Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04052503 |
| Other study ID # |
Pro20160000053 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2016 |
| Est. completion date |
August 4, 2017 |
Study information
| Verified date |
December 2020 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Knowledge brokers can facilitate knowledge translation (KT) interventions to improve the use
of outcome measures by physical therapists. Following the Knowledge-to-Action cycle, a
knowledge broker (a researcher who facilitates the translation of knowledge in the local
context) will: (1) complete a barrier assessment, (2) develop and implement a tailored
multi-modal intervention and (3) determine the outcome. The KB will determine the barriers
and facilitators to using outcome measures by PTs who work in inpatient rehabilitation and
design a locally tailored KT intervention with input from the key stakeholders (PTs). This
cluster randomized trial will compare two active interventions with full or partial supported
implementation by a knowledge broker using a cluster randomized trial (randomization will
occur by site) to determine the impact on the PTs and patients.
Aim 1: Determine if the KT intervention designed and implemented by a KB will increase PTs
the use of a selected standardized assessment as compared to an intervention that is designed
but not implemented by the KB.
Hypothesis1a: Physical therapists use (documented and self-reported) of a selected
standardized assessment will improve to a significantly greater extent immediately following
the intervention designed and implemented by a KB compared to the partially supported group.
Hypothesis1b: Physical therapists in the fully supported group will retain the use of the
standardized assessment to a significantly greater extent at 6 month follow-up.
Aim 2: Explore and compare both groups of physical therapists satisfaction and concerns with
each KT intervention on standardized assessment use.
Hypothesis 2: The physical therapists in the fully supported group will express greater
satisfaction with the KT intervention and identify fewer barriers for implementing the
standardized assessment in practice as compared to the partially supported group immediately
after and retained at 6 month follow-up.
Aim 3: Explore and compare the patients' experience who were seen by therapists in the fully
and partially supported group Hypothesis 3: Patients who were treated by clinicians in the
fully supported group will demonstrate an understanding of the patient standardized
assessment, why it's relevant to complete the test, and how the information gathered from the
standardized assessment can be used to guide the plan of care.
Description:
Purpose/Specific Aims
1. Design two locally tailored multi-modal knowledge translation interventions using a
mixed methods barrier assessment with input from the clinicians.
2. Compare the effectiveness of the interventions on physical therapists' use of
standardized assessments/outcome measures.
- The fully supported group will have the intervention designed and implemented by
the investigator (knowledge broker)
- The partially supported group will have the intervention designed and only partial
implementation by the investigator (knowledge broker)
3. Determine the impact of the intervention on patients who were evaluated by PTs in both
groups.
Objectives
1. To determine the immediate and longer term (6 months following the intervention)
effectiveness of a theoretically informed multi-modal tailored intervention designed and
implemented by a knowledge broker as compared to a tailored intervention designed, but
only partially implemented by the knowledge broker on the use of a selected patient
standardized assessment by physical therapists who work in rehabilitation.
2. To explore and compare patients' experiences of being evaluated by PTs in the fully
supported and partially supported groups.
The proposed study intends to compare two KT interventions designed by a KB using an
fully supported and partially supported implementation groups. The outcomes will be
measured through mixed methods to determine the immediate and 6 month retention of
behavior change, impact of the intervention, and investigate the impact of the
intervention on patients. Quantitative data analysis will be used through chart audit to
determine documentation of outcome measures and a self-reported survey (Goal Attainment
Scale). Qualitative analysis (focus groups) will be used to determine reasons for
behavior change which can be used to guide future interventions. Long term analysis also
helps investigators determine if the behavior was retained after the intervention was
completed. Finally, few studies have investigated the impact of the intervention on the
patients and an exploratory focus group will compare patients treated by physical
therapists in the experimental and control groups.
3. Research Design and Methods This is a mixed methods cluster randomized controlled trial
with 2 sites. Phase I: Barrier Assessment and Intervention Design The interventions will
be designed by the knowledge broker with input from the clinicians through a barrier
assessment. The barrier assessment will include a chart audit, a questionnaire and a
focus group. The chart audit will be used to determine current use of standardized
assessments. The questionnaire will be used assess current use, barriers, and
facilitators to evidence based practice and using standardized assessments. The
clinicians will be given a link to access and complete the barrier assessment survey
anonymously. The barriers and facilitators to evidence based practice (EBP) and using
outcome measures questionnaire was developed and validated in a previous study and
designed using the Theoretical Domains Framework (TDF). The questionnaire contains a
question on which outcome measure the participants would like to use more frequently, to
help guide selection of the standardized assessment. The focus group will present chart
audit and questionnaire data, confirm barriers and facilitators, and determine the
strategies that will be used in the intervention based on the Theoretical Domains
Framework consensus matrix.
Standardized assessments will be selected by the groups through the following process:
Participants will complete a question on the questionnaire about which standardized
assessments they would like to use more frequently. Those results will be tallied and two
standardized assessment will be briefly presented to the experimental and active control
groups during the first focus group. The two standardized assessments presented must be
performance based, comprise of only a few steps, be easy to interpret and have at least
adequate psychometric properties (reliability and validity testing) Each group will select a
comparable outcome measure/standardized assessment based on the two standardized assessment
the investigators selects to present. The group will be asked to select one assessment based
on group consensus of 80%. Disagreement will be handled through discussion. Each group can
choose different standardized assessments.
