Pharmaceutical Case Management and Living Well with a Disability

描述（由申请人提供）：美国特定州的年龄调整残疾患病率从13.6%到21.8%不等。三分之一到一半的残疾人有药物治疗问题，每年有25%到45%的人有药物不良反应，而且几乎所有人都经常经历至少一种继发性疾病。本随机对照试验的目的是测试为期八周的小组会议健康促进计划与残疾人一起生活（LW）与药物管理（药物病例管理；PCM）的合作护理模式相结合的有效性。我们的理论是，综合干预措施的补充机制将比单独的生活良好计划更能减少次要条件。通过减少继发性疾病的症状，我们的总体目标是改善活动受限患者的健康和生活质量。这项研究在更广泛的人群中扩展和复制了两种有希望的基于证据的干预措施，而不是之前的研究：我们将在252名活动受限的成年人中测试干预措施，这些成年人可能认为自己是残疾人，也可能不认为自己是残疾人。通过结合两种干预措施，本研究还评估了一种新的综合干预措施。我们的主要具体目的是比较随机参加加PCM的生活良好计划的成年人与随机参加传统生活良好计划的成年人以及随机参加无干预对照组的成年人的6个月和12个月继发性疾病的平均症状。次要目的是比较两组患者的用药质量、用药态度和不良反应。通过邮寄一份筛选问卷给年龄分层的成年人（18-44岁，45- 64岁，65岁以上），这些成年人来自爱荷华州选民登记名单，居住在爱荷华州三个县的研究设施30英里内，以人群为基础的成年人样本将被确定。为了符合我们的研究资格，一个人必须报告：(1)根据两个BRFSS残疾筛查问题的活动限制；(2)身体缺陷，包括由损伤、疾病或先天性障碍引起的解剖损失或肌肉骨骼、神经、呼吸或心血管缺陷；(3)继发性疾病的三个或三个以上症状。那些被随机分配到传统LW的人将参加8周的LVV会议。增加的LW组将额外接受四次与研究药剂师的一对一面谈，与受试者的初级保健医生合作制定药物治疗行动计划。调查问卷将在基线、6个月和12个月进行，这将是主要研究结果变量的来源，也是态度和药物不良反应的衡量标准。处方配药记录和医疗记录将成为使用标准化指南评价药物使用质量的数据源。

DESCRIPTION (provided by applicant): The United States state-specific age-adjusted disability prevalence ranges from 13.6% to 21.8%. A third to half of people with disability have drug therapy problems, 25 to 45% have an adverse drug effect each year, and virtually all regularly experience at least one secondary condition. The purpose of this randomized controlled trial is to test the effectiveness of the eight-week group-session health promotion program Living Well with a Disability (LW) augmented with a cooperative care model of medication management (Pharmaceutical Case Management; PCM). We theorize that the complementary mechanisms of the combined interventions will result in greater reduction in secondary conditions than the Living Well program alone. By reducing symptoms from secondary conditions our overall goal is to improve the health and quality of life of people with activity limitations. This research expands and replicates two promising evidence-based interventions in a broader population than they have previously been studied: we will test the interventions in a population-based sample of 252 adults with activity limitations who may or may not identify themselves as disabled. By combining the two interventions, this research also evaluates a new integrated intervention. Our primary specific aim is to compare the 6 and 12 month mean symptoms of secondary conditions among adults randomized to participate in the Living Well program augmented with PCM with those randomized to the traditional Living Well program and with those randomized to a no- intervention control group. Secondary aims are to compare the medication use quality, attitudes and adverse effects between the study groups. A population-based sample of adults with activity limitations will be identified by mailing a screening questionnaire to an age-stratified random sample of adults (18-44,45- 64, 65+) from the Iowa voters registration list living within 30 miles of the study facilities in three Iowa counties. To be eligible for our study, a person must report: (1) activity limitations according to the two BRFSS disability screening questions; (2) a physical impairment, including an anatomical loss or musculoskeletal, neurological, respiratory, or cardiovascular impairment which results from injury, disease, or congenital disorder; and (3) three or more symptoms from secondary conditions. Those randomized to traditional LW will participate in 8 weekly LVV sessions. The augmented LW group will additionally receive four one-on-one in-person sessions with a study pharmacist to create a medication therapy action plan in cooperation with the subject's primary care physician. Questionnaires will be administered at baseline and 6 and 12 months and will be the source of the primary study outcome variable as well as measures of attitudes and adverse medication effects. Prescription dispensing records and medical records will be the data source for rating medication use quality using standardized guidelines.