Implementing Diabetes Group Visits in Community Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- glycosylated hemoglobin
研究概览
简要总结
Community health centers across the US are seeking to address the growing prevalence of diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians' Network (MWCN) to conduct a research study to train community health center staff and providers to implement and sustain diabetes group visits, also referred to as shared medical appointments, at their health center. The study's aims are to: 1) Develop, conduct, and evaluate a training program for health center staff to implement a diabetes group visit intervention in their health center; 2) Assess the implementation of diabetes group visits in the community health center setting and determine the cost of implementation; 3) Assess the feasibility and cost of implementing a text-messaging intervention in addition to the implementation of diabetes group visits in the CHC setting at one health center and 4) Assess the impact of the diabetes group visits alone and diabetes group visits plus text-messaging on diabetes process measures, patient outcomes, and patient satisfaction compared to control patients from the same health center with six months of follow-up once the six-month group visit program ends.
详细描述
Community health centers across the US are seeking to address the growing prevalence of diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians' Network (MWCN) to conduct a research study to train community health center staff and providers to implement and sustain diabetes group visits, also referred to as shared medical appointments, at their health center. The study's aims are to: 1) Develop, conduct, and evaluate a training program for health center staff to implement a diabetes group visit intervention in their health center; 2) Assess the implementation of diabetes group visits in the community health center setting and determine the cost of implementation; 3) Assess the feasibility and cost of implementing a text-messaging intervention in addition to the implementation of diabetes group visits in the CHC setting at one health center and 4) Assess the impact of the diabetes group visits alone and diabetes group visits plus text-messaging on diabetes process measures, patient outcomes, and patient satisfaction compared to control patients from the same health center with six months of follow-up once the six-month group visit program ends.
The MWCN Research Committee is looking for six community health center (CHC) teams comprised of three to four members to participate in the study. The study will last 18 months and will require study participants to complete the following activities as part of the study:
- Attend two mandatory learning sessions in Chicago in the spring and fall of 2015 that will each last two days (Friday and Saturday all day, 9am-5pm)
- Participate in a mandatory third learning session conducted through a series of 4 or 5 weekly webinars in the spring of 2016
- Participate in monthly conference calls and/or webinars intended for tracking progress, trouble-shooting obstacles encountered, and further training in the months between each learning session
- Complete a training in the protection of human subjects in research
- Implement a monthly diabetes group visit intervention for at least six months at their health center
- Recruit 15 health center patients with diabetes who might benefit from participating in diabetes group visits to enroll in the program
- Complete four surveys (20-60 minutes each), one brief evaluation (10-15 minutes), monthly time and expense logs, and one telephone interview (25-40 minutes) between February 2015 and May 2016
- Collect patient data through survey administration at two time-points for patients who attend at least one group visit session and through telephone interviews for 1) patients who said they would enroll in the group visit program but who did not attend at least one session and 2) patients who attended less than four group visit sessions
- Collect patient data through EMR / chart abstraction for up to 15 patients who enroll in the group visit program at three study time points over the course of a year from mid-2015 to mid-2016 and for up to 30 patients who do not participate in the group visit program and who will serve as control patients for the study.at one point in mid-2016.
The learning sessions will include various module topics that have been developed based on a review of the current literature of diabetes group visit interventions, preliminary research done through site visits to CHCs with diabetes group visit experience, and input from the MWCN Research Committee. The learning sessions will also provide the opportunity for each health center to share their own unique experiences and to learn from other health centers' experiences.
The first learning session will provide an overview of the benefits of group visits, "best practices" for implementing a diabetes group visit program in a health center, the barriers and challenges that may arise in implementing diabetes group visits, strategies to overcome these barriers, and factors that facilitate the implementation of group visits and affect their sustainability. During the first learning session, participating health centers will also have some time to develop a detailed plan for the implementation of a group visit program at their center. In addition, they will learn how to evaluate the implementation of their program and the impact of their program on patient outcomes. Each team will also be given a patient curriculum guide which they can tailor to the needs of their patient population and use to implement the diabetes group visit program in their health center. The health center selected to implement the text-messaging intervention in addition to the group visit intervention will be asked to attend additional training modules relating to the implementation of the text-messaging intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patients must be at least 18 years of age
- •Patients must have been a patient at the health center since the beginning of 2013
- •Patients must have attended at least two appointments at the health center within the past year
- •Patients must have a diagnosis of type 2 diabetes
- •(For group visit patients only) Patients' last documented A1c result must have been greater than or equal to 8.0% and the test must have been done during the last 18 months at the time of the selection
- •(For group visit plus text-messaging patients only) Patients must own a cellular phone with text-messaging capabilities
- •(For control patients only) Patients must have attended at least three individual appointments at the health center between February 2015 and July
- •(For control patients only) Patients' last documented A1c result prior to the start of the group visit program must have been greater than or equal to 8.0% and the test must have been done during the 18 months prior to the start of the group visit program
排除标准
- •Patients who are under 18 years old, have not been a patient at the health center since the beginning of 2013, have not attended at least two appointments at the health center within the past year, do not have a diagnosis of type 2 diabetes, have not had an A1c test done during the 18 months prior to the start of the group visit program, or whose last documented A1c result before the start of the group visit program was less than 8.0%, will be excluded from the study.
- •Pregnant women; patients with an uncontrolled psychiatric problem, such as schizophrenia, psychosis, dementia, or another cognitive impairment; and patients with hearing difficulties or a severe physical disability will also be excluded from the study.
- •Additionally, patients who do not own a cellular phone with texting capabilities will not be eligible for inclusion as an intervention patient subject at the group visit plus text-messaging health center site.
- •Patients who have not attended at least three individual appointments at the health center between February 2015 and July 2016 will not be eligible for inclusion as a control patient subject in the study.
- •Patients will also be excluded from participation in the study if their primary care provider deems they would not benefit from participation in a diabetes group visit program and/or does not provide approval for them to be in the study.
研究组 & 干预措施
Diabetes Group Visit
Subjects in this arm will be asked to attend one group visit at their health center each month for six months. The group visits will involve various staff and providers at the health center who will teach them how to take care of their diabetes. Subjects will be scheduled to attend the same group visit appointments as the other subjects, and health center staff will encourage the group to share their own experiences about living with diabetes with the rest of the group.
If subjects at the health center additionally implementing the text-messaging intervention consent to enroll in the study, their phone number will also be entered into a secure system that will allow the group visit healthcare team to send them text messages during the course of the six months they are in the program. These text messages are intended to offer the subjects additional support in taking care of their diabetes.
干预措施: Diabetes group visit (Behavioral)
Usual care
Patients in the control arm will be selected after the follow-up period is over for the intervention arm. They will receive the care they normally receive at their health center.
结局指标
主要结局
glycosylated hemoglobin
时间窗: change from baseline to 6 months and 12 months.
次要结局
- Summary of Diabetes Self-Care Activities (SDSCA)(change from baseline to 6 months and 12 months.)
