An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania.

BACKGROUND: Chronic psychotic disorders (CPD) impose a particularly significant burden in resource-limited settings. Combining long-acting antipsychotic medication (LAI) with a customized adherence enhancement intervention (CAE-L) has potential to advance care. METHODS: Nineteen adults ≥ age 18 with CPD who self-reported missing ≥20% of antipsychotic medication within the last month were stabilized on oral haloperidol prior to transitioning to monthly haloperidol decanote for 25 weeks. Outcome evaluations were conducted at baseline and Week 25. Primary outcomes were oral medication adherence assessed via the Tablet Routines Questionnaire (TRQ) and LAI injection frequency. Secondary outcomes included CPD symptoms measured by the Brief Psychiatric Rating Scale and Clinical Global Impressions, functioning evaluated using the Social and Occupational Functioning Scale, and medication attitudes assessed with the Drug Attitudes Inventory. RESULTS: Mean sample age was 38.79 (SD = 9.31) with 18 individuals completing the study. There was one serious adverse event, a relapse into substance use, not deemed study-related. Mean endpoint LAI dosage was 65.79 mg (SD = 22.38). TRQ mean scores were 21.84 (SD =13.83) and 12.94 (SD = 11.93) at screen and baseline respectively. For only two individuals who were on concomitant oral medication at 25 weeks, TRQ change was not calculated. LAI injection frequency was 100%. Medication attitudes scores significantly improved from 7.89 (SD = 2.72) to 9.83 (SD = 0.52) (p = .001.) Changes in CPD symptoms and functioning were non-significant. CONCLUSIONS: CAE-L appears to be preliminarily feasible and acceptable in Tanzanians with CPD. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov (NCT04327843) on March 31, 2020.

Playing the numbers: how hepatitis C patients create meaning and make healthcare decisions from medical test results.

In this article we describe how patients assign meanings to medical test results and use these meanings to justify their actions. Evidence is presented from lay interpretations of medical tests for monitoring hepatitis C viral infection (HCV) to show how numeracy becomes embodied in the absence of physical symptoms. Illness narratives from 307 individuals infected with HCV were collected from the internet and analysed qualitatively. As part of standard medical care, chronically infected HCV patients are required to have periodic blood tests for laboratory testing. The lab results are presented numerically and compared with established physiological standards. HCV patients' knowledge and interpretations of test results have important consequences for their health behaviour and their medical decisions. In their stories, the patients described their decisions to begin, delay or stop treatment and developed strategies to alter their diet, exercise and use alternative therapies according to changes in their test result. The perceived meanings of test results are powerful signifiers that are capable of altering the course of HCV patients' illness, lives and stories. An interpretive model of health numeracy has the advantage of promoting understanding between patients and healthcare providers over a model that views innumeracy as a skill deficit.

Modification of an Intervention to Improve Adherence in Adolescents and Young Adults With Bipolar Disorder.

Objective: Managing bipolar disorder (BD) is particularly challenging for adolescents and young adults (AYAs) ages 16 to 21. Few interventions exist that address self-management in AYAs with BD. Thus, this study aimed to modify the customized adherence enhancement behavioral intervention for AYAs through an iterative, patient-centered process. Method: The Obesity-Related Behavioral Intervention Trials (ORBIT) model was used for intervention development. In phase 1a, adherence barriers and facilitators were identified to refine intervention content. Phase 1b occurred following curriculum modification to ensure that the modified intervention was relevant and usable by the target population. Data were collected via focus groups and interviews with AYAs with BD, parents, and providers. Transcripts were analyzed using directed content analysis. Results: Phase 1a included focus groups/interviews with AYAs (n = 10), parents (n = 4), and providers (n = 9) who described the difficulties and successes in managing BD symptoms, improving adherence, and transitioning care from caregivers. Phase 1b included an advisory board composed of 8 phase 1a participants who provided feedback on modified session activities, module delivery, and curriculum. Phase 1b involved usability testing with new participants (n = 8), revealing the need for modifiable language based on developmental level, more engaging visual images, and confirmation that topics were salient to AYAs with BD. Conclusion: Though sample sizes were small and not representative of the population of AYAs with BD, the ORBIT methodology informed the adaptation of the customized adherence enhancement intervention to improve adherence in AYAs with BD. Important next steps are to conduct a pilot randomized clinical trial of customized adherence enhancement for AYAs.

A survey of patients and providers at free clinics across the United States.

This study set out to demonstrate the need for free clinics on a national level, to identify difference among types of free clinics in the US, to identify which services were commonly used, and to determine where else patients would seek care if not at the free clinics. Two separate, distinct surveys were sent out, one to free clinic directors and another to free clinic patients. Chi-squared tests, two tailed t-tests, and percentages were used to describe results and significant differences. 1,114 free clinics were identified in the US. 172 free clinics and 362 patients responded. Most clinics (44%) were independent. A mean of 4,310 annual visits was reported. Most patients used primary care (86%) and pharmacy (80%) services. If the free clinic did not exist, 24% would not seek care, 21% due to cost. Most would seek care at another free clinic (47%), or the emergency room (23%). Most patients were satisfied with their care at the free clinic (97%). Patient satisfaction correlated with use of primary care (P = 0.0143). Most patients (77%) reported greater satisfaction with the care they received at the free clinic than with their prior care. Free clinics provide primary care to a substantial number of uninsured and working poor. They provide an alternative to patients who might otherwise seek primary care in the emergency room. Even with reform of the national health care system, free clinics will provide primary care to millions of uninsured. How they will adapt to provide this care is yet to be seen.

Lay management of chronic disease: a qualitative study of living with hepatitis C infection.

OBJECTIVES: To examine management strategies and goals reported by people diagnosed with chronic hepatitis C. METHODS: We analyzed data from semistructured interviews (N = 42) and from electronic sources [illness narratives (N = 79) and Internet threaded discussions (N = 264)]. Line-by-line coding, comparisons, and team discussions generated catalogs of lay management strategies and goals. We analyzed code-based files to identify informants' selection of specific strategies for each goal. RESULTS: We classified lay management strategies into 3 categories: medical self-care, behavior change, and coping. These strategies were used selectively in addressing multiple goals, categorized as fighting the virus, strengthening the body, and managing consequences. CONCLUSIONS: Results underscore the diversity of strategies for living with a disease characterized by uncertain prognosis and variable expression of symptoms.

Communicating about alcohol consumption to nonharmful drinkers with hepatitis C: patient and provider perspectives.

BACKGROUND: Abstaining from alcohol consumption is generally recommended for patients with Hepatitis C (HCV). However, mixed research findings coupled with a lack of consistent guidelines on alcohol consumption and HCV may influence what healthcare providers tell their HCV patients about drinking. This may be more problematic when advising nonharmful drinkers with HCV, a population for whom consumption would not be a problem in the absence of their HCV diagnosis. OBJECTIVE: This study explores what healthcare providers advise their HCV patients who are drinking alcohol at nonharmful levels about alcohol use and what these patients actually hear. DESIGN: We conducted separate focus groups and interviews about alcohol use and HCV with nonharmful drinkers with HCV (N = 50) and healthcare providers (N = 14) at a metropolitan teaching hospital. All focus groups and interviews were audio-taped, transcribed, and analyzed using NVivo, a qualitative data management and analysis program. RESULTS: We found similar themes about HCV and alcohol consumption (stop completely, occasional drink is ok, cut down, and provision of mixed/ambiguous messages), reported by both providers and patients. Patient respondents who reported hearing "stop completely" were more likely to have had their last medical visit at the gastroenterology (GI) clinic as opposed to the internal medicine (IM) clinic. Furthermore, IM providers were more likely to give their recommendations in "medical language" than were GI providers. CONCLUSIONS: To make the best health-related decisions about their disease, HCV patients need consistent information about alcohol consumption. Departments of Internal Medicine can increase provider knowledge about HCV and alcohol use by providing more education and training on HCV.

Communicating about alcohol consumption to nonharmful drinkers with Hepatitis C: patient and provider perspectives.

BACKGROUND: Abstaining from alcohol consumption is generally recommended for patients with Hepatitis C(HCV). However, mixed research findings coupled with a lack of consistent guidelines on alcohol consumption and HCV may influence what healthcare providers tell their HCV patients about drinking. This may be more problematic when advising nonharmful drinkers with HCV, a population for whom consumption would not bea problem in the absence of their HCV diagnosis. OBJECTIVE: This study explores what healthcare providers advise their HCV patients who are drinking alcohol at nonharmful levels about alcohol use and what these patients actually hear. DESIGN: We conducted separate focus groups and interviews about alcohol use and HCV with nonharmful drinkers with HCV (N=50) and healthcare providers (N=14) at a metropolitan teaching hospital. All focus groups and interviews were audio-taped, transcribed, and analyzed using NVivo, a qualitative data management and analysis program. RESULTS: We found similar themes about HCV and alcohol consumption (stop completely, occasional drink is ok, cut down, and provision of mixed/ambiguous messages), reported by both providers and patients.Patient respondents who reported hearing "stop completely"were more likely to have had their last medical visit at the gastroenterology (GI) clinic as opposed to the internal medicine (IM) clinic. Furthermore, IM providers were more likely to give their recommendations in"medical language" than were GI providers. CONCLUSIONS: To make the best health-related decisions about their disease, HCV patients need consistent information about alcohol consumption. Departments of Internal Medicine can increase provider knowledge about HCV and alcohol use by providing more education and training on HCV.

