Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04888416 |
| Other study ID # |
2021H0162 |
| Secondary ID |
AOTFIR21JUCKETT |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Ohio State University |
| Contact |
Lisa Juckett, PhD |
| Phone |
614-657-9322 |
| Email |
lisa.juckett[@]osumc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objective of this study is to tailor and test implementation strategies to
support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer
Assessment and the Action Research Arm Test. The study's interdisciplinary team will address
this objective through the following specific aims: (a) Tailor a package of implementation
strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to
promote outcome measure use across the care continuum, (b) Determine the effectiveness of
I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and
feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study
design is informed by implementation science methodologies, and the tailoring of I-STROM will
be guided by input from stakeholders, including occupational therapy practitioners and
administrators. The investigators will collect robust quantitative and qualitative data by
means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This
study, "Strategies to Promote the Implementation of Outcome Measures in Stroke
Rehabilitation," will address core barriers to outcome measure use through a package of
implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems
nationwide.
Description:
Recruitment of Stakeholders. OSUWMC is comprised of several facilities that provide optimal
care to patients throughout Ohio and the Midwest. OSUWMC's acute care hospital serves ~1200
stroke survivors annually. A total of 220 stroke survivors were admitted in 2019 to OSUWMC's
Dodd Rehabilitation Hospital, which is a 60-bed inpatient rehabilitation facility. OSUWMC
also provides outpatient rehabilitation services at its main ambulatory care location, Martha
Morehouse Medical Pavilion, and serves ~150 stroke survivors each year. Additionally, each
setting has an appointed evidence-based practice (EBP) Team Leader who organizes quality
improvement activities to promote the use of evidence in practice. The inpatient Team Leader
will serve as Co-Investigator for the proposed study and regularly collaborates with the Team
Leaders in acute care and outpatient rehabilitation. Three OT practitioners will serve as
outcome measure "champions." The investigators plan to invite all OT practitioners from acute
(N ~ 30), inpatient (N ~ 15), and outpatient (N ~ 10) as well as administrators (N ~6) to
participate in I-STROM, complete the electronic surveys, and participate in focus groups.
Inclusion criteria for participants include full- or part-time employment at OSUWMC and
experience evaluating stroke survivors or overseeing the provision of stroke care in the past
3-months.
Study Procedures and I-STROM Description. At the start of the study, the PI and Co-I
(Wengerd) will train the three site "champions" on the use of the Fugl-Meyer and Action
Research Arm Test and review procedures for trouble-shooting implementation issues. The study
team will then conduct a baseline retrospective chart review to determine the extent to which
the Fugl-Meyer and Action Research Arm Test have been adopted in acute, inpatient, and
outpatient stroke rehabilitation. Baseline survey data will capture perceptions of (a) the
acceptability, appropriateness, and feasibility of the Fugl-Meyer and Action Research Arm
Test and (b) the core barriers of outcome measure use. In Months 2-4, focus group data will
be collected to inform the tailoring of I-STROM based on the needs of each rehabilitation
setting. Description of I-STROM. Three core strategies will be included in I-STROM: initial
and booster educational meetings, learning collaboratives, and outcome measure champions.
Though the study team will tailor I-STROM to the needs of each of our three settings, the
team expects that initial educational meeting will be delivered in a webinar format that will
be recorded and accessible to stakeholders during and after the study. Follow-up educational
meetings will be held in person on a quarterly basis to assist practitioners with outcome
measure use. Learning collaborative sessions will initially occur quarterly to allow
practitioners to share their outcome measure experiences with their professional peers.
Lastly, the team anticipates that outcome measure champions will meet with the PI at least
2x/month to identify challenges and successes with I-STROM and outcome measure adoption.
I-STROM will be delivered through Months 8-20 of the study with quarterly chart audits
(random 10-30 of eligible charts) to monitor outcome measure use. Upon the conclusion of
I-STROM, we will collect posttest data by administering our follow-up survey to practitioners
and administrators (Month 20) to assess changes in (a) the acceptability, appropriateness,
and feasibility of the Fugl-Meyer and Action Research Arm Test and (b) the core barriers of
outcome measure use. We will supplement survey data with a retrospective chart review to
determine I-STROM's effect on outcome measure adoption over time. Follow-up focus groups with
stakeholders will explore experiences with I-STROM and illuminate how I-STROM can translate
to non-OSUWMC settings. Widespread scalability of I-STROM will be evaluated via an electronic
survey administered (via REDCap) to practitioners and administrators nationwide. T
Retrospective chart reviews. All OSUWMC practitioners document stroke survivor evaluations,
goals, notes, and discharge plans in the EPIC record system. The study team plans to manually
extract the following chart data that pertain to Fugl-Meyer and Action Research Arm Test
implementation (Appendix A): use of Fugl-Meyer (YES/NO), use of Action Research Arm Test
(YES/NO), date of use, and initial onset of client stroke. These data fields will be obtained
by request from OSUWMC's Information Warehouse Honest Broker Operations Committee at the
following study time points: baseline, quarterly during the deployment of I-STROM, and upon
I-STROM's conclusion. The PI (Juckett) and Co-I (Banhos) will extract chart data using an
approach similar to the chart review methodology applied in the PI's dissertation (Juckett et
al., 2019b). Stroke survivors whose charts will be included in our study will (a) have had a
stroke in the past 12-months, (b) receive acute, inpatient, or outpatient services at OSUWMC,
and (c) have undergone an evaluation with an OT. Baseline data will be obtained to examine
outcome measure use among a random 30% of stroke survivor charts from each setting (N ~ 360
acute; N ~ 60 inpatient, N ~ 45 outpatient) 12-months prior to the study start date. Monthly
audits will be performed on eligible charts (10-30 per setting) during the delivery of
I-STROM to monitor outcome measure adoption. At I-STROM conclusion, the study team will then
extract data from another 30% of charts from the previous 12-months to identify pre-post
effectiveness of I-STROM on outcome measure adoption.
