Improving transitional patient safety: research protocol of the Transitional Incident Prevention Programme
© Melle et al. 2015
Received: 27 March 2015
Accepted: 15 May 2015
Published: 14 September 2015
Patient transitions between primary and hospital care include referral, discharge, and simultaneous care by the outpatient clinic and the general practitioner (GP). Research on referrals and discharge shows that safety incidents in these transitions are common. We developed the multifaceted Transitional Incident Prevention Programme (TIPP), which aims to improve transitional patient safety preventing future incidents. With this study, we aim to evaluate the effectiveness of the TIPP programme on transitional patient safety, and to evaluate its implementation and the acceptance in GP-practices and hospitals.
The TIPP intervention study is a controlled before and after study combined with qualitative methods. The study will be conducted in both rural and urban settings including three hospitals, together with referring primary care practices. The TIPP intervention is aimed at three aspects of transitional safety:
1) Healthcare process, 2) Transitional patient safety culture, and 3) Patient participation. Together with the participating hospital departments, GPs and patients, we will develop a tailored improvement programme, taking into account the different context of each setting.
The purpose of this protocol paper is to present and discuss the research design and methodology of the TIPP intervention.
Dutch trial register NTR4810
KeywordsPatient safety Transitional care Transitions of care Handoff of care Continuity of care Discharge Referral Outpatient Hospital General practice Quality improvement
Internationally, there is an increasing shift from secondary to primary care in order to reduce healthcare costs simultaneously with sustained quality and safety of care [1, 2]. This restructures care by creating healthcare chains that connect current organisations along similar patient groups, in which the general practitioner (GP) has a coordinating role [3, 4].
In these healthcare chains patients transfer from primary care to hospital care for diagnostics, treatment, and monitoring to receive adequate care at the right healthcare level. The increase of both collaborative care between different care levels as well as the number of patient transitioning enlarges the challenge of securing safe continuity of care, which in this study is summarised in the concept of ‘transitional patient safety’.
Patient risks do not present homogeneously within the different care levels, for primary and hospital care differ in patient presentation, epidemiology of diseases and obviously also in organisation of healthcare . Nor do these organisations share a common view on the concept of patient safety. These differences result in errors when patients pass the boundaries .
Indeed, research on patient transitions between primary and hospital care, e.g. discharge, referral, and simultaneous care at both levels, revealed many patient safety incidents. Numbers on incidents vary between 20 %  and 50 %  of discharged patients, depending on design of the study, definition and patient group. The incidents’ consequences ranged from minor harm to disability and death and half were supposedly preventable. At referral, GPs often fail to communicate relevant patient information or the reasons for the referral to the specialist or patients are referred inappropriately according to the specialist . Martinussen et al. showed that specialists considered only 15.6 % of the referral letters to be “usually good” .
To improve transitional patient safety, it is vital that healthcare professionals in primary and secondary care understand each other’s working methods, and practice good communication and openness . Many emphasize the need for a system-based approach in healthcare in which the patient has a central role [11, 12]. A system-based approach is defined as: the demonstration of “an awareness of and responsiveness to the larger context and system of healthcare and the ability to effectively call on system resources to provide care that is of optimal value.” 
This system-based approach would facilitate physicians to move competently within the larger systems of care providing interdisciplinary, coordinated, and safe care , the main focus in this approach being the patient [3, 14]. The healthcare professional should learn to read the medical case stories from a patient point of view. This awareness may reduce adverse events, and help doctors to recognise the complete patient journey through the healthcare chain .
In such system, patients themselves also should be aware of their health status and their journey through the healthcare chain . Indeed, they are the only constant in the whole process of the transition from general practice to hospital and vice versa.
Many tools aiming to improve the transition in referral or discharge have been developed and implemented [6, 16–20], such as regular meetings between GPs and specialists, case managers, the patient record (either patients carrying their own patient health record or accessible digital medical records for patients provided by the hospital), discharge guidelines, and guidelines for referral and discharge letters. However, only few tools have been systematically studied on their effect . Also, these tools have been studied separately whilst a comprehensive intervention targeting the healthcare process, culture and patient aspects simultaneously seems more appropriate for improving transitional patient safety.
We developed a multi-faceted programme (the Transitional Incident Prevention Programme; TIPP) to improve transitional patient safety and prevent future incidents. With this study, we aim to evaluate the effectiveness of the TIPP programme on transitional patient safety, and to evaluate its implementation and the acceptance in GP-practices and hospitals.
Study design and hypotheses
We include a convenience sample of two voluntary participating health regions in our study. Both regions include at least one hospital and multiple general practices. The two regions contrast in setting, i.e. rural vs. urban, which will provide sufficient heterogeneity to assess the influence of contextual factors on the effect of TIPP.
We hypothesize that: (i) Implementing TIPP will reduce unplanned emergency room (ER) visits, rehospitalisation and inappropriate referrals (ii) Implementing TIPP improves the transitional patient safety culture, (iii) Implementing TIPP reduces healthcare costs due to preventing ER visits, rehospitalisation and inappropriate referrals.