Developing a mentorship program for clinical researchers.

INTRODUCTION: In academic health centers, the number of physician investigators and the number of research studies headed by clinicians has been declining. The U.S. Institute of Medicine and the National Institutes of Health suggest improved mentoring is important to reversing these trends. METHODS: This is a case study review of the role of mentors in developing and sustaining clinical investigators at the Cleveland Clinic. RESULTS: Issues influencing mentoring relationships at the Cleveland Clinic include whether mentoring contracts are formally or informally related and are agreed on; whether there are scheduled meetings for mentors and protégés; whether there are clearly articulated benchmarks and manageable steps; and whether there is a code of mentorship. CONCLUSIONS: Interactive group formats can lead to development of a code of mentorship and increased awareness of faculty regarding clinical investigation.

A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

OBJECTIVES: A 60-week randomized controlled trial assessed the effects of targeted training in illness management (TTIM) versus treatment as usual among 200 individuals with serious mental illness and diabetes mellitus. METHODS: The study used the Clinical Global Impression (CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Brief Psychiatric Rating Scale (BPRS) to assess psychiatric symptoms; the Global Assessment of Functioning (GAF) and the Sheehan Disability Scale (SDS) to assess functioning; the 36-Item Short-Form Health Survey (SF-36) to assess general health, and serum glycosylated hemoglobin (HbA1c) to assess diabetes control. RESULTS: Participants' mean±SD age was 52.7±9.5 years, and 54% were African American. They were diagnosed as having depression (48%), schizophrenia (25%), and bipolar disorder (28%). At baseline, depression severity was substantial but psychosis severity was modest. At 60 weeks, there was greater improvement among TTIM participants versus treatment-as-usual recipients on the CGI (p<.001), the MADRS (p=.016), and the GAF (p=.003). Diabetes knowledge was significantly improved among TTIM participants but not in the treatment-as-usual group. In post hoc analyses among participants whose HbA1c levels at baseline met recommendations set by the American Diabetes Association for persons with high comorbidity (53%), TTIM participants had minimal change in HbA1c over the 60-week follow-up, whereas HbA1c levels worsened in the treatment-as-usual group. CONCLUSIONS: TTIM was associated with improved psychiatric symptoms, functioning, and diabetes knowledge compared with treatment as usual. Among participants with better diabetes control at baseline, TTIM participants had better diabetes control at 60 weeks compared with recipients of treatment as usual.

Menopausal hormone therapy (HT) in patients with breast cancer.

OBJECTIVES: To assess the effect of menopausal hormone therapy (HT) on reoccurrence, cancer-related mortality, and overall mortality after a diagnosis of breast cancer. METHODS: We performed a quantitative review of all studies reporting experience with menopausal HT for symptomatic use after a diagnosis of breast cancer. Rates of reoccurrence, cancer-related mortality, and overall mortality were calculated in this entire group. A subgroup analysis was performed in studies using a control population to assess the odds ratio of cancer reoccurrence and mortality in hormone users versus non-users. RESULTS: Fifteen studies encompassing 1416 breast cancer survivors using HT were identified. Seven studies included a control group comprised of 1998 patients. Among the 1416 HT users, reoccurrence was noted in 10.0% (95% CI: 8.4-11.6%). Cancer-related mortality occurred at a rate of 2.6% (95% CI: 1.8-3.7%), while overall mortality was 4.5% (95% CI: 3.4-5.8%). Compared to non-users, patients using HT had a decreased chance of reoccurrence and cancer-related mortality with combined odds ratio of 0.5 (95% CI: 0.2-0.7) and 0.3 (95% CI: 0.0-0.6), respectively. CONCLUSIONS: In our review, menopausal HT use in breast cancer survivors was not associated with increased cancer reoccurrence, cancer-related mortality or total mortality. Despite conflicting opinions on this issue, it is important for primary care physicians to feel comfortable medically managing the increasing number of breast cancer survivors. In the subset of women with severe menopausal symptoms, HT options should be reviewed if non-hormonal methods are ineffective. Future trials should focus on better ways to identify breast cancer survivors who may safely benefit from HT versus those who have a substantial risk of reoccurrence with HT use.

What women want: understanding obesity and preferences for primary care weight reduction interventions among African-American and Caucasian women.

PURPOSE: To explore attitudes and perceptions of obesity, and identify preferences for weight-management interventions by African-American and Caucasian women who were followed in general internal medicine clinics. PROCEDURE: Surveys exploring these issues were mailed to African-American (n=240) and Caucasian (n=240) women with a BMI of > or =30. MAIN FINDINGS: Caucasian women felt past weight-loss efforts were helped by weight-loss programs significantly more than African-American women (P<0.001); African-American women were more likely to feel that their cultural background contributed to their weight gain than did Caucasian women (P=0.001). African-American women expressed a higher need for one-on-one counseling with their physician (P<0.001) as well as group meetings with the dietician, physician and other women (P=0.004) than did Caucasian women. African-American women also felt it was more important for weight-loss programs to have information on food common to their culture than did Caucasian women (P<0.001). CONCLUSIONS: Differences in cultural background and preferences about weight loss interventions have important policy implications for how the U.S. healthcare system provides care to an ever-increasing multicultural population with a national epidemic such as obesity.

Values and beliefs about obesity and weight reduction among African American and Caucasian women.

Designing culturally relevant weight-reduction programs requires understanding of ethnic variations and illness beliefs. Preliminary data on the values and beliefs about obesity and weight reduction were obtained from women of different ethnic/racial backgrounds. Purposive sampling was used to recruit African American (AA) and Caucasian (C) women with a body mass index (BMI)>or= 30 from the general internal medicine clinics of a large tertiary care facility. Four focus groups (2 with AA women and 2 with C women) consisting of a total of 20 subjects were conducted in a 2-month period. AA women cited culture specific barriers to weight loss more so than did C women. AA women and C women also differed on how health care professionals could help them with weight loss. These findings have implications for nursing's role in the design of culturally relevant weight-loss programs.

Barriers to Self-management of Serious Mental Illness and Diabetes.

OBJECTIVES: Individuals with serious mental illness (SMI) (major depressive disorder, bipolar disorder, schizophrenia), and diabetes (DM), face significant challenges in managing their physical and mental health. The objective of this study was to assess perceived barriers to self-management among patients with both SMI and DM in order to inform healthcare delivery practices. METHODS: We conducted 20 in-depth interviews with persons who had diagnoses of both SMI and DM. All interviews were audiotaped, transcribed verbatim, and analyzed using content analysis with an emphasis on dominant themes. RESULTS: Transcript-based analysis generated 3 major domains of barriers to disease self-management among patients with both DM and SMI: (1) personal level barriers (stress, isolation, stigma); (2) family and community level barriers (lack of support from family and friends); and (3) provider and health care system level barriers (poor relationships and communication with providers, fragmentation of care). CONCLUSIONS: Care approaches that provide social support, help in managing stress, optimize communication with providers, and reduce compartmentalization of medical and psychiatric care are needed to help these vulnerable individuals avoid health complications and premature mortality.

Cultural and clinical issues in the care of Asian patients.

Special problems of Asian patients have considerable impact on diagnosis and treatment, and the number of persons of Asian ancestry seen in primary care in the United States is increasing. Knowledge of how to provide optimal care despite language barriers, low socioeconomic status, different health beliefs and practices, and medical issues unique to this heterogeneous group is crucial to competent health care.

A pilot study of health education via a nurse-run telephone self-management programme for elderly people with osteoarthritis.

We conducted a pilot study of a nurse-run telephone self-management programme for elderly people with osteoarthritis (OA). Thirty-two subjects, aged 60 years or more, with a diagnosis of OA were recruited from two hospital rheumatology clinics and were randomized to a control or intervention group. The intervention group received six weekly mailings of OA health education modules, a relaxation audio-tape and six weekly 45 min follow-up telephone self-management sessions. There was a 100% compliance rate in the intervention group, and all subjects completed baseline and three-month interviews; one subject in each group was lost to six-month follow-up. There were no significant differences in self-management between the control and intervention groups. However, at three months there were improvements in the intervention group (relative to baseline) on some outcome measures. The results suggest that the telephone may be a useful tool for reinforcing health-promoting activities for patients.

