A Multifaceted Quality Improvement Intervention in Cyprus
The translation and implementation of the above described theories and models into a busy day-to-day clinical practice, represents a formidable challenge. Common experience with other quality improvement interventions [26] coupled with the above described insights from industrial examples, suggest that sustained improvements in chronic illness care require a comprehensive, continuous, and systematic change approach following a specific intervention. Our operational model was based on a multifaceted intervention that was facilitated through a multidisciplinary quality improvement team.
Current literature supports the implementation of multifaceted interventions in the health care sector, since many components may interact and reinforce each other in encouraging the change of professional practice and promoting workplace satisfaction [27]. Our multifaceted intervention was designed to involve several implementation strategies including a combination of educational components (educational materials, workshops, local opinion leaders' presentations, academic detailing), audit and feedback, and an electronic decision support system enabled through e-library and electronic reminder system tailored to the local needs. Particular tailoring characteristics took into consideration the lack of motivators in the public primary care centers, the scarcity of use of clinical guidelines in daily practice, the absence of referral and appointment systems as well as other organizational weaknesses and the existence of a computer naïve environment. Thus, we incorporated the use of physician facilitators, who introduced several non-monetary incentives for the health professionals, provided them with practical tools such as foot examination screening checklist, and developed tailored organizational changes. We also promoted a strong theoretical framework consisting mainly of the UTAUT and CCM supporting the computer naïve environment, and appointed a responsible individual who had to identify specific resources at each center including the support of a new appointment and referral system. Finally, an informed consent form was developed in order to be used during the implementation phase. The study was approved by the National Bioethics Committee.
Organizational Changes
Structural and organizational changes were employed, as equally important components in designing a quality improvement intervention for the management of disease co-morbidities, along with the introduction of standard clinical guidelines [28].
Consensus building meetings were planned in order to identify potential barriers and evaluate alternatives for the introduction of an appointment-based electronic scheduling system, secure continuity of secretarial support during and after the project ended, and introduce an effective specialist referral system. After reaching a consensus, the adopted decision along with necessary organizational changes could take place awaiting the institutionalization of the selected changes. Additionally, a specific plan was applied through a framework of changes that would guide health professionals in their everyday practice. Upper management support from the administrative health services of the Ministry of Health was actively sought.
Introduction of Electronic Medical Record (EMR)
The introduction of the EMR system, which was based on the International Classification System for Primary Care (ICPC-2), consisted of the introduction of a windows-based software program (Transhis) described in detail elsewhere [29]. The secretaries, nurses and physicians at the intervention primary care centers were provided with personal computers, printers and a high-speed broadband internet access for all. Primary care physicians (PCPs) and nurses were asked to serve as evaluators of the EMR system performance. In addition, 18 randomly selected patients, half of which were males and half females, were scheduled to undergo personal interviews in order to provide detailed feedback on their experience with the EMR and identify barriers in its daily implementation. Among many other software programs, Transhis, a windows-based EMR system, incorporating episode of care and reminder systems was selected to serve as the supporting electronic interface based on defined criteria for appropriateness, efficiency, and feasibility for the general clinical practice [30].
Chronic Disease Clinical Guidelines
Chronic disease guidelines represented our decision support tool, one of the main components of the Chronic Care Model. Such a tool was scheduled to provide evidence-based clinical information to the health care professionals that were readily available through electronic databases facilitated by EMR [31]. Type II diabetes mellitus guidelines were based on the American Diabetes Association and St. Vincent Declaration guidelines. Hypertension management guidelines were based on the VII Report of the Joint National Committee, the European guidelines on cardiovascular disease prevention and the European Society of Hypertension – European Society of Cardiology Guidelines, whereas lipid control practice guidelines were based on the National Cholesterol Education Program III.
Quality Improvement Team
Setting up a multidisciplinary quality improvement team was thought to be of paramount importance for the successful facilitation and fide implementation of our intervention. The use of a quality improvement team has been described long ago by industrial quality experts [32]. Our study team consisted of two family physicians serving as program facilitators, three academic experts in family medicine with previous extensive experience in QI interventions, and one family physician with expertise in EMR.
Both study facilitators were scheduled to meet with providers in their practice settings during regular time intervals in order to undertake the following actions: (a) record baseline characteristics of participants in the study and present quality indicators for each selected illness; (b) facilitate consensus building for the management of selected illnesses, according to given clinical guidelines; (c) assist in the development and adaptation of tools and strategies for implementing the intervention; (d) facilitate meetings to assess progress and potential barriers in the implementation of the intervention while being able to modify the plan accordingly; (e) conduct interviews of the participating doctors, nurses and patients; and (f) develop and complete electronic chart audits, monthly reports and outreach visit forms.
Setting and Participants
Primary Health Care Centers
The study was scheduled to take place in Nicosia, the capital of Cyprus, in two urban and two rural public primary health care centers (PHCC), which were selected based on population served and employee criteria (age, duration of medical education, number of years in practice). One rural and one urban center were designed to serve as controls being observed to follow regular practice. Each center was designed to have a worksite leader who would leverage resources and be the primary contact person in collaboration with the quality improvement team. All PCPs and nurses from the intervention primary care centers were scheduled to participate in the study as evaluators of the intervention.
