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De-implementation of Low-value Pharmacological Prescriptions (De-imFAR)

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ClinicalTrials.gov Identifier: NCT04022850
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Health Department of the Basque Government
Information provided by (Responsible Party):
Alvaro Sanchez Perez, Basque Health Service

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

  1. To design and model in a collegiate way among the agents involved (professionals, patients, managers and researchers) a 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 a 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
  2. To evaluate the feasibility and potential effectiveness of the de-implementation strategy to reduce the low-value prescription of lipid-lowering drugs in primary prevention of cardiovascular disease, in accordance with the recommended clinical practice, as compared to the usual procedures of dissemination of clinical practice guidelines, focused in the distribution of materials, support tools and training in the reference group.

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

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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, 2020
Estimated Primary Completion Date : December 31, 2021
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%)




Primary Outcome Measures :
  1. low-value pharmacological prescription rate in CVD primary prevention [ Time Frame: 12 months ]
    Proportion (%) of attending patients, aged between 40 and 74 years in men and between 45 and 74 years in women, with hypercholesterolemia but without ischemic heart disease / CVD , and with low CVD Risk (<5%), with a prescription of statins 12 months after exposure of physicians to the compared implementation strategies

  2. Healthy lifestyles intervention rate in CVD primary prevention [ Time Frame: 12 months ]
    Proportion (%) of attending patients, aged between 40 and 74 years in men and between 45 and 74 years in women, with hypercholesterolemia but without ischemic heart disease / CVD , and with low CVD Risk (<5%), receiving advice regarding healthy lifestyles 12 months after exposure of physicians to the compared implementation strategies



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged between 40 and 74 years
  • Hypercholesterolemic patients (Ldl-cholesterol between 70 and 190 md/dl
  • Low estimated CVD Risk (<5%)

Exclusion Criteria:

  • Diagnosis of ischemic heart disease or cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022850


Contacts
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Contact: Alvaro Sanchez, PhD (+34) 946006673 alvaro.sanchezperez@osakidetza.eus

Locations
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Spain
Primary Care Research Unit of Bizkaia Not yet recruiting
Bilbao, Bizkaia, Spain, 48014
Contact: Alvaro Sanchez, PhD    (+34) 946006673    alvaro.sanchezperez@osakidetza.eus   
Sponsors and Collaborators
Basque Health Service
Health Department of the Basque Government

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Responsible Party: Alvaro Sanchez Perez, Research Technician, Basque Health Service
ClinicalTrials.gov Identifier: NCT04022850     History of Changes
Other Study ID Numbers: 2018111085
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No