Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05523882 |
| Other study ID # |
ID 242-3 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2022 |
| Est. completion date |
November 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Aalborg University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Being a hybrid type 2 effectiveness-implementation study, this study aims to simultaneous
assess the clinical effectiveness of the introduction of point-of-care unltrasound in general
practice and to measure the impact of the implementation strategy as co-primary aims.
Description:
In 2023/2024 the POCUS IN PRACTICE (PIP) study, a large stepped wedged cluster randomized
clinical trial (SW-CRT) will be conducted in general practice in Denmark. The overarching aim
of this study is to evaluate the implementation of point-of-care ultrasound (POCUS) in Danish
general practice. An educational intervention for this study has been developed and tested in
a previous study (Evaluating scanning competence following a structured POCUS training
program for general practitioners: A hybrid effectiveness-implementation study: Clinical
trials registration: NCT05274581). Since then, the intervention has been further developed
and in line with the medical research council's framework for developing and evaluating
complex interventions , the intervention is ready for the next stage of evaluation.
We use the effectiveness-implementation hybrid trial design typology proposed by Curran et al
which has been found suitable for preparatory studies in relation to implementing complex
interventions . This is a hybrid type 2 effectiveness-implementation trial3, with
simultaneous testing of both the effectiveness of an Ultrasound course (the intervention) and
the feasibility of the implementation strategy. We previously tested other effectiveness
related outcomes (the educational intervention's ability to give participating GPs' scanning
competence) in a hybrid type 1 effectiveness-implementation trial and the present study
builds on the evaluation of implementation-related outcomes from the previous study.
This study will be conducted in office-based general practice in Denmark with the educational
sessions taking place at two different ultrasound educational facilities.
Outcomes to assess the effectiveness of the intervention:
Following the use of POCUS in the general practice consultations the GPs will follow normal
procedures for registration of activities in general practice using remuneration codes,
fee-specific codes for using POCUS, and referrals in the medical record system. Prior to this
study 11 fee-specific codes for 11 different POCUS examinations will be installed in the
medical record system. The Primary Sector Data Provider Platform (PLSP) will develop an
algorithm that allows for the following data extraction on each participating GP in a given
time frame: (1) number of POCUS examinations performed, (2) number of referrals, and (3)
number of consultations (outcomes E1-3). PLSP will deliver monthly aggregated data for each
participating GP from the first teaching seminar to 12 months after the first teaching
seminar. These continues data will be summarized to demonstrate variation over time.
For the registration of the clinical effect of POCUS use in the consultation (outcome E4), we
will use an adapted version of a questionnaire used in a previous cohort study . The GPs will
be asked to specify the following for each POCUS examination: (1) organs/structures examined
with POCUS (drop down menu or free text), (2) whether POCUS use entailed a change in
diagnosis (yes/no), (3) whether POCUS use entailed a change in referral (yes/no), (4) whether
POCUS use entailed a change in treatment (yes/no), (5) whether POCUS use entailed a change in
diagnostic certainty for the GP (yes/no), (6) whether POCUS use was helpful for the GP in
terms of making a decision for patient management (5-point Likert scale), (7) whether POCUS
use was helpful for the GP in terms of arriving at a diagnosis (5-point Likert scale). GP
will assess the questionnaire immediately after performing POCUS during consultations in
clinical practice. These categorical data will be collected for each participating GP from
the first teaching seminar to 12 months after the first teaching seminar..
For the registration of unwanted cases (outcome E5), we will use a questionnaire giving the
GPs the possibility to explain in free text using their own words to explain (1) what was
scanned, (2) circumstances surrounding the scan, (3) what happened, and (4) reflections after
the scan. Data will be collected from day 7 to day 372. We will report the aggregated total
number of monthly registrations for each participating GP. The free text elaborations will
not be reported, but passed on to the safety committee (see section 5d). The assessment of
unwanted cases for the study does not substitute the GP's registration of untoward incidents
required by Danish law
(https://stps.dk/da/ansvar-og-retningslinjer/vejledning/rapporteringspligt/).
Outcomes to assess implementation strategy effects:
For the assessment of implementation strategy effects (outcomes I1-4), we will use the
register data (fee specific codes) collected by PLSP on the monthly use of POCUS for each
participating GP (outcomes I1 and I4) and the activities logged (pre-post tests, webinars,
assignments, attendance on seminar days, logbook registrations) in the online platform used
in the educational intervention (outcomes I2-3) to estimate the frequency of use and the
percentage of adherence, respectively. The continues data (outcomes I1and I4) will be
collected prospectively from the first teaching seminar to 12 months after the first teaching
seminar, while the binary data (outcomes I2 and I3) are collected retrospectively at the end
of the educational intervention including registration made in the online platform during the
educational intervention.
