Interprofessional RelationsPREDIAPSNCT03254979
Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care
A study testing Healthy lifestyle prescription in people with Interprofessional Relations and Primary Health Care/Organization & Administration, run by Basque Health Service at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Interprofessional Relations, Primary Health Care/Organization & Administration, Diabetes Mellitus, Type 2/Prevention & Control
- What is being tested?
- Healthy lifestyle prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2017to 30 Dec 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients without diabetes aged ≥30 years old who attend at least once in collaborating centres at high risk of developing T2DM (Body Mass Index >=25 or intermediate hyperglycaemia) will be eligible for program inclusion.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
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.
- Conditions
- Interprofessional Relations, Primary Health Care/Organization & Administration, Diabetes Mellitus, Type 2/Prevention & Control, Primary Prevention/Methods, Risk Reduction Behavior, Randomized Controlled Trial
- Being tested
- Healthy lifestyle prescription
- Medical subject headings
- Diabetes Mellitus, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle prescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequential engagement | Experimental | 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 Receives: Behavioral: Healthy lifestyle prescription |
| Global engagement | Active comparator | 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 Receives: Behavioral: Healthy lifestyle prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of the recommended clinical intervention by health care porfessionals
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
Measured: 12 months
Secondary outcomes (1)
Lifestyle change at patient level
Proportion of exposed patients who change their habits (physical activity and diet) and lose 5% of their body weight
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 posted21 Aug 2017
- Study start15 Mar 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interprofessional RelationsStudies 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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alvaro Sanchez Perez, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254979
- Sponsor's protocol ID
- PI15/00350
- Acronym
- PREDIAPS
- Status last verified
- Jul 2020
- First submitted
- 16 Aug 2017
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez A, Pablo S, Garcia-Alvarez A, Dominguez S, Grandes G; PREDIAPS Group. Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy-the PVS-PREDIAPS strategy-to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial. Implement Sci. 2021 May 27;16(1):58. doi: 10.1186/s13012-021-01127-x.
PubMed 34044869Sanchez A, Rogers HL, Pablo S, Garcia E, Rodriguez I, Flores MA, Galarza O, Gaztanaga AB, Martinez PA, Alberdi E, Resines E, Llarena AI, Grandes G; PREDIAPS Group. Fidelity evaluation of the compared procedures for conducting the PVS-PREDIAPS implementation strategy to optimize diabetes prevention in primary care. BMC Fam Pract. 2021 Feb 11;22(1):34. doi: 10.1186/s12875-021-01378-z.
PubMed 33573600Sanchez A, Grandes G, Pablo S, Espinosa M, Torres A, Garcia-Alvarez A; PREDIAPS Group. Engaging primary care professionals in collaborative processes for optimising type 2 diabetes prevention practice: the PREDIAPS cluster randomised type II hybrid implementation trial. Implement Sci. 2018 Jul 11;13(1):94. doi: 10.1186/s13012-018-0783-0.
PubMed 29996928
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03254979
- Acronym / sponsor ID
- PREDIAPS / PI15/00350
- Conditions
- Interprofessional Relations, Primary Health Care/Organization & Administration, Diabetes Mellitus, Type 2/Prevention & Control, Primary Prevention/Methods, Risk Reduction Behavior, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Aug 2017 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequential engagement | Experimental | Behavioral: Healthy lifestyle prescriptionInter-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 |
| Global engagement | Active comparator | Behavioral: Healthy lifestyle prescriptionInter-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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients without diabetes aged ≥30 years old who attend at least once in collaborating centres at high risk of developing T2DM (Body Mass Index >=25 or intermediate hyperglycaemia) will be eligible for program inclusion.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Healthy lifestyle prescription3 actions for the prevention of DM2 in the clinical setting are recommended: 1. 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. 2. 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). 3. A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits. | Behavioural | Global engagement, Sequential engagement |
Primary outcome
Implementation of the recommended clinical intervention by health care porfessionals
Time frame: 12 months
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
1 secondary outcome
Lifestyle change at patient level
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 9 Jul 2020.
- Derived from this study: PubMed 34044869Sanchez A, Pablo S, Garcia-Alvarez A, Dominguez S, Grandes G; PREDIAPS Group. Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy-the PVS-PREDIAPS strategy-to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial. Implement Sci. 2021 May 27;16(1):58. doi: 10.1186/s13012-021-01127-x.
- Derived from this study: PubMed 33573600Sanchez A, Rogers HL, Pablo S, Garcia E, Rodriguez I, Flores MA, Galarza O, Gaztanaga AB, Martinez PA, Alberdi E, Resines E, Llarena AI, Grandes G; PREDIAPS Group. Fidelity evaluation of the compared procedures for conducting the PVS-PREDIAPS implementation strategy to optimize diabetes prevention in primary care. BMC Fam Pract. 2021 Feb 11;22(1):34. doi: 10.1186/s12875-021-01378-z.
- Derived from this study: PubMed 29996928Sanchez A, Grandes G, Pablo S, Espinosa M, Torres A, Garcia-Alvarez A; PREDIAPS Group. Engaging primary care professionals in collaborative processes for optimising type 2 diabetes prevention practice: the PREDIAPS cluster randomised type II hybrid implementation trial. Implement Sci. 2018 Jul 11;13(1):94. doi: 10.1186/s13012-018-0783-0.
- Individual participant dataSharing planned: No
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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 Healthy lifestyle prescription in people with Interprofessional Relations and Primary Health Care/Organization & Administration, 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.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. 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?
Implementation of the recommended clinical intervention by health care porfessionals (time frame: 12 months). 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 NCT03254979, which also lists 3 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 9 Jul 2020.