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PURPOSE: Neither the United States nor the European oncology guidelines include details for appropriate management of hyperglycemia in cancer patients. The aim was to identify fasting and random blood glucose thresholds, and hemoglobin A1c (HbA1c) targets used by oncologists in clinical practice when managing hyperglycemia in patients with cancer undergoing chemotherapy. METHODS: This national, cross sectional study utilized a questionnaire to collect oncologists' perceptions about optimal blood glucose thresholds and HbA1c targets in patients with cancer undergoing chemotherapy. Descriptive statistics were calculated to summarize glucose thresholds, HbA1c targets, and sample characteristics. Responses to an open-ended question about oncologists' approach to hyperglycemia management were analyzed via thematic analysis using an inductive approach. RESULTS: Respondents (n = 229) were on average 52.1 years of age, 67.7% men, and 91.3% White. For patients without diabetes but experiencing hyperglycemia, oncologists targeted lower and upper fasting blood glucose levels between 75-121 mg/dL and 105-135 mg/dL, respectively. For patients with diabetes, the targets for lower and upper fasting blood glucose levels ranged between 100-130 mg/dL and 128-150 mg/dL, respectively. Fasting blood glucose (95.6%) and HbA1c (78.6%) were the most commonly used clinical indicators to consider chemotherapy dose reduction, delay, or discontinuation due to hyperglycemia in patients receiving chemotherapy with curative intent. Among those receiving palliative intent chemotherapy, the preferred clinical parameters were random blood glucose (90.0%), patient-reported blood glucose readings (70.7%), continuous glucose monitoring readings (65.1%), and patient-reported symptoms of hyperglycemia (65.1%). Three main themes emerged about oncologists' approach to hyperglycemia management: 1) identification of high-risk patients; 2) need for early identification, screening, and diagnosis of hyperglycemia; and 3) multiple hyperglycemia management strategies. CONCLUSION: Oncologists reported a wide variation of target blood glucose ranges considered appropriate in patients undergoing chemotherapy. Lack of clear guidance for hyperglycemia management during chemotherapy in the United States may be contributing to a lack of consistency in clinical practice.
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Antineoplásicos , Glucemia , Hemoglobina Glucada , Hiperglucemia , Neoplasias , Oncólogos , Pautas de la Práctica en Medicina , Humanos , Estudios Transversales , Hiperglucemia/inducido químicamente , Masculino , Femenino , Persona de Mediana Edad , Glucemia/análisis , Glucemia/efectos de los fármacos , Hemoglobina Glucada/análisis , Pautas de la Práctica en Medicina/estadística & datos numéricos , Pautas de la Práctica en Medicina/normas , Neoplasias/tratamiento farmacológico , Encuestas y Cuestionarios , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Adulto , Anciano , Estados UnidosRESUMEN
AIMS: Dried blood volumetric absorptive microsamples (VAMS) may facilitate home-based sampling to enhance therapeutic drug monitoring after transplantation. This study aimed to clinically validate a liquid chromatography-tandem mass spectrometry assay using 2 VAMS devices with different sampling locations (Tasso-M20 for the upper arm and Mitra for the finger). Patient preferences were also evaluated. METHODS: Clinical validation was performed for tacrolimus and mycophenolic acid by comparison of paired VAMS and venipuncture samples using Passing-Bablok regression and Bland-Altman analysis. Conversion of mycophenolic acid VAMS to serum concentrations was evaluated using haematocrit-dependent formulas and fixed correction factors defined a priori. Patients' perspectives, including useability, acceptability and feasibility, were also investigated using established questionnaires. RESULTS: Paired samples (n = 50) were collected from 25 kidney transplant recipients. Differences for tacrolimus whole-blood concentration were within ±20% for 86 and 88% of samples from the upper arm and fingerstick, respectively. Using correction factors of 1.3 for the upper-arm and 1.47 for finger-prick samples, 84 and 76% of the paired samples, respectively, were within ±20% for mycophenolic acid serum concentration. Patient experience surveys demonstrated limited pain and acceptable useability of the upper-arm device. CONCLUSIONS: Tacrolimus and mycophenolic acid can be measured using 2 common VAMS devices with similar analytical performance. Patients are supportive of home-based monitoring with a preference for the Tasso-M20 device.
