Pharmaceutical Case Management and Living Well with a Disability

药品案例管理和残疾人的美好生活

• 批准号: 7223348
• 负责人: Elizabeth A Chrischilles
• 金额: $ 32.5万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7223348
• 关键词: chemotherapy; clinical research; clinical trials; combination therapy; functional ability; group therapy; human subject; human therapy evaluation; patient care management; patient oriented research; person with disability; quality of life; questionnaires; sign /symptom

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.

描述(由申请人提供)：美国各州特定年龄调整的残疾流行率从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，25%到45%的人每年都有药物不良反应，几乎所有人都经常经历至少一种继发性疾病。这项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的有效性，该计划以药物管理的合作护理模式(Pharmtics Case Management；PCM)为补充，与残疾生活良好(LW)相结合。我们的理论是，联合干预的互补机制将比单独的改善生活质量计划更能减少继发性疾病。通过减少继发性症状，我们的总体目标是改善活动受限人群的健康和生活质量。这项研究在更广泛的人群中扩展和复制了两种有希望的循证干预措施：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。通过将两种干预措施相结合，本研究还对一种新的综合干预措施进行了评估。我们的主要具体目标是比较随机参加生活改善计划的成年人与随机参加传统生活改善计划的成年人以及随机分为非干预对照组的成年人的6个月和12个月的继发性疾病的平均症状。次要目的是比较研究组之间的用药质量、态度和不良反应。活动受限的成年人样本将通过向爱荷华州选民登记名单中按年龄分层的成年人(18-44岁，45岁-，65岁以上)邮寄一份筛选问卷来确定，这些成年人居住在爱荷华州三个县研究设施30英里以内。符合我们研究条件的患者必须报告：(1)根据BRFSS两项残疾筛查问题进行的活动限制；(2)身体受损，包括因损伤、疾病或先天性疾病而导致的解剖学或肌肉骨骼、神经、呼吸系统或心血管功能受损；以及(3)三种或三种以上继发性疾病症状。那些被随机分配到传统LW组的患者将参加每周8次的LVV治疗。增强的LW小组还将接受与一名研究药剂师的四次一对一面对面会谈，以与受试者的初级保健医生合作制定药物治疗行动计划。问卷将在基线、6个月和12个月进行，并将作为主要研究结果变量的来源，以及态度和不良药物影响的衡量标准。处方配药记录和医疗记录将成为使用标准化指南对用药质量进行评级的数据源。