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Multi-Component Behavioral Intervention for Complex Patients with CVD Risk

针对具有 CVD 风险的复杂患者的多成分行为干预

基本信息

批准号：
9434534
负责人：
RICHARD W GRANT
金额：
$ 3.74万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9434534
关键词：
Accident and Emergency department Address Adherence Adult Age Alcohol consumption Alcohol dependence Anxiety Behavior Behavior Therapy Behavioral Blood Pressure California Cardiovascular Diseases Caring Cause of Death Characteristics Cholesterol Chronic Chronic Disease Clinical Communication Comorbidity Complex Diabetes Mellitus Disease Management Effectiveness of Interventions Enrollment Glycosylated hemoglobin A Goals Health Health Resources Health Status Health behavior Health system Heart Diseases Hyperlipidemia Hypertension Individual Intervention LDL Cholesterol Lipoproteins Mail Order Measures Medicaid Medical Medicare Mental Depression Mental Health Modeling Motivation Outcome Outpatients Patient Admission Patients Pharmaceutical Preparations Pharmacy facility Population Prevention Primary Health Care Provider Randomized Research Risk Risk Factors Risk Reduction Self Care Self Management System Treatment Efficacy Visit alcohol misuse arm behavioral health cardiovascular disorder risk care delivery care systems cost design diet and exercise evidence based guidelines falls good diet health care service utilization high risk improved medication compliance member multiple chronic conditions novel strategies patient oriented personalized care primary outcome programs public health relevance randomized trial response screening skills subclinical depression therapy design treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) is the leading cause of death in the U.S. Despite the availability of evidence-based guidelines and efficacious therapies, however, many patients do not achieve the full benefit of CVD risk reduction. In particular, complex patients (defined as those patients who do not respond to current disease management approaches) with multiple concurrent chronic conditions represent a key segment of the population that would benefit from new approaches to care. In response to PA-12-024: Behavioral Interventions to Address Multiple Chronic Conditions in Primary Care, which seeks "practical interventions...to modify behaviors using a common approach" among patients with multiple co-morbidities, we propose to implement and rigorously evaluate an integrated behavioral intervention designed to improve a core set of chronic disease self-management skills and to overcome common barriers to care engagement encountered by this increasingly important segment of the U.S. adult primary care population. This randomized trial will be conducted within Kaiser Permanente Northern California (KPNC), an integrated care delivery system serving over 3.2 million members, including patients insured through Medicare and state Medicaid programs. We will evaluate our intervention in 3 KPNC primary care practices by enrolling 576 complex patients who have persistently (e 2 years) uncontrolled CVD risk factors (e.g. hypertension, hyperlipidemia, diabetes) despite being enrolled in a CVD disease management program. This behavioral intervention is designed to activate and engage patients, identify potentially hidden barriers to care such as alcohol misuse or sub-clinical depression, and to develop individualized care plans that are designed to catalyze more effective primary care management. Randomization will be at the patient-level, blocked by primary care provider, with the following aims: 1) To examine the impact of (intervention + usual care) vs. (usual care alone) on control of systolic blood pressure [primary outcome], LDL cholesterol, Framingham Risk Score (if no baseline CVD), and HbA1c (if with diabetes) at 12 months; 2) To examine effectiveness of (intervention + usual care) vs. (usual care alone) on proximal outcomes (patient activation, medication adherence, and mental health status) after 3 and 12 months, and 3) To identify baseline patient factors associated with more vs. less successful clinical response among intervention arm patients. By focusing on core health skills and care barriers, this patient-focused intervention seeks to enable complex patients to become more effective agents of their own care and to thereby achieve similar clinical benefits as less complex patients.

描述（由申请人提供）：心血管疾病（CVD）是美国的主要死亡原因。尽管有循证指南和有效的治疗方法，但许多患者并未获得CVD风险降低的全部益处。特别是，患有多种并发慢性疾病的复杂患者（定义为对当前疾病管理方法无反应的患者）代表了受益于新护理方法的关键人群。在回应PA-12-024：行为干预，以解决多种慢性疾病的初级保健，其中寻求“实际干预...在患有多种合并症的患者中，我们建议实施并严格评估一种综合行为干预措施，旨在改善一套核心的慢性病自我管理技能，并克服美国成人初级保健人群中越来越重要的部分所遇到的共同障碍。这项随机试验将在Kaiser Permanente北方加州（KPNC）进行，这是一个综合护理提供系统，为320多万成员提供服务，包括通过医疗保险和州医疗补助计划投保的患者。我们将通过招募576名复杂患者来评估我们在3种KPNC初级保健实践中的干预措施，这些患者尽管参加了CVD疾病管理计划，但仍具有持续（e2年）不受控制的CVD风险因素（例如高血压，高脂血症，糖尿病）。这种行为干预旨在激活和吸引患者，识别潜在的隐藏障碍，如酒精滥用或亚临床抑郁症，并制定个性化的护理计划，旨在促进更有效的初级保健管理。随机化将在患者层面进行，由初级保健提供者阻止，目的如下：1）检查（干预+常规护理）与（仅常规治疗）控制收缩压[主要结局]、LDL胆固醇、脆性风险评分（如果无基线CVD）和HbA 1c（如果患有糖尿病）12个月时;（2）检查有效性（干预+常规护理）与（仅常规治疗）对近端结局的影响（患者激活、药物依从性和心理健康状态），和3）确定与干预组患者中更多与更少成功临床应答相关的基线患者因素。通过关注核心健康技能和护理障碍，这种以患者为中心的干预措施旨在使复杂患者成为更有效的自我护理代理人，从而实现与复杂程度较低的患者相似的临床获益。

项目成果

期刊论文数量（11）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Engaging patients in population-based chronic disease management: A qualitative study of barriers and intervention opportunities.

DOI：
10.1016/j.pec.2021.04.038
发表时间：
2022-01
期刊：
Patient education and counseling
影响因子：
3.5
作者：
Fang A;Abdelgadir D;Gopalan A;Ross T;Uratsu CS;Sterling SA;Grant RW;Iturralde E
通讯作者：
Iturralde E

CREATE Wellness: A multi-component behavioral intervention for patients not responding to traditional Cardiovascular disease management.

DOI：
10.1016/j.conctc.2017.10.001
发表时间：
2017-12
期刊：
Contemporary clinical trials communications
影响因子：
1.5
作者：
Miller-Rosales C;Sterling SA;Wood SB;Ross T;Makki M;Zamudio C;Kane IM;Richardson MC;Samayoa C;Charvat-Aguilar N;Lu WY;Vo M;Whelan K;Uratsu CS;Grant RW
通讯作者：
Grant RW

Building a Career as a Delivery Science Researcher in a Changing Health Care Landscape.

在不断变化的医疗保健环境中建立交付科学研究人员的职业生涯。

DOI：
10.1007/s11606-015-3178-9
发表时间：
2015
期刊：
Journal of general internal medicine
影响因子：
5.7
作者：
Grant,RichardW;Schmittdiel,JulieA
通讯作者：
Schmittdiel,JulieA

The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

DOI：
10.1177/1740774516631530
发表时间：
2016-06
期刊：
Clinical trials (London, England)
影响因子：
0
作者：
Adams AS;Bayliss EA;Schmittdiel JA;Altschuler A;Dyer W;Neugebauer R;Jaffe M;Young JD;Kim E;Grant RW;Diabetes Telephone Study Team
通讯作者：
Diabetes Telephone Study Team

Overcoming barriers to diabetic polyneuropathy management in primary care.

克服初级保健中糖尿病多发性神经病管理的障碍。