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US Latine adults who prefer the Spanish language for healthcare encounter communication have high risk of health disparitiesm in part from low organizational health literacy, mental health stigma and discrimination. Organizational health literacy includes the provision of culturally responsive, language concordant health information, which supports good comprehension and usefulness and could mitigate some health disparities. We conducted a pilot study to assess commonly provided patient health information handouts about depression treatment and antidepressant consumer medication information sheets. Thirty Latine adults with a Spanish language preference and a history of depression and antidepressant use participated in one phone interview. Descriptive statistics and thematic analysis were used to assess comprehension and usefulness of selected sections extracted verbatim from these documents. Overall, 83% (n = 25) participants reported that all sections were easy to understand, and 97% (n = 29) said that they were useful. Yet, responses to open-ended questions for 53% (n = 16) of participants revealed 'confusing' terminology in at least one section, and 10% (n = 3) expressed concerns about or misunderstood an idiomatic phrase as reinforcing mental health stigma. The seriousness of the organizational health literacy-based issues identified in this and previous studies require that government and health service organizations make necessary and timely revisions to address them.
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Comprensión , Depresión , Alfabetización en Salud , Hispánicos o Latinos , Lenguaje , Humanos , Femenino , Adulto , Persona de Mediana Edad , Proyectos Piloto , Hispánicos o Latinos/psicología , Masculino , Antidepresivos/uso terapéutico , Estigma Social , Entrevistas como AsuntoRESUMEN
INTRODUCTION: Targeted oral anticancer agents (OAAs) are increasingly used to treat cancer, including haematological malignancies and ovarian cancer, but they can cause serious symptomatic side effects such as arrhythmias, hypertension, and hyperglycaemia. Unaddressed OAA symptoms or inadequately managed symptoms may also lead to unnecessary and unscheduled healthcare use that decreases patient quality of life and financially burdens both patients and the healthcare system. Limited information is available about patient symptoms, self-management behaviours, and use of healthcare services over time while taking targeted OAAs, but is needed to ensure successful OAA therapy. The primary objective is to understand patient experiences and behaviours on initiating targeted OAA, and elicit cancer care clinicians' (ie, physicians, advanced practice practitioners, nurses, and pharmacists) perspectives on supporting patients during therapy. Study results will inform comprehensive and realistic interventions that minimise disruptions to therapy while maximising quality of life. METHODS AND ANALYSIS: We will conduct a remote single-arm, convergent-parallel mixed-methods cohort study within a large academic medical centre. A minimum of 60 patients will be enrolled. Patients will complete several validated patient-reported outcome measures at six timepoints over 6 months. Mixed-effects logistic regression will be used to predict the primary binary outcome of unscheduled healthcare use by patient self-efficacy for symptom self-management. Semistructured interviews will be conducted with patients and clinicians and thematically analysed. Triangulated quantitative and qualitative results will be reported using cross-case comparison joint display. ETHICS AND DISSEMINATION: This study protocol is approved by the Institutional Review Board of University of Michigan Medical School (IRBMED). Study results will be published in peer-reviewed journals, presented at conferences, and disseminated to study participants.
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Antineoplásicos , Automanejo , Humanos , Calidad de Vida , Estudios de Cohortes , Atención a la Salud , Antineoplásicos/uso terapéuticoRESUMEN
BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.
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Diabetes Mellitus , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Medicare Part D , Anciano , Adulto , Humanos , Estados Unidos , Estudios Retrospectivos , Antihipertensivos/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Cumplimiento de la Medicación , Diabetes Mellitus/tratamiento farmacológico , EnvejecimientoRESUMEN
BACKGROUND: Medication use for depression among US Latinx adults is low (34%) and commonly associated with systems-related and individual-related cultural factors. Social determinants of health (SDH) include economic, environmental, educational, community, and healthcare systems factors. Ethnic determinants of health (EDH) are SDH factors specific to an ethnic group and described by an ethnic and disparities framework. OBJECTIVE: To assess relationships between EDH factors and depression medication use among non-Latinx White (NLW) and Latinx adult populations using data from a weighted national sample for hypothesis building. METHODS: Weighted responses to 2015-2018 National Survey on Drug Use and Health surveys from NLW, Latinx, and Latinx adult respondents from Puerto Rico, Mexico, and other Latinx countries were compared. Bivariate analyses were conducted using 2-way cross tabulation and a Wald chi-square test of association. EDH variables were characterized within the construct domains of systems-related geographic location, education, and economic stability, and individual-related cultural factors. RESULTS: Prescription medication use for depressive symptoms is 16.6% (P < 0.05) lower among a national sample of Latinx compared with NLW adults with major depressive episode (MDE). Many differences among systems-level EDH variables between Latinx and NLW populations with MDE were also found between populations with depression medication use. Of note, seeing a primary care provider or psychologist or social worker was significantly different among populations with MDE but not for those with depression medication use. Individual-related cultural EDH variables of overall health and serious psychological distress were significantly worse for Latinx than NLW populations with depression medication use. However, stigma, healing beliefs, and religious beliefs were not different between populations with MDE or depression medication use. Differences between certain Latinx populations with depression medication use were found with limited English proficiency and living in poverty. EDH variables for environment-physical characteristics or community and interpersonal levels of analysis were not represented within the NSDUH survey. CONCLUSION: Seeing a primary care provider or behavioral health specialist, depression severity, and overall health status appear to be important factors related to depression medication use among Latinx adults. Given the limitations of these analyses, multivariate analyses of EDH factors and other Latinx populations are warranted.
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Trastorno Depresivo Mayor , Adulto , Humanos , Depresión , Etnicidad , Hispánicos o Latinos/psicología , Puerto Rico , BlancoRESUMEN
PURPOSE: Oral anti-cancer agents (OAAs) represent a new frontier in cancer treatment, but we do not know how well patients incorporate the strategies that they are taught for managing the side effects of OAAs into their daily lives. The purpose of this study was to understand how OAA side effects influenced patients' lives and what strategies patients used to manage them. METHODS: The study used an interpretive descriptive design utilizing photo elicitation interviews (PEI). Two pharmacists employed at the study ambulatory oncology clinic assisted with recruitment. Participants took photos and subsequent interviews focused on talking to participants about each photo, eliciting participant perspectives describing side effects of OAAs and management strategies. A directed content analysis approach was used to analyze the transcribed interviews. RESULTS: A total of nine participants were included in the study. Three themes and associated sub-themes emerged: making changes to nutritional habits due to OAA side effects (hydration and food), strategies to alleviate OAA side effects (medication and non-medication related), and methods of coping with OAA effects (intra- and interpersonal). Changing nutritional habits was an important strategy to manage OAA side effects. Medication-related strategies to alleviate OAA side effects could be nuanced and, additionally, there was wide variability in coping methods used. CONCLUSION: Patient education on OAAs and side effects is not always tailored to each unique patient and their circumstances. This study uncovered how participants devised their own distinct strategies to prevent or manage OAA side effects in an effort to help improve patients' experiences when taking OAAs.
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Antineoplásicos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Proyectos Piloto , Adaptación Psicológica , Instituciones de Atención Ambulatoria , Evaluación del Resultado de la Atención al PacienteRESUMEN
Background: Telemonitoring of blood pressure (BP) may improve BP control. However, many patients are not using BP telemonitoring due to personal, technological, and health system barriers. Individuals are required to have electronic health literacy (e-HL), defined as knowledge and skills to use technology services effectively, such as BP telemonitoring. Objective: The objective was to determine the facilitators and barriers experienced by patients with hypertension in telemonitoring of BP using the e-HL framework (e-HLF). Methods: This study was a prospective mixed-methods study using a convergent design. We recruited a convenience sample of 21 patients with hypertension. The qualitative section was online or phone individual in-depth interviews based on the e-HLF, which has seven domains. The quantitative section was an online survey consisting of demographics, an e-HL questionnaire, and patient-provider communication preferences. A joint display was used in the mixed-methods analysis. Results: Five themes including knowledge, motivation, skills, systems, and behaviors along with 28 subthemes comprising facilitators or barriers of BP telemonitoring were identified. The mixed-methods results showed concordance between the participants' e-HL status and their experiences in the ability to actively engage with BP monitoring and managing digital services (domain 3) of the e-HLF. Other e-HL domains showed discordance. Conclusion: Patients may engage with BP telemonitoring when they feel the usefulness of concurrent access to telemonitoring services that suit their needs.
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PURPOSE: To assess oncologists' responsibility, comfort, and knowledge managing hyperglycemia in patients undergoing chemotherapy. METHODS: In this cross-sectional study, a questionnaire collected oncologists' perceptions about professionals responsible for managing hyperglycemia during chemotherapy; comfort (score range 12-120); and knowledge (score range 0-16). Descriptive statistics were calculated including Student t-tests and one-way ANOVA for mean score differences. Multivariable linear regression identified predictors of comfort and knowledge scores. RESULTS: Respondents (N = 229) were 67.7% men, 91.3% White and mean age 52.1 years. Oncologists perceived endocrinologists/diabetologists and primary care physicians as those responsible for managing hyperglycemia during chemotherapy, and most frequently referred to these clinicians. Reasons for referral included lack of time to manage hyperglycemia (62.4%), belief that patients would benefit from referral to an alternative provider clinician (54.1%), and not perceiving hyperglycemia management in their scope of practice (52.4%). The top-3 barriers to patient referral were long wait times for primary care (69.9%) and endocrinology (68.1%) visits, and patient's provider outside of the oncologist's institution (52.8%). The top-3 barriers to treating hyperglycemia were lack of knowledge about when to start insulin, how to adjust insulin, and what insulin type works best. Women (ß = 1.67, 95% CI: 0.16, 3.18) and oncologists in suburban areas (ß = 6.98, 95% CI: 2.53, 11.44) had higher comfort scores than their respective counterparts; oncologists working in practices with > 10 oncologists had lower comfort scores (ß = -2.75, 95% CI: -4.96, -0.53) than those in practices with ≤ 10. No significant predictors were identified for knowledge. CONCLUSION: Oncologists expected endocrinology or primary care clinicians to manage hyperglycemia during chemotherapy, but long wait times were among the top barriers cited when referring patients. New models that provide prompt and coordinated care are needed.
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Hiperglucemia , Insulinas , Neoplasias , Oncólogos , Masculino , Humanos , Femenino , Persona de Mediana Edad , Estudios Transversales , Oncología Médica , Neoplasias/tratamiento farmacológico , Encuestas y Cuestionarios , Hiperglucemia/inducido químicamente , Hiperglucemia/prevención & control , Actitud del Personal de Salud , Pautas de la Práctica en MedicinaRESUMEN
BACKGROUND: Rural older adults are at risk of readmissions and medication-related problems after hospital discharge. OBJECTIVES: This study aimed to compare 30-day hospital readmissions between participants and nonparticipants and describe medication therapy problems (MTPs) and barriers to care, self-management, and social needs among participants. PRACTICE DESCRIPTION: The Michigan Region VII Area Agency on Aging (AAA) Community Care Transition Initiative (CCTI) for rural older adults after hospitalization. PRACTICE INNOVATION: Eligible AAA CCTI participants were identified by an AAA community health worker (CHW) trained as a pharmacy technician. Eligibility criteria were Medicare insurance; diagnoses at risk of readmission; length of stay, acuity of admission, comorbidities, and emergency department visits score more than 4; and discharge to home from January 2018 to December 2019. The AAA CCTI included a CHW home visit, telehealth pharmacist comprehensive medication review (CMR), and follow-up for up to 1 year. EVALUATION METHODS: A retrospective cohort study examined the primary outcomes of 30-day hospital readmissions and MTPs, categorized by the Pharmacy Quality Alliance MTP Framework. Primary care provider (PCP) visit completion, barriers to self-management, health, and social needs were collected. Descriptive statistics, Mann-Whitney U, and chi-square analyses were used. RESULTS: Of 825 eligible discharges, 477 (57.8%) enrolled in the AAA CCTI; differences in 30-day readmissions between participants and nonparticipants were not statistically significant (11.5% vs. 16.1%, P = 0.07). More than one-third of participants (34.6%) completed their PCP visit within 7 days. MTPs were identified in 76.1% of the pharmacist visits (mean MTP 2.1 [SD 1.4]). Adherence (38.2%) and safety-related (32.0%) MTPs were common. Physical health and financial issues were barriers to self-management. CONCLUSION: AAA CCTI participants did not have lower hospital readmission rates. The AAA CCTI identified and addressed barriers to self-management and MTPs in participants after the care transition home. Community-based, patient-centered strategies to improve medication use and meet rural adults' health and social needs after care transitions are warranted.
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Transferencia de Pacientes , Farmacéuticos , Humanos , Anciano , Estados Unidos , Estudios Retrospectivos , Medicare , Alta del Paciente , Readmisión del Paciente , EnvejecimientoRESUMEN
Background: An innovative approach of Norm Balance is proposed under the Theory of Planned Behavior (TPB). In this approach, the measurement score of subjective norm is weighted by the relative importance of others, and the measurement score of self-identity is weighted by the relative importance of self. The study objective was to examine the effect of Norm Balance to predict behavioral intentions in two groups of college students. Methods: Cross-sectional surveys were used in two studies. For 153 business undergraduates, Study 1 examined three common intentions: eating a low-fat diet, exercising regularly, and dressing business-like. For 176 PharmD students, Study 2 examined three pharmacy-related intentions: informing relatives about counterfeit medications, buying prescription medications online, and completing a pharmacy residency. The relative importance of others vs. self was measured by asking study subjects to allocate 10 points between important others and oneself. Two sets of regressions were conducted and compared across six intentions using the traditional model and the Norm Balance model. Results: The 12 regressions explained 59-77% of intention variance. The variance explained by the two models was similar. When subjective norm or self-identity was non-significant in the traditional model, the corresponding Norm Balance component was significant in the Norm Balance model, except for eating a low-fat diet. When both subjective norm and self-identity were significant in the traditional model, the two Norm Balance components were significant in the Norm Balance model with increased coefficients. Conclusions: The proposed approach of Norm Balance provides a different view about the significance and coefficients of subjective norm and self-identity toward intention prediction.
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BACKGROUND: Polypharmacy is highly prevalent among older adults. This study's purpose was to provide nationally representative estimates of self-reported comprehensive medication review (CMR) receipt among older adults and describe factors associated with their receipt, as CMRs are available through the Medicare Part D program. METHODS: This cross-sectional study used data from the National Poll on Healthy Aging (NPHA), a nationally representative online survey of community-dwelling adults aged 50-80, administered in December 2019. Participants included older adults aged 65-80 with any health insurance (n = 960). Outcomes were self-reported CMR receipt, awareness of CMR insurance coverage, and interest in a future CMR with a pharmacist. Sociodemographic and health-related variables were included. Descriptive statistics and multivariable logistic regression with NPHA population sampling weights were used. RESULTS: Among older adults on 2 or more prescription medications, only 20.8% had received a CMR while 34.3% were interested in a future CMR. Among individuals who had not received a CMR, most (83.4%) were unaware their insurance might cover a CMR. Factors associated with higher odds of receiving a CMR included taking 5 or more prescription medications (adjusted odds ratio [AOR] = 2.6, 95% CI: 1.59-4.38) and reporting food insecurity (AOR = 2.9, 95% CI: 1.07-7.93). Having fair or poor self-reported physical health was associated with lower odds of receiving a CMR (AOR = 0.49, 95% CI: 0.25-0.97). CONCLUSIONS: Most older adults on 2 or more prescription medications with health insurance had not received a CMR and many were interested in one. Targeted strategies to increase older adults' awareness and receipt of CMRs are warranted.
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Medicare Part D , Medicamentos bajo Prescripción , Humanos , Anciano , Estados Unidos , Administración del Tratamiento Farmacológico , Estudios Transversales , Revisión de Medicamentos , Medicamentos bajo Prescripción/uso terapéuticoRESUMEN
The Multi-Professional Oncology Safety and Simulation Training (MOSST) program, supported by the National Cancer Institute was launched in Fall 2018. The original workshop was conducted in person. As the COVID pandemic hit the program was transitioned to an online/distance simulation program using best practices in healthcare simulation design and implementation. The full day workshop was moved to an online platform using Zoom and the in-person simulations were re-developed as video branching case simulations. Learner outcomes that were identical in each modality were evaluated using the evaluation metrics from the original workshop. The use of a distance simulation modality to deliver the MOSST workshop resulted in a high-quality educational experience for the learners and the educational outcomes were comparable to the in-person version. Distance simulation using virtual unfolding case studies and didactic content showed comparable subjective and objective outcomes from participating learners. This work adds to the developing body of research on distance simulation.
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PURPOSE: A focus on oral medications for patients receiving care from both oncologists and primary care providers elicits an opportunity for improvement in patient outcomes. The purpose of this pilot study was to explore the feasibility and appropriateness of a comprehensive medication review (CMR) by a primary care pharmacist in a population of patients with cancer and chronic conditions. METHODS: Adult patients who received both cancer and primary care at Michigan Medicine, received active systemic cancer treatment, and had a comorbid condition of diabetes, hypertension, chronic heart failure, depression, and/or anxiety were eligible to receive a CMR by the primary care clinical pharmacist. Data collected included number eligible for the CMR (feasibility), patient demographics, medication-related problems (MRPs) and medication interventions (appropriate), number of patients requiring follow-up with the clinical pharmacist or physician, and pre/post-intervention changes in A1c and BP, as applicable. RESULTS: Of the 96 patients that met inclusion criteria, 55 patients (57%) received a CMR. Pharmacists provided 66 instances of patient education and identified 22 medication-related problems (MRPs) in 15 (27%) of patients. After CMRs were completed, 22 patients (40%) were referred to primary care pharmacists or physician providers for ongoing care. CONCLUSION: A CMR was feasible and appropriate for patients with chronic conditions receiving treatment for cancer.
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Administración del Tratamiento Farmacológico , Neoplasias , Adulto , Humanos , Proyectos Piloto , Estudios de Factibilidad , Revisión de Medicamentos , Farmacéuticos , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológicoRESUMEN
Improvements in chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) treatment options have increased the 5-year survival rates for patients with these hematologic malignancies. In addition to cancer management, these patients may need help to manage multiple chronic conditions (MCC). The overall objective of this study is to examine the impact and implementation of a model that coordinates care between oncology and primary care pharmacists for people taking an oral anti-cancer agent (OAAs) and medications for comorbid chronic conditions. This is a multi-center, prospective, single-arm pilot study that will recruit up to 40 patients from Michigan Medicine and Vanderbilt University Medical Center (VUMC). Eligible participants will be 18 years of age or older, prescribed an OAA, have a diagnosis of either CML, CLL or MM, and be diagnosed with and taking medication for at least two specified chronic conditions. The Pharmacists Coordinated Care Oncology Model (PCOM) is a two-month intervention that builds upon current pharmacist clinical responsibilities. Generally, participants will complete a patient-reported outcome measure at 2 and 6 weeks post-OAA initiation that is sent to their oncology pharmacist, and they will also receive a comprehensive medication review at week 4 from a primary care pharmacist for their chronic medications. The pharmacists will communicate about the results via electronic medical record (EMR) and intervene if necessary. The primary endpoints are (1) dose-adjusted OAA proportion of days covered (PDC), and (2) PDC for chronic condition medications. PDCs will be determined via prescription records. The association of OAA and chronic medication PDCs will be quantified via correlation and chi-squared tests. The association between symptom experience and OAA adherence will be examined via correlation analyses. For implementation, characteristics of patient participants, feasibility, acceptability, adoption, fidelity, and trialability will be described. Data will be collected via EMR and pharmacist and patient interviews. Median/IQR for acceptability, adoption and fidelity will be reported, and patient interviews will be analyzed using a grounded theory approach and pharmacist interviews will be analyzed using thematic analyses.
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Importance: Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment. Objectives: To determine if a CBT-CP program that personalizes patient treatment using reinforcement learning, a field of artificial intelligence (AI), and interactive voice response (IVR) calls is noninferior to standard telephone CBT-CP and saves therapist time. Design, Setting, and Participants: This was a randomized noninferiority, comparative effectiveness trial including 278 patients with chronic back pain from the Department of Veterans Affairs health system (recruitment and data collection from July 11, 2017-April 9, 2020). More patients were randomized to the AI-CBT-CP group than to the control (1.4:1) to maximize the system's ability to learn from patient interactions. Interventions: All patients received 10 weeks of CBT-CP. For the AI-CBT-CP group, patient feedback via daily IVR calls was used by the AI engine to make weekly recommendations for either a 45-minute or 15-minute therapist-delivered telephone session or an individualized IVR-delivered therapist message. Patients in the comparison group were offered 10 therapist-delivered telephone CBT-CP sessions (45 minutes/session). Main Outcomes and Measures: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ; range 0-24), measured at 3 months (primary end point) and 6 months. Secondary outcomes included pain intensity and pain interference. Consensus guidelines were used to identify clinically meaningful improvements for responder analyses (eg, a 30% improvement in RMDQ scores and pain intensity). Data analyses were performed from April 2021 to May 2022. Results: The study population included 278 patients (mean [SD] age, 63.9 [12.2] years; 248 [89.2%] men; 225 [81.8%] White individuals). The 3-month mean RMDQ score difference between AI-CBT-CP and standard CBT-CP was -0.72 points (95% CI, -2.06 to 0.62) and the 6-month difference was -1.24 (95% CI, -2.48 to 0); noninferiority criterion were met at both the 3- and 6-month end points (P < .001 for both). A greater proportion of patients receiving AI-CBT-CP had clinically meaningful improvements at 6 months as indicated by RMDQ (37% vs 19%; P = .01) and pain intensity scores (29% vs 17%; P = .03). There were no significant differences in secondary outcomes. Pain therapy using AI-CBT-CP required less than half of the therapist time as standard CBT-CP. Conclusions and Relevance: The findings of this randomized comparative effectiveness trial indicated that AI-CBT-CP was noninferior to therapist-delivered telephone CBT-CP and required substantially less therapist time. Interventions like AI-CBT-CP could allow many more patients to be served effectively by CBT-CP programs using the same number of therapists. Trial Registration: ClinicalTrials.gov Identifier: NCT02464449.
