Health BehaviorEIRANCT03136211
Complex Multiple Risk Behavior Intervention in People Between 45 to 75 Years (EIRA Study)
A study testing EIRA intervention in people with Health Behavior and Health Promotion, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
This study examines the effectiveness and the costs of a complex multiple risk behavior intervention to promote healthy behaviors in people aged between 45 and 75 years attended in Primary Health Care services. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Promotion, Primary Health Care
- What is being tested?
- EIRA intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,062 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2017to 31 Dec 2018
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who carry out 2 or more of the following unhealthy behaviors: tobacco consumption, low adherence to the Mediterranean dietary pattern or insufficient physical activity. In addition, they must have a professional provider of the health center assigned and voluntarily agree to participate.
Who cannot join
- Advanced serious illnesses
- Cognitive impairment
- Dependence in basic everyday activities
- Severe mental illness
- People included in a long term home health care program
- People in treatment for cancer
- People in end-of-life care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care
This study examines the effectiveness and the costs of a complex multiple risk behavior intervention to promote healthy behaviors in people aged between 45 and 75 years attended in Primary Health Care services. This intervention aims to reduce tobacco use, to enhance adherence to the Mediterranean dietary pattern and to increase physical activity. The study also seeks to provide evidence on the strategies to integrate health promotion into the usual clinical practice of primary care providers.
Read the detailed description
Health promotion interventions are complex and need in-depth understanding of the context which is part of its effect. In this respect, the methodology proposed by the Medical Research Council offers a unique opportunity. This methodology proposes a development in five sequential phases in which both quantitative and qualitative methods are used, which include: a) definition of the theoretical basis (preclinical phase), b) modeling (phase I), c) exploratory trial (phase II), d) definitive randomized controlled trial (phase III) and e) long-term implementation (phase IV). This methodology promotes the participation of citizens and professionals in research and increases the acceptability and the feasibility of intervention. It is also an ideal tool to achieve the sustainability of interventions and the transfer of research to practice. Research on complex interventions marks a turning point in the conventional way of conducting experimental studies in which the most important thing is finding value and understanding the context of practice rather than trying to control its influence. Hybrid trials represent the ideal design because they allow a joint assessment of clinical effectiveness and implementation, thanks to their dual approach.
In this connection, the researchers started in 2012 the EIRA study and carried out the first three phases (preclinical phase, phase I and phase II). Currently, researchers are pursuing the phase III whose purpose is to assess the cost-effectiveness and the implementation of a health promotion intervention through a hybrid design.
This cluster randomized controlled trial aims to assess the effectiveness and the implementation of a complex multiple risk behavior intervention with two parallel groups (intervention and usual care). It is based on:
- The "Consolidated Framework for Implementation Research" (CFIR) which identifies five constructs: 1) intervention characteristics (intervention source, evidence strength and quality, relative advantage, adaptability, trialability, complexity, design quality and packaging; and cost); 2) outer setting (patient needs and resources, cosmopolitanism, peer pressure, and external policy and incentives); 3) inner setting (structural characteristics, networks and communications, culture, implementation climate and readiness for implementation); 4) characteristics of individuals (knowledge and beliefs about the intervention, self-efficacy, individual state of change, individual identification with the organization, and other personal attributes); and 5) the implementation process itself.
- A set of discrete implementation strategies which includes: plan strategies (gather information, adapt and pilot material and processes, build buy-in, initiate leadership and develop relationships); educate strategies (develop materials, educate, educate through peers, inform and influence stakeholders); finance strategies (modify incentives and facilitate financial support); restructure strategies (revise professional roles and create community and group interventions committees) and quality management strategies (develop and organize implementation monitoring systems, conduct continuous assessment and feedback, establish a system of reminders, obtain and use patient opinion, centralize technical assistance focused on implementation issues).
- An evaluation framework to determine the success of implementation.
