Clinical trial NCT04787081: Nighttime Postural Care: Caregiver Training Program and Outcome Measure Feasibility
Official title: Nighttime Postural Care: Caregiver Training Program and Outcome Measure Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: competence post learning
nighttime postural care education
online caregiver education
postural care
cerebral palsy
sleep positioning
Lead sponsor: St. Catherine University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2021-03-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed methods double-blind parallel group design, involving a consecutive sample of adults being randomly assigned to an educational intervention (Group A or B). The Principal Investigator enrolled participants, designating subject numbers and professional or non-professional labels. The research assistant completed randomization, drawing concealed numbers from an envelope to determine participant's educational intervention group (A or B). To balance the number of professionals and non-professionals across groups, the research assistant used co-variate adaptive group randomization and applied a difference threshold of 3.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: Inclusion Criteria:

* Professional and non-professional caregivers of children with movement disorders or cerebral palsy.

Exclusion Criteria:

* Caregivers without knowledge of sleep habits and routines of persons with such diagnoses

Primary outcomes:
measure: Baseline Sleep Care Positioning Questionnaire
timeFrame: Completed immediately before training/educational intervention. Same day as training.
measure: Post Sleep Care Positioning Program Questionnaire
timeFrame: Completed immediately after training / educational intervention. Same day as training.
measure: Post Simulation Sleep Care Positioning Program Questionnaire
timeFrame: Completed immediately after simulation activity, after positioning a person in a sleep system. Same day as training.
Secondary outcomes:
measure: Simulation Observation Instrument
timeFrame: Completed after training and post-training questionnaire. Same day as training.
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: St. Catherine University
state: Minnesota
Study officials:
affiliation: St. Catherine University
name: John Schmitt
role: STUDY_CHAIR
References:
citation: Hutson, J.A. (2020). Nighttime Postural Care Sleep-Based Outcome Measures and Education: Preparing Care Providers of Children with Cerebral Palsy (Doctoral Dissertation). University of Minnesota, Available from ProQuest Dissertations Publishing. (Dissertation Number: 27741484)