- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06405347
The M-Well Inpatient Whole Health Bundle
Engineering Whole Health Into Hospital Care to Improve Wellness: The Inpatient Whole Health Bundle
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-Intervention Participants
Randomly selected patients who had been discharged within the two months prior to the intervention will be recruited to provide information via a survey.
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Experimental: Whole Health Intervention Participants
Hospitalized patients on the intervention units will be offered participation in the Inpatient Whole Health Bundle.
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Hospitalized patients on the intervention units will be offered participation in the Inpatient Whole Health Bundle, which is comprised of a variety of offerings aimed at improving the wellbeing of the patient.
They can choose to use any or none of the bundle elements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with Whole Health Bundle and Components
Time Frame: 1-2 weeks post discharge (10 minutes to complete)
|
A survey will be sent to selected patients discharged from the respective implementation units during the 2 months prior to implementation and to all participants in the intervention during the 2-month implementation period.
Questions will assess if patients were offered any of the Whole Health elements and their satisfaction with those offerings.
Satisfaction with each element will be assessed on a 5 point Likert scale from 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
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1-2 weeks post discharge (10 minutes to complete)
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General Patient Satisfaction
Time Frame: 1-2 weeks post discharge (10 minutes to complete)
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A survey will be sent to selected patients discharged from the respective implementation units during the 2 months prior to implementation and to all participants in the intervention during the 2-month implementation period.
Questions will assess overall patient satisfaction with their hospital stay.
The primary measure of satisfaction will be scored on a scale of 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible.
Questions will also be asked about the the care provided by their physicians and nurses while in the hospital and if the patient would recommend this hospital to friends and family.
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1-2 weeks post discharge (10 minutes to complete)
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Satisfaction with Physical Hospital Environment
Time Frame: 1-2 weeks post discharge (10 minutes to complete)
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A survey will be sent to selected patients discharged from the respective implementation units during the 2 months prior to implementation and to all participants in the intervention during the 2-month implementation period.
Questions will ask about the patient's satisfaction with various aspects of the physical hospital environment using a scale of 1 - Very dissatisfied to 5- Very satisfied.
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1-2 weeks post discharge (10 minutes to complete)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Stay
Time Frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
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Average length of stay prior to intervention will be compared to average length of stay during the intervention at the unit level for all patients regardless of study enrollment status.
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4 months (2 months of pre-intervention data and 2 months of intervention data)
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Number of Palliative Care Consultations
Time Frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
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Total number of palliative care consultations prior to intervention will be compared to total number of palliative care consultations during the intervention at the unit level for all patients regardless of study enrollment status.
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4 months (2 months of pre-intervention data and 2 months of intervention data)
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Enrollment in Hospice
Time Frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
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Total number of patients enrolled in hospice prior to intervention will be compared to total number of patients enrolled in hospice during the intervention at the unit level for all patients regardless of study enrollment status.
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4 months (2 months of pre-intervention data and 2 months of intervention data)
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Inpatient Mortality
Time Frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
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Total number of patients who died in the hospital prior to intervention will be compared to total number of patients who died in the hospital during the intervention at the unit level for all patients regardless of study enrollment status.
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4 months (2 months of pre-intervention data and 2 months of intervention data)
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Hospital Readmissions
Time Frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
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Total number of patients who stayed on a study unit prior to discharge and were readmitted to the hospital within 30 days of discharge will be compared to total number of patients who stayed on a study unit during the intervention period and were readmitted to the hospital within 30 days of discharge at the unit level for all patients regardless of study enrollment status.
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4 months (2 months of pre-intervention data and 2 months of intervention data)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathan Houchens, MD, VA Ann Arbor Healthcare System
- Study Director: Sanjay Saint, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAAAHS1792275
- 1R18HS028963-01 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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