The De-imFAR study 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 and roll-out of de-implementation strategies for reducing low-value pharmacological prescription, against the usual system-level procedures based on the principles of linear dissemination of "Not-to-do" guidelines and recommendations. In doing so, the De-imFAR project has identified two low-value pharmacological prescriptions object of study: The prescription of statins in primary prevention of cardiovascular disease (CVD) and the prescription of Proton Pump Inhibitors (PPIs). The present study refers to the first of the two areas.
Aims
Hypothesis The implementation strategy derived from the systematic process of identification of determinants and mapping of adapted interventions with the TDF framework, will be more effective in reducing and/or abandoning the prescription of statins in primary prevention of CVD, as compared to a strategy based on the procedures for diffusion of clinical practice guidelines ("Do not" recommendations) focused on the distribution of materials, support tools and training, in the reference group. Likewise, the exposure to the de-implementation strategy will increase the knowledge, will generate a more favorable attitude towards and increase the ability to perform health promotion actions of professionals.
Design Phase I formative research to design and model de-implementation strategies and Phase II feasibility and potential effectiveness evaluation through a comparative hybrid feasibility/potential effectiveness trial. 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.
The evaluation of at least one active de-implementation strategy produced through the phase I formative evaluation with respect with the usual procedures of dissemination of clinical practice guidelines ("Not to do" guidelines, focused in the distribution of materials, support tools and training) in a reference group will be conducted. A mixed methods evaluation will be used: quantitative for the results of implementation at professional level (process indicators with respect to the adoption, reach and implementation or execution of the recommended clinical practice) and qualitative methods to determine the viability and the perceived impact of the de-implementation strategy by health professionals, and the experience of patients related to the reception of clinical care.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inappropriate Prescribing Implementation Science Behavioral Sciences | Behavioral: Intuitive de-implementation Behavioral: Reflexive de-implementation Behavioral: Passive dissemination | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6464 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Health Services Research |
Official Title: | De-implementation of Low-value Pharmacological Prescriptions |
Estimated Study Start Date : | March 15, 2021 |
Estimated Primary Completion Date : | March 15, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Passive dissemination
Passive dissemination strategies focused on the distribution of materials, support tools and training
|
Behavioral: Passive dissemination
Usual procedures of dissemination of clinical practice guidelines, focused in the distribution of materials, support tools and training in the reference group.
|
Experimental: Intuitive de-implementation
Mindless externally imposed de-implementation strategies to discourage the non-desired behavior and to encourage the preferred/desired behavior
|
Behavioral: Intuitive de-implementation
A set of de-implementation strategies targeting automatic cognition to alter the clinical decision making of physicians regarding the CVD primary prevention practice to be performed with hypercholesterolemic patients aged 40-75 years old without ischemic heart disease or diagnosed cardiovascular disease and with low CVD risk (<5%)
|
Experimental: Reflexive de-implementation
Active de-implementation strategies targeting conscious cognition processes to discourage the non-desired behavior and to encourage the preferred/desired behavior
|
Behavioral: Reflexive de-implementation
A set of de-implementation strategies targeting reflexive cognition to alter the clinical decision making of physicians regarding the CVD primary prevention practice to be performed with hypercholesterolemic patients aged 40-75 years old without ischemic heart disease or diagnosed cardiovascular disease and with low CVD risk (<5%)
|
Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alvaro Sanchez, PhD | (+34) 946006673 | alvaro.sanchezperez@osakidetza.eus |
Spain | |
Primary Care Research Unit of Bizkaia | |
Bilbao, Bizkaia, Spain, 48014 | |
Contact: Alvaro Sanchez, PhD (+34) 946006673 alvaro.sanchezperez@osakidetza.eus |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 11, 2019 | ||||
First Posted Date ICMJE | July 17, 2019 | ||||
Last Update Posted Date | January 28, 2021 | ||||
Estimated Study Start Date ICMJE | March 15, 2021 | ||||
Estimated Primary Completion Date | March 15, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | De-implementation of Low-value Pharmacological Prescriptions | ||||
Official Title ICMJE | De-implementation of Low-value Pharmacological Prescriptions | ||||
Brief Summary |
The De-imFAR study 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 and roll-out of de-implementation strategies for reducing low-value pharmacological prescription, against the usual system-level procedures based on the principles of linear dissemination of "Not-to-do" guidelines and recommendations. In doing so, the De-imFAR project has identified two low-value pharmacological prescriptions object of study: The prescription of statins in primary prevention of cardiovascular disease (CVD) and the prescription of Proton Pump Inhibitors (PPIs). The present study refers to the first of the two areas. Aims
Hypothesis The implementation strategy derived from the systematic process of identification of determinants and mapping of adapted interventions with the TDF framework, will be more effective in reducing and/or abandoning the prescription of statins in primary prevention of CVD, as compared to a strategy based on the procedures for diffusion of clinical practice guidelines ("Do not" recommendations) focused on the distribution of materials, support tools and training, in the reference group. Likewise, the exposure to the de-implementation strategy will increase the knowledge, will generate a more favorable attitude towards and increase the ability to perform health promotion actions of professionals. Design Phase I formative research to design and model de-implementation strategies and Phase II feasibility and potential effectiveness evaluation through a comparative hybrid feasibility/potential effectiveness trial. 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. The evaluation of at least one active de-implementation strategy produced through the phase I formative evaluation with respect with the usual procedures of dissemination of clinical practice guidelines ("Not to do" guidelines, focused in the distribution of materials, support tools and training) in a reference group will be conducted. A mixed methods evaluation will be used: quantitative for the results of implementation at professional level (process indicators with respect to the adoption, reach and implementation or execution of the recommended clinical practice) and qualitative methods to determine the viability and the perceived impact of the de-implementation strategy by health professionals, and the experience of patients related to the reception of clinical care. |
||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Health Services Research |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Sanchez A, Pijoan JI, Pablo S, Mediavilla M, de Rozas RS, Lekue I, Gonzalez-Larragan S, Lantaron G, Argote J, García-Álvarez 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
6464 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | March 15, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 40 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04022850 | ||||
Other Study ID Numbers ICMJE | 2018111085 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Alvaro Sanchez Perez, Basque Health Service | ||||
Study Sponsor ICMJE | Basque Health Service | ||||
Collaborators ICMJE | Health Department of the Basque Government | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Basque Health Service | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |