Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000741684
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
11/07/2014
Date last updated
13/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effects of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)-guidelines training on knowledge and implementation of these guidelines by physicians who are providing COPD-care in the eastern province of Saudi Arabia: cluster randomized controlled trial.
Scientific title
Evaluation of the effects of GOLD-guidelines training on knowledge and implementation of these guidelines by physicians who are providing chronic obstructive pulmonary disease (COPD)-care in the eastern province of Saudi Arabia: cluster randomized controlled trial.
Secondary ID [1] 284912 0
Nil known
Universal Trial Number (UTN)
U1111-1158-5465
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lack of knowledge of physicians in the eastern province of Saudi Arabia regarding Chronic obstructive pulmonary disease (COPD) guidelines recommendations (e. g GOLD) 292382 0
Lack of implementation of COPD guidelines by physicians in the eastern province of Saudi Arabia recommendations (e.g. GOLD) 292383 0
Condition category
Condition code
Respiratory 292696 292696 0 0
Chronic obstructive pulmonary disease
Public Health 292744 292744 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physicians of the ‘intervention hospitals’ who agreed to participate in the study were provided a link to the GOLD statement training modules via the Virtual Medical Academy website and asked to complete all five modules within a two week period. A maximum of three emails and two phone calls were used as reminders to complete the modules. In the control group, the physicians were asked to continue with their usual care of COPD management.
The primary aim of the education intervention was to increase physicians’ awareness and knowledge of COPD guideline recommendations (i.e. GOLD and SICAD). The online GOLD statement training was presented over five modules: 1) introduction to the GOLD training modules 2) specific recommendations regarding COPD management; 3) spirometry; 4) pulmonary rehabilitation; and 5) training in the use of a flowsheet that included the main GOLD and SICAD recommendations during consultations with patients with COPD.

The five modules included one to six short presentations (approximately five to 20 minutes each) completed by three of the investigators (MA, PF, and PC) and senior respiratory scientists. The information contained in the GOLD Statement 2014 (1) was adapted by the investigators (MA and PF). Recordings of the presentations were composed at Flinders University. The PowerPoint slides and a hardcopy of the GOLD statement (2014) were also provided in the online training modules. The physicians were allowed to download the intervention materials, so they had access to it throughout the entire study period. Physicians were encouraged to use a flowsheet in their practice. An optional two hour live interactive general discussion lecture was provided (by PF) via Virtual Medical Academy two weeks after completion of the initial training.
Intervention code [1] 289732 0
Behaviour
Comparator / control treatment
For the control group, physicians will not receive any intervention modules. At the same time with intervention group.
Control group
Active

Outcomes
Primary outcome [1] 292541 0
Primary Outcome 1: physicians’ knowledge of Chronic obstructive pulmonary disease (COPD) guidelines recommendations (e. g GOLD) as assessed using a self-administered structured questionnaire based on the results of other studies that have assessed physicians’ knowledge of GOLD guideline recommendations.

Timepoint [1] 292541 0
Timepoint: at baseline, directly after the intervention (2 weeks), and 12 months after the intervention
Secondary outcome [1] 309180 0
Secondary Outcome 1: barriers that prevent physicians to implement the GOLD guideline recommendations as assessed using a self-administered structured questionnaire based on the results of other studies that have assessed barriers that prevent physicians to implement the GOLD guideline recommendations.
Timepoint [1] 309180 0
Timepoint: at baseline, directly after the intervention (2 weeks), and 12 months after the intervention
Secondary outcome [2] 309181 0
Secondary Outcome 2: readiness of physicians to implement the GOLD guideline recommendations as assessed by using a questionnaire based on the Prochaska’s trans-theoretical model
Timepoint [2] 309181 0
Timepoint: at baseline, directly after the intervention (2 weeks), and 12 months after the intervention
Secondary outcome [3] 309182 0
Secondary Outcome 3: the level of implementation of components of the GOLD guidelines as assessed using a self-developed evaluation sheet (data will be transferred from patient’s medical record)
Timepoint [3] 309182 0
Timepoint: at baseline and 12 months after the intervention
Secondary outcome [4] 309183 0
Secondary Outcome 4: health care resources for patients with COPD in the intervention hospitals (e.g. number of hospital admissions, length of stay during admissions to the hospital, and visits to the emergency department and to internal medicine or respiratory outpatient clinics) using a self-administered structured questionnaire based on the results of other studies that have assessed health care resources for patients with COPD to be completed by the Director of the Internal Medicine Department of each hospital.
Timepoint [4] 309183 0
Timepoint: at baseline and 12 months after the intervention

Eligibility
Key inclusion criteria
Physicians will be included if they:
1) Work at the Department of Internal Medicine in one of the five selected government hospitals in the eastern province in Saudi Arabia.
2) Evaluate, treat and provide care for patients with COPD with a minimum of 10 cases per year.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
physicians do not meet the inclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In this study the census survey method will be used because the target number is small. We will consider five of the 22 hospitals assessed in a previous study (paper currently written). Based on this study we know that the other hospitals are referring most COPD patients to these five hospitals for specialised care. In our previous study it was concluded that these five hospitals have already reasonable services in terms of management of COPD such as respiratory physicians, spirometry and intensive care units available. None of the other 17 hospitals had respiratory physicians nor spirometry services available. All physicians who provide COPD-specific care in these five hospitals in the eastern province (Eastern are (n=4) and Al Ahsa area (n=1)) will be asked to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this cluster randomized controlled study, five government hospitals in the eastern province (Eastern area (n=4) and Al Ahsa area (n=1)) will be randomly assigned to an intervention group or control group based on the hospital size (number of beds) using paper and envelopes. The investigator will write down each name of these five hospitals on a paper and put it inside an envelope. Then, the investigator will ask an independent person to select envelopes for intervention group and envelopes for control group.

