NCT03661359

Brief Summary

The primary objective of this study is to connect patients with community resources to improve social determinants of health. Secondary objectives are improving patient satisfaction within the trauma and general surgery service, enhancement of physician-patient communication, betterment of surgery department Hospital Consumer Assessment of Healthcare Providers and Systems scores, and increased understanding of correlations between patient satisfaction and social determinants of health. The investigators hypothesize that (1) directed screening and intervention can have a positive effect for patients and hospitals, (2) directed patient advocacy will have an effect on patients' perception of care, (2) social determinants of health will have an effect on patients' perception of care, and (4) traumatic injury and acute surgery will have an effect on patients' perception of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

June 20, 2018

Results QC Date

November 4, 2020

Last Update Submit

January 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk

    evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and system HCAHPS, 9 questions based on positive or negative patient response to hospital care. positive (yes) responses correlate to a 1, negative (no ) responses correlate to a 2. the lower the number correlates to higher hospital satisfaction score. also included a hospital rating of 1-10 with 1 being lowest score and 10 being the highest rating. A higher score correlates to a higher patient satisfaction level. Domains at risk related to social determinants of health

    Within 15 days of discharge

  • Patients Who Filled Out Community Service Questionnaires

    During hospital admission each consented patient was assessed for the 5 domains of social determinants of health. Domains are education, economic stability, environment, health/healthcare, and social/community with 11 questions including financial strain, food insecurity, training/employment, housing instability education, utility needs, transportation, childcare, exposure to violence, social connection, behavioral health/substance abuse. A positive (yes) response flagged the patient for a referral to a community service including community financial resources, food banks and kitchens, community employment and training programs, local shelters. adult education programs, utility assistance programs, community transportation programs, community day resources, domestic violence programs, community centers including senior and religious, mental health and substance abuse resources.

    Within 30 days of discharge

  • Correlation Co-efficient Between Physical Quality of Life and Mental Quality of Life

    evaluate the patients perception of their own health with a short form health questionnaire (SF-12). Physical component score (PCS-12): A score of 50 or less may indicate a physical condition. Mental component score (MCS-12): A score of 42 or less may indicate clinical depression. General health: Scores above 50 indicate better-than-average health, while scores below 50 indicate below-average health. This compares the physical and mental scores. A correlation coefficient is a statistical measure that indicates the strength and direction of a linear relationship between two variables, expressed as a number between -1 and 1, where -1 signifies a perfect negative correlation, 0 indicates no correlation, and +1 represents a perfect positive correlation; essentially, it tells you how closely two variables are related to each other in a linear fashion.

    within 30 days of discharge

Secondary Outcomes (2)

  • Communication Between Patient and Health Care Givers Questionnaire

    Within 15 days of discharge

  • Baseline HCAHPS Data

    Within 15 days of discharge

Study Arms (1)

Social Determinants of Health

EXPERIMENTAL

Intervention will be the Social Determinants of Health Referrals.

Other: Social Determinants of Health Referrals

Interventions

Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.

Social Determinants of Health

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Admitted to the trauma or general surgery services
  • Live within Lucas County (for county referrals)
  • Patient or legally authorized representative agrees to participate and is willing to sign informed consent

You may not qualify if:

  • Anyone less than 18 years old
  • Any patient or legally authorized representative unwilling to sign informed consent
  • Anyone who lives outside of Lucas County or expresses unwillingness to use referral services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Heather Klepacz, M.D, Principle Investigator
Organization
University of Toledo

Study Officials

  • Heather Klepacz, MD

    University of Toledo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Each patient who consents will be given the community resource interventions which apply to them based on the results of the Social Determinants of Health Screening Tool.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

September 7, 2018

Study Start

May 14, 2018

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

January 27, 2025

Results First Posted

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data collection is still in early stages. Further discussion will be needed before a decision is finalized.

Locations