Foundational Programs to Combat Clinician Stress
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation, Health Education Program (HEP).
- Кому может быть актуально
- Состояния в реестре: Burnout, Professional, Stress, Psychological, Stress, Physiological, Psychological Well-Being. Базовые параметры: 25 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.
Обзор
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.
Подробное описание
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:
Depression (PROMIS 8a: 8-item Emotional Distress - Depression scale) Anxiety (PROMIS 8a: 8-item Emotional Distress - Anxiety scale) Sleep (PROMIS 8a: 8-item Sleep-Related Impairment scales) Intent to Leave (1 item) Self-Valuation (Stanford Self-Valuation Scale, 4 items) Stanford Impact of Work on Personal Relationships scale (IWPR, 4 items) Social Connectedness Scale-Revised (SCS-R; 20 items) Mindful Attention (5-item Mindful Attention Awareness Scale) Cognitive Errors (12-item Attention-Related Cognitive Errors Scale) Measurement of Self-Reported Medical Errors (SRME, 4 items)
The survey data will be statistically analyzed using linear mixed effects models. The goal of the project is to mitigate or reverse initial symptoms of clinician burnout with the SKY program at a statistically significant difference as compared to the control. The intended outcome is to implement the foundational wellness SKY program on a wider scale to other healthcare professionals
Further details about the study design and references can be found in the full study protocol, once uploaded.
Вмешательства
- Поведенческое Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation
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 - Другое 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 PFI Week 1, Week 4, and Week 6. Evaluation of the impact of the progra
Первичные конечные точки
- Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index. [Срок оценки: Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).]
Вторичные конечные точки (12)
- Evaluation of Heart Rate Variability (HRV) as a physiologic metric for well-being in clinicians through continuous readings using the Oura Ring. [Срок оценки: Daily for 6 weeks.]
- Evaluation of sleep scores as physiologic metrics for well-being in clinicians through continuous readings using the Oura Ring. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: Assess at Baseline (week 1) and Endpoint (week 6).]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 6 центров
- Massachusetts General Hospital — Boston
- Princeton Medical Center / Princeton Health affiliated sites — Plainsboro
- Penn Medicine Lancaster General Health — Lancaster
- Hospital of the University of Pennsylvania — Philadelphia
- Penn Presbyterian Medical Center — Philadelphia
- Pennsylvania Hospital — Philadelphia
Публикации
- Ligibel JA, Goularte N, Berliner JI, Bird SB, Brazeau CMLR, Rowe SG, Stewart MT, Trockel MT. Well-Being Parameters and Intention to Leave Current Institution Among Academic Physicians. JAMA Netw Open. 2023 Dec 1;6(12):e2347894. doi: 10.1001/jamanetworkopen.2023.47894. PMID 38100103
- Carriere JS, Cheyne JA, Smilek D. Everyday attention lapses and memory failures: the affective consequences of mindlessness. Conscious Cogn. 2008 Sep;17(3):835-47. doi: 10.1016/j.concog.2007.04.008. Epub 2007 Jun 15. PMID 17574866
- Osman A, Lamis DA, Bagge CL, Freedenthal S, Barnes SM. The Mindful Attention Awareness Scale: Further Examination of Dimensionality, Reliability, and Concurrent Validity Estimates. J Pers Assess. 2016;98(2):189-99. doi: 10.1080/00223891.2015.1095761. Epub 2015 Nov 11. PMID 26560259
- Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. PMID 12703651
- Trockel J, Bohman B, Wang H, Cooper W, Welle D, Shanafelt TD. Assessment of the Relationship Between an Adverse Impact of Work on Physicians' Personal Relationships and Unsolicited Patient Complaints. Mayo Clin Proc. 2022 Sep;97(9):1680-1691. doi: 10.1016/j.mayocp.2022.03.005. PMID 36058580
- Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781. PMID 20550019
- Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. PMID 21697139
- Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005- PMID 20685078
Идентификаторы
NCT: NCT07220421 · 857510