Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05627531 |
| Other study ID # |
2022-159-ACH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 9, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Akron Children's Hospital |
| Contact |
Daniel H Grossoehme, DMin, MS |
| Phone |
330-543-3343 |
| Email |
dgrossoehme[@]akronchildrens.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A quarter of a million children and teenagers are hospitalized annually in Pediatric
Intensive Care Units (PICUs) in North America. Having a child hospitalized in a PICU is
stressful and affects the mood and coping of their parents. The investigators' prior work has
shown how narrative medicine may help. Narrative medicine includes at least one session
reading and then having a guided discussion of a poem or short story. The readings are
individually selected by the Narrative Medicine Coordinator who also provides a guided
writing exercise (in the form of poetry, creative non-fiction, journaling, or fiction). After
writing, the parent/guardian had the option to share their writing out loud with the
Narrative Medicine Coordinator. At the end of each session, the parent/guardian receives
personalized writing prompts they are encouraged to use writing each day. The Investigators
want to see how this session helps parents make sense of their time in the PICU and how it
may help them cope. The investigators ask participants to fill out some surveys when they
enroll and three days after their session.
Description:
A quarter of a million children and teenagers are hospitalized annually in Pediatric
Intensive Care Units (PICUs) in North America. Having a child hospitalized in a PICU is
stressful with persistent psychological impact: 23% reported post-traumatic stress symptoms,
21% moderate-severe anxiety, and 9% moderate-severe depression six months post-discharge.
Intensive care unit (ICU) diaries have been used with hospitalized adults and are thought to
promote better outcomes by filling memory gaps, validating the experience's severity, and
catalyzing patient-family conversation about the experience. Limited data exist in pediatrics
or when caregivers write. Following the NIH ORBIT model for development of behavioral
interventions, investigators conducted a Stage 2a trial whose primary objective was to
quantify feasibility and acceptability of writing interventions among caregivers of children
in a PICU.
The investigators' data from a three-arm randomized clinical trial with caregivers of
children in the Akron Children's Hospital PICU showed that this intervention was feasible to
deliver and acceptable to caregivers (manuscript currently under review by the Journal of
Palliative Medicine). Of the three treatment arms, the one with the highest engagement and
acceptability was the arm providing a blank composition book with daily writing prompts
developed during at least one in-person session with the Narrative Medicine Coordinator to
discuss the caregiver's writing and their writing process. These one-on-one sessions included
a 30-60 minute initial session followed by weekly sessions while the caregiver's child was
admitted to the PICU. Sessions included the reading and guided discussion of a poem or short
story with the participating caregiver, with texts individually selected by the Narrative
Medicine Coordinator who also provided the caregiver with a guided writing exercise (in the
form of poetry, creative non-fiction, journaling, or fiction). After writing, the caregiver
had the option to share their writing out loud with the Narrative Medicine Coordinator. At
the end of each session, the caregiver received personalized writing prompts they might use
during the encouraged daily writing. The other two treatment arms had lower acceptability and
are no longer being considered. Qualitative data provided by participants suggested that
acceptability would be enhanced if their written texts were not collected for analysis, and
that many found the experience meaningful. However, that phase of study development did not
include examination of quantifiable outcomes. Thus, the investigators have a potentially
efficacious intervention which we intend to advance to the next (efficacy) stage of testing
and development with the following trial. The primary objective is to test the efficacy of a
narrative medicine intervention with caregivers of children hospitalized in a PICU compared
with a sample not receiving the intervention. The hypothesis is that caregivers who receive
the intervention will have increased scores on the Meaning subscale of the FACIT-Sp-12, a
measure of quality of life which are at least 5% higher than baseline. The investigators will
prospectively enroll up to 40 participants with the intention of retaining 17 participants
per intervention group after attrition. Participants will be legal guardians of children who
are in the PICU at Akron Children's Hospital at the time of their enrollment. Persons who are
illiterate will not be excluded from this study because it is not the act of writing, but the
telling of a narrative, which is the likely mechanism of action. Accommodations will be made,
as with usual clinical care, by participants verbalizing their narrative and the Narrative
Medicine Coordinator transcribing it on her computer and providing a printed copy to the
participant. Persons speaking languages other than English will be excluded because there are
no validated outcome measures freely available. Investigators will use a quasi-experimental
design with untreated comparison group with a dependent pre- and post-test sample developed
using non-probability convenience sampling. The comparison group (n=17), consisting of all
persons enrolled every other week, will complete measures at baseline (T0) and repeated 2-4
later(T1). Participants will receive a blank composition book with encouragement to write. If
a non-study-related referral is made for narrative medicine while the child is hospitalized,
the enrollees will administratively be withdrawn from further participation in the study,
though their data will be included in the intent-to-treat analyses. If the enrollee is unable
to write on their own due to physical restrictions, a study staff member (not the Narrative
Medicine Coordinator) will be available for transcription. They will be instructed not to
offer guidance to the enrollee. Follow-up measures (T1) will be administered 2-4 days post
enrollment. This variability allows for clinical changes and participant availability. If the
participant's child is still hospitalized at the completion of T1 and desires to receive the
intervention, participants who were enrolled in the control group will be offered a single
one-on-one narrative medicine session with a facilitator. The location, content, and method
of narrative medicine administration will follow those outlined below. Once off-study, the
parent or legal guardian may continue with narrative medicine sessions if the child's
inpatient provider makes a formal referral. The intervention group (n=17), consisting of all
persons enrolled in the alternate weeks (opposite the comparison group), after completing T0
measures, will receive a blank composition book with daily writing prompts developed during
at least one in-person session with the Narrative Medicine Coordinator to discuss their
writing and their writing process. The one-on-one sessions, which will include a 30-60 minute
initial session followed by subsequent sessions while their child is admitted to the PICU,
will be led by the Narrative Medicine Coordinator or study staff trained in narrative
medicine. The participating caregiver will have the option to have this session held in their
child's room, the Expressive Therapy Center, or in a mutually agreed upon location that
offers privacy. Each session will include the reading and guided discussion of a poem or
short story with the participating caregiver. The texts will be individually selected by the
Narrative Medicine Coordinator who will also provide the caregiver with a guided writing
exercise (in the form of poetry, creative non-fiction, journaling, or fiction). After
writing, the caregiver will have the option to share their writing out loud with the
Narrative Medicine Coordinator. At the end of each session, the caregiver will receive
personalized writing prompts they may use during the encouraged daily writing. The duration
of participation equates to the child's length of stay in intensive care (typically 5 days).
