Improving Access to Sleep Apnea Care: A Pragmatic Study of New Consultation Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,501
- 试验地点
- 6
- 主要终点
- Time from referral
研究概览
简要总结
The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).
详细描述
Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic: New OSA Evaluation
排除标准
- •Age < 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation
研究组 & 干预措施
Traditional clinical pathway for OSA
After referral, patients will have an initial encounter with a sleep care provider which might include in-person visits, telephone clinics, or video conferencing.
Intervention/Treatment: Patients in Arm 1 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.
DREAM clinical pathway for OSA
After referral, patients will not have an initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing.
Intervention/Treatment: Patients in Arm 2 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.
Negative predictive value of HSAT
Results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures.
Intervention/Treatment: Patients in Arm 3 will undergo
a) HSAT sleep testing followed by PSG testing, or b) simultaneous administration of PSG and HSAT sleep testing.
结局指标
主要结局
Time from referral
时间窗: 1 year
For Arms 1 \& 2: Compare time from referral to sleep testing and treatment of OSA
AHI scores
时间窗: 4 years
For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures
PAP adherence
时间窗: 1 year
For Arms 1 \& 2: PAP treatment adherence (for example, Percentage of days with usage \>= 4 hours) between Traditional and DREAM clinical pathways
次要结局
未报告次要终点