Integrating Behavioral Health and Primary Care for Comorbid Behavioral and Medical Problems
试验速览
- 阶段
- 不适用
- 入组人数
- 4,025
- 试验地点
- 2
- 主要终点
- PROMIS-29 v2
研究概览
简要总结
Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients.
Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team.
The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decision affected by the research is at the practice level: whether and how to use behavioral health services.
The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects in 40 practices with co-located behavioral health services. Practices randomized to the active intervention will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH.
The investigators plan to study adults who have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.
详细描述
The chronic diseases that drive the majority of mortality, morbidity and cost in America and around the globe are largely behavioral in origin or management. Tobacco, diet, physical inactivity, alcohol, substance abuse, non-adherence to treatment, insomnia, anxiety, depression, and stress are major causes of morbidity, mortality and expense, especially when chronic medical problems such as heart disease, lung disease, diabetes, or arthritis are also present. Behavioral problems can often be effectively managed with improved outcomes for patients, their families and the health care system, but the current health care system is often unable to provide such care.
Behavioral Health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychosocial factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer models have been proposed for helping these patients. In co-location, a behavioral health provider is located in or near the primary practice to increase the likelihood of successful referral and treatment initiation. An alternative is Integrated Behavioral Health (IBH) in which a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team. Although it is clear that the status quo of under-diagnosis or inadequate referral and treatment is not acceptable, it is not known which of the alternative models is best.
The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve patient-centered outcomes in patients with multiple morbidities? The key health decisions affected by the research are those made at the practice level: whether and how best to incorporate behavioral health (BH) services. At the patient level, the decision of whether to seek out or accept offered BH services will be influenced by the manner they are made available.
Aim 1: Determine if increased integration of evidence-supported behavioral health and primary care results in better patient-centered outcomes than simple co-location of behavioral providers without systematic integration.
Aim 2: Determine if structured improvement process techniques are effective in increasing BH integration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •At least one target chronic medical condition:
- •arthritis
- •chronic obstructive lung disease
- •heart failure
- •or hypertension.
- •Evidence of a behavioral problem or need:
- •Diagnosis of:
- •chronic pain including headache
- •depression
- •fibromyalgia
- •irritable bowel syndrome
- •problem drinking
- •substance use disorder
- •OR persistent use of certain medications used for behavioral concerns:
- •antidepressants
- •anxiolytics
- •antineuropathy agents
- •OR persistent failure to attain physiologic control of a medical problem:
- •blood pressure>165 while on 3 or more medications
- •A1C > 9% for 6 months)
- •OR the presence of three or more of the target chronic medical conditions.
排除标准
- •Not seeking care at a participating practice
- •Inability to consent due to cognitive and/or developmental impairment/delays
- •Living in the same household as a previously enrolled study participant
结局指标
主要结局
PROMIS-29 v2
时间窗: 24 months
Change in general health
次要结局
- Patient Report of Utilization(24 months)
- Global Appraisal of Individual Needs - Short Screener(24 months)
- 30-day use(24 months)
- Hgb A1C(24 months)
- Patient Activation Measure-13(24 months)
- Asthma Symptom Utility Index(24 months)
- CAHPS 12-Month PCMH Adult Questionnaire 2.0(24 months)
- Systolic blood pressure(24 months)
- Consultation and Relational Empathy measure(24 months)
- Modified Self-reported Medication-taking Scale(24 months)
- Restricted Activity Days(24 months)
- Duke Activity Status Index(24 months)
研究者
Benjamin Littenberg
Professor
University of Vermont