Patient self-management in kidney transplantation. definition, measurement, and intervention

While one-year graft survival rates for deceased donor transplants have soared from about 40% in 1975 to more than 90% in 2005 [1], the long-term perspective has changed very little. From 1996-2005, 10-year deceased donor graft survival has remained at about 40%, only slightly above that of the 1987-1995 period [1]. Furthermore, the gain in graft survival between 1988 and 1995, based on calculated real half-lives, has been reported as 4.7 or 8.4 months, for first or further deceased donor transplants, respectively. These numbers reveal that estimates of doubled half-lives rom 1988 to 1995, which were based on projected half-lives, were far from accurate [2]. The remarkable short-term improvements have thus not translated into long-term advantages [1, 2]. Improving long-term post-transplantation outcomes should therefore be a priority of transplant recipient management. Investing in chronic illness management, which focuses on improving patient self-management and medication adherence, is a promising pathway in that direction. Chronic illness management has lately emerged as a response to the reported dramatic global increase in chronic conditions [3]. A chronic condition is defined as one that is never completely cured [4] and that requires ongoing long-term management of the illness, coexisting morbidities, treatments, or measures to prevent further disability [3]. Such management imposes a heavy burden on current health care systems. The gravity of the situation is increased by the application of acute care models (i.e., prioritizing the treatment and cure of peoples’ acute and urgent symptoms), which have limited effects on chronic conditions [3]. Effective chronic care models, i.e., care that improves chronically ill patient populations’ conditions, are characterized by continuity of care, partnership with patients, families, and communities, support for patients in improving self-management skills, attention to preventive measures, decision-making support for healthcare providers, and availability of clinical information systems [3, 5-7]. Empirical evidence underlines the effectiveness of chronic illness management [8-10]. Of these, models that incorporate patient self-management support show the most improved outcomes [3, 7, 11]. Patient self-management refers to actions performed by patients for themselves in daily life to manage their illness and treatment, and to avoid health deterioration [5, 12]. Related support consists of two components: the training of disease specific knowledge and technical skills, and the training of non-disease specific problem solving and other skills to assist behavior change [13]. A growing body of evidence in patients with chronic illness demonstrates that supporting patient self-management positively impacts outcomes [10, 14-19]. An essential component of patient self-management is managing the medical regimen, including adherence, i.e., “the extent to which a person’s behavior (taking medications, following a recommended diet, and/or executing lifestyle changes) corresponds with the agreed recommendations of a healthcare provider” [8]. The scale and impact of medication adherence regarding patient outcomes have been widely demonstrated in chronic patient populations [20-22]. Recent literature reviews regarding kidney transplantation [23-25] demonstrate that non-adherence to immunosuppressive therapy is a major contributor to poor clinical outcomes. Given that inadequate medication adherence has critical implications on health outcomes, focusing prominently on adherence as an essential part of patient self-management is crucial to improve outcomes in the kidney transplant population.
The gaps in the literature guiding this research program were as follow: 1) as no conceptualization was available for patient self-management in the kidney transplant population, it was necessary to define one; 2) little information was available on the diagnostic accuracy of measurement methods to identify medication non-adherence in the kidney transplant population, 3) there was a need to test medication adherence enhancing interventions, as very little information was available on this patient group; and 4) there was a need to evaluate a technological intervention designed for patient use, as such information was lacking.
