The M-Well Inpatient Whole Health Bundle

NCT06405347 | Completed

• 2 other identifiers: VAAAHS17922751R18HS028963-01
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Keywords

Holistic Health; Mindfulness; Hospitalization

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1-2 weeks post discharge (10 minutes to complete)

Secondary Outcomes (5)

• Length of Stay

  4 months (2 months of pre-intervention data and 2 months of intervention data)

• Number of Palliative Care Consultations

  4 months (2 months of pre-intervention data and 2 months of intervention data)

• Enrollment in Hospice

  4 months (2 months of pre-intervention data and 2 months of intervention data)

• Inpatient Mortality

  4 months (2 months of pre-intervention data and 2 months of intervention data)

• Hospital Readmissions

  4 months (2 months of pre-intervention data and 2 months of intervention data)

Study Arms (2)

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.

Behavioral: Inpatient Whole Health Bundle

Interventions

Inpatient Whole Health Bundle BEHAVIORAL

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.

Whole Health Intervention Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nathan Houchens, MD

  VA Ann Arbor Healthcare System

  PRINCIPAL INVESTIGATOR

• Sanjay Saint, MD

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Medicine, VA Ann Arbor, and Associate Professor of Medicine, University of Michigan

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 8, 2024
• Study Start: June 12, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: April 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the final publication from this study, for at least 6 years.
• Access Criteria: De-identified data will be provided after requesters sign a Letter of Agreement (LOA) detailing the mechanisms by which the data will be kept secure. The LOA will also state that the recipient will not attempt to identify any individual in the data, will not share the data outside of their research team, and will provide information on any files to be linked to the data. The dataset will not include personal identifying information and all dates will be changed to integers to allow for calculation of time periods.

Locations

US (1)