Clinical trial NCT06405347: The M-Well Inpatient Whole Health Bundle
Official title: Engineering Whole Health Into Hospital Care to Improve Wellness: The Inpatient Whole Health Bundle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Keywords: Holistic Health
Mindfulness
Hospitalization
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-05-08
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pre-post study. Over a two month period recently discharged patients from each participating unit will be asked to complete a study survey. Over the next two months, patients on that unit will be recruited to participate in the intervention. These intervention patients will be asked to complete the same study survey as during the pre-intervention phase once discharged.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will utilize a quasi-experimental pre-test/post-test design and will be conducted on the medical and medical/surgical units at the VA Ann Arbor Healthcare System. Hospitalized patients on the intervention units will be offered the Inpatient Whole Health Bundle. This study will evaluate overall satisfaction with the hospital environment and care as well as the bundle and components using a mailed survey of patients discharged from each unit. This study will also conduct a qualitative assessment of the intervention to understand intervention experiences as well as barriers and facilitators to improving hospitalized patient well-being. Finally, the study will assess unit-level metrics.

Detailed description: Whole Health is a model designed to address multiple patient needs. This includes physical and spiritual wellness, personal surroundings, nutrition, relationships, and mental wellness. The Whole Health approach focuses on improving overall patient wellness and includes increased availability of complementary and alternative medicine services. While some Whole Health work is being done at outpatient facilities, this study seeks to expand and test this approach to the inpatient setting, given the potential Whole Health has for addressing patient wellness.

The goal of this study is to implement and evaluate an inpatient Whole Health Bundle intervention to improve hospitalized patients' well-being. This study will assess if implementing an Inpatient Whole Health Bundle is associated with improved patient-centric outcomes (such as perceptions of the healing environment and patient satisfaction) among hospitalized patients.

This is a quasi-experimental pre-test/post-test trial. The study will be conducted at one Veterans Affairs hospital. Study subjects will be hospitalized patients. The study will be conducted in 2 phases- pre-intervention and intervention. Each study phase will last 2-months on each study unit. During the pre-intervention phase, a sample of patients recently discharged from the hospital will be mailed a study survey. The survey will ask questions about their satisfaction with their hospital stay.

During the intervention phase, patients staying in the hospital will be asked if they would like to participate in the study. Participants will be offered a menu of items and services that could help improve their overall well-being and their hospital stay. Patient will be free to choose or decline any of the items on the menu. A researcher will record which items, if any, a patient selects. Patients in the intervention will be mailed the same study survey as the pre-intervention phase after they are discharged from the hospital. Researchers will compare patient satisfaction responses between patients staying in the hospital during the pre-intervention phase to those who participated in the intervention. A few patients will be asked to participate in a study interview. The interviews are to better understand intervention experiences as well as barriers and facilitators to improving patient satisfaction with their hospital stay. In addition, unit level metrics will be assessed between the pre-intervention and intervention time periods.

Eligibility criteria: Inclusion Criteria:

* Adult hospitalized patients on medical and medical/surgical units at the VA Ann Arbor Healthcare System

Exclusion Criteria:

* Patients who cannot speak English
* Patients who are cognitively impaired

Primary outcomes:
measure: Satisfaction with Whole Health Bundle and Components
timeFrame: 1-2 weeks post discharge (10 minutes to complete)
measure: General Patient Satisfaction
timeFrame: 1-2 weeks post discharge (10 minutes to complete)
measure: Satisfaction with Physical Hospital Environment
timeFrame: 1-2 weeks post discharge (10 minutes to complete)
Secondary outcomes:
measure: Length of Stay
timeFrame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
measure: Number of Palliative Care Consultations
timeFrame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
measure: Enrollment in Hospice
timeFrame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
measure: Inpatient Mortality
timeFrame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
measure: Hospital Readmissions
timeFrame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: Nathan Houchens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Sanjay Saint, MD
role: STUDY_DIRECTOR
References: