Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04787081 |
Other study ID # |
938 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2018 |
Est. completion date |
September 22, 2018 |
Study information
Verified date |
January 2021 |
Source |
St. Catherine University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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 and/or 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 child's 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 child's 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 Zelen's 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 university's 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 (i.e. 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 participant's 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 (0.05) 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 1.06 standard deviations, where "standard
deviation" describes variation within groups (i.e., Cohen's d = 1.06). 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. 14.0.0 Pro, SAS Institute,
Cary NC).
Observed competence. Investigators computed participants' average positioning/simulation
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 Pearson's correlation
(r) to measure the association between participants' average self-ratings on
positioning-based competence items and their average correct positioning/simulation 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 participant's 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 palsy's 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.