NCT04329637

Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS

An Integrative, Patient-Centered Model of Care: Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Cyclic vomiting syndrome is a chronic functional gastrointestinal disorder that is a significant health care problem. It affects 1-2% of the population and imposes an enormous burden on patients, families and the health care system. Due to the recalcitrant nature of the disease, patients have high rates of health care utilization with multiple emergency department visits and hospitalizations. These in turn lead to school and work absenteeism, job loss, divorce and even disability. CVS is also associated with multiple comorbid conditions such as anxiety and depression, which further contribute to disease severity. Both neuroimaging studies and other data demonstrate the role of the central nervous system in the pathophysiology of CVS with stress being a significant trigger for episodes of CVS. In summary, CVS is common, disabling and expensive and is associated with significant psychosocial comorbidity that contributes to impaired quality of life . Our current healthcare delivery model is disease-centric and does not adequately address the psychosocial barriers that contribute to poor health in this patient population. We propose a novel, collaborative, integrative health care model that shifts the paradigm of care from one that is episodic and disease-centered to a patient-centered approach that addresses psychosocial determinants of health not addressed in our current traditional health care system. We will incorporate meditation practices that have been shown to reduce psychological distress and also add a care coordinator to our health care delivery team. The primary role of the care coordinator is to identify patient goals, preferences and barriers to self-management and address psychosocial and environmental issues that determine health. Patients will be randomized to either the integrative health care model or usual care. The primary aim of our study is to determine the impact of our proposed integrative health care model on health care outcomes which will include a reduction in psychological distress, improvement in coping skills for managing chronic disease, cognitive symptom management, improvement in health-related quality of life and reduction in health care utilization. This collaborative effort between physicians, community partners, and allied health personnel will redesign the health care delivery system, facilitate access to appropriate healthcare services, optimize chronic disease management and improve overall healthcare outcomes.

Detailed description

Background \& Aims: Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. The current disease-centered model of care does not address psychosocial factors that impact patient outcomes. The investigators hypothesized that a holistic, patient-centered care model integrating meditation and addressing psychosocial needs through a care coordinator, will improve healthcare outcomes in CVS. Methods: The investigators conducted a prospective randomized controlled trial of 49 patients with CVS (mean age: 34 ± 14 years; 81% female) who were randomized to conventional healthcare (control group) or Integrative Health Care (IHC) (27: control group, 22: IHC group;). In the IHC group, patients were assigned a care coordinator and received meditation sessions from certified trainers from the Heartfulness Institute. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life were measured with validated tools. An intention-to-treat analysis was performed.

Conditions

• Cyclic Vomiting Syndrome

Interventions

Type	Name	Description
OTHER	Integrative healt care	Meditation and use of a care cordinator

Timeline

• Start date: 2016-10-05
• Primary completion: 2019-02-05
• Completion: 2019-12-15
• First posted: 2020-04-01
• Last updated: 2020-04-01