The work and studies incorporated in this research program to address these gaps used a variety of methods, including both quantitative and qualitative approaches. The studies are summarized as follows. First, a comprehensive definition of kidney transplant recipient self-management has been developed, summarizing evidence from the transplant literature. This definition provides both detailed kidney transplant specific self-management activities and core skills that patients may acquire or further develop for successful self-management. It also provides a conceptual model using a care paradigm that regards the patient as a worker having expertise at managing the illness in daily life. This is a crucial aspect of chronic illness management. The model outlined here can be used as a basis for the development of systematic and comprehensive kidney transplant recipient self-management support. It furthermore constitutes a crucial first step to allow transplant clinics to shift from an acute to a chronic care model for long-term transplant recipient management. Second, the literature summarized current understanding about medication nonadherence, and provided an overview of current knowledge regarding correlates of medication non-adherence, as well as of medication adherence enhancing interventions in the kidney transplant population. Further, to offer a concrete example on how to implement theory based adherence enhancing strategies into an individual situation, it reports on a case study [26]. Third, we used a cross sectional study to test the diagnostic accuracy of immunosuppression assay, patients’ self-reports, clinicians’ collateral reports, and constructed composite adherence scores using electronic monitoring as a reference standard for a convenience sample of 249 kidney transplant recipients (female: 43.4%; mean age 53.6 (SD: 12.7), median 7 years (IQR: 9 years) post-transplantation). Medication non-adherence prevalence, as assessed by electronic monitoring, was 17.3%. Across the measurement methods, prevalence rates varied from 12.4% for self-reports to 38.9% for composite adherence scores. Of all the measures, the composite adherence score yielded both the highest sensitivity (72.1%) and the highest likelihood ratio of a positive test (2.74), while collateral reports of at least three clinicians showed the highest specificity (93.1%). While no measures showed high sensitivity alongside high specificity, combining measures increased diagnostic accuracy, indicating the relevance of combined measures for clinical and research purposes [27]. Fourth, we tested the efficacy of an educational/behavioral intervention and enhanced social support intervention to increase medication adherence in 18 non-adherent renal transplant recipients (age: 45.6±1.2 yr; 78.6% male). Using a pilot randomized controlled trial, the study showed a remarkable decrease in non-adherence in the intervention group (IG, n=6) and in the enhanced standard care group (EUCG, n=12) over the first three months (IG, χ2 =3.97, df=1, p=.04; EUCG, χ2=3.40, df=1, p=.06). The interventions appeared to add further benefit to medication adherence levels in the IG, as the greatest decrease in non-adherence was observed there. This result was not, however, statistically significant (at 90 days:, χ2=1.05, df=1, p=.31), owing to insufficient sample size [28]. Fifth, we tested the content validity and usability of a computer based patient information and education tool (OTISTM), from the perspectives of clinicians and patients. Using qualitative methods and a purposive sample of 8 clinicians and 14 patients, the study identified deviations from current medical practice regarding the content, language, and information structure of OTISTM. Seven of the eight clinicians rated OTISTM as nonrelevant for implementation in clinical practice and all patients encountered usability problems, mostly regarding the program’s interface. Emerging categories from the patients’ perspectives vis à vis content were knowledge acquisition, illness management, and partnership forming. The study demonstrated the need to establish the presented material’s content validity and usability by involving clinicians and patients well before its clinical implementation phase [29]. The results of our research program contribute in five main ways to the evidence base regarding kidney transplant recipients’ self-management, and, more specifically, adherence to post-transplantation medication taking. First, it described, for the first time, a comprehensive kidney transplant recipient self-management model, outlining disease specific activities and non-disease specific patient core skills. Second, it summarized knowledge on current understanding, correlates of medication adherence, and posttransplant adherence enhancing interventions. Third, it added detailed knowledge on diagnostic accuracy of state-of-the art measures to identify medication non-adherence in renal transplant recipients. Fourth, it provided evidence and thus added to the very limited amount of available information, supporting the feasibility of enhancing medication adherence in non-adherent renal transplant recipients using a package of educationalbehavioral interventions and social support. Finally, it suggested that in order to ensure and maximize benefits to its intended users, technological interventions for patient use need to be evaluated with regard to usability and content validity. Future research should focus on further development and testing of the conceptual model presented here, with attention to relationships between the model variables, to develop and evaluate valid kidney transplant recipient self-management measures, and to test whether supporting such self-management results in improved long-term health outcomes.