Cost-Effectiveness Analysis: Personal Systems Approach in Improving Medication Adherence in Adult Kidney Transplant Patients.

ABSTRACT: Interventions to improve medication nonadherence in transplantation have recently moved from a focus on motivation and intention, to a focus on person-level quality improvement strategies. These strategies link adherence to established daily routines, environmental cues, and supportive people. The objective of this evaluation was to estimate the cost of implementation and the cost-effectiveness of a person-level intervention shown to increase medication adherence. To estimate the intervention costs, a direct measure microcosting approach was used after key informant interviews with project champions and a review of implementation expenditures. Cost-effectiveness was calculated by comparing the incremental implementation costs and healthcare costs associated with nonadherence to the incremental percent adherent, defined as the percent of patients who took greater or equal to 85% of their medication doses, for each pairwise comparison. The intervention was low-resource to implement, costing approximately $520 to implement per patient, and was associated with significant improvements in medication adherence. These implementation costs were more than outweighed by the expected healthcare savings associated with improvements in adherence. This person-level intervention is a low-cost, efficacious intervention associated with significant statistical and clinical improvements in medication adherence in adult kidney transplant recipients.

A Pilot Randomized Controlled Trial Using SystemCHANGE™ Approach to Increase Physical Activity in Older Kidney Transplant Recipients.

BACKGROUND: Cardiovascular disease is the leading cause of death in kidney transplant recipients. Physical activity after transplant is the most modifiable nonpharmacological factor for improving cardiovascular outcomes. Few studies have tested walking interventions to enhance daily steps and health outcomes in older kidney recipients. METHODS: Using a pilot feasibility randomized clinical trial design, we tested the feasibility and efficacy of a 6-month SystemCHANGE™ (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention for recruitment, retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function). The SystemCHANGE™ + Activity Tracker intervention taught participants to use a multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker to achieve daily step goals. RESULTS: Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group. The study protocol was feasible to deliver with high adherence to the protocol in both groups. The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283, P = .03) compared to the control group. The secondary outcome of heart rate decreased for the intervention group (baseline [mean] 74.4+ 10.8 [standard deviation, SD;] vs 6 months [mean] 67.6+ 11.3 [SD]; P = .002) compared to the control group (baseline [mean] 70.67+ 10.4 [SD]; vs 6 months [mean] 70.2 + 11.1 [SD]; P = .83). CONCLUSIONS: SystemCHANGE™ + Activity Tracker intervention appears to be feasible and efficacious for increasing daily steps in older kidney recipients.

Improving medication adherence and outcomes in adult kidney transplant patients using a personal systems approach: SystemCHANGE™ results of the MAGIC randomized clinical trial.

This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.

Recruitment of Older Kidney Transplant Recipients to a Longitudinal Study.

BACKGROUND: Currently, limited information is available regarding selection of the most successful strategies for recruitment of older adult kidney transplant recipients as research participants. OBJECTIVE: The aim of this study was to explore multiple modes of recruitment strategies to enroll older kidney transplant recipients in a 1-year longitudinal study. METHODS: We used a feasibility design to explore the following recruitment methods: face-to-face contact in the transplant clinic, paper flyers placed in the transplant clinic, Facebook, an online transplant newsletter, and a university website listing of research studies. RESULTS: Enrollment was open for 9 months, during which time websites and the Facebook portal were active, 142 newsletters were e-mailed, and 424 patients were approached in the transplant clinic. Among patients approached in the clinic, 12 did not own a smartphone required for the study. The sample consisted of 60 participants (39 men, 21 women), with a mean age of 64.5 ± 4.7 years. Of the participants who enrolled in the study, the largest number (75%, n = 45) was recruited using the face-to-face method in the transplant clinic. The online transplant newsletter was the second-best recruitment source (18%, n = 11). DISCUSSION: Recruitment strategies using face-to-face contact and the online newsletter associated with the transplant clinic organization appeared to be more effective than strategies not associated with the transplant clinic (Facebook and university website). Findings suggest that using a familiar organization communication method to recruit older chronic disease population may be the most beneficial.

