The project
The European Quality of Care Pathways (EQCP) study is an international multicentre research project launched by the European Pathway Association (E-P-A) (http://www.E-P-A.org) [35]. The E-P-A is collaborating with the Center for Health Services and Nursing Research of the Faculty of Medicine of Leuven University (Belgium) and the School of Public Health of the Amedeo Avogadro University of Eastern Piedmont (Italy), which is taking the scientific lead in this study. The study will be executed in four countries: Belgium, Ireland, Italy and Portugal. In each country, a research centre is coordinating the project based on an internationally agreed protocol. In Belgium, the lead coordinating centre is the Center for Health Services and Nursing Research of the Faculty of Medicine of Leuven University. For Ireland, the lead centre is the Health Service Executive in Dublin. In Italy, the School of Public Health of the Amedeo Avogadro University of Eastern Piedmont is coordinating the project with support from ARESS Piemonte. In Portugal, the lead coordinating centre is the National School of Public Health in Lisbon. In each of the four countries, hospitals will be selected by E-P-A in close collaboration with a national coordinator. In each participating hospital, a study coordinator will be appointed to facilitate implementation of the care pathway. The study coordinator will be trained by the E-P-A team on how to develop and implement care pathways [12, 29].
Study design
To evaluate the effect of a care pathway, a cluster-randomized controlled trial (cRCT) will be conducted [12, 17, 18, 20, 22, 36] (Figure 1). In cRCTs, organizations rather than individuals are randomized to an intervention and a control group, and outcomes are measured on an individual level within the clusters [20]. Each cluster consists of patients hospitalized for PFF in a particular hospital and cared for by a specific interprofessional care team.
Stratified randomization will be used to assign hospitals to an intervention group (development and implementation of an evidence-based care pathway) and a control group (no intervention/usual care). To ensure that clusters in both arms are in balance, clusters will be stratified according to country-level, hospital type (teaching versus non teaching), hospital size (<600 and ≥600 beds), and annual volume of patients (<300 and ≥300 patients). Hospitals included in the control group will have the opportunity to develop a care pathway one year later, based on the protocol and experience gained in the experimental group. Through this process, a network of high-performing organizations for PFF can be built.
Inclusion – exclusion criteria
Organizations are included if the hospital management and the patient care team provide written consent to participate and, when randomized in the control group, agree not to develop and implement a pathway for PFF within the time frame of the study. All patients consecutively admitted for PFF will be considered for inclusion based on the following criteria: (i) provide written informed consent; (ii) minimum age of 65 years; (iii) closed fracture; (iv) eligible for surgical intervention; (v) American Society of Anesthesiology score 1, 2, or 3; and (vi) able to communicate in the native language. Each patient will be included only once in the study, at the initial admission, even if a patient is rehospitalized during the enrollment period. Exclusion criteria are: (i) severe dementia (based on DSM IV-criteria); pathological fracture; or a peri-prosthetic fracture.
Study sample
Sample size calculation in a cRCT was based on the expected improvement in the main outcome variables [12, 17, 18, 20, 22]. The selection of main outcomes for the EQCP-study was based on three criteria: frequency of use in the literature, expert opinion and timing of the research project with respect to organizational constraints (sustainability of the design, time to include patients). Based on these criteria, six-month mortality rate was identified as the main study outcome for in-hospital management of PFF. Based on a power of 80% and an α of 0.05 (two-sided), it was calculated in Statistica® that 325 patients per arm are needed to observe a reduction from 15% to 8% [37, 38]. After adjustment for the cluster design, based on two previous cRCTs by Panella et al. [17, 18] (ICC: 0.018; IFF: 1.342; n = 20), the effective sample size increased to 437 patients per arm. Assuming a number of 20 consecutive admitted patients in each unit, 22 hospitals need to be included in each intervention and control group [17, 18].
The complex intervention: care pathway implementation in the intervention arm
The care pathway will include three active components. (i) The first component is a formative evaluation of the quality and organization of the care process and will be performed by measuring performance on key interventions (see Figure 2) [12, 39]. The formative evaluation is an evaluation of the actual performance of the care process in each of the experimental clusters. This evaluation is led by local contact persons who each followed a workshop. The goal of this workshop was to inform the contact persons and to standardize the procedure. During this one day workshop the national coordinator, supported by the international research team, presented how and what to evaluate. The main focus was the multidisciplinary teamwork and the performance of the key interventions. Key interventions are those that have a significant impact on patient outcomes. These are performed by all professional groups within the patient care team that treats PPF patients, i.e., orthopedic surgeons, geriatricians, nurses, physiotherapists, and social workers. Key interventions are performed in the domains of pre- peri-, and postoperative care and include patient assessment, appropriate medication, execution of essential laboratory tests and medical imaging, passive and active mobilization, pain management, discharge management and patient information. Feedback will be provided on the data obtained to help the teams understand their performance on process indicators as potential areas for improvement and redesign of the actual care process. To this end, a formal evaluation will be performed before developing the care pathway. During this evaluation, performance on a set of key-interventions will be measured in 20 consecutive patients (see ii). All data will be transferred to the research center for analysis. A feedback report will be provided to allow the teams to benchmark their performance compared to all other teams participating in the study. (ii) A set of evidence-based key interventions will be provided to the team. This set will be based on an extensive literature review, Map of Medicine® (http://www.mapofmedicine.com), and consensus among international clinical experts using a Delphi-survey. The key interventions and outcomes will include both in-hospital interventions and information for a safe discharge. In this second part of the intervention, each of the experimental teams will receive and discuss a feedback report. This feedback report will provide information on the actual performance (see i). Per team a local contact person and 2 representatives of the team are invited to a seminar. During this seminar the international coordinator, supported by the national coordinator will present the findings. The lead in this seminar is with the international coordinator to make sure the data are presented in a standardized way. (iii) All study coordinators will be trained to improve the organization of the care process by developing and implementing a care pathway, based on the evaluation of the care process and the set of evidence-based key interventions. In the training workshops, a care pathway implementation protocol will be used that is based on the Deming-PDSA cycle, a generally accepted standard method for quality improvement [40]. This workshop will be led by the international coordinator. He will be supported by local experts in care pathways who each followed a five day international summer school on the development, implementation and evaluation of care pathways [41]. This summer school was organized by the European Pathway Association [35].
