跳至主要内容
临床试验/NCT04565899
NCT04565899已完成不适用

Implementation Intervention to Improve Care for Unhealthy Alcohol Use (CDA 20-057)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Maintenance of alcohol-related care via electronic health record

研究概览

简要总结

In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

详细描述

Alcohol use is a significant risk factor of disability and death for U.S. adults and one out of every six Veterans seen in primary care report unhealthy alcohol use. Based on substantial evidence from randomized controlled trials and the U.S. Preventive Services Task Force, VA/DoD clinical guidelines stipulate that all Veterans screening positive for unhealthy alcohol use should receive evidence-based alcohol care in primary care, including brief counseling interventions (BI) and additional treatment (e.g., pharmacotherapy) for those with alcohol use disorders (AUD). The VA was a pioneer in implementing alcohol screening and BI in primary care, yet substantial implementation gaps remain. In order to improve the quality and fidelity of alcohol-related care, the current research proposes to use an evidence-based implementation strategy, practice facilitation, at one VA to pilot test whether practice facilitation has the potential to improve quality of primary care-based alcohol-related care.

The project will first conduct qualitative interviews assessing Veteran and clinical stakeholders to understand barriers and facilitators to high-quality alcohol care. Results from qualitative interviews will be used to refine and hone the practice facilitation intervention. Clinical stakeholders will then be recruited to participate in focus groups in order to evaluate the acceptability and feasibility of the proposed practice facilitation intervention prior to testing it. Last, a pilot test of the practice facilitation intervention will be conducted within one VA primary care clinic to understand whether practice facilitation improves the quality of primary care-based alcohol-related care.

研究设计

研究类型
Interventional
分配方式
Na
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
是

入选标准

  • •Veteran patients:
  • •Veteran presenting for care at VA primary care site during pilot testing of the practice facilitation intervention, AND
  • •Age 18 years and older.
  • •Primary care providers:
  • •Primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week.

排除标准

  • 未提供

研究组 & 干预措施

Practice facilitation implementation intervention

Experimental

6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.

干预措施: Practice facilitation implementation intervention (Other)

结局指标

主要结局

Maintenance of alcohol-related care via electronic health record

时间窗: 12-months post implementation intervention

Reach and Adoption outcomes using electronic health record data will be assessed again at 12-months post active implementation to examine whether high-quality alcohol care was sustained after practice facilitation.

Adoption of alcohol related care via self-report change

时间窗: 3- and 6-months post implementation intervention

Brief self-report questions to determine whether providers have adopted the suggested evidence-based components of alcohol-related care (e.g., shared decision making, patient-centered discussions, setting goals with patients) will be administered at the start of the active implementation phase, at the end of the active implementation phase, and 3- and 6-months post practice facilitation.

Reach of alcohol-related care via electronic health record change

时间窗: 3- and 6-months post implementation intervention

Reach outcomes will be expressed as a rate, with the denominator (for all outcomes) defined as all Veterans with a visit to the primary care site during active implementation of the practice facilitation pilot test. The numerator for each Reach outcome is as follows: the number of Veterans who screened positive for unhealthy alcohol use (AUDIT-C \>= 5) AND had any documented brief intervention, specialty addictions treatment (inpatient and outpatient clinic visits for substance use disorder treatment encounters with an accompanying AUD diagnosis), or pharmacotherapy for AUD (any filled prescription for FDA-approved medications: acamprosate, disulfiram, or oral/injectable naltrexone) in the 30 days following a positive screen. Rates at the start of active implementation and at 3- and 6-months post Active Implementation will be calculated to examine change in Reach outcomes over time.

Adoption of alcohol-related care via electronic health record change

时间窗: 3- and 6-months post implementation intervention

Adoption outcomes will be identified as the percentage of providers from the primary care clinic who deliver alcohol-related care when a Veteran screens positive for unhealthy alcohol use (e.g., delivery of brief interventions, consults to specialty addictions treatment, providing pharmacotherapy for AUDs). Rates of alcohol-related care at the start of active implementation and at 3- and 6-months post active implementation will be used to measure whether adoption rates of alcohol-related care increased over time.

次要结局

  • Clinical Effectiveness via electronic health record(12-months post implementation intervention)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验