In addition, we will conduct a process evaluation, assessing acceptability, appropriateness, and feasibility of the intervention in each setting, related to the differences in contextual factors that influence adoption, fidelity, and penetration of TIPP .
The first rural region consists of a regional hospital (Röpcke-Zweers, 197 beds), together with 18 referring primary care practices in the same region. Together these healthcare professionals treat the majority of patients in this area. The estimated number of patients in this area is 68000. We will focus on healthcare paths with high turnovers, in which many transitions are expected. In this rural area, we will limit our intervention to medical disciplines internal medicine (including gastroenterology) and cardiology.
The second setting consists of two hospitals, a University Hospital (UMC Utrecht, 1042 beds), which provides both nation-wide and regional care and a smaller city hospital (Diakonessenhuis, 480 beds). Together they provide hospital healthcare for the patients in the Utrecht area. In addition, we have selected 44 referring primary care practices, working in two collaboration groups in the Utrecht area. The estimated number of patients in this area is 194000. In this urban area, we will limit our intervention to the cluster of ‘medical disciplines’ gastroenterology and cardiology.
The control group consists of the non-participating departments in the hospitals in the Utrecht region, and the non-participating general practices in the larger Utrecht area. These departments and practices continue to work as usual.
We will include patients in usual care who are at risk for a transitional incident. These patients have experienced a transition from GP to hospital or vice versa: they have either been referred to or discharged from hospital, or have visited the outpatient clinic at the time of the study. It is a dynamic population.
TIPP is a multi-faceted intervention containing several components aimed at different aspects of transitional safety, developed in an earlier phase of the project using the Intervention Mapping approach . With extensive literature search and qualitative methods we assessed both general transitional safety problems, as well as the major setting-specific transitional problems.
The healthcare process
Transitional patient safety culture
Active patient participation
In the TIPP programme each aspect will be targeted by either general or setting specific intervention components. The components can be tailored to the specific wishes of each setting because implementation of a complex intervention largely depends on context [24, 25].
The intervention component aiming at the healthcare process consists of a renowned risk assessment tool such as a prospective risk analysis of a major problem in their setting or the systematic report and analysis of transitional incidents. These tools will identify the most common processes that fail during transition of care for each participating hospital department together with the referring GPs [26, 27]. In addition, we will provide existing tools to improve these processes. The participants themselves are responsible for designing and executing their own improvement plans. We will include and facilitate both (i) already existing plans that touch on and influence transitional care (e.g. an initiative to improve medication reconciliation) and (ii) initiatives of healthcare organisations which originated from the TIPP diagnosis of transitional care.
Transitional patient safety culture
We will organise a transitional safety workshop for professionals. In this workshop we will provide information about transitional safety, but especially focus on creating a shared vision of communication, collaboration and responsibility in transitional care. Also, introducing the GPs and specialists to each other is an intervention in itself [28, 29]. Preliminary results of a qualitative study suggest this will lower the threshold for spontaneous feedback between professionals, in order to facilitate approaching the colleague to whom the patient is transferred for discussing medical policy or problems. Furthermore, mutually reporting and analysing transitional incidents together are culture interventions themselves .
From the start, patients are involved in the TIPP project (i) through participation of the Dutch Federation of Patients and Consumer Organisations in the Netherlands (NPCF) in the advisory board of the project, (ii) participation of trained patients in the local project groups that determine the intervention components, together with representatives of the participating hospital departments and GPs, and (iii) through patient interviews with patients that have experienced a transitional incident preceding the trial.
We used the information gathered from these patients to create a tool for patient empowerment: a patient info card. The patient info card provides information to address major safety items in transitional care using cartoons and short easy understandable language . During the intervention period, the hospitals and GPs will be requested to supply this card to their patients.
Many other patient tools have already been created to minimize transitional risks (e.g. a patient record: either patients carrying their own patient health record or accessible digital medical records for patients provided by the hospital, medication lists, patient access to medical files [31, 32]). The local project groups, consisting of patients involved in regional and national patient unions, staff from our participating hospital departments and affiliated GPs, will decide whether they will use one or more of these tools, and if so, which one. The patients in our local project groups are “professional” patients recruited by patient platforms for helping with quality improvement.
Examples of intervention components for each of the three important aspect of transitional safety voiced by the TIPP participants
Health care process
Transitional patient safety culture
Transitional incident reporting committee: Providing a neutral place for feedback of incidents, will provide insight in system errors in transitional patient safety and fosters improvement of the healthcare process. Also, it improves transitional patient safety culture by stimulating feedback between GP and hospital and exchanging news.
Patient info card: providing information to patients to address major safety items in transitional care using cartoons and short easy understandable language
Safe email communication: providing a place to communicate short messages about specific patients. This does not replace the extensive communication (e.g. discharge letters), but offers a place to communicate important (but not urgent) messages about medical policy requests (e.g. control lab tests a week after discharge) or changes (e.g. medication changes after outpatient visit)
Transitional patient safety culture workshop: Introducing GP’s and hospital professionals and providing information about transitional risks and safety, to create a shared vision on communication, collaboration and responsibility in transitional care. Introducing the professionals to each other will lower the threshold to communicate and provide feedback on specific patients.
Medication passports: providing patients with (empty) medication passports before the first outpatient appointment. A patient will be requested to fill in the passport according to the medication they use at that moment. There is also room for their medical background and allergies.
A prospective risk analysis (PRA) or Healthcare Failure Mode and Effect Analysis (HFMEA) of a regional problem in transitional care. E.g. an HFMEA on discharge of patients from the outpatient clinic to the GPs or hospital diagnostics requested by the GP (like gastroscopy or cardiac stress test) [26, 27].
Regular (half-yearly) informal gatherings between professionals from GP and hospital: personal acquaintance between professionals from GP and hospital will lower the threshold to communicate and provide feedback on specific patients.
A patient health app: providing a patient with a digital medication passport on their smartphone or tab to register their medication, medical background, and allergies and update the medication regularly (after every adjustment).
Outcomes and measurements
Primary outcomes of between group comparisons
We will use the following proxy measures to assess the effectiveness of the intervention: death, number of rehospitalisations within 30 days of discharge, number of visits to the GP within 30 days of discharge, number of GP visits, number of visits to the ER, number of single outpatient visits, number of written communication from the hospital within 3 months of referral, number of referral letters available at first visit in hospital, and number of patients initially referred to one specialty but admitted for another specialty. All proxy measures are measured in a six months’ time period.
Within group comparison
Within the intervention group we aim to assess the effect of TIPP in more detail. Because we measure in more detail, we use more sources of data. Also, we use qualitative measurements to better understand the links between theory and empirical findings.
The proxy measures from the between group comparisons.
A composite endpoint of: serious adverse events (death, possibility of death or major permanent loss of function), unplanned visits to the ER, re-admission within 30 days, and non-appropriate referrals, all within a six months’ time period. This composite endpoint will be extracted from a different data source from the proxy measures.
Number, nature and harm of incidents collected through a combination of methods: professional- and patient-reported incidents and incidents found in a medical record review.
Transitional patient safety culture according to the healthcare workers, as measured by the TRAnsitional patient safety Culture Evaluation (TRACE) (see § Data collection; Transitional patient safety culture).
The costs of (avoided) visits to the ER, readmissions, non-appropriate referrals and incidents in a six months’ time period compared to the direct costs of TIPP.
Patient perception of transitional patient safety, as measured by the Transitional Risk and Incident Questionnaire (TRIQ) (see § Data collection; Patient perceptions on transitional patient safety and incidents).
Components of TIPP that were actually implemented and used in the healthcare chain (process evaluation)
Experiences of participants (user evaluation)
Measurements and instruments
Between group comparison
General Practitioners and hospital database; proxy measures for transitional care will be collected from the routine care data registries of the participating general practices and from the hospital database for each participating hospital departments.
Within group comparison
Patient and professional characteristics
The patient characteristics collected are: gender, age, education level, co-morbidity and the number of types of medication used at this moment. The professional characteristics collected are: gender, age, function, and working experience (years).
Medical record review study
At both T = 0 and T = 1, a trusted third party (TTP; an independent organisation) will select a random sample of patients equally spread over all participating hospital departments who were at risk of transitional incidents in the last 6 months. These patients will then be cross-referenced with the database of the GPs in our study group, and a random selection of patients will be pulled from these. Then, the TTP will link the GP and hospital files and anonymise them. Trained employees will screen the records by using triggers indicating potential transitional risks or incidents. Because no trigger tool exists for transitional safety problems, we are developing a transitional trigger tool. Medical records positive for at least one trigger will further be reviewed by a physician. They will be trained in recognising and evaluating transitional incidents. Patient characteristics (age, gender, comorbidity and total number of medicine used at this moment) and characteristics of incidents (type, harm, location) will be scored. According to the Eindhoven Classification Model, the type of incidents will be scored as incidents in organisation, technology, human behaviour, or as patient related . Harm and potential harm will be classified according to The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) harm index , which is a 9-point scale from “none” to “death”.
For our composite endpoint, data on serious adverse events, acute visits to the ER, re-admission within 30 days and non-appropriate referrals will be registered. To assess the inter-observer reliability of the doctors’ review, a second doctor will review a random sample of records and the absolute agreement and intraclass correlation coefficient (ICC) for inter-observer agreement (absolute agreement, single measurement) will be calculated 
Approximately every 4 months, the professionals (the entire staff of the participating hospital departments and GP practices) and patients will be requested to report all transitional incidents for a week. Hospital personnel will report through the hospital incident reporting system, which will be slightly adjusted to fit transitional incidents. GPs will use a confidential digital reporting system that can be traced back to the reporting professional and patients can use either an anonymous paper or digital incident reporting form.