The study will be carried out in three stages:
STAGE 1: PRE-IMPLEMENTATION. During this stage, the researchers will assess local needs and resources to develop specific implementation strategies. Likewise, the scientific literature will be reviewed and the perspectives of clinicians on the internal resources will be measured by the "Survey of Organizational Attributes for Primary Care". All the support material for the intervention will be drawn up, besides the facilitator (member of the research team) and the leader (member of the primary care team) of the implementation will be designated. Mechanisms for the effective communication and the case report form (CRF) will be defined and piloted. Formal compromises will be made with the managers (at the macro, meso and micro levels) and with the professionals involved. Training activities will be carried out in which training in motivational interview will have a central role. In addition, a checklist (on-line database) will be developed and piloted to monitor the progress of implementation in each primary care center.
STAGE 2: IMPLEMENTATION. In this stage the implementation plan will be carried out. The facilitator and the leader of implementation will monitor the implementation processes, identify opportunities for improvement and optimize implementation. Likewise, positive feedback techniques will be used towards the main stakeholders in order to keep the agreed compromise and the motivation. Besides, health professionals will receive continuous training in motivational interview.
STAGE 3: POST-IMPLEMENTATION.
The evaluation of the implementation will be carried out through qualitative and quantitative research. It will be evaluated in terms of:
- OUTCOMES (see section "Outcome Measures"). B) DETERMINANTS. Three focus groups (one of health professionals and two of participants) will be conducted in each health center. Sampling will be theoretical (discursive plurality). Sessions will be transcribed in an anonymous fashion. A thematic content analysis will be done. The CFIR constructs will be scored following standard criteria that they will reflect the influence of the construct on the implementation (positive or negative) and its magnitude (between 1 and 2).
- LEVEL OF DEVELOPMENT. The level of development of each of the implementation strategies will be determined from the online database. Updating of this database will be carried out by the facilitator of implementation. Likewise, logistic regression models will be developed in which the dependent variable will be the effectiveness of the intervention, considered as a positive change in any of the three behaviors studied. In one of the models the independent variables will be the quantitative measures of the results of the implementation and in the other, the degree of implementation of the different strategies. The purpose of these analyzes is to model the relationship between the implementation variables and those of effectiveness. On the other hand, the influence and the magnitude of the determinants of the implementation and the results will be established through multivariate models.
SAMPLE SIZE It will be necessary to study a minimum of 3640 people (1820 for each of the two groups). This sample size will allow to detect an increase of 8% in the proportion of people who show a positive change in one or more of the three behaviors in the intervention group over control group. The proportion of losses during follow-up estimated was of 30%. The sample size was decided taking into account the effect of design (intraclass correlation coefficient of 0.01).The power was 80% and alpha risk 5%.
- Conditions
- Health Behavior, Health Promotion, Primary Health Care, Implementation Research, Smoking Cessation, Mediterranean Diet
- Being tested
- EIRA intervention
- Medical subject headings
- Health Behavior, Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIRA interventionBehavioural
Individual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages.
| Study group | Role | What they receive |
|---|---|---|
| EIRA intervention | Experimental | EIRA intervention It is based on the Transtheoretical Model (TTM) and States of Change and it is made by physicians and nurses in routine care of primary care practices according to the conceptual framework of the "5A": Ask, Advise, Assess, Assist, and Arrange. It consists of a first visit of screening ("Ask"). Subsequently, the professional develops a personalized plan that is negotiated with the participant ("Advise" and "Assess"). This plan is reviewed during successive visits and positive changes are reinforced and new objectives are negotiated ("Assist" and "Arrange"). The motivational interview is the essential tool of the intervention. The intervention is carried out to different levels: individual, group and community. Receives: Behavioral: EIRA intervention |
| Usual care | No intervention | Health providers of this group integrate in their practice the recommendations of the Program of Preventive Activities and Health Promotion (PAPPS)". These guidelines are based on systematic screening and brief advice for the prevention of cardiovascular and mental diseases and cancer as well as vaccine recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Positive change in baseline eating behavior
Adherence to the Mediterranean dietary pattern in low adherence people. For the evaluation, the 14-item Questionnaire of Mediterranean diet adherence (PREDIMED study) will be used.
