Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03719651 |
| Other study ID # |
LOCI Norway |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Norwegian Center for Violence and Traumatic Stress Studies |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The project will develop knowledge on how managers can lead the implementation of practices
that have proven to be effective for post-traumatic stress disorders (PTSD) in child and
adult specialized mental health services. Specifically, the project will test the
effectiveness of an intervention named the Leadership and Organizational Change for
Implementation (LOCI). This is an empirically and theoretically based innovation for
implementation leadership that aims to support leaders in their organizational work of
leading the implementation of EBPs in their clinics.
It is hypothesized that the implementation of LOCI will improve leaders' general leadership
qualifications, their implementation leadership qualifications, and the implementation
climate in the clinics. Further, the investigators hypothesize that training in trauma
screening will increase the amount of trauma screenings, moderated by the LOCI
implementation, and also that training in trauma treatment will increase the amount of
patients to be offered this kind of treatment, also moderated by the LOCI implementation.
Description:
Leadership for implementation require leadership that supports effective implementation
strategies at the organizational level. The Leadership and Organizational Change for
Implementation (LOCI) is a leadership training program focusing on enhancing general
leadership and implementation leadership in particular (Aarons, Ehrhart, Moullin, Torres, &
Green, 2017). The aim of the project is to evaluate the implementation strategy used to
implement evidence-based treatment for PTSD in child and adult specialized mental health
services in Norway.
The Leadership and Organizational Change for Implementation (LOCI) consists of several
components:
1. 360° assessment A 360° assessment where the LOCI leaders, the therapists who report to
them, and the executive leader are asked to complete a web-based survey focused primarily on
the leadership of the LOCI leader and the implementation climate in his/her unit. Questions
to therapists and the executive leaders are worded so that they are reporting on the
appropriate LOCI leader. The LOCI leaders are asked questions about their own leadership,
climate in their clinic, and on the implementation citizenship of their therapists.
Descriptive results from the 360° assessment are presented in an individual feedback report
for each of the LOCI leaders in the LOCI condition. Each of the LOCI leaders will receive
their own feedback reports during the initial and follow-up leadership trainings, and they
will not be required to share it with anyone besides the research group. Feedback reports for
the executives will utilize data aggregated across all clinics within the respective health
trusts. Executives will be presented with their feedback reports at initial and follow-up
organizational strategy meetings (see below).
Leadership training 2.1 Training 2.1.1 Initial leadership training: The LOCI intervention
begins with a two-day workshop for the LOCI leaders. The workshop addresses leadership in
general, with a particular focus on the full-range leadership model, transactional
leadership, and implementation leadership. The LOCI leaders are challenged to share own
experiences and views on leadership, and examples of leadership styles are shared and
discussed. Implementation climate is also addressed, with a focus on strategies leaders can
use to support implementation of EBPs. Mid-way in the workshop at both day 1 and 2, the
feedback reports from the 360° assessment will be shared individually with each of the LOCI
leaders. The LOCI facilitator and the LOCI leader review the report together, identifying
strengths and areas they would like to further develop. In a collaborative method, the LOCI
facilitator and the LOCI leader draft that leader's individual leadership development plan
wherein goals and committed actions are detailed to facilitate enhancement in their
leadership and the implementation climate of their clinic.
2.1.2 Booster leadership training: The leadership training is followed by a one-day booster
session after 4 and 8 months. Before each booster session, a new 360° assessment will be
completed, resulting in updated feedback reports, where the data is presented in graphs so
that it is easy to see the development from the baseline assessment to the assessment at 4
and 8 months. The feedback report makes the basis for the leaders´ subsequent work with the
individual leadership development plan. Organizational strategies, goals, and leadership are
addressed through group discussions.
2.1.3 Graduation: At month 12, there will be a ritual to mark the completion of the program.
Accomplishments are celebrated, challenges are addressed, and plans for further sustainment
are shared.
2.2 Coaching calls with first-level leaders The LOCI leaders will participate in weekly brief
consultation calls over the phone (10-30 minutes) with their LOCI facilitator where the goals
are to give the leaders the opportunities to strategize methods for overcoming barriers to
EBP implementation; to follow up on the leadership development plan; and to update the
leadership development plan according to the work being done and new information. Once a
month the individual calls are replaced with one-hour group consultation calls with all the
LOCI leaders within the cohort.
2.3 Organizational strategy meetings (OSMs) LOCI leaders and executives meet with the LOCI
facilitator(s) for 2 hours following the first leadership training. The first meeting is
in-person. At this meeting, the LOCI leaders and executives will receive feedback from the
360° survey followed by the iterative development of an implementation climate development
plan in light of the results from the survey. The subsequent meetings take place on a web
conferencing platform at months 4, 8, and 12. The executive will participate in brief (15-30
minutes) monthly telephone coaching calls with the LOCI facilitator where the focus is to
follow up on the implementation climate development plan in light of the results from the
360° survey.
