Healthcare staff perceptions of integrated care in a programme for complex chronic patients admitted to hospital because of heart failure (ProMIC)

Abstract

Introduction

Patients with heart failure are usually a frail population characterised by complex care needs. To ensure an integrated care approach, it is necessary to work collaboratively across organisational boundaries. The purpose of this study is to measure and understand the perception of collaboration between clinicians participating in a comprehensive care programme for patients with heart failure, known as PROMIC.

Methods

A sequential mixed-method study design was used. A sample of PROMIC clinicians completed a survey in which they evaluated 10 dimensions of collaboration in 2010 and in 2014. The perspectives of clinicians were studied more in depth in a focus group in 2012, which was analysed using content analysis.

Outcomes: Professionals’ perception of collaboration showed an improvement by 1.18 points (53%) over the period 2010–14. The comprehensive programme proved to be of major support to the professionals. Sometimes, the study participants did not feel prepared to manage cases due to the complexity of the situations with regard to patients’ care. Both, the quantitative and the qualitative methods, showed up a congruent information about the positive perception of participants of the programme itself and the collaboration.

Discussion

The complexity of care processes and the need for continuity of care mean that large-scale collaboration is necessary between care levels as well as major interdisciplinary teamwork, to achieve the best possible outcomes in terms of health. ProMIC intervention has helped to improve professionals’ perception in terms of collaboration between levels.

Keywords

Heart failure patient care management multiple chronic conditions primary health care intersectoral collaboration delivery of health care integrated

Introduction

The search for greater healthcare integration has become an explicit goal in most healthcare systems in the most advanced countries, and international agencies such as the World Health Organisation have set out recent recommendations in this regard to offer guidance to the development of integrated healthcare services that focus on the needs of individuals.¹

A wide range of initiatives exists whose aim is to ensure that healthcare becomes more integrated (or at least less fragmented) and the purpose of which is, ultimately, to improve the quality and outcomes of care. Diverse initiatives have been developed and implemented by healthcare organisations to promote integrated care, and they tend to be complex (multi-component and multi-level) and geared towards changing the behaviour and the ways in which healthcare professionals, healthcare organisations, patients and other key agents in the sector act. Many of these initiatives are structured around Comprehensive Care programmes² that seek to provide integrated care to improve the quality of life of complex chronic patients and optimise the use of resources, while their implementation entails a challenge for healthcare organisations.

Hence, taking the theoretical framework about complex interventions as a reference within the clinical context of the United Kingdom’s Medical Research Council,³ our research group embarked on a collaborative research process in 2008 together with strategic assessment of needs in order to select areas of optimisation in the care of patients admitted to hospital because of HF. To this end, we designed the ProMIC “Multidisciplinary Programme for Care of Patients admitted to Hospital with HF”.⁴ From the organisational standpoint, ProMIC is a care management programme based on the six components of the Chronic Care Model.^5,6 The clinical intervention is based on practical guidelines for HF and its comorbilities.^7–9

Between 2010 and 2012, the effectiveness of ProMIC was demonstrated via a one-year prospective quasi-experimental monitoring test compared to a habitual care control group. The programme team comprised nurses, family doctors, cardiologists, internists, social workers and pharmacists from both primary healthcare and hospitals. The outcomes were statistically significant in terms of reduction in number of re-admissions because of HF, improvement in quality of life after 6 months and the knowledge acquired for self-care after 6 and 12 months’ monitoring. No significant differences were found in the rest of the variables studied.¹⁰

The next step taken was to generalise and transfer the programme to other organisations. Given the existence of difficulties in transferring the outcomes obtained from studies,¹¹ multi-factor intervention programmes benefit from additional qualitative research in order to establish aspects of their implementation in daily practice, bearing in mind that the difficulty in setting effective strategies in motion lies in the lack of understanding of the organisational context.

For all the aforementioned reasons and with a view to improving an understanding of the dynamics of integration in the ProMIC programme, the purpose of this study was to identify the barriers and facilitating elements in its implementation, in addition to exploring participants’ perception about the context of collaboration between levels of care and about the effect of the programme on patients and caregivers beyond the variables studied in previous works within the project and to evaluate if there were any differences between study participants because of gender, level of care (primary or hospital care) and years of experience and professional group.

Methods

A mixed method approach was applied in this study.¹² Data were collected sequentially using quantitative and qualitative methods, according to the following phases:

Phase one was a baseline survey study among the project team in 2010

Phase two was a focus group study moderated by an external facilitator in 2012

Phase three was a survey study among the project team in 2014, using the same questionnaire, enabling pre-post outcomes to be shown.

The triangulation between quantitative and qualitative measurements provides the most reliable, valid and valuable information, since it includes the human experience from different points of view.

Theoretical frameworks

The theoretical framework used in the quantitative study was the “Structuration Model of Inter-professional Collaboration” developed by D’Amour et al.¹³ This model emerged from organisational theory and takes into account both a “meso-structural” level and “micro-level” of collaboration. Both levels (structural – interpersonal) are captured in four dimensions. The framework is proven to be useful in earlier research^14,15 for analysing collaboration in a comprehensive way and to identify any shortfalls and areas where collaboration may be optimised.

The theoretical framework used in the qualitative study is the Consolidated Framework for Implementation Research (CFIR).¹⁶ The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation.

Data collection

Phase 1: Baseline survey research

We used a validated questionnaire, which is the operationalisation of the D’Amour model.¹⁷ This survey assesses the degree of collaboration between professionals from different care levels participating in ProMIC. Participants were asked to evaluate 10 aspects of collaboration on a 5-point Likert scale. On this scale, 1 corresponds to the lowest degree of collaboration and 5 to the highest. The aspects of collaboration were presented and explained throughout the questionnaire. The D’Amour questionnaire comprises 10 items (see Table 1).

Table 1.

Questionnaire to assess professional collaboration between two different care levels.

SHARED GOALS. The existence of explicit shared goals facilitates collaboration and coordination between primary and specialist care.

PATIENT-CENTRED APPROACH. Explicitly giving priority to the interests and preferences of patients in the interaction between levels of care favours collaboration and coordination between professionals working at the different levels.

MUTUAL KNOWLEDGE. Knowledge among professionals of each other’s values, specific competences and focus with respect to care, as well as of the environment in which they each work, has an impact on the development of team spirit and collaborative work. Knowing colleagues personally is also helpful.

TRUST. Mutual trust makes inter-professional collaboration possible, reduces uncertainty and contributes to the formation of networks of multidisciplinary professionals that focuses on the needs of patients.

STRATEGIC GUIDELINES. The existence of guidelines, issued by the corresponding Health Authority, which promote collaborative work between professionals from different levels of care, influences coordination and collaboration between professionals of both care levels.

SHARED LEADERSHIP. Shared leadership between managers and clinicians at a local level allows for the development of collaboration between professionals and organisations.

SUPPORT FOR INNOVATION. Collaboration requires changes in clinical practice and in the distribution of responsibilities for both primary and specialist care professionals. Such changes require innovation that may or may not be supported by your organisation.

FORUMS FOR MEETING. For professionals of primary and specialist care to collaborate, they need forums, communication channels and activities that enable them to come into contact with one another, discuss shared issues and establish links and agreements.

PROTOCOLISATION. The preparation and establishment of protocols clarifies and makes it possible to negotiate how to share the responsibilities of each professional. Indeed, there are many mechanisms for formalising agreements and understanding among professionals at the two levels: care pathways, information systems, agreements between organisations or units, etc., as well as protocols.

INFORMATION SYSTEMS. The effective exchange of high-quality information among professionals is an element that facilitates collaboration and makes it possible to provide better care to patients.

Source: Nuño et al., 2013¹⁷.

The questionnaires were distributed to the project team, first in 2010, in order to obtain baseline data.

Phase 2: Focus group interview

A focus group was formed in order to gather the perception of professionals participating in ProMIC about facilitating elements and barriers to the programme, as a source of information for its implementation. This was undertaken via the paradigm of constructivism¹⁸ with participants from different professional profiles, after completing the test and prior to disseminating the outcomes. A sociologist (I.R.), an expert in social research techniques and who did not form part of the programme, moderated the debate. Facilitating factors or barriers to implementation of the intervention were grouped together according to the dimensions of the CFIR framework, i.e.: the features of the intervention, the external context, the internal context, professionals’ characteristics and the implementation process itself.

To put together the focus group, professionals were invited from all profiles forming part of the programme to take part in the debate based on a pre-established script comprising three areas: the effect on patients, the caregivers experience and their own experience.

The focus group took place right after completing the Promic Intervention study in 2012.

Phase 3: Final measurement survey research

The questionnaires were distributed to the project team in 2014, and the outcomes of both pre- and post-questionnaires were compared. The questionnaire was sent to professionals taking part in the ProMIC intervention study in the different categories and care levels prior to commencement of the programme in 2010 and 2 years after its completion, in 2014. The link to an online version of the questionnaire was sent by email to all the participants from the organisations involved, and two successive dispatches of the questionnaire were forwarded over the two aforementioned years.

Setting and participants

Thirty-four complete responses to the questionnaire were received in 2010 out of a total 50 clinicians taking part in ProMIC, i.e. a 68% response rate. In the 2014 survey, 19 responses were obtained out of 33 clinicians involved in the project at that time, i.e. a 57.58% response rate.

For its part, the focus group was made up of seven individuals from two professional profiles: six nurses and one family doctor. Participation was not forthcoming from the other roles that make up the programme.

The study participants belonged to different organizations from Araba and Bizkaia within the Basque country health care service, Osakidetza.

Data analysis

Focus group analysis

The verbal discourse that arose during the debate was transcribed for subsequent study, and a phenomenological standpoint was taken. A sociological analysis was carried out using the discourse system technique proposed by Conde. It is based on discourse as a social production that represents the different sectors of society exceeding the individual.¹⁹ The three distinct phases were: identification of units, classification and grouping together using the MAXQDA computer programme in a triangulated way via a multidisciplinary team. The outcomes provided a descriptive summary of the responses.

Quantitative research

All the questionnaires were analysed in 2014, and the main gauge of outcomes was the average global assessment given by professionals with regard to the culture of integrated care, measured using the D’Amour questionnaire. The partial scores obtained for each item were measured as secondary variables, while the t Student test was used to make comparisons between the different care levels owing to the normal nature of the variable. The significance level was established at 0.5 and all calculations were made using Stata 12.

Ethical considerations

This study adheres to the Helsinki Declaration and subsequent revised versions, as well as to correct clinical practice. It was approved by the Ethics Committee and by the research committee of the participating centres, with informed consent being obtained from each of the participants. Data were treated anonymously and confidentially via encrypting systems and centralised management in accordance with the Law governing Data Protection and the Law governing Patients’ Autonomy.

Outcomes

Qualitative method: Focus group

Features of the intervention

Facilitating elements

According to the perception of participants in the discussion group, the outcomes obtained were good and managed to ensure that the individuals attended would gain more autonomy through the intervention. The study participants pointed out that, heart failure patients had no specific programme for their pathology at their disposal and that, in this sense, the innovation was deemed positive.

Barriers

The study participants thought the large amount of data collection demanded by the programme was a design error, a factor of the intervention itself that might have a negative influence on the outcomes. They also thought patients were overloaded in many cases, in the sense of exposing them to the obligation to answer numerous questionnaires and bearing in mind they were fragile, elderly individuals currently in difficult situations like having to deal with the hospital admission itself. The study participants stated that these aspects might have led to the questionnaires not being answered so rigorously, and also believed that there were those who abandoned the programme as a result of excessive measurements having been taken – above all in the case of control patients, whose effort in responding was not offset by the benefit they received in terms of care.

External context

Facilitating elements

The study participants stated that the ProMIC programme had been a help to caregivers, as they were able to find a professional team in it with whom they could check any doubts and who could lend support to them. They did not think that the learning about care that the programme entails would have increased the load to which they were exposed. The study participants also said that it perhaps initially constituted an investment in terms of time, but did not think they would have experienced overload in terms of their responsibilities towards the patient.

Barriers

In the opinion of the participants in the discussion group, the caregiver was a key aspect in achieving good outcomes with the patient. The study participants believed that they were not as much as they needed in most cases, and described how in the initial interview with family members during admission, the commitment they said they had taken on in terms of care was to that extent subsequently not adhered to.

The study participants commented that there were even several cases where patients were excluded from the programme owing to the fact that the family initially said they were going to be involved but ultimately wanted nothing to do with the matter. They pointed out that, in many cases, the family presence was even greater during admission than when the patient returned home when they started to relax and stopped being quite so involved and present.

In terms of the existence or otherwise of family overload in the caregivers, the study participants raised their doubts about the measuring specifically done to assess the existing extent of the Zarit Burden Interview, a caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire.^20,21 They thought that they possibly did not answer sincerely, because family members were not able to express what they were really feeling. They believed they were not prepared to admit to others what on a personal level – and on all levels – attention and care for their family member entailed.

The study participants drew attention to the fact that there was little male presence in the role of caregiver. If the patient was a man, it was usually his wife – if he had one – who would be in charge of his care. Yet if the patient was a woman, it would generally be the daughter who would be in charge of looking after their mother.

Internal context

Facilitating elements and barriers

The study participants suspected that the outcomes obtained in the two territories in which work had been carried out would be different, as they believed there would have been substantial differences between the two areas that might have an effect on them. Among these differences, mention should be made of those related to the different internal conditions, given the extra time made available to professionals in one of the territories in which the intervention had been designed to care for ProMIC patients, which was not the case in the other territory. In cases in which such elements were not facilitated, the study participants pointed out that their perception was one of not having been able to carry out their work as they would have liked, and that the programme meant more work and overstrain for them.

Professionals’ characteristics

Facilitating elements

The study participants stated that on a professional level, the intervention enables palpable outcomes to be observed in the patient and, in this sense, they found it gratifying. They stressed they had learned a lot about this type of patient and how to handle their illness: how to educate them and even get closer to them.

Barriers

The study participants pointed out that had not felt sufficiently prepared and trained to manage the cases on numerous occasions. They highlighted the overstrain and professional overload that their participation in ProMIC entailed, and perceived internal organisational troubles, as it has been presented in the internal context barriers paragraph, which did not favour the professionals’ work, therefore expressing feelings of frustration. They also said that had to work outside their working timetable to be able to complete the programme.

They related many of the difficulties found in properly developing the intervention to human aspects, such as professional misgivings and inequality in terms of individuals’ involvement. In this sense, they commented that there were many differences in terms of collaboration among the professionals who did not form part of the ProMIC team, but who were needed just as much to ensure its smooth running, such as cardiologists or family doctors from the healthcare centres involved. We made a summary of the facilitating elements and barriers identified, based on the elements within the CFIR framework (see Table 2).

Table 2.

Focus group outcomes.

	Facilitating elements	Barriers
Features of the intervention	Patient’s autonomyInnovation with positive outcomes	Excessive research measures
External context	Support and help for caregivers	Lack of involvement of some caregiversObjectivity in terms of measuring the Zarit questionnaire
Internal context	Greater organisation and support in one of the two areas where the research was conducted	Less organisation and support in one of the two areas where the research was conducted
Professionals’ characteristics	Excellent learning	Overstrain and professional overloadProfessional misgivings and inequality in terms of individuals’ involvement

Source: Own processing.

Quantitative method: D'Amour questionnaire

The outcomes obtained from the survey show an improvement in the 10 dimensions analysed can be observed in Table 3 and Figure 1.

Table 3.

Comparison between outcomes obtained using the D’Amour questionnaire 2010–2014.

Items	Mean (SD) 2010	Mean (SD) 2014	Change %
1 Common goals	1.82 (0.87)	3.84 (1.12)	111
2 Patient-centred approach	2.94 (1.07)	3.42 (0.96)	16
3 Mutual knowledge	1.94 (0.85)	3.42 (0.90)	76
4 Trust	2.91 (1.00)	3.53 (0.90)	21
5 Strategic guidelines	2.15 (0.86)	3.21 (1.18)	49
6 Shared leadership	2.18 (1.14)	3.21 (1.18)	47
7 Support for innovation	2.29 (0.91)	3.26 (0.99)	42
8 Forums for meeting	1.94 (1.01)	3.37 (0.83)	74
9 Protocolisation	2.12 (0.95)	3.37 (1.12)	59
10 Information systems	2.15 (0.89)	3.53 (0.96)	64
Global	2.24 (1.01)	3.42 (1.01)	53

Source: Own processing.