Measured: at the study entry and at 12 months
Effectiveness: Positive change in baseline physical activity behavior
Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.
Measured: at the study entry and at 12 months
Effectiveness: Positive change in baseline smoking behavior
Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).
Measured: at the study entry and at 12 months
Implementation: adoption
Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.
Measured: Within 2 months prior to the start of the intervention
Implementation: early acceptability
They will be evaluated in professionals and participants by means of a survey.
Measured: Within 2 months prior to the start of the intervention
Implementation: final acceptability
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Measured: at 12 months post intervention
Implementation: early appropriateness
They will be evaluated in professionals and participants by means of a survey.
Measured: Within 2 months prior to the start of the intervention
Implementation: final appropriateness
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Measured: at 12 months post intervention
Implementation: Cost of time invested in training and organizational meetings
Cost of time invested in training and organizational meetings to carry out the intervention.
Measured: at 12 months post intervention
Implementation: feasibility
On the basis of the calculation of participation, recruitment and retention rate.
Measured: at 12 months post intervention
Implementation: fidelity of the motivational interview technique
The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".
Measured: Within 2 months prior to the start of the intervention
Implementation: fidelity of the planned intervention
The degree of compliance of the activities recorded in the case report form will be analyzed.
Measured: at 12 months post intervention
Implementation: penetration
The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.
Measured: Within six months of the end of intervention
Secondary outcomes (4)
Effectiveness: Beginning or making of a behavior change
Proportion of people who are in the stages of action, maintenance or termination according to the transtheoretical model at the entry and at the end of the study.
Measured: at the study entry and at 12 months
Effectiveness: Change from baseline on arterial stiffness at 12 months
Arterial stiffness assessed by the "Cardio-Ankle Vascular Index (CAVI)". CAVI will be measured in the routine clinical practice by the Vascular Screening System VaSera VS-1500N.
Measured: at the study entry and at 12 months.
Change from baseline on health-related quality of life
Health-related quality of life as measured by the EuroQol-5D questionnaire.
Measured: at the study entry and at 12 months.
Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity
Number in the last 12 monts of: primary-care and specialists visits, outpatient diagnostic tests, community resources used, group sessions attended and days off work per participant
Measured: at the study entry and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 3,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya, Parc Sanitari Sant Joan de Déu, Sanidad de Castilla y León, Servei de Salut de les Illes Balears, Institut Català de la Salut, Servicio Aragones De Salud, Osakidetza, Andaluz Health Service, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Servicio Gallego de Salud
- Responsible party
- Principal investigator, Bonaventura Bolíbar Ribas, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Bonaventura Bolibar-Ribas, MD MSc, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136211
- Sponsor's protocol ID
- 4R15/032
- Other IDs
- PI15/00114, SLT002/16/00112
- Acronym
- EIRA
- Status last verified
- Jul 2020
- First submitted
- 7 Apr 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morton K, Beauchamp M, Prothero A, Joyce L, Saunders L, Spencer-Bowdage S, Dancy B, Pedlar C. The effectiveness of motivational interviewing for health behaviour change in primary care settings: a systematic review. Health Psychol Rev. 2015;9(2):205-23. doi: 10.1080/17437199.2014.882006. Epub 2014 Feb 12.
PubMed 26209209Prestwich A, Webb TL, Conner M. Using theory to develop and test interventions to promote changes in health behaviour: Evidence, issues, and recommendations. Curr Opin Psychol. 2015;5:1-5.
Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral counseling to promote a healthy lifestyle in persons with cardiovascular risk factors: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 Oct 21;161(8):568-78. doi: 10.7326/M14-0130.
PubMed 25155549Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26.
PubMed 22203646Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N, Wensing M, Fiander M, Eccles MP, Godycki-Cwirko M, van Lieshout J, Jager C. Tailored interventions to address determinants of practice. Cochrane Database Syst Rev. 2015 Apr 29;2015(4):CD005470. doi: 10.1002/14651858.CD005470.pub3.