Psychosocial correlates of alcohol use and reduction for individuals with hepatitis C.

OBJECTIVE: Patients with hepatitis C virus (HCV) are advised to refrain from alcohol consumption. A questionnaire was developed to measure concepts associated with alcohol use for individuals with HCV. METHOD: Subjects with HCV (N = 527) completed a telephone survey. Eligible respondents had screened negative for current abuse/dependence disorders (Alcohol Use Disorders Identification Test [AUDIT] ≤ 10). Measures of personality, self-efficacy, knowledge, readiness, coping styles, stigma, and symptoms were examined for associations with alcohol use. RESULTS: Factor analysis supported a measurement structure of 105 items in 35 subdomains. A total of 26 subdomains had significant bivariate associations with alcohol use. Higher self-efficacy for resisting drinking in social situations was associated with lower alcohol use (r = -.68, p < .001), as was knowledge of alcohol and HCV (r = -.27, p < .001). Although agreeableness and marital status are typically associated with lower current drinking in samples of those with alcohol use problems, in our study agreeableness (ß = .13, p < .01) and marital status (ß = .08, p < .05) were modestly associated with higher current drinking. The final multivariate R² was .55. CONCLUSIONS: The pattern of associations suggests the importance of the social aspects of drinking for drinking decisions. Existing brief interventions will need to be tailored to a contextualized psychosocial model for medical patients with HCV and AUDIT scores ≤ 10 to optimize effectiveness. Such future interventions should emphasize the potential medical hazards of drinking for persons with HCV, the maintenance of social relationships in the absence of alcohol use, and strategies for building confidence for resisting drinking in specific situations.

Best practices: Optimizing care for people with serious mental illness and comorbid diabetes.

Diabetes and obesity among patients with serious mental illness are common. Use of second-generation antipsychotics compounds risk, and widely prevalent unhealthy behaviors further contribute to negative outcomes. This column describes Targeted Training in Illness Management, a group-based psychosocial treatment that blends psychoeducation, problem identification, goal setting, and behavioral modeling and reinforcement. The intervention has been adapted to the primary care setting and is targeted at individuals with serious mental illness and diabetes. A key feature of the intervention is the use of peer educators with serious mental illness and diabetes to teach and model self-management. Promising results from a 16-week trial are reported.

Alcohol Consumption Decisions among Nonabusing Drinkers Diagnosed with Hepatitis C: An Exploratory Sequential Mixed Methods Study.

Most studies of decisions to curtail alcohol consumption reflect experiences of abusing drinkers. We employ an exploratory sequential research design to explore the applicability of this research to the experience of nonabusing drinkers advised to curtail alcohol consumption after a Hepatitis C diagnosis. A qualitative component identified 17 new decision factors not reflected in an inventory of factors based on synthesis of existing scales. We triangulated qualitative data by supplementing semi-structured interviews with Internet postings. A quantitative component estimated prevalence and association with current drinking of these new decision factors. Patients who quit drinking tended to attribute post-diagnosis drinking to occasional triggers, whereas patients who were still drinking were more likely to endorse rationales not tied to specific triggers.

Alcohol consumption within the context of hepatitis C: a qualitative study of non-problematic drinkers.

AIMS: Little is known about how non-problematic drinkers respond to advice to reduce alcohol consumption as part of disease management. In this article, we examine patient reports of drinking behaviour after being diagnosed with chronic hepatitis C, a condition for which alcohol consumption is contraindicated. METHODS: In this qualitative study, we analyzed transcripts of semi-structured interviews with hepatitis C virus+ (HCV+) patients whose level of alcohol consumption would not be considered problematic in the absence of their diagnosis. RESULTS: Most respondents reported some instances of adherence, but only half adhered to the advice to limit drinking consistently over time. Respondents who did not stop drinking often modified their behaviour by changing the type of alcohol consumed or limiting drinking to particular occasions. CONCLUSION: Most informants understood the risks of drinking after HCV infection, particularly in the presence of symptoms, with the onset of complications, or when undergoing treatment. But some believed they could monitor their bodies for evidence of disease progression or that drinking was acceptable during early, asymptomatic stages of infection. Our results also identified situations in which patients need support in adhering to intentions not to drink, including social pressures, stressful situations, or environmental triggers.