<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254979</url>
  </required_header>
  <id_info>
    <org_study_id>PI15/00350</org_study_id>
    <nct_id>NCT03254979</nct_id>
  </id_info>
  <brief_title>Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care</brief_title>
  <acronym>PREDIAPS</acronym>
  <official_title>How to Engage Primary Health Care Providers in an Inter-professional Collaborative Modeling Process for the Optimization of Type-2 Diabetes Primary Prevention: a Randomized Hybrid Implementation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE The translation into clinical practice of Primary Care (PHC) of effective and&#xD;
      sustainable interventions to prevent of type-2 diabetes (T2D) remains an unresolved&#xD;
      challenge. Leadership, active involvement of professionals, facilitation and adaptation to&#xD;
      the local context and their determinants are known to be key components in the success of&#xD;
      implementation strategies that seek to optimize clinical practice. However, one of the areas&#xD;
      in which there is still no evidence is related to the effectiveness of different strategies&#xD;
      to engage healthcare professionals in such innovation processes. Especially in real-world&#xD;
      Primary Care clinical contexts characterized by work overload and limited time, with marked&#xD;
      differentiation of professional status, both at the level of identity and competency.&#xD;
&#xD;
      OBJECTIVES To assess the effect of PHC providers engagement procedure in the creation and&#xD;
      execution of a facilitated collaborative modelling process, in the adoption, reach,&#xD;
      implementation and effectiveness of the recommended clinical practice for the prevention of&#xD;
      type-2 Diabetes&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      Randomized cluster hybrid trial in which 9 PHC centres from Osakidetza will be allocated to&#xD;
      two different strategies to engage professionals and create an inter-professional&#xD;
      collaborative practice directed by a local leader and an external facilitator, to optimize&#xD;
      the integration of a T2D primary prevention program:&#xD;
&#xD;
        -  A strategy focused on the sequential activation: started in nursing, which finally&#xD;
           manages to involve the whole center&#xD;
&#xD;
        -  A global strategy with the participation of all professionals from the beginning&#xD;
&#xD;
      All centres and PHC professionals will receive training on current guidelines and scientific&#xD;
      evidence in primary prevention of T2D and effective interventions to promote healthy&#xD;
      lifestyles. Headed by a local leader and an external facilitator, centres will conduct a&#xD;
      collaborative structured process to model and adapt the intervention and its implementation&#xD;
      to the specific context of professionals and centres, and the determinants of T2D prevention&#xD;
      practice. One of the groups will perform this strategy globally, promoting the cooperation of&#xD;
      all health professionals from the beginning. The other will perform it sequentially, centred&#xD;
      first in nursing, who will lately seek the pragmatic cooperation of physicians and other&#xD;
      professionals.&#xD;
&#xD;
      All patients without diabetes aged ≥30 years old who attend at least once in collaborating&#xD;
      centres at high risk of developing T2DM (FINDRISC&gt; = 14 points and / or intermediate&#xD;
      hyperglycaemia) will be eligible for program inclusion. The main outcome measures focus on&#xD;
      observed changes in T2DM prevention clinical practice at centre level after 12 and 24 months,&#xD;
      as a result of the implementation of one or another engagement strategy. Secondary outcomes&#xD;
      will compare their clinical effectiveness in changing exposed eligible patients' main&#xD;
      cardio-metabolic risk factors (Weight, BMI, Cholesterol, Glucose, Triglycerides) and&#xD;
      lifestyles behaviours (physical activity and diet) after 12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The implementation strategy to facilitate the adoption of the recommended clinical intervention in primary prevention of T2DM will be common to both comparison groups. In order to differentiate and isolate the effect of the procedure of creation of the Multi-professional Community of Practice, the centers have been randomly assigned to two comparison groups: 5 centers assigned to the sequential procedure and the other 4 centers to the group procedure.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Since the new program is an optimization of the type-2 diabetes prevention services already offered in Osakidetza, it is expected that the participating patients will be blind to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation of the recommended clinical intervention by health care porfessionals</measure>
    <time_frame>12 months</time_frame>
    <description>The proportion of non-diabetic patients at high risk of developing DM2 exposed to the recommended intervention actions : assessing habits, personalized advice, prescription of lifestyle change plans and follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lifestyle change at patient level</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of exposed patients who change their habits (physical activity and diet) and lose 5% of their body weight</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">432</enrollment>
  <condition>Interprofessional Relations</condition>
  <condition>Primary Health Care/Organization &amp; Administration</condition>
  <condition>Diabetes Mellitus, Type 2/Prevention &amp; Control</condition>
  <condition>Primary Prevention/Methods</condition>
  <condition>Risk Reduction Behavior</condition>
  <condition>Randomized Controlled Trial</condition>
  <condition>Life Style</condition>
  <arm_group>
    <arm_group_label>Sequential engagement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a sequential engagement of professional categories, initiated in nursing, which finally involves the whole professional groups of the center (eg. physicians, etc), will be followed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Global engagement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a global strategy of engagement with the participation of all professionals from the beginning, will be followed</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy lifestyle prescription</intervention_name>
    <description>3 actions for the prevention of DM2 in the clinical setting are recommended:&#xD;
A screening strategy for people with impaired glucose regulation or high risk of developing DM2, with the following recommendations: screening for DM2 within the strategy of opportunistic screening for CV risk factors in population ≥45 years Or ≥30 years in the presence of a previous risk factor (eg, hypertension); Screening for DM2 based on the presence of a BMI ≥25 in the population aged 40-70 years; Or, risk screening for DM2-FINDRISC in a population of 45-70 years.&#xD;
With those identified at high risk, perform a structured program of intensive intervention focused on the prescription of personalized plans on lifestyle modification (low calorie and low fat diet, and at least 150 minutes of physical exercise per week).&#xD;
A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits.</description>
    <arm_group_label>Global engagement</arm_group_label>
    <arm_group_label>Sequential engagement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients without diabetes aged ≥30 years old who attend at least once in&#xD;
             collaborating centres at high risk of developing T2DM (Body Mass Index &gt;=25 or&#xD;
             intermediate hyperglycaemia) will be eligible for program inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Primary Care Research Unit of Bizkaia, OSAKIDETZA</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Alvaro Sanchez Perez</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254979
org study id: PI15/00350
nct id: NCT03254979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
RATIONALE The translation into clinical practice of Primary Care (PHC) of effective and
      sustainable interventions to prevent of type-2 diabetes (T2D) remains an unresolved
      challenge. Leadership, active involvement of professionals, facilitation and adaptation to
      the local context and their determinants are known to be key components in the success of
      implementation strategies that seek to optimize clinical practice. However, one of the areas
      in which there is still no evidence is related to the effectiveness of different strategies
      to engage healthcare professionals in such innovation processes. Especially in real-world
      Primary Care clinical contexts characterized by work overload and limited time, with marked
      differentiation of professional status, both at the level of identity and competency.