PubMed 25923419Ramos R, Baena-Diez JM, Quesada M, Solanas P, Subirana I, Sala J, Alzamora M, Fores R, Masia R, Elosua R, Grau M, Cordon F, Pera G, Rigo F, Marti R, Ponjoan A, Cerezo C, Brugada R, Marrugat J. Derivation and validation of REASON: a risk score identifying candidates to screen for peripheral arterial disease using ankle brachial index. Atherosclerosis. 2011 Feb;214(2):474-9. doi: 10.1016/j.atherosclerosis.2010.11.015. Epub 2010 Nov 19.
PubMed 21167488Rubio-Valera M, Pons-Vigues M, Martinez-Andres M, Moreno-Peral P, Berenguera A, Fernandez A. Barriers and facilitators for the implementation of primary prevention and health promotion activities in primary care: a synthesis through meta-ethnography. PLoS One. 2014 Feb 28;9(2):e89554. doi: 10.1371/journal.pone.0089554. eCollection 2014.
PubMed 24586867Zabaleta-del-Olmo E, Bolibar B, Garcia-Ortiz L, Garcia-Campayo J, Llobera J, Bellon JA, Ramos R. Building interventions in primary health care for long-term effectiveness in health promotion and disease prevention. A focus on complex and multi-risk interventions. Prev Med. 2015 Jul;76 Suppl:S1-4. doi: 10.1016/j.ypmed.2015.03.011. Epub 2015 Mar 14. No abstract available.
PubMed 25778858Fernandez A, Moreno-Peral P, Zabaleta-del-Olmo E, Bellon JA, Aranda-Regules JM, Luciano JV, Serrano-Blanco A, Rubio-Valera M. Is there a case for mental health promotion in the primary care setting? A systematic review. Prev Med. 2015 Jul;76 Suppl:S5-11. doi: 10.1016/j.ypmed.2014.11.019. Epub 2014 Dec 2.
PubMed 25475684Garcia-Campayo J, del Hoyo YL, Valero MS, Yus MC, Esteban EA, Guedea MP, Botaya RM. Primary prevention of anxiety disorders in primary care: A systematic review. Prev Med. 2015 Jul;76 Suppl:S12-5. doi: 10.1016/j.ypmed.2014.10.015. Epub 2014 Oct 16.
PubMed 25456801Gili M, Vicens C, Roca M, Andersen P, McMillan D. Interventions for preventing relapse or recurrence of depression in primary health care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S16-21. doi: 10.1016/j.ypmed.2014.07.035. Epub 2014 Sep 3.
PubMed 25192769
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of a Complex Multiple Risk Intervention to Promote Healthy Behaviors in People Between 45 to 75 Years Attended in Primary Health Care
- ClinicalTrials.gov ID
- NCT03136211
- Acronym / sponsor ID
- EIRA / 4R15/032
- Conditions
- Health Behavior, Health Promotion, Primary Health Care, Implementation Research, Smoking Cessation, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,062 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya, Parc Sanitari Sant Joan de Déu, Sanidad de Castilla y León, Servei de Salut de les Illes Balears, Institut Català de la Salut, Servicio Aragones De Salud, Osakidetza, Andaluz Health Service, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Servicio Gallego de Salud
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 May 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.
This study examines the effectiveness and the costs of a complex multiple risk behavior intervention to promote healthy behaviors in people aged between 45 and 75 years attended in Primary Health Care services. This intervention aims to reduce tobacco use, to enhance adherence to the Mediterranean dietary pattern and to increase physical activity. The study also seeks to provide evidence on the strategies to integrate health promotion into the usual clinical practice of primary care providers.
Detailed description
Health promotion interventions are complex and need in-depth understanding of the context which is part of its effect. In this respect, the methodology proposed by the Medical Research Council offers a unique opportunity. This methodology proposes a development in five sequential phases in which both quantitative and qualitative methods are used, which include: a) definition of the theoretical basis (preclinical phase), b) modeling (phase I), c) exploratory trial (phase II), d) definitive randomized controlled trial (phase III) and e) long-term implementation (phase IV). This methodology promotes the participation of citizens and professionals in research and increases the acceptability and the feasibility of intervention. It is also an ideal tool to achieve the sustainability of interventions and the transfer of research to practice. Research on complex interventions marks a turning point in the conventional way of conducting experimental studies in which the most important thing is finding value and understanding the context of practice rather than trying to control its influence. Hybrid trials represent the ideal design because they allow a joint assessment of clinical effectiveness and implementation, thanks to their dual approach.
In this connection, the researchers started in 2012 the EIRA study and carried out the first three phases (preclinical phase, phase I and phase II). Currently, researchers are pursuing the phase III whose purpose is to assess the cost-effectiveness and the implementation of a health promotion intervention through a hybrid design.
This cluster randomized controlled trial aims to assess the effectiveness and the implementation of a complex multiple risk behavior intervention with two parallel groups (intervention and usual care). It is based on:
- The "Consolidated Framework for Implementation Research" (CFIR) which identifies five constructs: 1) intervention characteristics (intervention source, evidence strength and quality, relative advantage, adaptability, trialability, complexity, design quality and packaging; and cost); 2) outer setting (patient needs and resources, cosmopolitanism, peer pressure, and external policy and incentives); 3) inner setting (structural characteristics, networks and communications, culture, implementation climate and readiness for implementation); 4) characteristics of individuals (knowledge and beliefs about the intervention, self-efficacy, individual state of change, individual identification with the organization, and other personal attributes); and 5) the implementation process itself.
- A set of discrete implementation strategies which includes: plan strategies (gather information, adapt and pilot material and processes, build buy-in, initiate leadership and develop relationships); educate strategies (develop materials, educate, educate through peers, inform and influence stakeholders); finance strategies (modify incentives and facilitate financial support); restructure strategies (revise professional roles and create community and group interventions committees) and quality management strategies (develop and organize implementation monitoring systems, conduct continuous assessment and feedback, establish a system of reminders, obtain and use patient opinion, centralize technical assistance focused on implementation issues).
- An evaluation framework to determine the success of implementation.
The study will be carried out in three stages:
STAGE 1: PRE-IMPLEMENTATION. During this stage, the researchers will assess local needs and resources to develop specific implementation strategies. Likewise, the scientific literature will be reviewed and the perspectives of clinicians on the internal resources will be measured by the "Survey of Organizational Attributes for Primary Care". All the support material for the intervention will be drawn up, besides the facilitator (member of the research team) and the leader (member of the primary care team) of the implementation will be designated. Mechanisms for the effective communication and the case report form (CRF) will be defined and piloted. Formal compromises will be made with the managers (at the macro, meso and micro levels) and with the professionals involved. Training activities will be carried out in which training in motivational interview will have a central role. In addition, a checklist (on-line database) will be developed and piloted to monitor the progress of implementation in each primary care center.
STAGE 2: IMPLEMENTATION. In this stage the implementation plan will be carried out. The facilitator and the leader of implementation will monitor the implementation processes, identify opportunities for improvement and optimize implementation. Likewise, positive feedback techniques will be used towards the main stakeholders in order to keep the agreed compromise and the motivation. Besides, health professionals will receive continuous training in motivational interview.
STAGE 3: POST-IMPLEMENTATION.
The evaluation of the implementation will be carried out through qualitative and quantitative research. It will be evaluated in terms of:
- OUTCOMES (see section "Outcome Measures"). B) DETERMINANTS. Three focus groups (one of health professionals and two of participants) will be conducted in each health center. Sampling will be theoretical (discursive plurality). Sessions will be transcribed in an anonymous fashion. A thematic content analysis will be done. The CFIR constructs will be scored following standard criteria that they will reflect the influence of the construct on the implementation (positive or negative) and its magnitude (between 1 and 2).
- LEVEL OF DEVELOPMENT. The level of development of each of the implementation strategies will be determined from the online database. Updating of this database will be carried out by the facilitator of implementation. Likewise, logistic regression models will be developed in which the dependent variable will be the effectiveness of the intervention, considered as a positive change in any of the three behaviors studied. In one of the models the independent variables will be the quantitative measures of the results of the implementation and in the other, the degree of implementation of the different strategies. The purpose of these analyzes is to model the relationship between the implementation variables and those of effectiveness. On the other hand, the influence and the magnitude of the determinants of the implementation and the results will be established through multivariate models.
SAMPLE SIZE It will be necessary to study a minimum of 3640 people (1820 for each of the two groups). This sample size will allow to detect an increase of 8% in the proportion of people who show a positive change in one or more of the three behaviors in the intervention group over control group. The proportion of losses during follow-up estimated was of 30%. The sample size was decided taking into account the effect of design (intraclass correlation coefficient of 0.01).The power was 80% and alpha risk 5%.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EIRA intervention | Experimental | Behavioral: EIRA interventionEIRA intervention It is based on the Transtheoretical Model (TTM) and States of Change and it is made by physicians and nurses in routine care of primary care practices according to the conceptual framework of the "5A": Ask, Advise, Assess, Assist, and Arrange. It consists of a first visit of screening ("Ask"). Subsequently, the professional develops a personalized plan that is negotiated with the participant ("Advise" and "Assess"). This plan is reviewed during successive visits and positive changes are reinforced and new objectives are negotiated ("Assist" and "Arrange"). The motivational interview is the essential tool of the intervention. The intervention is carried out to different levels: individual, group and community. |
| Usual care | No intervention | –Health providers of this group integrate in their practice the recommendations of the Program of Preventive Activities and Health Promotion (PAPPS)". These guidelines are based on systematic screening and brief advice for the prevention of cardiovascular and mental diseases and cancer as well as vaccine recommendations. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who carry out 2 or more of the following unhealthy behaviors: tobacco consumption, low adherence to the Mediterranean dietary pattern or insufficient physical activity. In addition, they must have a professional provider of the health center assigned and voluntarily agree to participate.
Key exclusion criteria (7 listed)
- Advanced serious illnesses
- Cognitive impairment
- Dependence in basic everyday activities
- Severe mental illness
- People included in a long term home health care program
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 |
|---|---|---|
| EIRA interventionIndividual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages. | Behavioural | EIRA intervention |
Primary outcome
Effectiveness: Positive change in baseline eating behavior
Time frame: at the study entry and at 12 months
Adherence to the Mediterranean dietary pattern in low adherence people. For the evaluation, the 14-item Questionnaire of Mediterranean diet adherence (PREDIMED study) will be used.
Effectiveness: Positive change in baseline physical activity behavior
Time frame: at the study entry and at 12 months
Sufficient physical activity in insufficiently active people. For the evaluation, the "International Physical Questionnaire (IPAQ)" will be used.
Effectiveness: Positive change in baseline smoking behavior
Time frame: at the study entry and at 12 months
Smoking cessation in smokers. For the evaluation, the interview will be used and the cooximetry (optional).
Implementation: adoption
Time frame: Within 2 months prior to the start of the intervention
Proportion of professionals who express their willingness to participate in the study between of total of potential professionals.
Implementation: early acceptability
Time frame: Within 2 months prior to the start of the intervention
They will be evaluated in professionals and participants by means of a survey.
Implementation: final acceptability
Time frame: at 12 months post intervention
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Implementation: early appropriateness
Time frame: Within 2 months prior to the start of the intervention
They will be evaluated in professionals and participants by means of a survey.
Implementation: final appropriateness
Time frame: at 12 months post intervention
They will be evaluated in professionals and participants by means of a survey. What is more, discussion groups will be held at the end of the intervention with the professionals and participants.
Implementation: Cost of time invested in training and organizational meetings
Time frame: at 12 months post intervention
Cost of time invested in training and organizational meetings to carry out the intervention.
Implementation: feasibility
Time frame: at 12 months post intervention
On the basis of the calculation of participation, recruitment and retention rate.