Improvement of Immunosuppressive Medication Adherence Using a SystemCHANGE Intervention: Case Study of an Older Adult Kidney Transplant Recipient.

This article reports a case study of an older adult kidney transplant recipient with poor medication adherence enrolled in an innovative six-month SystemCHANGE intervention that seeks to systematically improve medication adherence by identifying and shaping routines, involving others in routines, and using medication-taking feedback through small, patient-led experiments. Medication adherence increased immediately and was sustained throughout the intervention and maintenance phases. This is the first case study to demonstrate effectiveness of the SystemCHANGE intervention for promoting medication adherence in a kidney transplant recipient. The intervention improved the timing of doses by linking them to a regularly occurring behavior and providing feedback. The SystemCHANGE intervention represents a systems-thinking approach for both provider and patients, and gives healthcare providers the tools needed to assist patients in using habits and routines, and feedback to improve medication taking and timing.

An Exploratory Correlational Study in the Use of Mobile Technology Among Adult Kidney Transplant Recipients.

INTRODUCTION: Rapidly growing use of mobile technology provides a platform for self-management of care support for those with chronic conditions. Few studies have explored the characteristics or access patterns of kidney transplant recipients who use mHealth applications (apps) for self-management of care. RESEARCH QUESTIONS: The primary aim of this study was to describe demographics, use, barriers, and perceptions of mobile apps for self-management of care among adult kidney transplants recipients. The secondary aim was to compare blood urea nitrogen, glomerular filtration rate, and number of hospitalizations among mHealth app users, other app users, and non-app users. METHODS: A cross-sectional design was used to administer the Mobile Application Use among Kidney Transplant Recipients Questionnaire. Descriptive statistics, χ2 statistics, and analysis of variance were used for the primary aim and linear regression was used for the secondary aim. RESULTS: The sample included mostly African American males (n = 123, 75.5%) with a mean age of 50 (13.2) years. Knowledge was the greatest barrier reported by the non-app users (mHealth app users 9%, other app users 12%, non-app users, 49%, P < .001). Significantly fewer hospitalizations were found in the mHealth app users compared to other app users (regression coefficient b = -1.2, standard error [SE] = 0.5) and non-app users ( b = -0.9, SE = 0.6), adjusting for patient demographic and clinical characteristics. DISCUSSION: Findings suggest a relationship may exist between mHealth app use and a decrease in the number of hospitalizations following kidney transplantation.

Students and Faculty Perceptions of an Undergraduate Nursing Research Internship Program.

Nursing students in baccalaureate programs report that research is not visible in practice, and faculty conducting research report rarely interacting with students in undergraduate nursing programs. We examined student and faculty perceptions of a research internship embedded in an existing evidence-based practice course. Students (n = 15) and faculty (n = 5) viewed the internship as a positive experience that provided meaningful hands-on skills while generating interest in a potential research career. The internship also provided faculty the opportunity to identify potential doctoral students.

Merging an Activity Tracker with SystemCHANGE™ to Improve Physical Activity in Older Kidney Transplant Recipients.

Motivational strategies to increase adherence to a long-term physical activity regimen have been unsuccessful for kidney transplant recipients. We propose a theory-based SystemCHANGE™ + Activity Tracker framework. The SystemCHANGE™ + Activity Tracker approach combines small, individual-driven experiments for increasing physical activity with visual feedback from the wireless activity tracker, which enables clients to study their progress in increasing physical activity. The SystemCHANGE™ + Activity Tracker approach is designed to empower kidney transplant recipients to improve and maintain their physical activity behavior.

Cardiovascular mortality among liver transplant recipients with nonalcoholic steatohepatitis in the United States-a retrospective study.

Nonalcoholic steatohepatitis (NASH) has become an increasingly important indication for liver transplantation (LT), and there has been a particular concern of excessive cardiovascular-related mortality in this group. Using the United Network for Organ Sharing-Standard Transplant Analysis and Research (UNOS STAR) dataset, we reviewed data on 56,995 adult transplants (January 2002 through June 2013). A total of 3,170 NASH liver-only recipients were identified and were matched with 3,012 non-NASH HCV+ and 3,159 non-NASH HCV- controls [matched 1:1 based on gender, age at LT (±3 years), and MELD score (±3)]. Cox regression analysis revealed significantly lower hazard of all-cause (HR 0.669; P < 0.0001) and cardiovascular-related mortality (HR 0.648; P < 0.0001) in the NASH compared to the non-NASH group after adjusting for diabetes, BMI, and race. Relative to the non-NASH HCV-positive group, NASH group has lower hazard of all-cause (HR 0.539; P < 0.0001) and cardiovascular-related mortality (HR 0.491; P < 0001). A lower hazard of all-cause mortality (HR 0.844; P = 0.0094) was also observed in NASH patients compared to non-NASH HCV-negative group, but cardiovascular mortality was similar (HR 0.892; P = 0.3276). LT recipients with NASH have either lower or similar risk of all-cause and cardiovascular-related mortality compared to its non-NASH counterparts after adjusting for diabetes, BMI, and race.

Characterization of Body Composition and Fat Mass Distribution 1 Year After Kidney Transplantation.

PURPOSE: In some recipients, significant weight gain occurs after kidney transplantation. Weight gain is associated with poor outcomes, particularly increased cardiovascular risk. In this study, we characterized changes in body mass index and body fat mass and compared them based on gender and race. METHODS: Fifty-two kidney transplant recipients (aged ≥18 years old, 50% men, 58% African American) were enrolled into a prospective study. Body mass index and body fat mass were measured at baseline and 12 months posttransplant. Body fat mass was determined by dual-energy X-ray absorptiometry. RESULTS: The mean increase in body weight was 3.7kg at 12 months; 36.5% (n=19) gained at least 10% of their baseline body weight. Body mass index, percentage of total body fat, and trunk fat were significantly increased. In subgroups, women and African American showed significant increases in body mass index and body fat measures. More participants were classified as obese based on total body fat compared to body mass index. Calories from fat were significantly increased at 12 months and associated with increased body mass index, total body fat, and trunk fat. Days of physical activity were significantly increased. CONCLUSION: Both body mass index and total body fat mass were significantly increased at 12 months following kidney transplantation, especially for women and African Americans. Importantly, more participants were classified as obese based on total body fat compared to body mass index. Relevant nutrition and physical intervention should be provided, and both body mass index and body fat mass should be evaluated when monitoring weight gain.

An Integrative Literature Review of Physical Activity Recommendations for Adult Renal Transplant Recipients.

OBJECTIVE: To establish the current state of knowledge regarding physical activity interventions for adult kidney transplant recipients. DATA SOURCES: A comprehensive literature search was conducted for the years 2009 to 2015 using 5 electronic databases: PubMed, CINAHL, Cochrane Library, Ovid, and ScienceDirect. DATA EXTRACTION: Of the 110 articles identified, only 6 met inclusion requirements. These studies were conducted between 2009 and 2015 and found that weight gain was reported most often within the first year of transplantation and that kidney transplant recipients desired early interventions to help them become more physically active. CONCLUSION: Further research is recommended to design age-appropriate physical activity interventions among this aging population living with a chronic condition known to have a high prevalence of obesity and cardiovascular disease.

MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients.

BACKGROUND: Among adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trial METHODS/DESIGN: We report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are <85 % adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined. DISCUSSION: Based on the large effect size of 1.4 found in our pilot study, intervention shows great promise for increasing adherence. Grounded in the socio-ecological model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating differences between the two groups at the end of the 6-and 12- month phases. Mediators and moderators of medication adherence will be examined. Patient outcomes will be compared and a cost-effectiveness analysis will be conducted. TRIAL REGISTRATION: ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.

An Internet-Assisted Weight Loss Intervention for Older Overweight and Obese Rural Women: A Feasibility Study.

Older Appalachian women are an understudied population with few resources available to prevent obesity and chronic disease. This study explored the feasibility of a 12-week weight loss intervention using Internet technology for older rural Appalachian women. The sample (N = 24) included women 55 years or older recruited from two senior centers in the Appalachian region. The women were randomly assigned to either an Internet program called "Lose It" (Internet program for recording of daily calories and physical activity) or to a daily wellness program (health tips) delivered via e-mail. The mean age of participants was 69 ± 8 years. Their mean body mass index (kg/m) at baseline was 34.2 ± 8. A significant difference (P = .036) was observed between intervention and control group scores on the Social Pressure Subscale. Both groups improved their intake of fruits and vegetables and lost weight from baseline to week 12. Internet weight loss programs appear feasible for older rural women. Internet-delivered weight loss interventions that provide a way to record daily calories, physical activity, and weight may provide a technology platform leading to increased self-efficacy for weight loss.

Measuring Health-Related Quality of Life of Adults With Down Syndrome.

This study examined self- and caregiver-reported health-related quality of life (HRQOL) of 60 adults with Down syndrome (DS) using the QualityMetric Short Form-12 version 2 (SF-12v2). All HRQOL scores exceeded means and fell within one standard deviation of the SF-12v2 normative sample. Similarities between eight self- and caregiver-reported HRQOL scales were found with the exception of role physical scores (impact of health problems on typical accomplishments), which were lower when obtained by caregiver-report. A positive association was found between self- and caregiver-reported physical functioning scores (impact of health problems on physical activity). The SF-12v2 had high construct validity in this study. These findings support the feasibility of measuring HRQOL of adults with DS using self-report rather than reliance on caregiver-report.

A Prospective Study of Depression and Weight Change After Kidney Transplant.

CONTEXT: Kidney transplant recipients have great risk for gaining significant weight (upward of 10 kg) in the first year posttransplant. Clinical depression can occur in response to life situations and is associated with weight gain. OBJECTIVE: To explore the association between demographic characteristics, weight change, and depression posttransplantation. DESIGN: Secondary data analysis on longitudinal data collected for a larger observational study. Demographic characteristics, weight, and Center for Epidemiologic Studies Depression Scale (CES-D) data were obtained at baseline (BL) (time of transplantation), 6, and 12 months posttransplant. The CES-D scores were compared among time points using means, standard deviations, correlations, t tests, and chi-square as well as by multiple regression modeling. SETTING: Regional transplant center in the mid-south United States. PARTICIPANTS: Forty-seven kidney transplant recipients (55% female, 57% African American, mean age 52.5 years). Weight change ranged from -18.1 to +24.8 kg. RESULTS: In all, 62% reported baseline CES-D scores indicative of depression, with lower scores indicating less psychological distress at 6 and 12 months (47% and 49%, respectively). We found no significant differences among CES-D scores at any time point. Regression models found age, race, gender, and weight change to be predictive of CES-D scores at 6 months (P = .04, R (2) = .137). Age was the most influential (P = .008), with older individuals more likely to obtain higher CES-D scores. Since the experience of depression is common at transplant and during the first year, it is important that transplant recipients be evaluated for depression early in the recovery period.

Factors Affecting Health-Related Quality of Life in Children Undergoing Curative Treatment for Cancer: A Review of the Literature.

BACKGROUND: Health-related quality of life (HRQoL) is an important measure to evaluate a child's reported treatment experience. Although there are numerous studies of HRQoL in children undergoing curative cancer treatment, there is limited literature on factors that influence this. OBJECTIVE: To review published studies that describe the HRQoL and associated factors in children undergoing curative cancer treatment. METHOD: Full-text publications in English from January 2005 to March 2013 were searched in PubMed, PsychINFO, and CINAHL for children ≤18 years of age undergoing curative cancer treatment. HRQoL-associated factors were categorized as cancer diagnosis, treatment, child, family, and community. RESULTS: Twenty-six studies met the inclusion criteria. The most frequently used generic and cancer-specific instruments were PedsQL (Pediatric Quality of Life Inventory) Generic and PedsQL Cancer, respectively. Cancer diagnosis and treatment were the most frequently identified variables; fewer studies measured family and community domains. Gender, treatment intensity, type of cancer treatments, time in treatment, and cancer diagnosis were correlated with HRQoL. CONCLUSION: Our study highlights the need to develop interventions based on diagnosis and treatment regimen to improve the HRQoL in children undergoing curative cancer treatment.