Phase II: Intervention The trial will be conducted in two inpatient rehabilitation hospitals
within the same organization, Kessler (Chester and Saddle Brook locations). The fully
supported group (enhanced arm) will receive a theoretically informed tailored multi-modal
intervention designed and implemented by a knowledge broker (investigator) to increase the
use of a selected standardized assessment. A knowledge broker (KB) is a researcher who brings
evidence to the clinicians with the purpose to change practice. KBs are able to locally
tailor interventions for the clinicians. The partially supported arm will also receive a
theoretically informed tailored multimodal intervention that will be designed, and only
partially implemented by the KB. The groups will be randomization, by site, after the barrier
assessment is completed (Chester or Saddle Brook). Randomization by site was selected to
reduce contamination among the therapists.
The fully supported group will have 2 additional meetings with the Knowledge Broker (KB) to
assist with implementation and barrier assessment. The KB will meet with the fully supported
group six times to design and implement the intervention, and the KB will meet with the
partially supported group four times to design and partially implement the intervention. The
KB will encourage both groups to use the selected standardized assessment. The fully
supported group will have four educational outreach visits over a four month period. Two of
the four outreach visits will occur simultaneously with focus groups and provide feedback
from chart audit data on current use of the selected standardized assessment and design the
intervention by discussing an action plan to determine strategies to increase the use of the
selected assessment. The investigator will implement the intervention in the two additional
outreach visits. Strategies will be tailored to the group and may include: distribution of
educational materials, an interactive educational meeting, and reminders. The partially
supported arm will have two educational outreach visits where the intervention/action plan
will be designed but not implemented by the investigator. The partially supported arm will be
encouraged to self-implement the intervention during months 2 and 4.
Phase III: Outcome Assessment Outcomes will be assessed to determine documented and
self-reported use of the selected standardized assessment through chart audit at baseline,
immediately post intervention and 6 month follow-up. Focus groups will be conducted at post
intervention and follow-up to explore and compare the impact of the intervention on behavior
change, facilitators to change and barriers that remained among each group. In addition, four
focus groups will be held with patients of the therapists' in each group to explore and
compare their experience.
3.3 Sample Size Justification Physical Therapist- up to 40 PTs, 20 at each location will be
invited to participate. The sample size is based on the number of PTs who work at Kessler and
a power calculation based on pilot research.
Patients treated by the enrolled PTs- up to 24; 3-6 in each group.
3.3.1 Power Calculation: A power calculation was completed using the pilot study data. Based
on the pilot study data, two groups of 6 will achieve an effect size of .7 and power of 81%.
Baseline data:
Group equivalency at baseline will be analyzed using the following variables: age, gender,
years of experience, and educational level will be analyzed using either an unpaired t-test
or Mann-Whitney U test. Continuous data (age, years of experience, use of standardized
assessments) will be analyzed using an unpaired t-test if assumptions of normality are met
and Levene's test of homogeneity is not significant. Level of significance will be set at .1.
A Mann-Whitney U test will be used for ordinal data and data that are not normal. Variables
on which the groups differ at baseline will be considered for inclusion in the final models
as covariates.
Barrier assessment questionnaire data will be analyzed descriptively to guide intervention
development. The baseline focus group will be transcribed, coded and themes will be created.
Documented use of the standardized assessment will be analyzed using a within-between,
repeated measures ANOVA, with time and group as factors. If data are non-normal attempts will
be made to transform the dependent variables to meet parametric standards. Another option
will be to explore statistical procedures that model non-Gaussian distributions. Level of
significance will be set at .05.
Self-reported use will be analyzed using the Goal Attainment Scale using the Friedman's test
because data are ordinal. The Friedman's test will used for within group analysis only.
Comparisons between groups will be reported descriptively or alternatively, a
post-intervention Mann-Whitney U may be used. Level of significance will be set at .05.
Focus group: Each focus group will be recorded and transcribed and conventional content
analysis will be conducted. After the focus group is transcribed, open coding will occur by
coding notes, observations, and comments in the margins of potentially relevant information.
Similar notes, observations and comments will be grouped together into categories or themes.
Appropriate categories will be associated with Theoretical Domains Framework and the
Consolidated Framework for Implementation Research (CFIR) into codes and rated. Experiences
will be determined by satisfaction with the intervention, perceived facilitators for changing
their behavior and barriers that remain. Several steps will be taken to establish
trustworthiness of the qualitative data..
Realist Analysis: Chart audit data will be used as the Outcome and Qualitative codes from the
CFIR will be entered as Mechanisms (Interventions) or Context. Codes and ratings will be
compared with chart audit data to determine reasons for use or non-use.
Patient Focus group: The patient focus group, will be used to compare the experiences of
patients treated by therapists in the intervention and control groups. Each focus group will
be recorded and transcribed. Open coding will occur as I will write notes, observations, and
comments in the margins of potentially relevant information of the transcribed focus group.
Similar notes, observations and comments will be grouped together into categories or themes.
Categories will be compared across groups.
