Impact of Nurse Case Management on Diabetes Co-morbidities
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- % of patients with BP goal (<130/80)
研究概览
简要总结
Although strong clinical evidence exists that patients with diabetes should achieve certain clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national surveys indicate that only a minority of people with diabetes achieves these goals.
Hypothesis: combination of nurse case management and enhanced behavior change counseling will improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients with Type 2 diabetes when compared to usual care over a 3 year period.
Study design- The study will be a three year randomized control trial that will select patients that have either A1C >8.5, LDL >130, or BP >140/90. Nurse case managers, trained in clinical guidelines and brief behavior change counseling techniques (motivational interviewing), will aim to foster patient adherence in the experimental group patients. Nurse case managers will use standing orders to set an implementation of clinical guidelines (for diabetes, hypertension, hyperlipidemia and depression) with individual follow up.
A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital affiliated clinics) will be sought. One third of the study patients will be recruited from the underserved Hispanic population in the Reading area. Patients will be randomized by physician i.e. one physician will be randomly assigned to have all their patients co-managed by a nurse case manager; the other will have usual care without any contact with nurse case manager.
Nurses will be trained and then initiate a small pilot study in July thru August. Full recruitment and initiation of study will begin in September 2006.
Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the supervision of the primary care physicians. A set of clinical guidelines will be developed with physician input that will serve as the over-riding framework for the nurses.
Outcomes - Over a three-year period the investigators will evaluate clinical response (improvements in A1C, BP, LDL, and depression when present) as well as a series of other measures that will be obtained by surveys (patient satisfaction, quality of life, self-management behaviors). Provider satisfaction will be measured using a standardized tool. Finally, cost effectiveness of the intervention and evaluation of the potential barriers to implementation will be studied.
详细描述
- Rationale: Diabetes mellitus is a prevalent disease and results in high health care expenditures, the majority of which are due to preventable complications of diabetes. Current evidence indicates that care of patients with diabetes mellitus falls short of the standards set by the American Diabetes Association and a large proportion of these patients do not achieve their treatment goals. Multiple ways to deliver care to patients with diabetes have been studies. The investigators propose a 3 year randomized-controlled study to assess impact of the combination of nurse case management (NCM) combined with enhanced behavior change counseling on glycemic control and co-morbidity outcomes in high-risk patients with Type 2 diabetes when compared to usual care
- Key Objectives:
Specific Aim 1. Determine the efficacy of an enhanced nurse case management (NCM) intervention to promote patient adherence leading to positive clinical outcomes (HbA1C, LDL, blood pressure, and process measures) in high-risk patients in primary care over a period of three years. High-risk patients with Type 2 diabetes will be recruited from 9 primary care clinics and randomized to NCM intervention vs. usual care. A major focus of this proposal is to test the efficacy of NCM in a minority population with high risk of poor outcomes (approximately 38 % of the study population will be Hispanic). The investigators anticipate a significant increase in percentage of patients reaching the goals for HbA1C (< 7.0%), BP (<130/80), LDL (<100 mg/dl) in patients in the NCM group compared to the control group of usual care. The investigators also hypothesize that there will be significant improvement in process measures (% patients having a yearly dilated eye exam, foot exam, urinary screen for microalbuminuria, aspirin use, lipid evaluation) and depression scores in patients in the NCM group compared to the control group of usual care.
Specific Aim 2. Quantify the impact of enhanced nurse case management on health-related quality of life, patient satisfaction, self-management behaviors, and provider satisfaction. A unique feature of our study is to address the impact of our intervention on these critical outcomes, which have not been addressed in the existing NCM literature. The investigators anticipate improved adherence, lower levels of diabetes specific emotional distress, higher levels of diabetes specific quality of life, increased patient satisfaction with treatment, and improved provider satisfaction in the NCM group compared to the usual care group. The following surveys will be completed and analysed:the PAID survey looking at Emotional distress associated with diabetes, the ADDQOL (Diabetes specific quality of life) survey, the DTSQ (Patient satisfaction) survey and the SDSCA (Diabetes self care activities) survey.