Outcomes to inform further development of the implementation strategy
For outcomes related to the development of the implementation strategy (outcomes D1-D11), we
will use a questionnaire distributed to participants three months after the first teaching
seminar. A reminder will follow after 2 weeks. The questionnaire will include the following
questions with a 5-point Likert scale:
(D1) Did the educational intervention meets local needs? (D2) Was the educational
interventions agreeable in terms of content and delivery? (D3) Was the educational
intervention suitable for implementation? (D4) Was the educational intervention in line with
your values, mission, priorities? (D5) Are you satisfied with the amount of support and
resources allocated to you? (D6) Was the educational intervention too difficult or complex to
implement? (D7) Did any organisational political, economic or social factors influence the
implementation of the educational intervention? (D8) Did the setting, including
organisational values or norms influence the implementation of the educational intervention?
(D9) Did you have the capacity (e.g. knowledge and skills) to implement the educational
intervention?
And the following questions with a free-text answer category:
(D10) How must did you have to invest financially to implement the educational intervention?
(D11) How much time and resources did you have to invest to implement the educational
intervention?
Outcomes to assess the feasibility of trial methods For the assessment of the feasibility of
trial methods (outcomes F1-F8), we will evaluate the data quality by calculating the
proportion of missing or incomplete registrations, recruited participants in relation to
possible number of participants as well as participant retention and adherence. The steering
committee will discuss the results and perform a qualitative evaluation based on predefined
progression criteria (see study protocol). For outcome F8, we will use validated scales to
determine GPs' perceived stress (Cohen's 10-item Perceived Stress Scale), GPs' job
satisfaction (Warr-Cook-Wall Job satisfaction Scale) and GPs burnout symptoms (Maslach
Burnout inventory). Prior to the study, these questionnaires were tested for face validity in
four focus groups with 18 POCUS using GPs (unpublished materiel).
The GP questionnaire will be distributed to participating GPs prior to the third teaching
seminar (day 37, at the end of the educational intervention). For each scale, we will
calculate a mean sum score with SD and a median sum score with IQR.
Participants characteristics On the first teaching seminar the following participant
characteristics will be collected: Age (years), gender (M, F, other), previous use of
ultrasound (number of months with regular use), previous ultrasound courses of minimum 1 day
duration (yes/no), scanner type (low range, mid-range, high end), type of practice
(collaboration, partnership, solo), location of practice (urban, rural, mixed), number of
patients assigned to the practice, number of GPs working in the practice.
From PLSP, we will receive the following aggregated data on patients (age, gender) calculated
based on patient ID in the medical records in the clinics (CPR numbers). These data are
extracted and transferred to CAM AAU anonymously.
Time schedule
We will invite participants from two PLO-e ultrasound course to participate:
Teaching seminars course 1: August 31st and September 28th and November 30th 2022 Teaching
seminars course 2: September 6th and October 10th and November 29th 2022
Sample size This is accompanying research and as such no formal sample size calculations are
made. Our potential study population is 36 GPs, who have signed up to participate in an
ultrasound course organized by PLO-e. We expect a participation rate of 66% corresponding to
21 GPs. Previous cohort studies from Danish general practice have shown that GPs' average use
of POCUS corresponds to once a day. With a data collection period of 12 months for
participants corresponding to 200 working days, we expect approximately 4200 POCUS
registrations in this study.
Recruitment Two ultrasound courses delivering the educational intervention have been included
in PLO-e's course catalogue for 2022 and as such all GPs working in Danish general practice
has had the opportunity to sign-up for the courses. PLO-e has handled the participant
recruitment and registration based on a first-come-first-served principle as well as the
financial and practical aspects of organizing and executing the courses. The two ultrasound
courses have a total of 36 available spots and all 36 participants are offered the
opportunity to participate in the data collection for this study. However, not all
participants will be offered financial compensation for participating in the study, as a
collective agreement between the Danish regions and the association of GPs only allows for
those GPs with in longest distance to a radiology department to have a free course attendance
and a fee for performing POCUS during the data collection.
The offer to participate in the study is made upon registration to the course and repeated at
the first webinar. At the webinar participants are informed about the research project and
written information about the project including a consent form is distributed to
participants. The signed consent forms are collected from participants on the first training
seminar.
Data collection Register data: Data regarding different POCUS examinations, number of
referrals, number of consultations will be delivered by PLSP (outcomes E1-3, I1 and 4). The
data are registered prospectively by GPs in the medical records during the consultations from
the first teaching seminar until 12 months after the first teaching seminar. We will receive
these data retrospectively from PLSP, who will use an algorithm to collect monthly aggregated
data for each participating GP.
PLSP will also deliver aggregated data on patients age and gender independent from other
study data.
