Maintaining Implementation Through Dynamic Adaptations (MIDAS) (QUE 20-025)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities.
研究概览
简要总结
Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program will help providers improve the way they treat VA patients for three common conditions, using specific strategies to ensure the reliable delivery of these treatments. The first project will focus on reducing potentially inappropriate medication (PIM) use using the VIONE practice, developed in VA. The second project will focus on better use of drugs called direct oral anticoagulants (DOACs) for patients with a history of severe blood clots or an abnormal heart rhythm. The third project will focus on increasing the use of cognitive behavioral therapy for insomnia as the first-line treatment for insomnia instead of sleep medications. The investigators will test two implementation approaches to improve medication use within these topics.
详细描述
Background The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: 1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; 2) appropriate dosing and drug selection of direct-acting anticoagulant medications (DOACs); and 3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies.
Methods For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to a clinical dashboard that flags patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve use of the EBPs: 1) individual-level academic detailing (AD); or 2) AD plus the team-based Learn. Engage. Act. Process. (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly percent of PIMs as the dependent variable. Primary comparative endpoint will be at 13-18 months post-baseline. Each trial will also be analyzed independently.
Discussion MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates use of actionable clinical dashboard data and making incremental changes, designed to be feasible within busy clinical settings.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Note- the investigators are recruiting clinics - not individual patients.
- •Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:
- •a team leader or champion
- •an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation
- •readily accessible data to measure process and impact of the implementation and use of the EBP
- •availability of required resources
排除标准
- 未提供
研究组 & 干预措施
Academic Detailing (AD) Only
One-on-one educational outreach to employees and providers.
干预措施: Academic Detailing (AD) (Behavioral)
AD + LEAP Combined
This arm combines use of AD plus the Learn. Engage. Act. Process (LEAP) program. LEAP is a 6-month quality improvement coaching program plus a 6-month monthly follow-up.
干预措施: Academic Detailing (AD) (Behavioral)
AD + LEAP Combined
This arm combines use of AD plus the Learn. Engage. Act. Process (LEAP) program. LEAP is a 6-month quality improvement coaching program plus a 6-month monthly follow-up.
干预措施: LEAP (Behavioral)
结局指标
主要结局
Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities.
时间窗: 13-18 months post-baseline
Percentage of PIMs across AD vs. LEAP+AD facilities were modelled as the difference between post-period and pre-period, using the average from the 1-6-month pre-baseline period as "pre" and the average 13-18-month post-baseline as "post." Data was collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome was computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers' list of patients 65 or older, actively following with the clinic, and not in hospice/palliative care; 2) DOACs; proportion of patients with flags for potentially inappropriate use on a DOAC safety dashboard of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. The outcome was analyzed by pooling across all three-EBPs.
次要结局
- Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities(13-18 months post-baseline)
- Change in Monthly Medication Costs for All Drugs Across Facilities(13-18 months post-baseline)
- Change in Number of Medication Reviews Across Facilities(13-18 months post-baseline)
- Change in Number of Inappropriate Medications at a Patient-level(13-18 months post-baseline)
- Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities(13-18 months post-baseline)
- Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities(13-18 months post-baseline)
- Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities(13-18 months post-baseline)
- Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities(13-18 months post-baseline)
- Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities(13-18 months post-baseline)
- Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed(13-18 months post-baseline)
- Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities(13-18 months post-baseline)
- Change in Percentage of Patients With First Line Sleep Medication Across Facilities(13-18 months post-baseline)