Inappropriate PrescribingDe-imFARNCT04022850
De-implementation of Low-value Pharmacological Prescriptions
A study testing A non-reflective decision assistance strategy, A both reflective and non-reflective decision information strategy and A reflective decision structure strategy in people with Inappropriate Prescribing and Implementation Science, run by Basque Health Service at 1 site in Spain.
Trial summary
The De-imFAR study is a two phase study that aims to carry out and test a structured, evidence-based and theory informed process involving the main stakeholders (managers, professionals, patients and researches) for the design, deployment, and evaluation of targeted de-implementation strategies for reducing… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Prescribing, Implementation Science, Behavioral Sciences
- What is being tested?
- A non-reflective decision assistance strategy, A both reflective and non-reflective decision information strategy and A reflective decision structure strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2022to 5 May 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Eligibility for professionals:
- FPs belonging to any of the 13 Integrated Healthcare Organizations of Osakidetza
- Non-zero annual incidence rate of PIP of statins at baseline (2021)
- A minimum cluster size of n ≥10 patients
Eligibility for patients:
- 40- to 74-year-old men and 45- to 74-year-old women
- No history of statin use
- LDL cholesterol levels between 70 and 189 mg/dL and/or TC between 200 and 289 mg/dL
- Without ischemic heart disease/CVD
- Estimated CVR REGICOR <7.5%
- Attend at least one appointment at the participating FPs' practices during the study period from May 2022 to May 2023, and followed until May 2024
Trial locations and contacts
1 site in 1 country.
About this study
The De-imFAR study is a two phase study that aims to carry out and test a structured, evidence-based and theory informed process involving the main stakeholders (managers, professionals, patients and researches) for the design, deployment, and evaluation of targeted de-implementation strategies for reducing potentially inappropriate prescribing (PIP). Specifically, the targeted low-value practice of the DE-imFAR study is the pharmacological prescription of statins in the primary prevention of cardiovascular disease (CVD) in low-risk patients. In order to prevent CVD, one of the leading causes of morbidity and death worldwide, there is general agreement on the indication of lipid-lowering treatment, mainly with statins, in patients with a cardiovascular risk (CVR) measurement greater than 10% over 10 years or in secondary prevention. Whereas, for primary prevention in patients with low CVR (<10%), preventive activities should be focused on the promotion of healthy lifestyles through optimizing diet, increasing physical activity, and stopping smoking.
Aims
Read more
- Phase I: To design and model in a collegiate way among the agents involved (professionals, patients, managers and researchers) de-implementation strategies to favour the reduction and / or abandonment of low-value prescription of lipid-lowering drugs in primary prevention of cardiovascular disease. This strategy will be designed using systematic, comprehensive frameworks based on theory and evidence for the design of implementation strategies - the Theoretical Domains Framework (TDF) and the Behavior Change Wheel (BCW), focused on addressing the main determinants (barriers and facilitators) of clinical practice of primary prevention of CVD and adapted to the specific context of primary care in Osakidetza-Basque Health System
- Phase II: To evaluate the effectiveness and feasibility of several de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks: a strategy based on providing evidence-based information communication technology tools to help and guide decision-making (a non-reflective decision assistance strategy); a decision information strategy based on the dissemination of the evidence concerning CVD primary prevention framed in a corporate campaign encouraging family physicians to move away from PIP (a both reflective and non-reflective decision information strategy) ; and a reflective decision structure strategy encouraging reflection on actual performance based on an audit/feedback system (A reflective decision structure strategy).
Hypothesis Professionals exposed to the de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks, will be effective in reducing and/or abandoning the prescription of statins in primary prevention of CVD. Among the evaluated de-implementation strategies, those that encourage self-reflection on actual performance will obtain the largest effects as compared to non-reflective strategies.