Figure 1.

Comparison between outcomes obtained using the D’Amour questionnaire 2010–2014.

An absolute improvement by 1.18 points and 53% can be observed in the global average. The items in which there was least variation in score were number 2 “patient-centred approach” and number 4 “trust”, while the items in which variation was greatest were number 1 “common goals”, number 3 “mutual knowledge” and number 8 “forums for meeting”.

As for overall (average) assessment of the collaboration, no significant differences were found either between the Men and Women groups or between Hospital Care and Primary Care, or between those who had been more than 15 years in the organisation and those who had been less than 15 years, and neither between professionals in medicine and nurses.

Both, the quantitative and the qualitative methods, showed up congruent information about the positive perception of participants about the ProMIC program itself and the collaboration within the program.

Discussion

This study shows that ProMic offers visible benefits for the patient in terms of reducing adverse events, improving self-care and quality of life, providing a gratifying experience for those professionals who took part. The programme provided major support for professionals, and they drew attention to the fact that they learned a lot about this type of patient and about how to deal with their illness: how to educate them and even get closer to them. The study participants pointed out that they did not feel sufficiently prepared in managing cases on numerous occasions owing to the complexity of the situations that may arise in caring and monitoring patients. Insecurity on the part of professionals when putting the programme into practice, which involves changing roles and taking on new duties, proved to be the key. The extent and state of insecurity vary among the different professionals, whereby it might be deemed necessary for participants’ training and preparation to be personalised.

Internal organisation is the key to developing the programme. They highlight aspects such as ensuring the staff who need to put it into practice have the time available to do so, and activating coordination mechanisms among the care levels involved in the process, led by those in charge of the services that form part of it.

Other factors that also influence the smooth running of the intervention are participants’ human aspects in the project, such as professional misgivings and the level of involvement shown by individuals. Existing differences in this area highlight the need to intensify efforts geared to making headway in terms of acceptance by and collaboration with professionals in developing the intervention.

The study participants raised doubts as to whether the outcomes might vary between the two areas of health involved owing to differences in how professionals are organised, so as to apply common elements of the intervention. Ultimately, this perception was not reflected in the outcomes.

The caregiver is a key aspect in achieving good outcomes with patients. The study participants affirm having perceived that the programme might lend support to the caregivers, who would thus have a team at their disposal both for advice and guidance. The caregivers, as a whole, can be considered as a group on which health prevention programmes should focus special attention. In most cases, the caregiver is a woman. The work load is usually not evenly distributed between men and women within the family unit; rather, the latter find themselves in a disadvantage situation.

In developing the programme, participants described how they had detected major social needs among patients that interact with health needs, thus aggravating the latter. A need is perceived for greater connection between social and health systems by combining efforts and resources to be able to best cover the largest number of shortfalls.

Only seven people took part in the focus group. They represented primary care nurses and one family physician. The lack of participation of other professionals from the hospital and the community was a great limitation of the qualitative part of the study.

In terms of the extent of collaboration between care levels, a low global rating was noted in 2010, while in 2014 the global rating was average. The items that most improved within the global improvement observed were those that were already the highest in the initial questionnaire (number 2 “patient-centred approach” and number 4 “trust”). The items with the greatest variation in score were the number 1 “common goals”, number 3 “mutual knowledge” and number 8 “forums for meeting” which, conversely, were the lowest ones in the initial questionnaire. No significant differences were noted in the responses of professionals from the different care levels. We can conclude by saying that the ProMIC intervention has helped to improve professionals’ perception in terms of collaboration between levels in general (global average score) and, to a larger extent, in the following items: common goals, mutual knowledge and forums for meeting in particular.

We did not found differences between due to gender, hospital care or primary care, time working for the organisation, and between professionals in medicine and nurses.

The complexity of care processes and the need for continuity in terms of care, especially in complex chronic patients such as those admitted to hospital because of HF, mean that large-scale collaboration is necessary between care levels as well as major interdisciplinary teamwork, so as to achieve the best possible outcomes in terms of health. The ProMIC intervention was designed with major standardisation in mind that envisages adherence to clinical practice and frequent meetings among professionals from both care levels. We might say that a clinical-functional programme was designed for this type of patient of the type referred to by Valentijn et al.,²² who refined the Rainbow Model of Integrated Care, which distinguishes six integration dimensions (clinical, professional, organisational, system, functional and normative integration).