Implementation: fidelity of the motivational interview technique
Time frame: Within 2 months prior to the start of the intervention
The quality of the motivational interview will be evaluated through videotapes of visits to simulated patients through the "motivational interviewing assessment scale".
Implementation: fidelity of the planned intervention
Time frame: at 12 months post intervention
The degree of compliance of the activities recorded in the case report form will be analyzed.
Implementation: penetration
Time frame: Within six months of the end of intervention
The proportion of professionals who have integrated the intervention into their usual clinical practice within six months of the end of intervention.
4 secondary outcomes
Effectiveness: Beginning or making of a behavior change
Time frame: at the study entry and at 12 months
Effectiveness: Change from baseline on arterial stiffness at 12 months
Time frame: at the study entry and at 12 months.
Change from baseline on health-related quality of life
Time frame: at the study entry and at 12 months.
Change from baseline on costs of number visits, diagnostic tests, community resources used and loss of productivity
Time frame: at the study entry and at 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 7 Jul 2020.
- Background: PubMed 26209209Morton K, Beauchamp M, Prothero A, Joyce L, Saunders L, Spencer-Bowdage S, Dancy B, Pedlar C. The effectiveness of motivational interviewing for health behaviour change in primary care settings: a systematic review. Health Psychol Rev. 2015;9(2):205-23. doi: 10.1080/17437199.2014.882006. Epub 2014 Feb 12.
- BackgroundPrestwich A, Webb TL, Conner M. Using theory to develop and test interventions to promote changes in health behaviour: Evidence, issues, and recommendations. Curr Opin Psychol. 2015;5:1-5.
- Background: PubMed 25155549Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral counseling to promote a healthy lifestyle in persons with cardiovascular risk factors: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 Oct 21;161(8):568-78. doi: 10.7326/M14-0130.
- Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 22203646Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26.
- Background: PubMed 20957426Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
- Background: PubMed 25923419Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N, Wensing M, Fiander M, Eccles MP, Godycki-Cwirko M, van Lieshout J, Jager C. Tailored interventions to address determinants of practice. Cochrane Database Syst Rev. 2015 Apr 29;2015(4):CD005470. doi: 10.1002/14651858.CD005470.pub3.
- Background: PubMed 21167488Ramos R, Baena-Diez JM, Quesada M, Solanas P, Subirana I, Sala J, Alzamora M, Fores R, Masia R, Elosua R, Grau M, Cordon F, Pera G, Rigo F, Marti R, Ponjoan A, Cerezo C, Brugada R, Marrugat J. Derivation and validation of REASON: a risk score identifying candidates to screen for peripheral arterial disease using ankle brachial index. Atherosclerosis. 2011 Feb;214(2):474-9. doi: 10.1016/j.atherosclerosis.2010.11.015. Epub 2010 Nov 19.
- Results publication: PubMed 24586867Rubio-Valera M, Pons-Vigues M, Martinez-Andres M, Moreno-Peral P, Berenguera A, Fernandez A. Barriers and facilitators for the implementation of primary prevention and health promotion activities in primary care: a synthesis through meta-ethnography. PLoS One. 2014 Feb 28;9(2):e89554. doi: 10.1371/journal.pone.0089554. eCollection 2014.
- Results publication: PubMed 25778858Zabaleta-del-Olmo E, Bolibar B, Garcia-Ortiz L, Garcia-Campayo J, Llobera J, Bellon JA, Ramos R. Building interventions in primary health care for long-term effectiveness in health promotion and disease prevention. A focus on complex and multi-risk interventions. Prev Med. 2015 Jul;76 Suppl:S1-4. doi: 10.1016/j.ypmed.2015.03.011. Epub 2015 Mar 14. No abstract available.
- 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.
Bonaventura Bolibar-Ribas, MD MSc principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIRA intervention in people with Health Behavior and Health Promotion, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 7 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 7 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?
Effectiveness: Positive change in baseline eating behavior (time frame: at the study entry and at 12 months). The study lists 13 primary outcomes in all. 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 NCT03136211, which also lists 33 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 7 Jul 2020.