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Dolor Crónico , Terapia Cognitivo-Conductual , Telemedicina , Inteligencia Artificial , Dolor Crónico/psicología , Dolor Crónico/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Dirigida al Paciente , Resultado del TratamientoRESUMEN
BACKGROUND: Primary care may offer innovations in delivering comprehensive medication reviews (CMRs). OBJECTIVES: This study aimed to (1) describe innovations to improve delivery and impact of CMR, (2) quantify CMR completion rates and patient satisfaction, and (3) characterize medication changes and impact on medication costs. PRACTICE DESCRIPTION: Board-certified ambulatory care pharmacists with collaborative practice agreements embedded in primary care provided CMRs in 5 clinics for eligible university prescription plan retirees. PRACTICE INNOVATION: Innovations included (1) physician review of potential CMR recipient list, (2) use of trained student pharmacists to recruit and set up CMR visits, (3) use of clinical information in a standardized CMR 2-visit approach by embedded pharmacists, and (4) enrollment into disease management programs or referrals to other providers. EVALUATION METHODS: Data from a retrospective cohort were collected. The CMR completion rate and therapeutic interventions were documented. Prescription fill data were available for 6 months before and after the CMR. An anonymous survey assessed patient satisfaction. Frequencies and descriptive statistics characterized completion rate, interventions, and patient satisfaction. The median cost to the plan of deleted versus added medications and per member per month total drug costs before and after the CMR were compared. RESULTS: Among 729 beneficiaries screened, 489 were eligible and 223 (46%) received a CMR. There were 388 medication interventions: the most common intervention was to delete medications (41.0%). One in 4 was enrolled into the pharmacists' disease management programs. Individuals reported 4.68 (SD 0.67) of 5 for helpfulness of the CMR. The ratio of median costs for medication deletions versus additions was $1.46 vs. $1.00. CONCLUSION: Innovations to deliver CMRs capitalized on well-established physician-pharmacist relationships and nonpharmacist personnel to recruit and prepare the intake. Almost half of eligible beneficiaries received a CMR, and the CMRs were impactful for patients and payers. The most prevalent intervention was to discontinue medications for efficacy reasons.
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Medicare Part D , Farmacéuticos , Humanos , Revisión de Medicamentos , Administración del Tratamiento Farmacológico , Preparaciones Farmacéuticas , Atención Primaria de Salud , Estudios Retrospectivos , Estados UnidosRESUMEN
BACKGROUND: The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE: The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions. METHODS: A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group ("app group") used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group ("no-app group") received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions. RESULTS: A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks. CONCLUSIONS: The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510.
Asunto(s)
Insuficiencia Cardíaca , Aplicaciones Móviles , Enfermedad Crónica , Insuficiencia Cardíaca/terapia , Humanos , Recurrencia Local de Neoplasia , Calidad de VidaRESUMEN
Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Actitud del Personal de Salud , Sistema Enzimático del Citocromo P-450/genética , Depresión/tratamiento farmacológico , Pruebas de Farmacogenómica/estadística & datos numéricos , Adulto , Trastorno por Déficit de Atención con Hiperactividad/genética , Depresión/genética , Femenino , Humanos , Masculino , Salud Mental , Persona de Mediana EdadRESUMEN
Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients' concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.