ProMIC was undertaken prior to the structural integration of primary care and hospital organisations, which has been gradually established in the Basque Country since 2011. The integration process among care levels concluded with the setting-up of IHS throughout the Basque Country, and assessments have been made via the central organisation using the D’Amour questionnaire in several IHS, with ProMIC obtaining similar outcomes to those obtained by the initial IHS Bidasoa.²³ In this research, almost all of items showed scores higher than 3 (except for shared leadership). Patient-centred approach was at the top. Researchers did not found significant differences between the opinion of primary and secondary care professionals, neither.

This questionnaire continues to use the culture of integrated care as a gauge in the Basque Country.¹⁵

In conclusion, we can say that this work shows the significant margin for improvement in terms of collaboration between areas of care even in systems deemed to be reference points in the field. The Basque Country developed a specific large-scale and far-reaching transformation initiative focused on changing the healthcare provision model towards integrated care of chronicity in 2010. This strategy favoured local innovation and the “bottom up” approach. It was not possible to overcome the political barriers or bureaucratic immobility, which limited the implementation and scope of the changes, especially those related to the scalability of successful local innovations.²⁴ Programmes such as ProMIC, which combine major standardisation based on clinical knowledge with frameworks for improvement in caring for chronically-ill patients, evidence positive outcomes in the Quadruple Aim by providing information about the experience of clinicians in order to improve the work life of health care providers.²⁵

Improvement in collaboration is achieved by working on easily manageable elements such as the setting of shared goals or protocolisation alongside others that foster organisational learning²⁶ such as mutual knowledge, trust and forums for meeting among care levels. Clinical-functional integration may also be developed via bottom-up initiatives within action research projects, like ProMIC, although assessment overload is something that needs to be reduced in the interests of ensuring that these types of initiative are successful. Programmes like ProMIC contribute to improve patient’s quality of life, support caregivers, change the way we usually delivery health services, and are a good living lab for policy decision-making. They are also a useful source of evidence for deeper research.

Footnotes

Authors’ note

The following are the awards received for this work: 2nd Bessos prize at the Congress on Chronic Patient Care, Barcelona 2013. 2nd prize for the best research work at the Semfyc Congress, Gran Canaria 2014.

Acknowledgements

The authors thank the Department of Health of the Basque Government and O-Berri, Basque Institute of Innovation. They also thank “Osakidetza,” represented by the different participant organisations.

The authors also thank the following researchers collaborating with the ProMIC Group: Fernando Aros, Jesus Torcal, Juana Oyanguren, Iñaki Lekuona, Agurtzane Otxandategui, Pilar Echevarria, M° Aranzazu Ortiz, Elena Lopez De Aretxaga, María Avelina Iñiguez, María Begoña Lopez, María Carmen Martínez, María Carmen Noriega, Francisca Díaz De Otazu, María Jesús Urbina, Yolanda Fernández, Carlos Ruiz de Vergara, Blanca Aguayo, M^a Dolores Martínez, Cristina Blanco, Iker Elguezabal, Olatz Urbina, Nere Mendizabal, Ana Isabel Conde, Concepción Bello, Rosario Braulia, Aitor Arbizu, Juan José Villarreal, Cristina Peña, Elena Dorado, Arantza González, Rosa Abalia, Juan Chirapozu, María Armendariz, Ascensión Martin, María Jesús Carrillo, Yolanda Salaberri, Milagros Oses, Eva Amuriza, Susana Martin, Amaya Santos, Asier Sainz, Begoña Gallego, Eguzkiñe Ibarra, Itziar Palacios, María Cubo, Pilar Gil, Teresa Gil, Oihana Mora, Ascensión Valdemoros, Francisco Javier Fresco, Joana González, Luciano Ramos, Begoña Isasi, Pedro La Torre and Gonzalo Grandes.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded by the Department of Health of the Basque Government: File No. 2010111182 Bizkaia and File No. 2010111088 Araba. Basque Foundation for Innovation and Research in Care BIOEF: File No. BIO10/EC/004.

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