The intervention group will do follow-up measures (T1) 1-3 days post intervention. The
variance in administering follow-up measures allows for weekend staffing, clinical changes,
and caregiver availability. Participants who have not received the narrative medicine
intervention within 4 days of enrollment (due to circumstances such as conflicting schedules,
deferral of services, or participant absence) may be offered T1 measures on day 4 and then
administratively moved to the control group. The participant will be offered narrative
medicine according to the procedure described previously. Sample size considerations.
Unpublished, pilot data from 140 adult subjects with cancer was used for conduct of the
sample size analysis. Mean (sd) for Meaning was 10.8 (1.9), hypothesized 5% improvement
yields a mean (sd) for pre-post difference of 0.5 (0.1). Primary analysis intended to be an
independent-samples T-Test. Hypothesizing a 5% improvement in the intervention group,
allowing for 2.5% improvement in the control group, and increasing the pooled standard
deviation from 0.1 to 0.2 to be conservative, while assuming 80% power and a Type I Error
Rate of alpha = 0.05 level of statistical significance, the minimum evaluable sample size is
n = 17 per group to detect a difference of at least this magnitude or greater. Should the
data be skewed, or there are any baseline differences in groups that will need to be
accounted for in the analysis, then the T-Test would not be appropriate, and the sample size
analysis would no longer be valid. Notes: 1) it may be necessary to enroll more than 17
subjects per group to ensure an evaluable sample size of 17 per group, and 2) sample data
provided may not accurately reflect the proposed study population, which if true would
invalidate the sample size calculations. Intent-to-treat analysis. An intent-to-treat
analysis will be performed using data from all persons who enrolled in the study. Descriptive
statistics will be computed for demographic, clinical, and outcome variables. Tests of
difference and association (distribution based: Independent Samples T-Test assuming normality
and Chi-Square Test of Independence, respectively) will be conducted for baseline demographic
and clinical variables to assess baseline comparability of groups. Additional analysis will
be conducted to compare propensity scores calculated from baseline covariate measures as a
quantification of the extent to which investigators have adequately controlled for selection
bias. Assuming groups are comparable, an Independent Samples T-Test will be performed to
examine between-group differences in pre-post change in Meaning. If evidence of baseline
differences between groups exists, then propensity scores will be used as a covariate in an
adjusted analysis for comparison of change in Meaning. Similarly, for secondary outcomes and
nonequivalent dependent variables, analysis will be conducted using the FACIT-Sp-12 Peace,
FACIT-Sp-12 Combined Meaning + Peace, ESAS, and DUREL scores. Finally, effects sizes will be
calculated for change in all as an adjunct to the intended analysis to aid in planning of a
subsequent, multi-site trial. Multiple imputation will be used to account for missing data. A
per protocol analysis will be performed using data from all persons who completed the study.
Descriptive statistics will be computed for demographic, clinical, and outcome variables.
Tests of difference and association (distribution based: Independent Samples T-Test assuming
normality and Chi-Square Test of Independence, respectively) will be conducted for baseline
demographic and clinical variables to assess baseline comparability of groups. Additional
analysis will be conducted to compare propensity scores calculated from baseline covariate
measures as a quantification of the extent to which investigators have adequately controlled
for selection bias. Assuming groups are comparable, an Independent Samples T-Test will be
performed to examine between-group differences in pre-post change in Meaning. If evidence of
baseline differences between groups exists, then propensity scores will be used as a
covariate in an adjusted analysis for comparison of change in Meaning. Similarly, for
secondary outcomes and nonequivalent dependent variables, analysis will be conducted using
the FACIT-Sp-12 Peace, FACIT-Sp-12 Combined Meaning + Peace, ESAS, and DUREL scores. Finally,
effects sizes will be calculated for change in all as an adjunct to the intended analysis to
aid in planning of a subsequent, multi-site trial. Multiple imputation will be used to
account for missing data.
