaboration with Parents training Program Parents received one randomized question from seven questions every evening during their infant hospitalization The tool was further developed based on feedback from parents staff and researchers to improve its content validity and feasibility after the first four hospitals In hospitals 5 to 9 parents received one randomized question from nine questions every evening during their infant hospitalization The questions were 1 To what extent did the staff listen to you today 2 To what extent did you participate in your babys care today 3 To what extent did the guidance provided by the staff meet your needs today 4 To what extent was your opinion considered in decisions made about your baby today 5 To what extent did you trust the staff in the care of your baby today 6 To what extent did the staff trust you in the care of your baby today 7 To what extent did you participate in the discussion during the medical round 8 To what extent did the information provided by the staff meet your needs today 9 To what extent did the staff offer you emotional support today Parents rated their responses on a 5-point Likert scale in hospitals 1 to 4 and in a 7-point Likert scale in hospitals 5 to 9 1-7 with 1 not at all 7 very much or 0 if they were not in the NICU that day
Nurses evaluated the quality of FCC with the DigiFCC-N tool Nurses answered corresponding questions with the parents questions exception of the question that concerned parental participation in the medical round Questions to nurses were in a form To what extent did you listen to parents today Nurses gave the answer through a Web questionnaire using the computer assigned for the research purpose Nurses replied one randomized question after each work shift during a 3-months study period before and after the training program
Statistical methods Parents presence was defined as at least one parent present Mothers and fathers presence and SSC were also analysed separately We compared the pre-intervention and post-intervention cohorts adjusting for gestational age siblings in the family and the neonatal unit in the statistical model These confounders were chosen based their significance on parents presence The comparison of presence and SSC was analyzed using a linear model where cohorts were independent families siblings in the family and neonatal unit were handled as categorical variables and gestational age as a continuous covariate Analyses were performed for mother and father separately and then also as combined at least one parent present either parent SSC All diaries until the last one were included in the analyses also the days without presence or SSC or missing data All statistical tests were performed as two-sided with a significance level set at 005 The analyses were performed using SAS System version 94 for Windows SAS Institute Inc Cary NC USA
Study NICUs and participants This study was an intervention study comparing the situation before and after the intervention It was carried out in nine NICUs in Finland including two level III hospitals and seven level II hospitals The study progressed stepwise between May 2012 and September 2018 two or three hospitals participated in the study simultaneously The study permission was granted by the Hospital District of Southwest Finland T572012 and separately by each study site
The study participants were recruited during three-month periods before and after the Close Collaboration with Parents training program which lasted for 18 months Every parent of an infant estimated to stay in the NICU longer than three days was approached Other inclusion criteria were 1 the infant had no major congenital anomalies or syndromes 2 the parents spoke Finnish or Swedish 3 the family lived in the catchment area of the hospital A log including infants gestational age birth weight the length of hospital period and the distance to home was kept for all admissions of infants with a length of stay longer than 3 days to identify eligible parents and evaluate drop-out rate
The staff introduced the study protocol to parents and gave them at least one day to consider their participation After the parents signed the informed consent form they were given instructions for use of the closeness diaries and text messages The parents provided infant characteristics including gestational age birthweight birth head circumference sex mode of delivery and whether the infant was a singletonmultiple or had siblings and family characteristics including parents age education socio-economic status and the distance from the hospital to home
Closeness diary The duration of parents presence in the NICU and skin-to-skin contact SSC was reported with closeness diaries Presence in the unit was defined by being inside the unit not necessarily all the time in the room of the baby SSC was defined as the baby lying on the parents bare chest dressed only in a diaper and a cap if necessary On the diary there were four different timelines where parents filled in the time spent in NICU and SSC with their infant mother present mother SSC father present and father SSC Parents were asked to fill in the diaries from the time of recruitment until discharge During data collection the diaries were stored in a folder at the bedside so that other families or nurses did not see the diaries
Intervention The Close Collaboration with Parents intervention was developed based on theoretical evidence from infant neurobehavioral and attachment theories The training is based on a multi-method learning philosophy using theoretical teaching hands-on teaching at bedside and reflective discussions supporting simultaneous implementation of practice change The intervention teaches new skills to the entire staff of a unit to collaborate with parents in order to support parents presence and involvement in infants care The original intervention was condensed to a structured 18-month-long training including four phases A facilitator network model was used including local mentors trained by the trainer mentors and a supervisor
BLISS Audit tool The data from staff were collected using the Bliss Baby Charter Audit Tool with permission of Bliss organization The audit tool is a self-assessment instrument identifying areas of improvement in the quality of FCC in NICUs The tool has 141 statements divided into seven core principles which summarize the care respect and support that infants and their parents should receive All seven principles contain different categories of family-centered care as defined by Bliss The categories are 1 Active care by parent and staff 18 criteria 2 Parent and family support 17 criteria 3 Communication 6 criteria 4 Developmental care 9 criteria 5 Empowered decision making 10 criteria 6 Facilities 17 criteria 7 Guidelines and policies 17 criteria 8 Staff skills and training 12 criteria 9 Information provision 27 criteria and 10 Service improvement and parent involvement 8 criteria
DigiFCC Parents evaluated the quality of FCC with DigiFCC-P tool by answering to the text-message questions delivered by mobile phones The tool was developed for the evaluation of the Close Collaboration with Parents training Program Parents received one randomized question from seven questions every evening during their infant hospitalization The tool was further developed based on feedback from parents staff and researchers to improve its content validity and feasibility after the first four hospitals In hospitals 5 to 9 parents received one randomized question from nine questions every evening during their infant hospitalization The questions were 1 To what extent did the staff listen to you today 2 To what extent did you participate in your babys care today 3 To what extent did the guidance provided by the staff meet your needs today 4 To what extent was your opinion considered in decisions made about your baby today 5 To what extent did you trust the staff in the care of your baby today 6 To what extent did the staff trust you in the care of your baby today 7 To what extent did you participate in the discussion during the medical round 8 To what extent did the information provided by the staff meet your needs today 9 To what extent did the staff offer you emotional support today Parents rated their responses on a 5-point Likert scale in hospitals 1 to 4 and in a 7-point Likert scale in hospitals 5 to 9 1-7 with 1 not at all 7 very much or 0 if they were not in the NICU that day
Nurses evaluated the quality of FCC with the DigiFCC-N tool Nurses answered corresponding questions with the parents questions exception of the question that concerned parental participation in the medical round Questions to nurses were in a form To what extent did you listen to parents today Nurses gave the answer through a Web questionnaire using the computer assigned for the research purpose Nurses replied one randomized question after each work shift during a 3-months study period before and after the training program
Statistical methods Parents presence was defined as at least one parent present Mothers and fathers presence and SSC were also analysed separately We compared the pre-intervention and post-intervention cohorts adjusting for gestational age siblings in the family and the neonatal unit in the statistical model These confounders were chosen based their significance on parents presence The comparison of presence and SSC was analyzed using a linear model where cohorts were independent families siblings in the family and neonatal unit were handled as categorical variables and gestational age as a continuous covariate Analyses were performed for mother and father separately and then also as combined at least one parent present either parent SSC All diaries until the last one were included in the analyses also the days without presence or SSC or missing data All statistical tests were performed as two-sided with a significance level set at 005 The analyses were performed using SAS System version 94 for Windows SAS Institute Inc Cary NC USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None