During the intervention different meetings with the study coordinators and team member representatives will be organized to present and discuss the feedback report and to discuss actual bottlenecks in implementing the care pathway. Change will be promoted by exchanging best practices among participants. During these meetings, local clinical champions and team change experts will help and stimulate the study coordinators to effectively share knowledge [12, 29].
Along with randomized controlled trials, in complex interventions, qualitative methods such as process evaluations are advised to promote quality care [42]. In this regard, the context in which the care pathway was developed and the implementation process itself will be evaluated using qualitative, observational approaches (e.g., semi-structured interviews with key stakeholders) during and after pathway-implementation.
The control group
In the control group, the complex intervention will not be implemented and the teams will provide usual care. Control hospitals agree not to develop a care pathway during the study period.
Measurements
To measure the effect of the care pathways, a set of process and outcome indicators for PFF were developed. The primary outcome measure is 6-month Mortality. Next to this indicator the following mortality indicators were defined: in-acute orthopedic ward mortality, overall in-hospital mortality, in-hospital mortality before surgical intervention, overall operative-theatre mortality, in-hospital mortality after surgical intervention, 30-day mortality. Next to mortality other secondary outcome measures were defined: a) Readmission: 30-days readmission, 6-month readmission, b) Length of stay: interval time between admission and surgery (anesthetic induction), overall operative-theatre time, length of stay in the orthopedic ward, overall in-hospital length of stay; c) In-hospital pain score at 24 and 48 h postoperatively and at discharge d) Postoperative complications during hospitalization, e) Functional status at discharge, f) Mobility status at discharge, g) Proportion of patients returning to previous home status after discharge, h) Health Related Quality of Life (HRQL).
As one of the goals of care pathways is to enhance the compliance to evidence based components of treatment, next to outcome measures a set of process indicators were defined. We used the same methodology as for the outcome indicators by screening the international guidelines and performing an international Delphi study. The process indicators are: a) Risk assessment of pressure sores/ulcers, b) Prevention of pressure sores/ulcers, c) Surgery within 24 h after admission, d) Performance of X-ray pre-operatively, e) Pré-operative care and assessment: ensure general analgesia is adequate, f) Pré-operative care and assessment: assessment of anemia, g) Antithrombotic prophylaxis, h) Antibiotic prophylaxis, i) Assessment of cognitive status: at admission, postoperatively at start of mobilization, j) Assessment of nutritional status, k) Management of nutritional status, l) Mobilization within 24 h postoperatively, m) Geriatric Assessment pré-operatively, n) osteoporosis screening and management and o) discharge management.
These indicators were translated during a consensus meeting in actual measurements by a multidisciplinary expert panel, consisting of a geriatrician, an orthopedic surgeon, a physiotherapist, a clinical nurse specialist, and researchers of the EQCP-study [12, 29]. To further understand why pathways work, information on the context of the organization is important. Within the EQCP study, a set of both generic and PFF-specific context indicators and team structure indicators was developed based on literature review, an international Delphi study, and expert opinion [12, 29]. The literature searches and the international Delphi studies on both the outcome and process measures will be submitted as separate international publications as part of the EQCP research output. The details on each of the indicators (definition, numerator, denominator, inclusion & exclusion criteria) will be downloadable from the website of the European Pathway Association (http://www.E-P-A.org) as soon as the data of the study will be collected. In this way these indicators can be used by other teams who are in search for analyzing and optimizing their processes of care.
Registration and ethical approval
The study has been registered as a cRCT at clinicaltrials.gov (identifier: NCT00962910). The ethical approval will be country-specific, but overall ethical approval will be obtained on three levels: (i) Ethical approval by the ethical committee of the coordinating centre on a country level; (ii) Ethical approval with regard to the participation in the intervention on a cluster level, i.e. by the ethical committee of each of the participating hospitals. These committees can agree or disagree with the overall approval of the coordinating centre. As indicated by the Medical Research Council, patient’s consent to participate in the study is not possible, because randomization occurred at the hospital level and not on the patient level. Moreover, the aim of the study is to improve adherence to evidence-based care through care pathways in the intervention group. In the control group, no intervention will be implemented and patients will only receive usual care. Participating in the intervention or control group should not imply any risk for the patients included; and (iii) Individual informed consent will be obtained from the patient with regard to the access of his/her record and participation in surveys. Approval of the ethical committee of the coordinating centre at Leuven University has already been obtained (identifier: ML5618/B32220096038) while approval in Portugal, Italy and Ireland is pending.