      OBJECTIVES To assess the effect of PHC providers engagement procedure in the creation and
      execution of a facilitated collaborative modelling process, in the adoption, reach,
      implementation and effectiveness of the recommended clinical practice for the prevention of
      type-2 Diabetes

      METHODOLOGY

      Randomized cluster hybrid trial in which 9 PHC centres from Osakidetza will be allocated to
      two different strategies to engage professionals and create an inter-professional
      collaborative practice directed by a local leader and an external facilitator, to optimize
      the integration of a T2D primary prevention program:

        -  A strategy focused on the sequential activation: started in nursing, which finally
           manages to involve the whole center

        -  A global strategy with the participation of all professionals from the beginning

      All centres and PHC professionals will receive training on current guidelines and scientific
      evidence in primary prevention of T2D and effective interventions to promote healthy
      lifestyles. Headed by a local leader and an external facilitator, centres will conduct a
      collaborative structured process to model and adapt the intervention and its implementation
      to the specific context of professionals and centres, and the determinants of T2D prevention
      practice. One of the groups will perform this strategy globally, promoting the cooperation of
      all health professionals from the beginning. The other will perform it sequentially, centred
      first in nursing, who will lately seek the pragmatic cooperation of physicians and other
      professionals.

      All patients without diabetes aged ≥30 years old who attend at least once in collaborating
      centres at high risk of developing T2DM (FINDRISC> = 14 points and / or intermediate
      hyperglycaemia) will be eligible for program inclusion. The main outcome measures focus on
      observed changes in T2DM prevention clinical practice at centre level after 12 and 24 months,
      as a result of the implementation of one or another engagement strategy. Secondary outcomes
      will compare their clinical effectiveness in changing exposed eligible patients' main
      cardio-metabolic risk factors (Weight, BMI, Cholesterol, Glucose, Triglycerides) and
      lifestyles behaviours (physical activity and diet) after 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The implementation strategy to facilitate the adoption of the recommended clinical intervention in primary prevention of T2DM will be common to both comparison groups. In order to differentiate and isolate the effect of the procedure of creation of the Multi-professional Community of Practice, the centers have been randomly assigned to two comparison groups: 5 centers assigned to the sequential procedure and the other 4 centers to the group procedure.
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
masking description: Since the new program is an optimization of the type-2 diabetes prevention services already offered in Osakidetza, it is expected that the participating patients will be blind to group allocation.
measure: Implementation of the recommended clinical intervention by health care porfessionals
time frame: 12 months
description: The proportion of non-diabetic patients at high risk of developing DM2 exposed to the recommended intervention actions : assessing habits, personalized advice, prescription of lifestyle change plans and follow-up
measure: Lifestyle change at patient level
time frame: 12 months
description: Proportion of exposed patients who change their habits (physical activity and diet) and lose 5% of their body weight
arm group label: Sequential engagement
arm group type: Experimental
description: Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a sequential engagement of professional categories, initiated in nursing, which finally involves the whole professional groups of the center (eg. physicians, etc), will be followed
arm group label: Global engagement
arm group type: Active Comparator
description: Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a global strategy of engagement with the participation of all professionals from the beginning, will be followed
intervention type: Behavioral
intervention name: Healthy lifestyle prescription
description: 3 actions for the prevention of DM2 in the clinical setting are recommended:
A screening strategy for people with impaired glucose regulation or high risk of developing DM2, with the following recommendations: screening for DM2 within the strategy of opportunistic screening for CV risk factors in population ≥45 years Or ≥30 years in the presence of a previous risk factor (eg, hypertension); Screening for DM2 based on the presence of a BMI ≥25 in the population aged 40-70 years; Or, risk screening for DM2-FINDRISC in a population of 45-70 years.
With those identified at high risk, perform a structured program of intensive intervention focused on the prescription of personalized plans on lifestyle modification (low calorie and low fat diet, and at least 150 minutes of physical exercise per week).
A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits.
arm group label: Global engagement
arm group label: Sequential engagement
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Alvaro Sanchez Perez
investigator title: PhD
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No