A team consisting of at least one independent specialist, one independent GP, and a researcher experienced in analysing incidents will judge incidents based on the characteristics of the incidents (type, harm, location) as mentioned in the medical record review study.
Patient perceptions on transitional patient safety and incidents
Because no questionnaires existed for this purpose, we developed the Transitional Risk and Incidence Questionnaire (TRIQ) which was based on literature and qualitative research. The TRIQ is a questionnaire asking patients whether they have experienced risky situations and transitional incidents. In the development of the TRIQ, we used Reid et al’s  framework for continuity of care (a related term, but broader than transitional care, for it also contains the continuity within one organisation). The framework consists of three dimensions: relational continuity, informal continuity and communicational continuity. The development of the TRIQ will be described elsewhere. During the TIPP trial, patients will be requested at T = 0 and T = 1 to fill in the TRIQ. Patients at risk for transitional incidents will be selected at the outpatient clinics. The patient can either fill in the questionnaire by him/herself or be assisted by a medical student.
Transitional patient safety culture
Because no questionnaires existed for this purpose, we developed the TRAnsitional patient safety Culture Evaluation (TRACE) which was adjusted from two current patient safety culture questionnaires used in the hospital setting (Dutch version of the AHRQ Hospital Survey on Patient Safety Culture; HSOPS)  and in a general practice (SCOPE questionnaire, which is derived from the Dutch version of the HSOPS, SCOPE is a Dutch acronym for systematic culture inquiry on patient safety) . The development of the TRACE will be described elsewhere. During the TIPP trial, professionals (all personnel with experience in transitional care from the participating hospital departments and general practices) will complete a patient safety culture questionnaire at T = 0 and T = 1.
The costs of (avoided) visits to the ER, readmissions, non-appropriate referrals, and incidents, all within a 6 months’ time period, will be compared to the direct costs of TIPP. The evaluation of the costs of (avoided) visits to ER, readmissions, referrals, contacts at the GP practice and incidents will be based on the most recent unit prices according to the reference prices for the Netherlands . To estimate the costs of the TIPP intervention, all direct costs will be calculated. We will include all personnel costs in organising, executing and participating in the components of the intervention. We will exclude the developing costs of the intervention and all research-related costs to the TIPP research programme itself.
Qualitative data collection
We will assess the actual implementation of the TIPP intervention by measuring implementation outcomes: the adoption, fidelity, and penetration of TIPP . These implementation outcomes will be collected from the participating hospital departments and GPs on a regular basis, using interviews, self-reporting and (participative) observations.
We will collect information from the participating hospital departments and GPs on their experience with TIPP. We will use participant (including patients) observations, interviews and group interviews to assess acceptability, adoption, penetration and appropriateness of TIPP .
Context/Characteristics of healthcare facilities
At the start of the study, the departments and GPs will be characterised by their context. In the participating GP practices we will observe and collect the following data: form of cooperation, yearly number of patients, patients’ gender, ethnicity and mean age, full-time equivalent positions of GPs and other personnel, mean regional social economic status, number of competitive hospitals in the region. In the participating departments we will observe and collect the following data: regional or university hospital; yearly number of patients; patients’ gender, ethnicity and mean age; full-time equivalent positions of physicians and other personnel; mean regional social economic status, number of regional competitive hospitals, and number of referring general physicians. Also, key process indicators for implementation of patient safety interventions will be described using a framework based on the Model for Understanding Success in Quality (MUSIQ tool) .
The power calculation for the effect of TIPP is based on the primary outcome, as collected in the medical record study. The following assumptions are used: a reduction of frequency of transitional incidents from 17 % to 13 % (25 % reduction) with a power of 80 % and an alpha of 0.05. We expect an average of 2 transitions in each patient within half a year. The percentage of 17 % transitional incidents was based on literature study; we averaged the mean of re-hospitalizations and non-appropriate referrals in systematic reviews on discharge and referrals, which probably is a conservative estimation of the total of transitional incidents. We adjusted the sample size to the expected cluster effects . This resulted in a sample size of 800 patients before and 800 patients after the intervention.
Patient- and setting characteristics will be analysed using descriptive statistics. They will also be used as possible determinants in the primary and secondary effects.
The difference in change in the primary outcome between intervention and control regions will be calculated using Poisson regression analysis, taking into account the clustering into departments and hospitals. Effects of implementation on transitional patient safety culture and patient perception will be calculated with multiple regression analysis, again taking into account the clustering into departments and hospitals. .
Cost-analysis will be analysed through subtraction of all direct costs of the intervention from the yield of the intervention (e.g. costs of ER visits, avoided readmissions, costs of inappropriate referrals.
All statistical analyses will be performed using SPSS 21 or SAS 9.2 for Windows.
