Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787081
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2021-01-22
Brief Title:
Nighttime Postural Care Caregiver Training Program and Outcome Measure Feasibility
Sponsor:
St Catherine University
Organization:
St Catherine University
Study Overview
Official Title:
Nighttime Postural Care Caregiver Training Program and Outcome Measure Feasibility
Status:
COMPLETED
Status Verified Date:
2021-01
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:
None
Brief Summary:
This experimental study investigated the feasibility of a sleep care positioning training protocol by comparing two educational interventions using a randomized control design The overarching Population Intervention Comparison Outcomes PICO question was Is the training protocol feasible for use in training caregivers Question one includes the following sub questions A Is there a difference in perceived competence to implement aspects of nighttime postural care intervention or observed ability to position the person in a sleep system between caregivers receiving one training program versus another B Does the training protocol prepare caregivers to implement nighttime postural care NTPC
Detailed Description:
Target Population
Investigators planned to recruit a convenience sample of 40 adult participants identified as professional or non-professional care providers primarily from two community organizations that specialize in serving clients with CP Care providers of children aged 6-12 with severe CP those with limited ability to move andor whom require use of a wheelchair were the primary target population since this matches the intended sample of a future intervention study However caregivers of children outside of the 6-12 age range whom were candidates for NTPC and had similar mobility limitations as those with severe CP would not be excluded Professional care providers could be nurses occupational and physical therapists assistive technology providers etc Non-professional care providers could be family members care attendants etc Only individuals with knowledge of the childs sleep habits or routines were to be included in the study
Investigators used a mixed methods double-blind parallel group design randomly assigning a consecutive sample of adults to an educational intervention Lesson A or Lesson B
Participant Recruitment
Investigators emailed flyers recruiting participants from clinics serving persons with CP and universities educating healthcare providers and included professional and non-professional caregivers of persons with movement disorders primarily CP with knowledge of a childs sleep habits and routines
Participant activities
Participants completed study activities on one scheduled date Consent process baseline questionnaire immediately before training online education post-training questionnaire positioning of a simulated client post-simulation questionnaire and exit interview Participants completing all aspects of the study received a 50 gift card
Randomization and blinding
The Principal Investigator PI enrolled participants designating subject numbers and professional or non-professional labels The research assistant completed randomization drawing concealed numbers from an envelope using Zelens model of co-variate adaptive group randomization and applying a threshold difference of three to balance professionals and non-professionals An information technologist registered participants into their assigned lesson At most five participants at a time were allowed in a classroom with each room assigned a single lesson A or B Research assistants instructed participants on accessing and navigating their lesson and keeping details confidential These processes helped ensure the PI participants and clinician simulation raters were not informed of lesson assignment
Participants had the option to complete the non-assigned lesson in addition to their assigned lesson Investigators verified participants completion of all research activities besides the exit interview before the optional non-assigned lesson
Intervention similarities and differences
Both online lessons included modules on evidence for NTPC risk factor monitoring sleep system types and set up positioning methods and outcome measures and were delivered via D2L Brightspace a cloud-based learning management system Both lessons positioning-methods modules included video-based instruction Lesson formats differed by source and design Lesson A created by a universitys postural-care scholars using Camtasia video creation software consisted of interactive videos embedded with learning checkpoints while Lesson B included written summary statements and links to freely available web-based information
Simulation
Following their lesson and post-training questionnaire participants positioned a client in a hospital bed using a designated commercial sleep system henceforth termed simulation The investigators followed protocols instructing that participants position the client to the best of their ability not using notes or asking observers for help the client be positioned using straps to facilitate tight hamstrings in an asymmetrical-lying position common for persons with CP ie head turned left legs windswept right and knee flexed and the clinician raters should complete the room set-up with the bed centered against the north wall sleep system parts arranged consistently on a designated table and that they should sit at predetermined observational locations
Simulation raters
Health practitioners two at a time serving as clinician raters used the simulation observation instrument independently observing and documenting a participants positioning skills An assistive technology professional and occupational therapist served as primary raters rating 30 and 29 participants respectively Two secondary raters both occupational therapists one the PI completed the remaining observations
Data collection measures
Investigators collected quantitative and qualitative data using questionnaires for obtaining participants self-perceptions of competence and lesson feedback An observation instrument was used for scoring and describing participants simulation performance Fieldnotes were used for recording participant activities across the study period The PI designed all study instruments after reviewing competency literature conducting a pilot study unpublished and consulting an academic measurement expert
Statistical power
Before data collection investigators chose a significance level 005 with plans for enrolling a minimum of 30 participants With 15 participants per group so there would be 80 power to detect a difference between groups of 106 standard deviations where standard deviation describes variation within groups ie Cohens d 106 Because this is the first study examining caregivers NTPC competence from online education no prior data could inform power calculation or supply a standard deviation value
Data analysis quantitative outcomes
Perceived Competence Each participant provided a total average perceived competence score total average from knowledge ability and confidence sub-scores at three times baseline post-training and post-simulation Investigators analyzed these scores using a mixed linear model the random effect was participant and fixed effects were group Lesson A or Lesson B professional vs non-professional status time baseline post-training and post-simulation and all two-way and three-way interactions Investigators tested change over time within groups using a contrast in the group-by-time interaction which combines professionals and non-professionals and compared groups at each time also using contrasts in the group-by-time interaction Statistical analyses used JMP v 1400 Pro SAS Institute Cary NC
Observed competence Investigators computed participants average positioningsimulation score number correct out of 16 tasks from the simulation observation instrument and used a mixed linear model to examine differences in observed positioning ability based on group Lesson A or B and professional vs non-professional status
Correlation of perceived and observed competence Investigators used Pearsons correlation r to measure the association between participants average self-ratings on positioning-based competence items and their average correct positioningsimulation scores to understand the groups ability to self-assess performance
Interrater Reliability Investigators measured interrater reliability using the intra-class correlation ICC once including all simulation observation raters and separately including the two primary clinician raters and the PI
Data analysis qualitative
For qualitative data investigators used a modified grounded theory approach of open axial and selective coding similar to that described by Bhattacherjee From questionnaire and exit interview data the PI read line-by-line coding responses into categories and themes From the simulation observation instrument the PI listed each participants incorrectly completed tasks and used a table to organize those tasks most frequently missed or completed incorrectly Then clinicians descriptive statements corresponding to incorrectly completed tasks were tabulated and reviewed line-by-line and coded into categories and themes
Note In addition to the above stated plan for examining the feasibility of the sleep care positioning training program investigators also planned to examine the internal consistency reliability of the sleep disturbance scale for children SDSC a 27-item inventory rated on a 5 point Likert-type scale which was created by Bruni et al in 1996 To examine its reliability study participants who self-identified as having night to night knowledge of a child with cerebral palsys sleep performance were asked to complete the SDSC While data was collected for this aspect of the study only 10 participants self-identified as having such knowledge thus further analysis of the tools reliability was not completed by investigators
Investigators planned to recruit a convenience sample of 40 adult participants identified as professional or non-professional care providers primarily from two community organizations that specialize in serving clients with CP Care providers of children aged 6-12 with severe CP those with limited ability to move andor whom require use of a wheelchair were the primary target population since this matches the intended sample of a future intervention study However caregivers of children outside of the 6-12 age range whom were candidates for NTPC and had similar mobility limitations as those with severe CP would not be excluded Professional care providers could be nurses occupational and physical therapists assistive technology providers etc Non-professional care providers could be family members care attendants etc Only individuals with knowledge of the childs sleep habits or routines were to be included in the study
Investigators used a mixed methods double-blind parallel group design randomly assigning a consecutive sample of adults to an educational intervention Lesson A or Lesson B
Participant Recruitment
Investigators emailed flyers recruiting participants from clinics serving persons with CP and universities educating healthcare providers and included professional and non-professional caregivers of persons with movement disorders primarily CP with knowledge of a childs sleep habits and routines
Participant activities
Participants completed study activities on one scheduled date Consent process baseline questionnaire immediately before training online education post-training questionnaire positioning of a simulated client post-simulation questionnaire and exit interview Participants completing all aspects of the study received a 50 gift card
Randomization and blinding
The Principal Investigator PI enrolled participants designating subject numbers and professional or non-professional labels The research assistant completed randomization drawing concealed numbers from an envelope using Zelens model of co-variate adaptive group randomization and applying a threshold difference of three to balance professionals and non-professionals An information technologist registered participants into their assigned lesson At most five participants at a time were allowed in a classroom with each room assigned a single lesson A or B Research assistants instructed participants on accessing and navigating their lesson and keeping details confidential These processes helped ensure the PI participants and clinician simulation raters were not informed of lesson assignment
Participants had the option to complete the non-assigned lesson in addition to their assigned lesson Investigators verified participants completion of all research activities besides the exit interview before the optional non-assigned lesson
Intervention similarities and differences
Both online lessons included modules on evidence for NTPC risk factor monitoring sleep system types and set up positioning methods and outcome measures and were delivered via D2L Brightspace a cloud-based learning management system Both lessons positioning-methods modules included video-based instruction Lesson formats differed by source and design Lesson A created by a universitys postural-care scholars using Camtasia video creation software consisted of interactive videos embedded with learning checkpoints while Lesson B included written summary statements and links to freely available web-based information
Simulation
Following their lesson and post-training questionnaire participants positioned a client in a hospital bed using a designated commercial sleep system henceforth termed simulation The investigators followed protocols instructing that participants position the client to the best of their ability not using notes or asking observers for help the client be positioned using straps to facilitate tight hamstrings in an asymmetrical-lying position common for persons with CP ie head turned left legs windswept right and knee flexed and the clinician raters should complete the room set-up with the bed centered against the north wall sleep system parts arranged consistently on a designated table and that they should sit at predetermined observational locations
Simulation raters
Health practitioners two at a time serving as clinician raters used the simulation observation instrument independently observing and documenting a participants positioning skills An assistive technology professional and occupational therapist served as primary raters rating 30 and 29 participants respectively Two secondary raters both occupational therapists one the PI completed the remaining observations
Data collection measures
Investigators collected quantitative and qualitative data using questionnaires for obtaining participants self-perceptions of competence and lesson feedback An observation instrument was used for scoring and describing participants simulation performance Fieldnotes were used for recording participant activities across the study period The PI designed all study instruments after reviewing competency literature conducting a pilot study unpublished and consulting an academic measurement expert
Statistical power
Before data collection investigators chose a significance level 005 with plans for enrolling a minimum of 30 participants With 15 participants per group so there would be 80 power to detect a difference between groups of 106 standard deviations where standard deviation describes variation within groups ie Cohens d 106 Because this is the first study examining caregivers NTPC competence from online education no prior data could inform power calculation or supply a standard deviation value
Data analysis quantitative outcomes
Perceived Competence Each participant provided a total average perceived competence score total average from knowledge ability and confidence sub-scores at three times baseline post-training and post-simulation Investigators analyzed these scores using a mixed linear model the random effect was participant and fixed effects were group Lesson A or Lesson B professional vs non-professional status time baseline post-training and post-simulation and all two-way and three-way interactions Investigators tested change over time within groups using a contrast in the group-by-time interaction which combines professionals and non-professionals and compared groups at each time also using contrasts in the group-by-time interaction Statistical analyses used JMP v 1400 Pro SAS Institute Cary NC
Observed competence Investigators computed participants average positioningsimulation score number correct out of 16 tasks from the simulation observation instrument and used a mixed linear model to examine differences in observed positioning ability based on group Lesson A or B and professional vs non-professional status
Correlation of perceived and observed competence Investigators used Pearsons correlation r to measure the association between participants average self-ratings on positioning-based competence items and their average correct positioningsimulation scores to understand the groups ability to self-assess performance
Interrater Reliability Investigators measured interrater reliability using the intra-class correlation ICC once including all simulation observation raters and separately including the two primary clinician raters and the PI
Data analysis qualitative
For qualitative data investigators used a modified grounded theory approach of open axial and selective coding similar to that described by Bhattacherjee From questionnaire and exit interview data the PI read line-by-line coding responses into categories and themes From the simulation observation instrument the PI listed each participants incorrectly completed tasks and used a table to organize those tasks most frequently missed or completed incorrectly Then clinicians descriptive statements corresponding to incorrectly completed tasks were tabulated and reviewed line-by-line and coded into categories and themes
Note In addition to the above stated plan for examining the feasibility of the sleep care positioning training program investigators also planned to examine the internal consistency reliability of the sleep disturbance scale for children SDSC a 27-item inventory rated on a 5 point Likert-type scale which was created by Bruni et al in 1996 To examine its reliability study participants who self-identified as having night to night knowledge of a child with cerebral palsys sleep performance were asked to complete the SDSC While data was collected for this aspect of the study only 10 participants self-identified as having such knowledge thus further analysis of the tools reliability was not completed by investigators
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