Specific Aim 3. Evaluate the cost-effectiveness of an enriched NCM intervention. The investigators expect that the NCM intervention will be effective in improving clinical outcomes for patients with type 2 diabetes; however, there may still be barriers to more widespread adoption unless the benefits of investing in or reimbursing for NCM can be justified by the costs. Toward that end, the investigators will evaluate the cost-effectiveness of the intervention from the perspective of the provider, payor, and society. These cost-effectiveness ratios will help decision makers generate informed decisions about appropriate and cost-effective treatment for high-risk patients with type 2 diabetes. 3. Study Population: Patients with Type 2 diabetes, older than 18 years of age, will be identified based on billing data (two visits with ICD-9 code of 250.xx in the preceding year) and subsequent chart review from nine Hershey Medical Center (HMC) primary care clinics and three Reading Hospital-affiliated primary care sites. 4. Major Inclusion Criteria: Inclusion criteria: Type 2 diabetes, age >18 who are at high risk based on any one of the following criteria: HbA1C >8.5, LDL >130, or BP >140/90. 5. Allocation to Groups: a stratified group randomization scheme whereby all patients being seen by the same doctor will be randomized to the same treatment group. The randomization will also be stratified by clinic site and size of doctor's practice. One group will be seen by nurse care managers, the other will continue with standard care. 6. Summary of Procedures: An initial pilot study will be performed with 60 patients from HMC and Reading Hospital clinics, for 2 months. This will consist of nurse case management intervention and feedback from the subjects to improve the study design. Subjects will be seen at 2, 4, 6 and 8 weeks. This study will end with focus groups of subjects to give their input as to what they did or did not like about the study, and how it might be improved. Pilot participants will have the option to enroll into the main study. No studies will be ordered for research purposes. Pregnancy screening will occur by verbally asking the subjects whether they believe they could be pregnant, since risk is very minimal.
The main study will enroll 820 subjects at clinics from the Hershey Medical Center and Reading Hospital, with 2/3 of the subjects being enrolled at HMC, and 1/3 from the underserved Hispanic population. The study intervention will continue for 3 years. Patients will be enrolled into the nurse case management group or the control group dependent upon where they see their physician - randomization will occur in blocks based on clinics and physicians, not randomly per patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetes
- •age > 18 years old who are at high risk based on any one of the following criteria:
- •HbA1C > 8.5
- •LDL > 130
- •BP > 140/90 within the last 6 months
排除标准
- •patients who are pregnant upon entry in the study (however if a patient becomes pregnant in the course of the study, she can continue with the study)
- •unable to communicate in either English or Spanish
- •in nursing homes (and therefore unable to attend outpatient visits)
结局指标
主要结局
% of patients with BP goal (<130/80)
时间窗: Two years after enrollment
% of patients reaching goal HbA1C (<7)
时间窗: 2 years after enrollment
% of patients with LDL at goal (<100)
时间窗: 2 years after enrollment
% of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100)
时间窗: 2 years after enrollment
次要结局
- Change in weight(2 years after enrollment)
- % of patients with yearly ophthalmologic exam(2 years after enrollment)
- % of patients with yearly foot exam(2 years after enrollment)
- % of patients with assessment for nephropathy(2 years after enrollment)
- % of patients with nephropathy on ACE inhibitor or ARB(2 years after enrollment)
- Diabetes specific quality of life (ADD QOL)(2 years after enrollment)
- Emotional distress (PAID survey)(2 years after enrollment)
- % of patients on aspirin(2 years after enrollment)
- % of patients at or above CES-D depression score 16 for severe depression(2 years after enrollment)
- Diabetes self care activities survey(2 years after enrollment)
- Patient satisfaction survey (DTSQ)(2 years after enrollment)
- Physician satisfaction - survey filled out by physician(2 years after enrollment)
- Costs and cost-effectiveness(2 years after enrollment)