Ethics and trial status
Our project is sponsored by the Ministry of Health, Welfare and Sport and ACHMEA. According to Dutch law, this study was exempt of formal medical-ethical approval (METC number 13/142, medical ethical committee UMC Utrecht). For the medical record study we requested an extra assessment by the medical ethical commission. The medical ethical committee Utrecht deemed the record study to be according to Good Clinical Practice; the privacy of the patients is assured (METC-letter - 13-142/C). The TIPP study is on-going. Active data collection started on November 1st 2014 and will run until June 2016.
The purpose of this protocol paper is to present the research design and methodology of the TIPP intervention. This trial assesses the effectiveness of a multifactorial complex intervention on transitional patient safety. In addition, it will give more insight into the major risks of transitional care, as well as determinants of successful implementation of a complex intervention. This will result in a matrix to diagnose and improve transitional patient safety that can be broadly implemented.
We faced several methodological challenges during the design of the TIPP trial.
Definitions of expressions used in the protocol
The prevention of errors and adverse effects to patients associated with healthcare .
Patient safety incident
A patient safety incident is any unintended or unexpected incident which could have or did lead to harm for one or more patients .
Patient safety culture
The safety culture of an organisation is the product of individual and group values, attitudes, perceptions, competencies, and patterns of behaviour that determine the commitment to, and the style and proficiency of, an organisation’s health and safety management. Organisations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures .
Continuity of care
Either (i) the provision of services that are coordinated across levels of care - primary care and referral facilities, across settings and providers; (ii) the provision of care throughout the life cycle; (iii) care that continues uninterrupted until the resolution of an episode of disease or risk; or (iv) the degree to which a series of discrete healthcare events are experienced by people as coherent and interconnected over time, and are consistent with their health needs and preferences .
A concept bringing together inputs, delivery, management and organisation of services related to diagnosis, treatment, care, rehabilitation, and health promotion. Integration is a means to improve services in relation to access, quality, user satisfaction and efficiency .
A set of actions designed to ensure the coordination and continuity of healthcare as patients transfer between different locations or different levels of care within the same location .
Transitional patient safety
Patient safety at transitions of care.
Any unintended or unexpected incident at transitions of care which could have or did lead to harm for one or more patients.
Circumstances or events that had the capacity to cause error .
Of course, the strongest design to evaluate the effect of an intervention is the randomized controlled trial. However, (clustered) randomisation in transitional healthcare creates insolvable problems because involvement of three different stakeholders (hospital, GP and patient). Randomising at each different level of the healthcare chain creates contamination in the other. Also, there is an important risk of contamination when assigning the GPs to a group because of the organisational structure in practices and the collaboration GP groups in the region (so-called ‘HAGROs’). Because of this assignment problem, interventions in transitional care are usually studied in a non-randomised observational design. Major observational studies on patient safety and transitional care have been criticized on the lack of a control group [45, 46]. Additionally, both settings (hospitals and GP structure) are crucially different in organisation, region and patient care. The participating departments within the three hospitals are different in patient category and risk of transitional incidents. Cluster randomising the hospitals or hospital departments is not possible because they are not comparable. In all, we chose a controlled before-after study design to evaluate the effect of TIPP. For the ‘between group’ comparisons, we only use surrogate outcomes to improve efficiency. Doing all measurements in the control group would mean that a major part of the intervention was also done in the control situation which would invalidate the control group comparison.
In TIPP, we consciously chose to combine quantitative and qualitative data. Using triangulation of these data helps to clarify the theoretical propositions and the basis of our results. This offers a better understanding of the links between theory and empirical findings .
Design of the intervention
TIPP is a multi-faceted intervention containing several components aimed at different areas of transitional safety. Research has shown that an intervention is more effective when aimed at different levels of a process [48–50]. We chose to intervene with the three different stakeholders (hospital, GP and patient), but also within the different facets of transitional patient safety; patient safety culture, the healthcare process and patient participation. The components can also be tailored to the specific wishes of each setting because it is known that implementation of a complex intervention largely depends on context.
To capture incidents there are two commonly used methods which both have limitations. The first one is reviewing medical records. The main risk is not recognising the incidents, which can lead to underestimation. The second method is incident reporting. The critical factor is the motivation and time of the healthcare worker (and patient in our study) to actually report events. In our study we decided to apply both methods. Also, the number of incidents reported is ambiguous as both an increase and decrease could indicate an improvement in transitional patient safety. Although one would expect a reduction in incidents, a raised awareness in healthcare will result in an increase in incident reporting. This effect especially shows in healthcare areas where patient safety initiatives are relatively new , like transitional care. Because of our relatively short study period, we do not expect to find a reduction during our research.
Selecting the proper setting for our study was challenging. We needed both the hospital and GPs in a region to voluntarily participate in our research. Therefore, we chose a convenience sample. This may lead to a selection because it is likely that the most motivated hospital and practices will decide to participate. Of course this selection may lead to overestimation of the effect, because forerunners may execute the intervention precisely. Underestimation of the effect is also possible because the room of improvement in forerunners op patient safety is smaller. To improve generalizability, we chose to include two very different settings (one rural and one urban, including a university hospital). By developing a context-related intervention, we aim to facilitate broader interest and implementation.