A Pilot Study of Demographic and Dopaminergic Genetic Contributions to Weight Change in Kidney Transplant Recipients.

Kidney transplant recipients often experience a significant amount of weight gain in the first year post-transplantation. While demographic factors such as age, race, and sex have been associated with weight gain in this population, these factors do not explain all of the variability seen. A number of studies have suggested that genetics also plays a critical role in weight changes. Recently, alterations in the activity of the neurotransmitter dopamine have been associated with weight change, and gene expression studies in kidney transplant recipients have supported this association. The purpose of this pilot study is to first examine the feasibility and methodology, and then to examine the associations of age, race, sex, and genotype for 13 SNPs and 3 VNTRs in 9 dopaminergic pathway genes (ANKK1, DRD2, DRD3, DRD4, SLC6A3/DAT1, MAOA, MAOB, COMT, CPE) for associations with percent weight change at 12 months post-transplantation. Seventy kidney transplant recipients had demographic and clinical data collected as a part of a larger observational study. DNA was extracted from repository buffy coat samples taken at the time of transplant, and genotyped using Taqman and PCR based methods. Three SNPs were independently associated with percent weight change: ANKK1 rs1800497 (r = -0.28, p = 0.05), SLC6A3/DAT1 rs6347 (p = 0.046), and CPE rs1946816 (p = 0.028). Stepwise regression modelling confirmed the combined associations of age (p = 0.0021), DRD4 VNTR 4/5 genotype (p = 0.0074), and SLC6A3/DAT1 rs6347 CC genotype (p = 0.0009) and TT genotype (p = 0.0004) with percent weight change in a smaller sample (n = 35) of these kidney transplant recipients that had complete genotyping. These associations indicate that there may be a genetic, and an age component to weight changes post transplantation.

Acceptability of wristband activity trackers among community dwelling older adults.

Wristband activity trackers have become widely used among young adults. However, few studies have explored their use for monitoring and improving health outcomes among older adults. The purpose of this study was to evaluate the feasibility and utility of activity tracker use among older adults for monitoring activity, improving self-efficacy, and health outcomes. A 12-week pilot study was conducted to evaluate the feasibility and utility of mobile wristband activity trackers. The sample (N = 34) was 65% women 73.5 ± 9.4 years of age who had a high school diploma or GED (38%) and reported an income ≤$35,000 (58%). Participants completing the study (95%) experienced a decrease in waist circumference (p > 0.009), however no change in self-efficacy. Participants found activity trackers easy to use which contributed to minimal study withdrawals. It was concluded that activity trackers could be useful for monitoring and promoting physical activity and improving older adults' health.

Neurogenetic and Neuroimaging Evidence for a Conceptual Model of Dopaminergic Contributions to Obesity.

As the incidence of obesity continues to rise, clinicians and researchers alike are seeking explanations for why some people become obese while others do not. While caloric intake and physical activity most certainly play a role, some individuals continue to gain weight despite careful attention to these factors. Increasing evidence suggests that genetics may play a role, with one potential explanation being genetic variability in genes within the neurotransmitter dopamine pathway. This variability can lead to a disordered experience with the rewarding properties of food. This review of literature examines the extant knowledge about the relationship between obesity and the dopaminergic reward pathways in the brain, with particularly strong evidence provided from neuroimaging and neurogenetic data. Pubmed, Google Scholar, and Cumulative Index to Nursing and Allied Health Literature searches were conducted with the search terms dopamine, obesity, weight gain, food addiction, brain regions relevant to the mesocortical and mesolimbic (reward) pathways, and relevant dopaminergic genes and receptors. These terms returned over 200 articles. Other than a few sentinel articles, articles were published between 1993 and 2013. These data suggest a conceptual model for obesity that emphasizes dopaminergic genetic contributions as well as more traditional risk factors for obesity, such as demographics (age, race, and gender), physical activity, diet, and medications. A greater understanding of variables contributing to weight gain and obesity is imperative for effective clinical treatment.