Electronic surveys. The first section of this four-part electronic survey will gather
participant demographics. Part two will assess stakeholder perceptions of two core barriers:
networks and communication and culture (Fernandez et al., 2018; Appendix B); the third
section will examine the third core barrier: access to knowledge and information (Gagliardi
et al., 2019). The last section of the survey will assess the acceptability, appropriateness,
and feasibility (Weiner et al., 2017) of implementing the Fugl-Meyer and Action Research Arm
Test. This survey will be administered at baseline and upon I-STROM conclusion. At I-STROM
conclusion, the study team will also administer a nationwide survey to OT practitioners and
administrators in stroke rehabilitation to assess perceptions of I-STROM's acceptability,
appropriateness, and feasibility and other strategies that should be incorporated into
I-STROM to enhance its relevance in diverse practice settings (Appendix C).
Qualitative focus groups. The study team will conduct four focus groups before the deployment
of I-STROM, each group consisting of 5-10 acute OT practitioners, inpatient OT practitioners,
outpatient OT practitioners, and OSUWMC administrators. Focus group data will aid in our
tailoring of core I-STROM strategies. Focus group questions will be guided by the ERIC
taxonomy (Appendix D). After I-STROM completion, the study team will hold another four focus
groups to assess stakeholder perceptions of I-STROM and outcome measure adoption. Focus
groups will last approximately 45 minutes in duration, will be audio recorded (with
permission), and will be transcribed prior to undergoing analysis.
Aim 1. Tailor a package of implementation strategies to facilitate use of the Fugl-Meyer and
Action Research Arm Test across the stroke continuum. Purpose and Design. The study team will
address Aim 1 using an explanatory sequential mixed-methods approach. Investigators will
first identify current rates of Fugl-Meyer and Action Research Arm Test use across the three
continuum sites (chart review) and evaluate the practitioners' perceptions of (a) the three
core barriers that have been found to influence implementation and (b) the acceptability,
appropriateness, and feasibility of implementing the Fugl-Meyer and Action Research Arm Test
(electronic survey). Focus groups with site stakeholders will inform the tailoring of I-STROM
strategies to each of the three practice settings. Data Analysis. Rates of outcome measure
adoption will be evaluated by means of descriptive statistics and will be reported in
percentages. The study team will use bivariate Pearson correlations to examine associations
between Fugl-Meyer and Action Research Arm Test use and practitioner perceptions of core
implementation barriers. Focus group data will be analyzed by two members of the research
team through directed content analysis with coders achieving a Cohen's kappa >.8 to ensure
consistency.
Aim 2. Determine the effectiveness of a package of implementation strategies designed to
support Fugl-Meyer and Action Research Arm Test adoption. Purpose and Design. The study team
will use an interrupted time series design to examine the effectiveness of I-STROM on the
adoption of the Fugl-Meyer and Action Research Arm Test over 12-months; follow-up survey data
will represent changes in (a) practitioner perceptions of core barriers and (b) perceptions
of outcome measure acceptability, appropriateness, and feasibility. The study team will
complete follow-up focus groups to identify perceptions of I-STROM and the relevance of
I-STROM across multiple practice settings. Data Analysis. Rates of outcome measure adoption
will be calculated as percentages for all three settings in individual and aggregate form.
Matched-paired t-tests will be used to detect significant differences in (a) outcome measure
adoption, (b) perceptions of acceptability, appropriateness, and feasibility, and (c) core
implementation barriers before and after I-STROM. Magnitude of differences will be expressed
in effect sizes (Cohen's d). The qualitative approach (e.g., directed content analysis) from
Aim 1 will be replicated to examine focus group data.
Aim 3. Evaluate the acceptability, feasibility, and appropriateness of I-STROM by OT
practitioners in stroke rehabilitation nationwide. Purpose and Design. The investigators will
use a cross-sectional electronic survey approach to evaluate the acceptability, feasibility,
and appropriateness of I-STROM to other stroke rehabilitation settings. The team will also
invite respondents to provide narrative comments that pertain to additional strategies to be
included in I-STROM to enhance I-STROM scalability and relevance to other sites. Data will be
used to inform future funding proposals that aim to extend I-STROM in a multi-site trial.
Data Analysis. Descriptive statistics will be used to examine I-STROM acceptability,
appropriateness, and feasibility. Demographics (e.g., age, education, practice setting) will
be analyzed by means of multiple linear regression to determine predictors of I-STROM
acceptability, appropriateness, and feasibility. Respondent comments will be examined through
descriptive content analysis by the PI and trained research assistant.