TIPP is a complex intervention and may have a diffuse effect which could blur quantitative measurement. The effect usually only manifests after a longer time period . Therefore, we use mixed methods to understand the potential effect.
Strengths and limitations
Summarizing the above-mentioned subparagraphs, our study has limitations caused by the methodological challenges. The TIPP intervention study is an observational study in which we recruited a voluntary convenience sample of regions and hospital departments, which differ in organisation, risks and patient care. This can lead to a selection of participants and either an under- or overestimation of the effect of the intervention. Another limitation is the measurement of the effect of the TIPP intervention. Improvement of transitional safety is difficult to capture in a measurement. Therefore, we chose different measurements for all the three aspects of transitional patient safety: healthcare process, transitional patient safety and patient empowerment. Still, the possibility remains that incidents will be missed.
The TIPP intervention’s strength is that it is unique because it involves all patient transitions between hospital and GP and vice versa (referral, discharge and simultaneous GP and outpatient treatment) and is the first to include all direct stakeholders in the transitional process (hospital, GP and patient and their families). It engages in different levels of the transitional process, from patient safety culture through the healthcare process to the patient him/herself. Research has shown that intervening at different levels of a system is more effective than a singular intervention. We implement TIPP in two very different settings, a rural and an urban/academic setting. This will result in additional information on the importance of the context when implementing the intervention. Additionally, we use both qualitative and quantitative methods to provide insight into how the interventions are implemented. By conducting semi-structural qualitative interviews with frontline staff, we will gain a deeper understanding of how the intervention works.
Although the design faced various challenges, TIPP offers a valid scientific evaluation of a structured and integrated approach to improve transitional safety and prevent transitional incidents. Once proven effective, it can be broadly implemented in daily clinical practice.
We would like to thank Dr. Peter Zuithoff and Dr. Hans Reitsma for their advice on the design of this study.
- Vos L, Chalmers SE, Duckers ML, Groenewegen PP, Wagner C, van Merode GG. Towards an organisation-wide process-oriented organisation of care: a literature review. Implement Sci. 2011;6.8-5908-6-8.Google Scholar
- Starfield B, Shi L, Macinko J. Contribution of primary care to health systems and health. Milbank Q. 2005;83(3):457–502.PubMed CentralPubMedView ArticleGoogle Scholar
- Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759–69.View ArticleGoogle Scholar
- Cresswell KM, Sadler S, Rodgers S, Avery A, Cantrill J, Murray SA, et al. An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice. Trials 2012;13.78-6215-13-78.Google Scholar
- Makeham MA, Mira M, Kidd MR. Lessons from the TAPS study - communication failures between hospitals and general practices. Aust Fam Physician. 2008;37(9):735–6.PubMedGoogle Scholar
- Hesselink G, Vernooij-Dassen M, Pijnenborg L, Barach P, Gademan P, Dudzik-Urbaniak E, et al. Organizational culture: an important context for addressing and improving hospital to community patient discharge. Med Care. 2013;51(1):90–8.PubMedView ArticleGoogle Scholar
- Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314–23.PubMedView ArticleGoogle Scholar
- Fertig A, Roland M, King H, Moore T. Understanding variation in rates of referral among general practitioners: are inappropriate referrals important and would guidelines help to reduce rates? BMJ. 1993;307(6917):1467–70.PubMed CentralPubMedView ArticleGoogle Scholar
- Martinussen PE. Referral quality and the cooperation between hospital physicians and general practice: the role of physician and primary care factors. Scand J Public Health. 2013;41(8):874–82.PubMedView ArticleGoogle Scholar
- G. van der Kaap. The weakest link: Interorganisational communication about (near) incidents in the health care chain. PhD thesis. Enschede, the Netherlands: University of Twente; 2012.Google Scholar
- Graham MJ, Naqvi Z, Encandela J, Harding KJ, Chatterji M. Systems-based practice defined: taxonomy development and role identification for competency assessment of residents. J Grad Med Edu. 2009;1(1):49–60.View ArticleGoogle Scholar
