Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial

Background: Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management. Methods/Design: This 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC + NP) or UHC complemented by an NP plus health coach (UHC + NP + HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients’/caregivers’ ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient’s reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment. Discussion: This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes. Trial registration: ClinicalTrials.gov NCT01918891; Registered 5 August 2013

Correlates to the variable effects of cannabis in young adults: a preliminary study

Background: Cannabis use can frequently have adverse affects in those that use it and these can be amplified by various characteristics of an individual, from demographic and environmental variations to familial predisposition for mental illnesses. Methods: The current study of 100 individuals, who were cannabis users during their adolescence and may still be users, was a survey of the self perceived effects of cannabis and their correlates. A reliable family member was also interviewed for determination of family history of various major mental illnesses and substance use. Results: As many as 40% of cannabis users had paranoid feelings (suspiciousness) when using cannabis, although the most frequent effect was feeling relaxed (46%). Having a familial background for mental illnesses such as depression or schizophrenia did not determine the effects of cannabis nor its pattern of use, although the number of subjects with such a history was small. An age at which an individual began using cannabis did have an effect on how heavily it was used and the heavier the cannabis use, the more likely the individual was also to have had psychotic symptoms after use. There were no sex differences in effects of cannabis. These results are tempered by the reliance on self-report for many of the variables ascertained. Conclusion: Cannabis can frequently have negative effects in its users, which can be amplified by certain demographic and/or psychosocial factors. Thus, users with a specific profile may be at a higher risk of unpleasant effects from cannabis use and caution should be noted when cannabis is administered to young people for medicinal purposes

Implementing a cognitive-behavioral pain self-management program in home health care, part 2: Feasibility and acceptability cohort study

Purpose: The prevalence of pain in older adults receiving home health care is high, yet safety concerns for analgesic therapy point to a need for nonpharmacologic approaches to pain management in this population. The purpose of this study was to determine the feasibility and acceptability to physical therapists (PTs) and patients of a cognitive-behavioral pain self-management (CBPSM) program. Methods: Thirty-one PTs volunteered to participate, completed two 4-hour training sessions, and recruited 21 patients with activity-limited pain who consented to participate in the study. Physical therapists completed pre- and posttest assessments of CBPSM knowledge at the first training session, provided structured survey feedback after the second training session, and responded to a phone survey 3 months after training. Patients provided feedback during weekly phone interviews, while receiving the CBPSM program. Treatment sessions were audiotaped during delivery of the self-management pain protocol. Audiotapes were evaluated by independent raters for program fidelity. Results: Participating PTs were experienced in physical therapy (average 16.5 years) and in home health care (average 11.0 years). Analysis of pre- and posttest data showed that PTs\u27 CBPSM knowledge increased from a pretest mean of 60.9% to a posttest mean of 85.9%. Audiotape analysis indicated 77.7% therapist adherence to the protocol. At 3-month follow-up, 24.0% of therapists continued to use the entire protocol with their patients presenting with activity-limiting pain. Patient data show high rates of patient recall of being taught protocol components, trying components at least once (ranging from 84.4% to 100.0%) and daily use of protocol components (ranging from 47.3% to 68.4%). The percentage of patients finding a technique helpful for pain management ranged from 71.4% to 81.2%. Conclusion: This study offers preliminary data on the use of nonpharmacologic pain self-management strategies by PTs in home health setting. Positive feedback from PTs and patients suggests that the translated protocol is both feasible and acceptable. Copyright © 2013 The Section on Geriatrics of the American Physical Therapy Association

A multi-language qualitative study of limited English proficiency patient experiences in the United States

Objective: The purpose of this study was to understand the limited English proficiency patient experience with health care services in an urban setting in the United States. Methods: Through a narrative analysis approach, 71 individuals who spoke either Spanish, Russian, Cantonese, Mandarin, or Korean shared their experiences through semi-structured interviews between 2016 and 2018. Analyses used monolingual and multilingual open coding approaches to generate themes. Results: Six themes illustrated patient experiences and identified sources of structural inequities perpetuating language barriers at the point of care. An important thread throughout all interviews was the sense that the language barrier with clinicians posed a threat to their safety when receiving healthcare, citing an acute awareness of additional risk for harm they might experience. Participants also consistently identified factors they felt would improve their sense of security that were specific to clinician interactions. Differences in experiences were specific to culture and heritage. Conclusions: The findings highlight the ongoing challenges spoken language barriers pose across multiple points of care in the United States' health care system. Innovation: The multi-language nature of this study and its methodological insights are innovative as most studies have focused on clinicians or patient experiences in a single language

Implementing a cognitive-behavioral pain self-management program in home health care, part 1: Program adaptation

Background and Purpose: Pain is highly prevalent among older adults receiving home care, contributing to disability, increased health care utilization, nursing home placement, and diminished quality of life. Pain is a particular problem in the home care setting, where current approaches are often inadequate, resulting in persistent high levels of pain and disability in this vulnerable population. Cognitive-behavioral approaches to pain management have demonstrated effectiveness in reducing pain intensity and associated disability but have not been systematically implemented in home health care. The purpose of this project was to adapt a communitybased, cognitive-behavioral pain self-management program designed for patients with persistent back pain for implementation by physical therapists (PTs) to use with patients with activity-limiting pain in the home care setting. Methods: In this observational study, 2 groups of PTs practicing in home care were trained in the community-based program and completed surveys and participated in discussions during the training workshops to gather input on the program components perceived to be most helpful for their patients with pain; modifications to the program and the patient education materials for use in home care; and recommendations concerning program training and support required for successful implementation. Data collected during the workshops were summarized and presented to 2 expert panels for additional input and final decisions regarding program adaptations. Results: Seventeen PTs with an average of 16.6 years of practice as a PT received the training and provided input on the community-based program. Program modifications based upon PT and expert panel review included reduction in the number of sessions, deletion of content, modification of the exercise component of the program, revision of patient materials, and modification of therapist training. Discussion/Conclusions: This study successfully adapted a group-based pain management program for implementation by health care providers in a home care setting. The process described here may be useful for other groups planning to implement evidence-based programs in new settings. Part 2 of this study, a companion article in this issue, describes the field-testing of this home-care adapted program. Copyright © 2013 The Section on Geriatrics of the American Physical Therapy Association

Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy

Although there is tremendous interest in stem cell (SC)–based therapies for cardiomyopathy caused by chronic myocardial infarction, many unanswered questions regarding the best approach remain. The TAC-HFT study is a phase I/II randomized, double-blind, placebo-controlled trial designed to address several of these questions, including the optimal cell type, delivery technique, and population. This trial compares autologous mesenchymal SCs (MSCs) and whole bone marrow mononuclear cells (BMCs). In addition, the study will use a novel helical catheter to deliver cells transendocardially. Although most trials have used intracoronary delivery, the optimal method is unknown and data suggest that the transendocardial approach may have important advantages. Several trials support the benefit of SCs in patients with chronic ischemic cardiomyopathy (ICMP), although the sample sizes have been small and the number of trials sparse. After a pilot phase of 8 patients, 60 patients with ICMP (left ventricular ejection fraction 15%-50%) will be randomized to group A (30 patients further randomized to receive MSC injection or placebo in a 2:1 fashion) or group B (30 patients further randomized to BMCs or placebo in a 2:1 fashion). All patients will undergo bone marrow aspiration and transendocardial injection of SCs or placebo. The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy (determined primarily by cardiac magnetic resonance imaging) of BMCs and MSCs administered transendocardially in patients with ICMP