A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 592
- 主要终点
- Short Form Health Survey (SF-12) Physical Component Score (PCS)
研究概览
简要总结
This is a multi-center randomized controlled trial comparing the effectiveness of community health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low socioeconomic status to improve their health outcomes.
详细描述
Community Health Workers (CHWs) have the potential to improve chronic disease outcomes among patients with low socioeconomic status (SES). Yet, widespread use of CHWs has been hampered by lack of standardized, scalable and evidence-based models. Our community-academic-health system team used participatory action research with low-SES patients to design IMPaCT (Individualized Management for Patient-Centered Targets). A randomized controlled trial (RCT) of 446 hospitalized patients with varied diseases demonstrated that a 2-week dose of IMPaCT improved access to care, mental health, activation, and quality of communication, while reducing recurrent hospital readmissions. We have adapted IMPaCT for use among low-SES primary care patients with multiple chronic conditions.
This RCT is designed to evaluate the newly adapted IMPaCT model in 3 primary care settings - academic, federally qualified health center, and VA. Upon enrollment in the trial, patients will collaboratively set a chronic disease management goal with their primary care provider. Patients will then be randomized to collaborative goal-setting versus goal-setting augmented by 6 months of support from an IMPaCT CHW. Follow-up will be conducted at 6- and 9- months post-enrollment.
The study design is a single-blinded, 2- armed, multi-site randomized controlled trial involving three clinic sites and 444 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months
- •Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19143, 19145, 19146, & 19151
- •Has 2 or more of the following conditions:
- •Obesity: BMI30
- •HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2)
- •tobacco (from EPIC Social History/Vital Signs)
- •Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI>=35); HTN (SBP >= 160); DM (HgBA1c >=9); Tobacco Use (>0 cigarettes)"
- •Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance
- •Has a scheduled appointment at a study clinic in the future.
- •Community Health Workers/CHWs/IMPaCT Partners involved in the care of patients of the three practices will be included in the qualitative portion of this study.
排除标准
- •Will not provide informed consent for this study.
- •Does not have the capacity to provide informed consent for this study.
- •Previously enrolled in this study.
- •Currently enrolled in another study focusing on chronic disease management.
- •Currently has a CHW
- •No one will be excluded on the basis of sex or race.
研究组 & 干预措施
Usual clinician support
Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.
干预措施: Usual care (Other)
CHW support
Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.
干预措施: IMPaCT (Behavioral)
结局指标
主要结局
Short Form Health Survey (SF-12) Physical Component Score (PCS)
时间窗: Baseline, 6 months
The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.
次要结局
- Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness(6 months, 9 months)
- Hospital Admission - Mean Number of Hospitalizations(6 months and 9 months)
- Change in Chronic Disease Control - Obesity(Baseline, 6 months, 9 months)
- Short Form Health Survey (SF-12) - Mental Component Summary (MCS)(Baseline, 6 months, 9 months)
- Change in Chronic Disease Control - Diabetes(Baseline, 6 months, 9 months)
- Change in Chronic Disease Control - Tobacco Use(Baseline, 6 months, 9 months)
- Hospital Admission - Total Hospital Days(6 months and 9 months)
- Change in Chronic Disease Control - Hypertension(Baseline, 6 months, 9 months)
- Number of Participants With Any Hospital Admission(6 months and 9 months)
- Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome(6 months)
- Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management(6 months, 9 months)
- Number of Participants With Multiple Hospital Admissions(6 months and 9 months)
- Number of Participants With 30 Day Hospital Readmissions(30 days)
- Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)(6 months and 9 months)