- Vincent C. Patient safety. 2nd ed. West-Sussex: Wiley-Blackwell; 2010.View ArticleGoogle Scholar
- Johnson JK, Miller SH, Horowitz SD. Systems-based practice: improving the safety and quality of patient care by recognizing and improving the systems in which we work. In: Henriksen K, Battles JB, Keyes MA, et al., editors. Advances in patient safety: New directions and alternative approaches, Culture and redesign, vol. 2. US: Agency for Healthcare Research and Quality; 2008. http://www.ncbi.nlm.nih.gov/books/NBK43731/. Accessed 24 March 2015.Google Scholar
- Haggerty JL, Reid RJ, Freeman GK, Starfield BH, Adair CE, McKendry R. Continuity of care: a multidisciplinary review. BMJ. 2003;327(7425):1219–21.PubMed CentralPubMedView ArticleGoogle Scholar
- Amalberti R, Vincent C, Auroy Y, de Saint MG. Violations and migrations in health care: a framework for understanding and management. Qual Saf Health Care. 2006;15 Suppl 1:i66–71.PubMed CentralPubMedView ArticleGoogle Scholar
- Laugaland K, Aase K, Barach P. Interventions to improve patient safety in transitional care–a review of the evidence. Work. 2012;41 Suppl 1:2915–24.PubMedGoogle Scholar
- Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02.PubMed CentralPubMedGoogle Scholar
- Akbari A, Mayhew A, Al-Alawi MA, Grimshaw J, Winkens R, Glidewell E, et al. Interventions to improve outpatient referrals from primary care to secondary care. Cochrane Database Syst Rev. 2008;4:CD005471. doi(4):CD005471.PubMedGoogle Scholar
- Shepperd S, Lannin NA, Clemson LM, McCluskey A, Cameron ID, Barras SL. Discharge planning from hospital to home. Cochrane Database Syst Rev. 2013;1:CD000313.PubMedGoogle Scholar
- Stoyanov S, Boshuizen H, Groene O, van der Klink M, Kicken W, Drachsler H, et al. Mapping and assessing clinical handover training interventions. BMJ Qual Saf. 2012;21 Suppl 1:i50–7.PubMedView ArticleGoogle Scholar
- Hesselink G, Zegers M, Vernooij-Dassen M, Barach P, Kalkman C, Flink M, et al. European HANDOVER Research Collaborative: Improving patient discharge and reducing hospital readmissions by using Intervention Mapping. BMC Health Serv Res. 2014;14.389-6963-14-389.Google Scholar
- Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Healt. 2011;38(2):65–76.View ArticleGoogle Scholar
- Kay Barthelomew L, Parcel GS, Kok G, Gottlieb NH, Fernández ME. Planning heath promotion plans; an intervention mapping approach. 3rd ed. San Francisco: Jossey-Bass books; 2011.Google Scholar
- Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–6.PubMed CentralPubMedView ArticleGoogle Scholar
- Damschroder 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;4.50-5908-4-50.Google Scholar
- Wierenga PC, Lie-A-Huen L, de Rooij SE, Klazinga NS, Guchelaar HJ, Smorenburg SM. Application of the Bow-Tie model in medication safety risk analysis: consecutive experience in two hospitals in the Netherlands. Drug Saf. 2009;32(8):663–73.PubMedView ArticleGoogle Scholar
- Habraken MM, Van der Schaaf TW, Leistikow IP, Reijnders-Thijssen PM. Prospective risk analysis of health care processes: a systematic evaluation of the use of HFMEA in Dutch health care. Ergonomics. 2009;52(7):809–19.PubMedView ArticleGoogle Scholar
- Gobel B, Zwart D, Hesselink G, Pijnenborg L, Barach P, Kalkman C, et al. Stakeholder perspectives on handovers between hospital staff and general practitioners: an evaluation through the microsystems lens. BMJ Qual Saf. 2012;21 Suppl 1:i106–13.PubMed CentralPubMedView ArticleGoogle Scholar
- Berendsen AJ, Benneker WH, Meyboom-de Jong B, Klazinga NS, Schuling J. Motives and preferences of general practitioners for new collaboration models with medical specialists: a qualitative study. BMC Health Serv Res. 2007;7:4.PubMed CentralPubMedView ArticleGoogle Scholar
- Ouboter S. De patiëntveiligheidskaart; Evaluatie van gebruik [The patient safety info card; User evaluation]. Dutch: NPCF; 2009. http://www.mijnzorgveilig.nl/links/documents/PatVeiligheidskaartEvalverslag0909klein.pdf. Accessed 24 March 2015.
- Coulter A, Ellins J. Effectiveness of strategies for informing, educating, and involving patients. BMJ. 2007;335(7609):24–7.PubMed CentralPubMedView ArticleGoogle Scholar
- Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006;166(17):1822–8.PubMedView ArticleGoogle Scholar
- Van Vuuren W, Shea CE, van der Schaaf TW. The development of an incident analysis tool for the medical field. Eindhoven, the Netherlands: Eindhoven University of Technology, Faculty of Technology Management; 1997Google Scholar
- National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Taxonomy of Medication Errors. [cited 2015 Feb 18]. Available from: http://www.nccmerp.org/home. Accessed 24 March 2015.
