Chronic Obstructive Pulmonary Disease (COPD)TICD-COPDNCT01893476
A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management
A study testing Implementation educational programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz at 1 site in Poland.
Trial summary
Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Implementation educational programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diagnosed COPD via the medical records with code J44
Who cannot join
- terminal illness
- cognitive impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Implementation for Chronic Diseases.
Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.
Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?
Read more
Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.
Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem. Worldwide it has been ranked as the sixth leading cause of death for both genders. In 2020 COPD is projected to rank fifth worldwide in burden of disease. It is also projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. The national survey conducted in Poland in 2007 indicated that 34% of men smoked daily, 2% were occasional smokers, 19% were former smokers and 45% never smoked. In women, these percentages were, respectively, 23%, 3%, 10% and 64%. Although COPD has received increasing attention from the medical community in some countries in recent years, it is still relatively unknown or ignored by the public as well as many healthcare providers and government officials.
Epidemiological studies of COPD on a representative sample have not been performed in Poland, but estimates from smaller suggested a relatively high prevalence. Studies which covered a selected geographical population found that signs and symptoms of COPD are seen in about 10% of patients over 40 years old. Studies in big cities in Poland showed a 9,8% prevalence of COPD in populations between 41 and 72 years old. These data are similar to European data, describing prevalence rates of 4-11% of COPD in adults in Europe. The absolute number of people suffering from COPD in Poland is estimated on about 2 million. This places COPD as the third most frequent - concerning frequency - chronic illness, and it is the fourth most common cause of death in Poland.
In Poland, many guidelines on COPD are used, some of which are national and some are international. There is no guideline in Poland which is designed for primary care.
Implementation of interventions directed on health professionals knowledge programme can change the professionals behavior. In this study the support strategy is applied to improve implementation process.
- Being tested
- Implementation educational programme
- Keywords
- chronic obstructive pulmonary disease, implementation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation educational programmeOther
Also called implementation programme
Implementation educational programme will include: brief anti-smoking counseling, mMRC scale, checklist, training patient on correct use of inhaling. Participating physicians will receive training in brief anti-smoking counselling and will be asked to record information about. Additional form containing the mMRC dyspnoea scale will be inserted into patients' medical records. We will elaborate a checklist for practitioners with information about what should be done while consulting a patient with COPD. Investigators will provide practices with training inhaler and train staff. Practitioners will be asked to teach patients in correct use of each device. Practitioners will be asked to put this information to the patient's medical records.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | In this arm, practitioners will provide usual care for COPD patients. |
| adherence to guideline | Other | Implementation educational programme: guideline adherences. The results of this trial will be directly applicable to primary care settings. Should the interventions delivered at the level of the GP practice be found to be effective in improving patients' quality of life then the findings would have a wider application. Receives: Other: Implementation educational programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records.
Brief anti-smoking counseling will be provided for GPs.
Measured: 1 year
Secondary outcomes (1)
Health outcomes in patients' medical records.
Investigators will review COPD patients' medical records to measure health outcomes such as smoking status change, quantity of and adherence to medication, change in modified Medical Research Council (mMRC) scale and number of exacerbations in the past and over the study period.
Also, investigators will consider utilization of the Chronic Respiratory Questionnaire (CRQ).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Maciej Godycki-Ćwirko, Medical University of Lodz
- Investigators
- Maciej Godycki-Cwirko, MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893476
- Sponsor's protocol ID
- 258837
- Acronym
- TICD-COPD
- Status last verified
- Oct 2015
- First submitted
- 2 Jul 2013
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Godycki-Cwirko M, Zakowska I, Kosiek K, Wensing M, Krawczyk J, Kowalczyk A. Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Trials. 2014 Apr 4;15:109. doi: 10.1186/1745-6215-15-109.
PubMed 24708623
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Implementation for Chronic Diseases.
- ClinicalTrials.gov ID
- NCT01893476
- Acronym / sponsor ID
- TICD-COPD / 258837
- Keywords
- chronic obstructive pulmonary disease, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.
Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?
Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.
Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem. Worldwide it has been ranked as the sixth leading cause of death for both genders. In 2020 COPD is projected to rank fifth worldwide in burden of disease. It is also projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. The national survey conducted in Poland in 2007 indicated that 34% of men smoked daily, 2% were occasional smokers, 19% were former smokers and 45% never smoked. In women, these percentages were, respectively, 23%, 3%, 10% and 64%. Although COPD has received increasing attention from the medical community in some countries in recent years, it is still relatively unknown or ignored by the public as well as many healthcare providers and government officials.
Epidemiological studies of COPD on a representative sample have not been performed in Poland, but estimates from smaller suggested a relatively high prevalence. Studies which covered a selected geographical population found that signs and symptoms of COPD are seen in about 10% of patients over 40 years old. Studies in big cities in Poland showed a 9,8% prevalence of COPD in populations between 41 and 72 years old. These data are similar to European data, describing prevalence rates of 4-11% of COPD in adults in Europe. The absolute number of people suffering from COPD in Poland is estimated on about 2 million. This places COPD as the third most frequent - concerning frequency - chronic illness, and it is the fourth most common cause of death in Poland.
In Poland, many guidelines on COPD are used, some of which are national and some are international. There is no guideline in Poland which is designed for primary care.
Implementation of interventions directed on health professionals knowledge programme can change the professionals behavior. In this study the support strategy is applied to improve implementation process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –In this arm, practitioners will provide usual care for COPD patients. |
| adherence to guideline | Other | Other: Implementation educational programmeImplementation educational programme: guideline adherences. The results of this trial will be directly applicable to primary care settings. Should the interventions delivered at the level of the GP practice be found to be effective in improving patients' quality of life then the findings would have a wider application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with diagnosed COPD via the medical records with code J44
Key exclusion criteria (2 listed)
- terminal illness
- cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation educational programmeAlso: implementation programmeImplementation educational programme will include: brief anti-smoking counseling, mMRC scale, checklist, training patient on correct use of inhaling. Participating physicians will receive training in brief anti-smoking counselling and will be asked to record information about. Additional form containing the mMRC dyspnoea scale will be inserted into patients' medical records. We will elaborate a checklist for practitioners with information about what should be done while consulting a patient with COPD. Investigators will provide practices with training inhaler and train staff. Practitioners will be asked to teach patients in correct use of each device. Practitioners will be asked to put this information to the patient's medical records. | Other | adherence to guideline |
Primary outcome
The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records.
Time frame: 1 year
Brief anti-smoking counseling will be provided for GPs.
1 secondary outcome
Health outcomes in patients' medical records.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 24708623Godycki-Cwirko M, Zakowska I, Kosiek K, Wensing M, Krawczyk J, Kowalczyk A. Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Trials. 2014 Apr 4;15:109. doi: 10.1186/1745-6215-15-109.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Godycki-Cwirko, MD, PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation educational programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.