Design Phase I formative research to design and model de-implementation strategies and Phase II effectiveness and feasibility evaluation through a cluster randomized implementation trial with an additional control group. Phase I formative research will include the following actions: Cross-sectional observational study of low value pharmacological prescription in the primary prevention of CVD; Literature review on the determinants of low value pharmacological prescription behaviour and effective intervention strategies; Qualitative study on the determinants of low value pharmacological prescription in primary prevention of CVD; Collegiate mapping of the de-implementation strategies; Selection of de-implementation strategies based in perceived effectiveness and feasibility. During Phase II, the evaluation of several de-implementation strategies produced through the phase I formative evaluation will be conducted. A mixed method evaluation will be used: quantitative for assessing the implementation results at the professional level and qualitative for assessing the feasibility and perceived impact of the de-implementation strategies from the family physicians' (FPs) perspective and the experience and satisfaction of patients concerning the clinical care received.
- Being tested
- A non-reflective decision assistance strategy, A both reflective and non-reflective decision information strategy, A reflective decision structure strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A non-reflective decision assistance strategyBehavioural
A strategy based on providing evidence-based information communication technology tools to help and guide decision-making: pop-up reminders and alerts with associated messages incorporated into the REGICOR CVR calculator in OSABIDE (Osakidetza's EHR system) and within the prescription pathway in PRESBIDE (the electronic drug prescribing component).
A both reflective and non-reflective decision information strategyBehavioural
This strategy consists of a corporate campaign entitled "Stopping Low-Value Prescribing" run by the organization (Osakidetza- Basque Health Service) that provides FPs with the evidence-based Clinical Practice Guidelines for the primary prevention of CVD in low-risk patients.
A reflective decision structure strategyBehavioural
The strategy involves the sending of regular audit/feedback reports with practice- and organizational-level performance indicators regarding PIP of statins and healthy lifestyle promotion to prompt reflection about their own care practice, provided along with intention formation and goal-setting-focused messages.
| Study group | Role | What they receive |
|---|---|---|
| Non-reflective decision assistance strategy | Active comparator | The decision support tools integrated in the electronic health record (EHR) for the non-reflective decision assistance strategy will be applied to all FPs from the 13 Integrated Healthcare Organizations (IHOs) of Osakidetza- Basque Health Service Receives: Behavioral: A non-reflective decision assistance strategy |
| Reflective and non-reflective decision information strategy in addition to the previous arm | Experimental | At least 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy) Receives: Behavioral: A non-reflective decision assistance strategy; Behavioral: A both reflective and non-reflective decision information strategy |
| A reflective decision structure strategy in addition to the previous arm | Experimental | At least other 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy + decision structure strategy) Receives: Behavioral: A non-reflective decision assistance strategy; Behavioral: A both reflective and non-reflective decision information strategy; Behavioral: A reflective decision structure strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
De-implementation strategies effectiveness: incidence of the PIP of statins
Change in the incidence of the PIP of statins recorded in the EHR in the target population.
Measured: from baseline to 12 months and 24 months
De-implementation strategies effectiveness: incidence of the provision of advice regarding healthy lifestyles promotion activities
Change in the incidence of the provision of advice regarding healthy lifestyles promotion activities recorded in the EHR in the target population.
Measured: from baseline to 12 months and 24 months
Secondary outcomes (4)
Reach of recommendations for CVD primary prevention
Absolute number and percentage of patients in the target population who received the recommended CVD primary prevention clinical intervention.
Measured: 12 months
De-implementation strategies secondary effectiveness: incidence of CVR (REGICOR)
Change in the incidence of CVR (REGICOR) recorded in the EHR in the target population.
Measured: from baseline to 12 months
FP's adoption: degree to which the recommended CVD primary prevention clinical intervention is adopted by the FPs
Percentage of FPs who reduce PIP of statins and/or increase health promotion activities recorded in the EHR in the target population.
Measured: 12 months
Strategies implementation fidelity
Process indicators of the delivery of and exposure to the de-implementation strategies (percentage of FPs exposed to the strategies compared)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start5 May 2022
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inappropriate PrescribingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Basque Government Department of Public Health, Carlos III Health Institute, European Union
- Responsible party
- Principal investigator, Alvaro Sanchez Perez, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022850
- Sponsor's protocol ID
- 2018111085
- Other IDs
- 2021111024, PI21/00025, RD16/0007/0002, RD21/0016/0003
- Acronym
- De-imFAR
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2019
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared that underlie results reported in the publication, after deidentification
Publications
Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, San Vicente R, Quindimil JA, Rotaeche R, Etxeberria A, Mozo C, Martinez-Cengotitabengoa M, Monge M, Gomez-Ramirez C, Vivanco L, Martin V, Merino-Inda N, Llarena M, Gonzalez Saenz de Tejada M, Garcia-Alvarez A. Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial. Implement Sci Commun. 2026 May 22;7(1):134. doi: 10.1186/s43058-026-00968-1.
PubMed 42174713Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, San Vicente R, Quindimil JA, Rotaeche R, Etxeberria A, Mozo C, Martinez-Cengotitabengoa M, Monge M, Gomez-Ramirez C, Samper R, Ogueta Lana M, Celorrio S, Merino-Inda N, Llarena M, Gonzalez Saenz de Tejada M, Garcia-Alvarez A, Grandes G. De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease. BMJ Open. 2024 Apr 17;14(4):e078692. doi: 10.1136/bmjopen-2023-078692.
PubMed 38631840Sanchez A, Elizondo-Alzola U, Pijoan JI, Mediavilla MM, Pablo S, Sainz de Rozas R, Lekue I, Gonzalez-Larragan S, Llarena M, Larranaga O, Helfrich CD, Grandes G. Applying the behavior change wheel to design de-implementation strategies to reduce low-value statin prescription in primary prevention of cardiovascular disease in primary care. Front Med (Lausanne). 2022 Oct 13;9:967887. doi: 10.3389/fmed.2022.967887. eCollection 2022.
PubMed 36314033Sanchez A, Pijoan JI, Pablo S, Mediavilla M, de Rozas RS, Lekue I, Gonzalez-Larragan S, Lantaron G, Argote J, Garcia-Alvarez A, Latorre PM, Helfrich CD, Grandes G. Addressing low-value pharmacological prescribing in primary prevention of CVD through a structured evidence-based and theory-informed process for the design and testing of de-implementation strategies: the DE-imFAR study. Implement Sci. 2020 Jan 22;15(1):8. doi: 10.1186/s13012-020-0966-3.
PubMed 31969175
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-implementation of Low-value Pharmacological Prescriptions
- ClinicalTrials.gov ID
- NCT04022850
- Acronym / sponsor ID
- De-imFAR / 2018111085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Basque Government Department of Public Health, Carlos III Health Institute, European Union
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
The De-imFAR study is a two phase study that aims to carry out and test a structured, evidence-based and theory informed process involving the main stakeholders (managers, professionals, patients and researches) for the design, deployment, and evaluation of targeted de-implementation strategies for reducing potentially inappropriate prescribing (PIP). Specifically, the targeted low-value practice of the DE-imFAR study is the pharmacological prescription of statins in the primary prevention of cardiovascular disease (CVD) in low-risk patients. In order to prevent CVD, one of the leading causes of morbidity and death worldwide, there is general agreement on the indication of lipid-lowering treatment, mainly with statins, in patients with a cardiovascular risk (CVR) measurement greater than 10% over 10 years or in secondary prevention. Whereas, for primary prevention in patients with low CVR (<10%), preventive activities should be focused on the promotion of healthy lifestyles through optimizing diet, increasing physical activity, and stopping smoking.