- de Vet HC, Terwee CB, Mokkink LB, Knol DL. Measurement in medicine; a practical guide. 1st ed. New York: Cambridge University Press; 2011.View ArticleGoogle Scholar
- Reid RC, Haggerty JL, McKendry R. Defusing the Confusion: Concepts and Measures of Continuity of Healthcare. Canadian Health Services Research Foundation; 2002. final report.Google Scholar
- Hammer A, Ernstmann N, Ommen O, Wirtz M, Manser T, Pfeiffer Y, et al. Psychometric properties of the Hospital Survey on Patient Safety Culture for hospital management (HSOPS_M). BMC Health Serv Res. 2011;11.165-6963-11-165.Google Scholar
- Zwart DL, Langelaan M, van de Vooren RC, Kuyvenhoven MM, Kalkman CJ, Verheij TJ, et al. Patient safety culture measurement in general practice. Clinimetric properties of ‘SCOPE’. BMC Fam Pract. 2011;12.117-2296-12-117.Google Scholar
- Hakkaart- van Roijen L, Tan SS, Bouwmans C.A.M. Handleiding voor kostenonderzoek; Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg 2010. [Dutch Manual for Costing: Methods and Standard Costs for Economic Evaluations in Health Care 2010]. [cited 2015 Feb 18]. Available from: https://www.zorginstituutnederland.nl/binaries/content/documents/zinl-www/documenten/publicaties/overige-publicaties/1007-handleiding-voor-kostenonderzoek/Handleiding+voor+kostenonderzoek.pdf. [in Dutch] Accessed 24 March 2015
- Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8.139-5908-8-139.Google Scholar
- Kaplan HC, Provost LP, Froehle CM, Margolis PA. The model for understanding success in quality (MUSIQ): building a theory of context in healthcare quality improvement. BMJ Qual Saf. 2012;21(1):13–20.PubMedView ArticleGoogle Scholar
- Wu S, Crespi CM, Wong WK. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials. Contemp Clin Trials. 2012;33(5):869–80.PubMed CentralPubMedView ArticleGoogle Scholar
- Holland DE, Harris MR. Discharge planning, transitional care, coordination of care, and continuity of care: clarifying concepts and terms from the hospital perspective. Home Health Care Serv Q. 2007;26(4):3–19.PubMedView ArticleGoogle Scholar
- Grone O, Garcia-Barbero M, WHO European Office for Integrated Health Care Services. Integrated care: a position paper of the WHO European Office for Integrated Health Care Services. Int J Integr Care. 2001;1:e21.PubMed CentralPubMedGoogle Scholar
- Conry MC, Humphries N, Morgan K, McGowan Y, Montgomery A, et al. A 10 year (2000–2010) systematic review of interventions to improve quality of care in hospitals. BMC Health Serv Res. 2012;12.275-6963-12-275Google Scholar
- Robertson ER, Morgan L, Bird S, Catchpole K, McCulloch P. Interventions employed to improve intrahospital handover: a systematic review. BMJ Qual Saf. 2014;23(7):600–7.PubMedView ArticleGoogle Scholar
- Ostlund U, Kidd L, Wengstrom Y, Rowa-Dewar N. Combining qualitative and quantitative research within mixed method research designs: a methodological review. Int J Nurs Stud. 2011;48(3):369–83.PubMedView ArticleGoogle Scholar
- Cleary PD, Gross CP, Zaslavsky AM, Taplin SH. Multilevel interventions: study design and analysis issues. J Natl Cancer Inst Monogr. 2012;2012(44):49–55.PubMed CentralPubMedView ArticleGoogle Scholar
- Charns MP, Foster MK, Alligood EC, Benzer JK, Burgess Jr JF, Li D, et al. Multilevel interventions: measurement and measures. J Natl Cancer Inst Monogr. 2012;2012(44):67–77.PubMed CentralPubMedView ArticleGoogle Scholar
- Taplin SH, Anhang Price R, Edwards HM, Foster MK, Breslau ES, Chollette V, et al. Introduction: Understanding and influencing multilevel factors across the cancer care continuum. J Natl Cancer Inst Monogr. 2012;2012(44):2–10.PubMed CentralPubMedView ArticleGoogle Scholar
- Leistikow I, Ridder den K, De Vries B. Patiëntveiligheid. Systematische Incident Reconstructie en Evaluatie. Root Cause Analysis. 2nd ed. Dutch; 2005Google Scholar
- Shojania KG, Thomas EJ. Trends in adverse events over time: why are we not improving? BMJ Qual Saf. 2013;22(4):273–7.PubMedView ArticleGoogle Scholar
- World Health Organisation. http://www.euro.who.int/en/health-topics/Health-systems/patient-safety. Accessed 24 March 2015.
- National patient safety agency. http://www.npsa.nhs.uk/nrls/reporting/what-is-a-patient-safety-incident/. Accessed 24 March 2015.
- Organising for Safety. Third report of the ACSNI (advisory committee on the safety of nuclear installations) study group on human factors. Health and safety commission (of great Britain). Sudbury, England: HSE Books; 1993.Google Scholar
- Coleman EA, Boult CE on behalf of the American Geriatrics Society Health Care Systems Committee. Improving the quality of transitional care for persons with complex care needs. J Am Geriatr Soc. 2003;51(4):556–7.PubMedView ArticleGoogle Scholar
- National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Medication Errors Council revises and expands index for categorizing errors. Definitions of medication errors broadened. http://www.nccmerp.org/sites/default/files/indexBW2001-06-12.pdf Accessed 06 May 2015.
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