Physicians in the five hospitals who are providing COPD care will not be randomized because the randomization will be performed on the hospitals level. Physicians will be asked to participate and to give informed consent. Our study assesses the effects of GOLD-guideline training on knowledge, readiness to change and the actual implementation of the guidelines in physicians who are providing COPD care in these government hospitals. Assessments will be performed at baseline, directly after the intervention (2 weeks), and 12 months after the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations:

Although we are going to recruit all internal and respiratory physicians in the five government hospitals in the eastern province, we have performed a power analysis to calculate the required sample size. The primary outcome variable in this study is the difference in mean score of physicians’ knowledge between groups post-test (12 months). The mean score for physicians’ knowledge was 52.1 (SD 8.4) at baseline and 65.1 at post-test.

Using 80% power, a 5% alpha level, and an intra-cluster correlation (ICC) of 0.005, a sample size of 6 physicians per hospital is needed to detect a clinical significant difference of 10 points in physicians’ knowledge score between the intervention and control group, assuming a standard deviation of 8.4 and a worst case correlation of zero between baseline and follow up scores. We expect a drop-out rate of 20%, for this reason we need to recruit 8 physicians per hospital. We expect to be able to recruit around 50 physicians (10 physicians in each hospital) based on a previous study that we conducted in the eastern province (paper is currently written).

Statistical analysis:
All data will be entered into the Statistical Package for Social Sciences (SPSS) version 19. Descriptive data for baseline characteristics will be reported.
The primary analysis will use a mixed effects linear regression models, clustering over hospitals to account for correlated readings. Statistical significance will be reported when P values were <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2014
Actual
20/10/2014
Date of last participant enrolment
Anticipated
Actual
1/02/2015
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
40
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 6191 0
Saudi Arabia
State/province [1] 6191 0
Eastern province

Funding & Sponsors
Funding source category [1] 289538 0
University
Name [1] 289538 0
Imam Abdulrahman Bin Faisal University
Country [1] 289538 0
Saudi Arabia
Primary sponsor type
University
Name
Imam Abdulrahman Bin Faisal University
Address
Imam Abdulrahman Bin Faisal University
P.O. Box 2435
Dammam 31441

Dammam, Kingdom of Saudi Arabia.
Country
Saudi Arabia
Secondary sponsor category [1] 288224 0
None
Name [1] 288224 0
Address [1] 288224 0
Country [1] 288224 0
Other collaborator category [1] 278027 0
University
Name [1] 278027 0
Flinders University
Address [1] 278027 0
Sturt Road, Bedford Park 5042, South Australia
Postal address : GPO Box 2100, Adelaide 5001, South Australia
General enquiries
Country [1] 278027 0
Australia
Other collaborator category [2] 278028 0
Hospital
Name [2] 278028 0
Repatriation General Hospital
Address [2] 278028 0
Daws Road Daw Park South Australia

Postal address:
Daws Road Daw Park SA 5041
Country [2] 278028 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291278 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291278 0
Southern Adelaide Clinical
Human Research Ethics Committee

The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 291278 0
Australia
Date submitted for ethics approval [1] 291278 0
18/07/2014
Approval date [1] 291278 0
24/09/2014
Ethics approval number [1] 291278 0

Summary
Brief summary
In this cluster randomized controlled study, five government hospitals in the eastern province (Eastern area (n=4) and Al Ahsa area (n=1)) will be randomly assigned to an intervention group or control group based on the hospital size (number of beds) using paper and envelopes. Randomization will be performed by an independent person.

Physicians in the five hospitals who are providing COPD care will be asked to participate and to give informed consent. Our study assesses the effects of GOLD-guideline training on knowledge, readiness to change and the actual implementation of the guidelines in physicians who are providing COPD care in these government hospitals. Assessments will be performed at baseline, directly after the intervention, and12 months after the intervention.
Trial website
Trial related presentations / publications
none. It is under the process of publication
Public notes

Contacts
Principal investigator
Name 49650 0
Dr Mohammed Al Subaiei
Address 49650 0
Department of Respiratory Medicine at Repatriation General Hospital

Street address:
Daws Road Daw Park South Australia
Postal address:
Daws Road Daw Park SA 5041
Country 49650 0
Australia
Phone 49650 0
Mobile Phone: +61435819667, +966505951422 (Mobile Phone in Saudi Arabia)
Fax 49650 0
Email 49650 0
[email protected]
Contact person for public queries
Name 49651 0
Dr Mohammed Al Subaiei
Address 49651 0
Department of Respiratory Medicine at Repatriation General Hospital

Street address:
Daws Road Daw Park South Australia
Postal address:
Daws Road Daw Park SA 5041
Country 49651 0
Australia
Phone 49651 0
Mobile Phone: +61435819667, +966505951422 (Mobile Phone in Saudi Arabia)
Fax 49651 0
Email 49651 0
[email protected]
Contact person for scientific queries
Name 49652 0
Dr Tanja Effing
Address 49652 0
Department of Respiratory Medicine at Repatriation General Hospital

Street address:
Daws Road Daw Park South Australia
Postal address:
Daws Road Daw Park SA 5041
Country 49652 0
Australia
Phone 49652 0
Work Phone: +61-8-8275 1189
Fax 49652 0
Email 49652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCOPD care in Saudi Arabia: Physicians' awareness and knowledge of guidelines and barriers to implementation.2017https://dx.doi.org/10.5588/ijtld.16.0656
N.B. These documents automatically identified may not have been verified by the study sponsor.