Background
Methods
Design
Participants
Primary care centres
Users of primary care services
Recommended clinical intervention based on evidence and clinical practice guidelines
Random allocation
Implementation strategy
Implementation actions: goals and concrete strategies
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Comparison Groups (Target agents)
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Facilitated community of practice
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Goals
: to facilitate a collaborative learning environment to improve the implementation of clinical innovation.
Concrete implementation strategies:
Create a learning collaborative, Facilitation in the form of outreach visits
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Global
Intergroup partnership and Relationship building |
Sequential
Pragmatic cooperation
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Strengthening of Local Leadership
Goals
:
to provide the local coordinator with skills in primary prevention of T2D and interpersonal and organisational strategies to support the implementation.
Concrete implementation strategies
: Recruit, designate and train for leadership; Educational meetings.
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3 training sessions (5 hours/session) | Local leaders for global strategy | Local leaders for sequential strategy |
Training in clinical intervention
Goals
: to provide initial training in recommended effective clinical intervention for the prevention of T2D and in how to use the information technology support tool in the electronic health record.
Concrete implementation strategies
: Educational and capacitation meetings; Changes in record systems
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Session 1: Primary prevention of T2D in PHC: evidence and recommended practice (90 min) Session 2: Computer application for the promotion of healthy habits in the Electronic Health Record (6 hours) | Doctors and Nurses | Nurses |
Collaborative structuring of the programme
Goals: to plan the local programme based on shared decision-making concerning: objectives, actions, agents, work flow, organisation and sharing out of tasks. Concrete implementation strategies: Local needs assessment; Educational and outreach meetings eliciting local consensus discussion; Ongoing training; Cyclical small tests of change; Develop a formal implementation blueprint | ||
Session 3 – Needs assessment and prioritisation of areas for improvement in T2D prevention (90 min) | ||
Session 4/5 – Planning T2D prevention programme (180 min) Session 6: Plan-Do-Study-Act cycle 1 (90 min) | Nurses (Prescription→Screening) | |
Session 7: Plan-Do-Study-Act cycle 2 (90 min) | Doctors and Nurses (Screening→Prescription) | |
Session 8: Refresher training (180 min) | Doctors and Nurses (from the 2nd pilot*) | |
Session 9: Plan-Do-Study-Act cycle 3 (90 min) | ||
Session 10: Final standardisation of the local T2D prevention programme (90 min) | ||
Ongoing sustainability
Goals
: to continually support and assess innovation being put into practice.
Concrete implementation strategies
: Develop quality monitoring systems; Audit and provide Feedback; Ongoing training
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Regular audits and ongoing facilitation: 6 follow-up sessions over the course of 12 months (90 min X 6 sessions) Continuing education in clinical intervention and information technology tools | All participating professionals |
Assessment of results
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The proportion of professionals who actively adopt the intervention programme, out of the total in each centre (adoption)
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The proportion of individuals in whom clinical practice recommendations on the screening for T2D risk are met out of the total number of potentially eligible individuals seeking medical care (reach and coverage)
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The proportion of non-diabetic patients at high risk of developing T2D exposed to interventions related to lifestyle habits 12 months after the introduction of the intervention programmes: assessment of lifestyle habits, provision of personalised advice, prescription of lifestyle changes and follow-up (execution of the recommended clinical intervention).