Evidence-based practices for post-traumatic stress disorders (PTSD) During the project,
therapists will be trained in screening for and diagnosing PTSD, using evidence-based
assessment tools. In addition, three well-documented EBPs for PTSD will be implemented in
Norwegian specialized mental health services. 1) In child services, therapists will be
trained in Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) (Cohen, Mannarino &
Deblinger, 2006). It builds on cognitive behavioral principle and incorporates principles
from family therapy. In adult services, two practices will be implemented: 1) Eye Movement
Desensitization and Reprocessing (EMDR) is an integrative eight-phase approach which is
guided by the Adaptive Information Processing model (Shapiro & Laliotis, 2015). 2) Cognitive
Therapy for PTSD (CT-PTSD) is based on a model assuming that PTSD develops if the traumatic
event is processed in a way that maintains the experience of serious current threat (Ehlers &
Clark, 2000).
Personnel in all clinics will receive training (2-3 hours) in screening for trauma and
post-traumatic stress symptoms. A sample of therapists will receive three days of training in
one of the specific practices (TF-CBT, EMDR, or CT-PTSD). In child services, the therapists
will participate in 30 minutes weekly consultation group calls with 4-5 other TF-CBT
therapists and a TF-CBT consultant. In adult services, the therapists will receive 10 hours
of group consultation divided by 2 hours once a month for 5 months.
Methods:
A stepped wedge randomized trial will be used. The clinics will be allocated into three
cohorts, based on which clinics to receive LOCI training at three different time-periods. The
LOCI intervention lasts for 12 months. Allocation will be determined by an independent
statistician. Co-located workgroups or closely working clinics will be assigned to the same
condition to reduce the chances of contamination. The innovation effect is determined by
comparing data points in the innovation section of the wedge with those in the control
section.
The project will consist of three groups of participants:
1. First-level leaders will participate in the LOCI innovation and complete 360 degrees
surveys. In addition, executive leaders will participate in organizational structural
meetings to support first-level leaders, in addition to completing the surveys.
2. All therapists in the participating clinics will participate in the training of PTSD
screening and the surveys. A sample of therapists will be trained and supervised in PTSD
treatment.
3. Patients that are referred to the clinics as normal, report traumatic experiences and
fulfill the criteria for PTSD will be offered to participate in the study. They will
receive PTSD treatment, and complete surveys in connection with the treatment sessions.
The project aims at recruiting 20 child and youth mental health clinics and 20 adult mental
health clinics in specialized services from all over Norway. The child and adult clinics will
be recruited via the four regional health trust, which will receive an invitation by e-mail.
Clinics may also receive information by the group giving lectures about the project in
different settings.
Inclusion and exclusion criteria Child and adult outpatient clinics in specialized health
services are included. All leaders and therapists in the clinics will be asked to participate
in the surveys. Administrative personnel are excluded as most of the measures will not be
applicable to these staff. Staff must be employees of the participating clinics. Leaders that
do not agree to participate in the leadership training (LOCI) will not be eligible to
participate.
Patients (6-100 years) with PTSD will be asked to participate in the study by their
therapist. There are no specific exclusion criteria, as the referrals should follow standard
procedures within the clinics.
Fidelity The TF-CBT therapists in the child clinics will audiotape all the trauma treatment
sessions through an application on iPads specifically programmed for this project. Randomly
chosen therapy sessions for each therapist will be checked for fidelity through a fidelity
check list developed by the TF-CBT research group. Trained TF-CBT supervisors will do the
fidelity assessments. The fidelity measure will be validated as part of this study. The
therapists in the adult clinics will videotape (EMDR) or audiotape (CT-PTSD) all sessions in
all cases. Randomly chosen therapy sessions for each therapist will be checked for fidelity.
Students will be trained to assess five fidelity sessions per therapist. The therapists will
receive written fidelity feedbacks as soon as possible after the session has been video or
audiotaped.
Data collection and management Data are collected from therapists, LOCI-leaders, and
executives from child and adult clinics at baseline, and at 4, 8, 12, 16, and 20 months. The
surveys are distributed by e-mail. Participants are not given any compensation for their
participation. The therapist and LOCI leader survey takes on average 25 minutes to complete,
whereas the executive survey takes on average 15 minutes to complete. Results from some of
the scales will be shared with the LOCI leaders (, MLQ, ILS, ICS, IC, EBPAS, ) and the
executive leaders (ICS, IC, and EBPAS)) as part of the LOCI.
Patients will fill out a questionnaire by iPad in connection with all therapy sessions. It
takes on average 30 minutes to complete. Patients can receive trauma treatment even if they
do not want to participate in the research. All data will be stored on the University center
for sensitive data and the Norwegian Centre for Research Data. Results from some of the
scales will be shared with the therapist by a report function on the iPad.
Discussion Implementation of EBP can be challenging. Leaders in the health care system have
the responsibility that the services provide effective treatments to a certain number of
patients within a given time period. In order to increase the probability that patients will
receive the most effective care for their symptoms, the leaders have to obtain effective
strategies to promote the adoption of the evidence-based treatment. The LOCI intervention
addresses leadership in general, implementation leadership in particular, and organizational
strategies in order to support the implementation of EBP and sustainment over time. Available
data suggest that LOCI is effective in supporting implementation of EBP through strengthening
leadership and a positive implementation climate (Aarons et al., 2017). This study will
examine the adaption of LOCI in a Norwegian mental health setting. A stepped wedge design
will be used to investigate whether the LOCI will have an effect on leadership, the
implementation climate at the clinics, and the clinic´s ability to offer trauma-focused
treatments to patients with elaborated levels of post-traumatic stress symptoms. The
knowledge derived from this study can be used to support the implementation of other EBPs
within the mental health system.