Patients and Eligibility Criteria
Several reasons supported the patient selection criteria including our objective to include a relatively small, however homogeneous patient population that has also been identified in the medical literature as a frequently neglected group of patients [33]. In addition, HTN and T2DM were found to be the most common diseases in the primary care system of Cyprus [21]. These health problems often occur in a concurrent fashion and lead to serious complications that may not be optimally treated [34, 35]. Finally, despite recommendations for more aggressive hypertension therapy in the presence of coexisting diabetes, it is unclear whether there are any differences in how clinicians manage blood pressure in hypertensive patients with or without diabetes [36].
Study Design
The proposed model was planned to be evaluated through a community-based open-label intervention control trial comparing regular practice to an EMR-enhanced practice aided by chronic disease management based on standard clinical guidelines. The design included three phases of evaluation including: (a) a baseline assessment, (b) an end of follow-up comparison and (c) an 18-month post intervention evaluation. A window of 3 months run-in-phase was planned for the eligible patients to enter the study. Due to the possibility that deviations from the protocol during the intervention could impact the validity of the trial, we proposed the proper handling and reporting of any non-adherence to the protocol events. In addition, our study design included process and outcome evaluation as depicted in Figure 1[37, 38], along with a brief economic analysis (accumulated cost of the personnel, equipment and the intervention itself).
Process Evaluation
Structured forms
The facilitators were expected to complete two structured forms: monthly reports (MR) and outreach visits reports (OVR), which were developed based on previous report from the literature [39]. Monthly reports were expected to provide detailed information on the recording of visits to a Primary Care Health Center (PCHC), the activities within each PCHC, the outcomes of those activities, the number of hours spent for both on-site and off-site activities, the implementation of guidelines in clinical practice and the utilization of the EMR including problems and barriers during its implementation.
Interviews and Audit
Apart from the above reports, the facilitators were scheduled to meet with the PCPs and the nurses at 6-month and 18-month follow-up visits in order to conduct semi-structured face-to-face interviews as well as focus group sessions at baseline and end of follow-up. The health professionals were expected to provide information on their overall satisfaction with the intervention, the experiences and potential barriers in the implementation of the study as well as their suggestions for improvements. At the end of the 6-month follow-up period, quality indicators audit were scheduled to be conducted in the intervention PCHCs. Additionally, semi-structured interviews of randomly selected patients from the intervention PCHCs were expected to take place at the end of the 18-month study period.
Outcome Evaluation
The outcome evaluation of our intervention included the quality indicators for the selected illnesses along with validated instruments measuring patients' opinion. Quality indicators included specific and measurable elements of practice that can be used to assess the quality of care [40]. A set of quality indicators was developed by combining experts' opinion with current scientific evidence. Quality indicators for diabetes included fasting blood sugar, levels of HbA1c, blood pressure (BP), body mass index (BMI), lipid profile (TC, HDL-C, LDL-C, TG), microalbuminuria, fundal and feet examination, and prevalence of smoking. Hypertension quality indicators included: blood pressure measurement (SBP, DBP), BMI, lipid profile and prevalence of smoking.
In addition, we used the EUROPEP questionnaire, distributed to all patients from the intervention and control PCHC, to evaluate patients' opinion before and after the intervention [41]. The EUROPEP instrument is a reliable and internationally validated questionnaire that measures patients' satisfaction with respect to the care received and the interpersonal skills of primary care physicians. The Greek version was planned to be used in our study [42] after the appropriate cultural adaptation of the questionnaire as deemed appropriate for Cyprus.
Statistical Analyses
Summary statistics were planned to be generated for baseline characteristics and clinical evaluations for each study arm. T-test and chi-square statistics were planned to be used to assess the homogeneity of study arms with respect to baseline characteristics. The primary outcome measure was the improvement in the quality indicators of patients with hypertension and diabetes assessed by three different statistical methods. The first was based on a comparison of patients found to be at target levels based on guideline recommendations, before and after the intervention, a comparison of quality improvement measurements using General Linear Model of Repeated Measures, and finally, the percentage of patients with more than 10% improvement over baseline in selected indicators at the end of follow up, as being consistent with previous work of Majumdar, et al [43].
Quantitative analyses of additional quality indicators included the following variables: monthly visits (total number of visits divided by the duration studied in months), and time to response measures (months until patient achieved target levels for specific indicators). Repeated measures were planned to be analyzed using mixed effects models. Correlations among measurements made on the same subject, were planned to be modeled using random effects and random regression coefficients, and through the specification of a covariance structure. All tests were planned to be two-sided and a level of statistical significance was set at 0.05. All study outcomes were planned to be analyzed on the basis of intention to treat.
Data obtained during the process evaluation would be qualitatively analyzed using audio tapes from face-to-face interviews. Focus groups and personal interview information would be transcribed and a framework approach analysis [44, 45], was planned to be performed based on the five-step approach: familiarization, identifying a thematic framework, indexing, mapping and interpretation.