Patient SatisfactionNCT06405347
The M-Well Inpatient Whole Health Bundle
A study testing Inpatient Whole Health Bundle in people with Patient Satisfaction, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Inpatient Whole Health Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hospitalized patients on medical and medical/surgical units at the VA Ann Arbor Healthcare System
Who cannot join
- Patients who cannot speak English
- Patients who are cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
About this study
Official title: Engineering Whole Health Into Hospital Care to Improve Wellness: The Inpatient Whole Health Bundle
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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- Inpatient Whole Health Bundle
- Keywords
- Holistic Health, Mindfulness, Hospitalization
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient Whole Health BundleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention Participants | No intervention | Randomly selected patients who had been discharged within the two months prior to the intervention will be recruited to provide information via a survey. |
| Whole Health Intervention Participants | Experimental | Hospitalized patients on the intervention units will be offered participation in the Inpatient Whole Health Bundle. Receives: Behavioral: Inpatient Whole Health Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Whole Health Bundle and Components
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.
Measured: 1-2 weeks post discharge (10 minutes to complete)
General Patient Satisfaction
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.
Measured: 1-2 weeks post discharge (10 minutes to complete)
Satisfaction with Physical Hospital Environment
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.
Measured: 1-2 weeks post discharge (10 minutes to complete)
Secondary outcomes (5)
Length of Stay
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.
Measured: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Number of Palliative Care Consultations
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.
Measured: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Enrollment in Hospice
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.
Measured: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Inpatient Mortality
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.
Measured: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Hospital Readmissions
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.
Measured: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start12 Jun 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Nathan Houchens, University of Michigan
- Investigators
- Nathan Houchens, MD, Principal investigator, VA Ann Arbor Healthcare SystemSanjay Saint, MD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405347
- Sponsor's protocol ID
- VAAAHS1792275
- Other IDs
- 1R18HS028963-01
- Status last verified
- Nov 2025
- First submitted
- 6 May 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created. Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at Jennifer.Burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. The most cost-effective means for sharing data after a data-sharing agreement has been reached will be used. For example, data may be copied to a compact disk (CD) or digital versatile disk (DVD), be posted on a password protected and secure website, or made available through a third-party data archive service. Resources that are patentable and/or protectable under intellectual property rights will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Whole Health Into Hospital Care to Improve Wellness: The Inpatient Whole Health Bundle
- ClinicalTrials.gov ID
- NCT06405347
- Acronym / sponsor ID
- VAAAHS1792275
- Conditions
- Patient Satisfaction
- Keywords
- Holistic Health, Mindfulness, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Participants | No intervention | –Randomly selected patients who had been discharged within the two months prior to the intervention will be recruited to provide information via a survey. |
| Whole Health Intervention Participants | Experimental | Behavioral: Inpatient Whole Health BundleHospitalized patients on the intervention units will be offered participation in the Inpatient Whole Health Bundle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult hospitalized patients on medical and medical/surgical units at the VA Ann Arbor Healthcare System
Key exclusion criteria (2 listed)
- Patients who cannot speak English
- Patients who are cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient Whole Health BundleHospitalized 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. | Behavioural | Whole Health Intervention Participants |
Primary outcome
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.
General Patient Satisfaction
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 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.
Satisfaction with Physical Hospital Environment
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 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.
5 secondary outcomes
Length of Stay
Time frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Number of Palliative Care Consultations
Time frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Enrollment in Hospice
Time frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Inpatient Mortality
Time frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Hospital Readmissions
Time frame: 4 months (2 months of pre-intervention data and 2 months of intervention data)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created. Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at Jennifer.Burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. The most cost-effective means for sharing data after a data-sharing agreement has been reached will be used. For example, data may be copied to a compact disk (CD) or digital versatile disk (DVD), be posted on a password protected and secure website, or made available through a third-party data archive service. Resources that are patentable and/or protectable under intellectual property rights will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Houchens, MD principal investigator
VA Ann Arbor Healthcare System
Sanjay Saint, MD study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient Whole Health Bundle in people with Patient Satisfaction, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Whole Health Bundle and Components (time frame: 1-2 weeks post discharge (10 minutes to complete)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.