Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 12
- 主要终点
- Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index.
研究概览
简要总结
This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.
详细描述
This study will not only measure psychometric data and cognitive metrics for clinician burnout but also assess physiological marker of wellbeing by collecting Heart Rate Variability (HRV) data and sleep scores. We expect to see significant improvement in psychophysiologic metrics including depression, anxiety, sleep problems, cognitive overload, mindfulness and heart rate variability.
The proposed prospective, randomized clinical trial will examine the effects of SKY in a large group of health care clinicians (physician, Advanced Practice Provider (APP), Certified Registered Nurse Practitioner (CRNP), Physician Assistant (PA), psychologist) within the US, examining the above constructs. Clinicians will be randomized one of 2 arms: SKY or an active control group.
This research initiative will enroll 90 clinicians in the SKY program. The SKY intervention is comprised of a week of baseline HRV and sleep metric readings, followed by an onboarding week of 3-day, 3.5 hours/day, online SKY workshops with a live instructor (10.5 hours total), followed by weekly online follow-up sessions with a live instructor (1 hour each) for a period of 4 weeks. Clinicians also practice on their own daily for 45 minutes during these 4 weeks and wear an Oura Ring continuously. They do not have to do their daily practice on the days that they have a follow-up session.
90 clinicians will be assigned as controls and participate in an active control group with Health Education Program (HEP). The HEP coaches will provide these sessions online with an initial onboarding week of 2-day, 3 hours/day online HEP workshop followed by weekly online follow up sessions for 2 hours each with a live instructor. They will also pursue 45 min of daily practice for a period of 4 weeks. They do not have to do their daily practice on the days that they have a follow-up session.
Well-being and burnout metrics will be assessed using Professional Fulfillment Index (PFI) collected at baseline (week 1), midpoint (week 4), and endpoint (week 6) in the SKY intervention and control group. HRV and sleep score will be used as physiologic markers of well-being and will be measured daily in the SKY and control groups. Secondary outcomes will be measured to evaluate the impact of the programs on other factors as measured by questionnaires at Week 1 and Week 6:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-70 years of age,
- •UPHS or MGH clinician (physician, APP, CRNP, PA, psychologist),
- •Access to smart phone and internet,
- •Ability to give informed consent,
- •Interested in wearing an Oura ring and being part of a study to evaluate breath and meditation-derived exercises,
- •Willing to do relaxation exercise every day for 4 weeks.
排除标准
- •Currently maintaining a regular/daily mind-body program practice (eg. meditation, yoga or breathing techniques),
- •Atrial fibrillation,
- •Pacemaker/defibrillator,
- •Untreated or severe obstructive sleep apnea (AHI>=30),
- •History of diaphragm paralysis,
- •Unable or unwilling to complete the workshop,
- •Severe chronic obstructive pulmonary disease (COPD),
- •Severe valvular heart disease,
- •Prior or planned chest/abdominal or nasal/facial surgery within 6 months,
- •Severe psychiatric illness (e.g. schizophrenia, schizoaffective disorder, bipolar disorder), active substance use, seizure disorder or major somatic illness (uncontrolled hypertension, lung disease, liver disease, cancer or heart disease).
结局指标
主要结局
Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index.
时间窗: Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).
The unit of measurement for the Stanford Professional Fulfillment Index is Likert scale scores, reflecting how often the individual experiences aspects of fulfillment or burnout. These are ordinal scores with ranked responses, but the exact intervals between the scores are not numerically defined.
次要结局
- Evaluation of Heart Rate Variability (HRV) as a physiologic metric for well-being in clinicians through continuous readings using the Oura Ring.(Daily for 6 weeks.)
- Evaluation of sleep scores as physiologic metrics for well-being in clinicians through continuous readings using the Oura Ring.(Daily for 6 weeks.)
- Evaluation of the impact of the programs on depression as measure by the PROMIS 8a: 8-item Emotional Distress - Depression scale.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on anxiety as measure by the PROMIS 8a: 8-item Emotional Distress - Anxiety scale.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on sleep as measure by the PROMIS 8a: 8-item Sleep-Related Impairment scales.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on intent to leave place of employment as measure by the Intent to Leave 1 item scale.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on self-valuation as measure by the Stanford Self-Valuation Scale, 4 items.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on impact of work on personal relationships as measure by the Stanford Impact of Work on Personal Relationships scale (IWPR, 4 items).(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on social connectedness as measure by the Social Connectedness Scale-Revised (SCS-R; 20 items).(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on mindful attention as measure by the 5-item Mindful Attention Awareness Scale.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on cognitive errors as measure by the 12-item Attention-Related Cognitive Errors Scale.(Assess at Baseline (week 1) and Endpoint (week 6).)
- Evaluation of the impact of the programs on self-reported medical errors as measure by the Measurement of Self-Reported Medical Errors (SRME, 4 items).(Assess at Baseline (week 1) and Endpoint (week 6).)