Aims
- Phase I: To design and model in a collegiate way among the agents involved (professionals, patients, managers and researchers) de-implementation strategies to favour the reduction and / or abandonment of low-value prescription of lipid-lowering drugs in primary prevention of cardiovascular disease. This strategy will be designed using systematic, comprehensive frameworks based on theory and evidence for the design of implementation strategies - the Theoretical Domains Framework (TDF) and the Behavior Change Wheel (BCW), focused on addressing the main determinants (barriers and facilitators) of clinical practice of primary prevention of CVD and adapted to the specific context of primary care in Osakidetza-Basque Health System
- Phase II: To evaluate the effectiveness and feasibility of several de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks: a strategy based on providing evidence-based information communication technology tools to help and guide decision-making (a non-reflective decision assistance strategy); a decision information strategy based on the dissemination of the evidence concerning CVD primary prevention framed in a corporate campaign encouraging family physicians to move away from PIP (a both reflective and non-reflective decision information strategy) ; and a reflective decision structure strategy encouraging reflection on actual performance based on an audit/feedback system (A reflective decision structure strategy).
Hypothesis Professionals exposed to the de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks, will be effective in reducing and/or abandoning the prescription of statins in primary prevention of CVD. Among the evaluated de-implementation strategies, those that encourage self-reflection on actual performance will obtain the largest effects as compared to non-reflective strategies.
Design Phase I formative research to design and model de-implementation strategies and Phase II effectiveness and feasibility evaluation through a cluster randomized implementation trial with an additional control group. Phase I formative research will include the following actions: Cross-sectional observational study of low value pharmacological prescription in the primary prevention of CVD; Literature review on the determinants of low value pharmacological prescription behaviour and effective intervention strategies; Qualitative study on the determinants of low value pharmacological prescription in primary prevention of CVD; Collegiate mapping of the de-implementation strategies; Selection of de-implementation strategies based in perceived effectiveness and feasibility. During Phase II, the evaluation of several de-implementation strategies produced through the phase I formative evaluation will be conducted. A mixed method evaluation will be used: quantitative for assessing the implementation results at the professional level and qualitative for assessing the feasibility and perceived impact of the de-implementation strategies from the family physicians' (FPs) perspective and the experience and satisfaction of patients concerning the clinical care received.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-reflective decision assistance strategy | Active comparator | Behavioral: A non-reflective decision assistance strategyThe decision support tools integrated in the electronic health record (EHR) for the non-reflective decision assistance strategy will be applied to all FPs from the 13 Integrated Healthcare Organizations (IHOs) of Osakidetza- Basque Health Service |
| Reflective and non-reflective decision information strategy in addition to the previous arm | Experimental | Behavioral: A non-reflective decision assistance strategy, Behavioral: A both reflective and non-reflective decision information strategyAt least 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy) |
| A reflective decision structure strategy in addition to the previous arm | Experimental | Behavioral: A non-reflective decision assistance strategy, Behavioral: A both reflective and non-reflective decision information strategy, Behavioral: A reflective decision structure strategyAt least other 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy + decision structure strategy) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| A non-reflective decision assistance strategyA strategy based on providing evidence-based information communication technology tools to help and guide decision-making: pop-up reminders and alerts with associated messages incorporated into the REGICOR CVR calculator in OSABIDE (Osakidetza's EHR system) and within the prescription pathway in PRESBIDE (the electronic drug prescribing component). | Behavioural | A reflective decision structure strategy in addition to the previous arm, Non-reflective decision assistance strategy, Reflective and non-reflective decision information strategy in addition to the previous arm |
| A both reflective and non-reflective decision information strategyThis strategy consists of a corporate campaign entitled "Stopping Low-Value Prescribing" run by the organization (Osakidetza- Basque Health Service) that provides FPs with the evidence-based Clinical Practice Guidelines for the primary prevention of CVD in low-risk patients. | Behavioural | A reflective decision structure strategy in addition to the previous arm, Reflective and non-reflective decision information strategy in addition to the previous arm |
| A reflective decision structure strategyThe strategy involves the sending of regular audit/feedback reports with practice- and organizational-level performance indicators regarding PIP of statins and healthy lifestyle promotion to prompt reflection about their own care practice, provided along with intention formation and goal-setting-focused messages. | Behavioural | A reflective decision structure strategy in addition to the previous arm |
Primary outcome
De-implementation strategies effectiveness: incidence of the PIP of statins
Time frame: from baseline to 12 months and 24 months
Change in the incidence of the PIP of statins recorded in the EHR in the target population.