Effectiveness in the optimisation of clinical practice for the primary prevention of T2D (experimental comparison)
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Measures
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Timing and Source
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Coverage: Screening indicators (depending on the screening strategy selected by the centre) | |
Case 1
: T2D screening as part of opportunistic screening for cardiovascular risk in individuals aged ≥45 years or ≥30 years with at least one known risk factor:
• % of non-diabetic patients aged ≥30 years with a cardiovascular risk factor (e.g., hypertension or BMI ≥30 kg/m2 or hyperglycaemia) attending to family doctor office in whom clinical practice guidelines are followed in terms of T2D screening using fasting glucose levels in the previous year; • % of non-diabetic patients aged ≥45 years with no cardiovascular risk factor attending to family doctor office in whom clinical practice guidelines are followed in terms of T2D screening using fasting glucose levels in the previous 4 years. | |
Case 2
: T2D screening based on a BMI≥25 kg/m2 in individuals aged 40 to 70 years:
• % of non-diabetic patients aged between 40 and 70 years attending to family doctor’s office whose BMI has been measured in the previous year, 12 months after the introduction of the T2D prevention programme in the centres; | Baseline and 12 months after the setting up of the programme |
• % of non-diabetic patients aged between 40 and 70 years attending to family doctor’s office with a BMI≥25 kg/m2 who have been screened for T2D using fasting glucose in the previous year, 12 months after the introduction of the T2D prevention programme in the centres. | Electronical Health Record |
Implementation: Execution of the elements of the intervention programme in high risk patients defined by the presence of prediabetes (fasting glucose 110-125 mg/dl) | |
•% of patients whose physical activity levels and diet have been assessed, after the identification of T2D risk; •% of patients who have been given preventative advice concerning the need to increase physical activity and eat a healthy diet, after the identification of T2D risk; | |
•% of patients who have been prescribed a plan for increasing physical activity and eating a healthy diet, after the identification of T2D risk; | Baseline and 12 months after the setting up of the programme |
•% of high risk patients (fasting glucose 110-125 mg/dl) who have undergone annual testing of fasting glucose and HbA1c. | Electronical Health Record |
Maintenance: Long-term execution of the healthy lifestyles promotion programme in T2D high risk patients | |
•Level of screening coverage among candidate patients (e.g., % of patients with screening for T2D) •Level of execution of the clinical intervention elements (e.g., % of pre-diabetic patients who have received a prescription for lifestyle change) 24 months the introduction of the programme | 0 to 24 months after the setting up of the programme (monthly rate) |
•Monthly rate of the change in the coverage and execution of intervention elements for the promotion of healthy lifestyles over a 24-month period. | Electronical Health Record |
Spreading: healthy lifestyles promotion actions in attending patients who do not meet the criteria of high risk of T2D (e.g., overweight or obese patients with normal glucose levels). | |
•% of patients whose physical activity levels and diet have been assessed, from those attending aged 10 to 80 years; | |
•% of patients who have been given preventative advice concerning the need to increase physical activity and eat a healthy diet, from those attending aged 10 to 80 years; | Baseline, 12 and 24 months after the setting up of the programme |
•% of patients who have been prescribed a plan for increasing physical activity and eating a healthy diet, from those attending aged 10 to 80 years; | Electronical Health Record |
Secondary outcome measures: clinical effectiveness of the intervention (observational comparison)
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Change in healthy lifestyles and cardiovascular risk factors of high risk patients exposed to the intervention programme 12 months after exposure | |
• Adherence to recommendations on physical activity and healthy diet: | |
i) % who meet the recommended level of physical activity (150 min/week of moderate physical activity or 75 min/week of intense physical activity) , among those who did not meet it at recruitment; | Baseline and 12 months after programme exposure |
ii) % who meet the recommended level of fruit and vegetable intake (5 portions/day), among those who did not meet it at recruitment. •Changes in physical activity (minutes of moderate to vigorous physical activity) or in fruit and vegetable intake | |
• % whose BMI decreases by 5% by 12 months after the intervention • potential effects of the preventative intervention on other cardiovascular factors including cholesterol and triglyceride levels, as well as BMI and blood glucose (data derived from the annual clinical follow-up) | Electronical Health Record |
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Health centre-based factors: Organisational willingness to change measured with the Organizational Readiness for Knowledge Translation (OR4KT) questionnaire [44], the Spanish version of the OR4KT instrument comprising 59 items assessing 6 dimensions and 23 sub-dimensions related to organisational predisposition to knowledge translation: organisational climate, organisational support, contextual factors, change content, leadership, and motivation; leadership assessed with the Implementation Leadership Scale (ILS) questionnaire [45]; and various characteristics of the primary care centres, namely, number of registered patients, number of healthcare professionals, mean number of registered patients per family doctor, and a socioeconomic deprivation index for the catchment area that combines variables related to employment (unemployment rate, manual and short-term employment) and education (educational attainment rate among young people and overall).
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Healthcare professional-related factors: sociodemographic variables (age, sex, professional group, etc.); and professionals’ healthy lifestyle behaviours; and Attitudes, knowledge and skills in the promotion of healthy habits in the clinical context, measured through the Preventative Activity Questionnaire [46].
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Patient-level factors: sociodemographic variables (age, sex, socioeconomic level- deprivation index, etc.); active health problems-morbidity (Adjusted Clinical Groups-ACG, etc.); and frequency of attendance.
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Number of centres included out of all those approached
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Percentage of health professionals who collaborate across all the centres
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Number of actions carried out (training, work sessions, etc.), and final duration compared to that originally anticipated (exposition to the implementation strategy)
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Participation of collaborating health professionals in each action
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Assessment of the content and usefulness of the actions by health professionals
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Resources allocated to the execution of the strategy in the health centres: actions and resources for the planning, organisation and execution of sessions; support materials, dedication of external facilitator, organisational support resources (freeing up of leader’s time, coverage of services, etc.)