GP registrations: For the GPs' registration of POCUS effect in the consultation (outcome E4),
GPs will use paper registrations in logbooks during the educational intervention (months
1-3). Here the registrations are made for the GPs own purpose as part of the learning
process. Following the educational intervention, we will ask the GPs to continue making these
registrations with the purpose of research, using a QR code to access an online
questionnaire. The paper registrations will be collected by the research team at the third
teaching seminar, while the online-questionnaire data are collected continuously from untill
12 months after the first teaching seminar.
For the reporting of anonymously unwanted cases, GPs will have a QR code and a link for an
online questionnaire (outcome E5). These data are collected prospectively continuously during
consultations.
GP questionnaire: For the cross-sectional questionnaire exploring burnout, stress and job
satisfaction at 3 months (outcome E6), an online questionnaire will be distributed by email
to participants following the third seminar day and a possible reminder will follow after two
weeks. The questionnaire collecting background characteristics on participating GPs will be
distributed on the first teaching seminar.
Online platform: For the evaluation of participant adherence (outcome I2) and reach (outcome
I3) we will use the registrations on the online platform (Microsoft Teams) supporting the
educational intervention. These are collected retrospectively at the end of the educational
intervention (three months after the first teaching seminar).
Process evaluation questionnaire: For the evaluation of implementation of the educational
intervention (outcomes D1-11) a questionnaire will be distributed by email to teachers and
participants following the educational intervention (three months after the first teaching
seminar).
Data management The data management will follow the rules of the General Data Protection
Regulation (GDPR) and the Danish Data Protection Agency. All study data will be stored on a
secure server at Aalborg University. Questionnaire data will be collected using the online
platform SurveyXact (Rambøll, Aarhus, Denmark). A data management agreement has been made
between Rambøll and Aalborg University. At the end of the data collection, data will be moved
from SurveyXact to Aalborg University's server.
Register data will be collected by PLSP. Data management agreements between PLSP and CAM AAU
will be made prior to the collection of data. PLSP will receive data from the different IT
suppliers for the general practice clinics. Data management agreements between the IT
suppliers and PLSP as well as the GP clinics and the IT suppliers already exists. For this
specific study, we will develop an instruction for the GPs to incorporate in the existing
data management agreement prior to the collection of data.
All patient-related data will remain in the GPs clinics until the end of the educational
intervention (three months after the first teaching seminar). No data will be transferred to
CAM AAU before legal approval by the health authorities has been obtained.
Statistical methods All statistical analyses will be performed using STATA version 17
(StataCorp, Texas, USA) and analyzed according to a predefined statistical analysis plan,
which will be uploaded to clinical Trials.org prior to the analysis of data (12 months after
baseline). Data will be summarized and reported using descriptive statistics.
For effectiveness related outcomes E1-E5, frequencies and variance are reported as mean and
95% CI or median and IQR depending on the distribution of data. We will use graphic
illustrations to demonstrate change over time. To test if changes over time are significant,
we will use repeated measures ANOVA analysis.
For outcomes related to the implementation strategy effects (I1-I4) and feasibility of trial
methods (F1-F7), we will report proportions as frequencies, while outcomes related to the
implementation strategy (D1-D9) will be reported with an average score and outcomes D10-D11
with a summarized estimate on costs. For fesability-related outcome F8,we will report the
questionnaire response rate and the corresponding 95% CI. For each scale, we will report a
mean sum score and SD as well as a median sum score and IQR.
Missing data Missing values, owing to e.g. premature termination of the questionnaire, are
considered completely random and will be declared for each outcome.
Research ethics approval The study will be performed in accordance with the Declaration of
Helsinki. The project was notified to The North Denmark Region Committee on Health Research
Ethics.
(Den Videnskabsetiske Komité for Region Nordjylland, reference number 2022-000764) who
responded that according to Danish Law (komitélovens § 14, stk. 2), no ethical approval is
needed for this project.
As we are collecting patient-related data for the purpose of research, we will seek
permission by the health authorities. All patient-related data will be collected
retrospectively after this approval is obtained. We will honor our information obligations to
patients about the project by making project information available in the GP's clinic as
hand-outs and posters.
The project has been registered and conducted according to the regulations of the Danish Data
Protection Agency (registration number ID 242-3).
Harms The participating GPs will be obliged to report any undesirable effects including
Suspected Unexpected Serious Adverse Reactions (SUSARs), Serious Adverse Events (SAEs) and
Adverse Events (AEs) related or possibly related to the use of POCUS to the safety committee.
Consent or assent Informed consent form the participating GPs will be collected by the
principal investigator prior to the study. We will not seek consent from patients, as no
collected study data are directly linked to the specific patient.
Dissemination policy We aim to publish positive, negative or inconclusive results of the
study in a peer-reviewed journal. The project group will also present results at conferences.
We aim for two scientific publications: Article 1 will include effectiveness-related outcomes
(E1-E6), while Article 2 will report the development of the intervention and
implementation-related outcomes (I1-4, D1-11 and F1-8).