De-implementation strategies effectiveness: incidence of the provision of advice regarding healthy lifestyles promotion activities
Time frame: from baseline to 12 months and 24 months
Change in the incidence of the provision of advice regarding healthy lifestyles promotion activities recorded in the EHR in the target population.
4 secondary outcomes
Reach of recommendations for CVD primary prevention
Time frame: 12 months
De-implementation strategies secondary effectiveness: incidence of CVR (REGICOR)
Time frame: from baseline to 12 months
FP's adoption: degree to which the recommended CVD primary prevention clinical intervention is adopted by the FPs
Time frame: 12 months
Strategies implementation fidelity
Time frame: 12 months
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 11 Feb 2025.
- Derived from this study: PubMed 42174713Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, San Vicente R, Quindimil JA, Rotaeche R, Etxeberria A, Mozo C, Martinez-Cengotitabengoa M, Monge M, Gomez-Ramirez C, Vivanco L, Martin V, Merino-Inda N, Llarena M, Gonzalez Saenz de Tejada M, Garcia-Alvarez A. Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial. Implement Sci Commun. 2026 May 22;7(1):134. doi: 10.1186/s43058-026-00968-1.
- Derived from this study: PubMed 38631840Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, San Vicente R, Quindimil JA, Rotaeche R, Etxeberria A, Mozo C, Martinez-Cengotitabengoa M, Monge M, Gomez-Ramirez C, Samper R, Ogueta Lana M, Celorrio S, Merino-Inda N, Llarena M, Gonzalez Saenz de Tejada M, Garcia-Alvarez A, Grandes G. De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease. BMJ Open. 2024 Apr 17;14(4):e078692. doi: 10.1136/bmjopen-2023-078692.
- Derived from this study: PubMed 36314033Sanchez A, Elizondo-Alzola U, Pijoan JI, Mediavilla MM, Pablo S, Sainz de Rozas R, Lekue I, Gonzalez-Larragan S, Llarena M, Larranaga O, Helfrich CD, Grandes G. Applying the behavior change wheel to design de-implementation strategies to reduce low-value statin prescription in primary prevention of cardiovascular disease in primary care. Front Med (Lausanne). 2022 Oct 13;9:967887. doi: 10.3389/fmed.2022.967887. eCollection 2022.
- Derived from this study: PubMed 31969175Sanchez A, Pijoan JI, Pablo S, Mediavilla M, de Rozas RS, Lekue I, Gonzalez-Larragan S, Lantaron G, Argote J, Garcia-Alvarez A, Latorre PM, Helfrich CD, Grandes G. Addressing low-value pharmacological prescribing in primary prevention of CVD through a structured evidence-based and theory-informed process for the design and testing of de-implementation strategies: the DE-imFAR study. Implement Sci. 2020 Jan 22;15(1):8. doi: 10.1186/s13012-020-0966-3.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared that underlie results reported in the publication, after deidentification
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A non-reflective decision assistance strategy, A both reflective and non-reflective decision information strategy and A reflective decision structure strategy in people with Inappropriate Prescribing and Implementation Science, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. 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 Spain. 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?
De-implementation strategies effectiveness: incidence of the PIP of statins (time frame: from baseline to 12 months and 24 months). The study lists 2 primary outcomes in all. 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 NCT04022850, which also lists 4 linked publications.
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 11 Feb 2025.