Social Determinants of Health Screening and Interventions (SDOH)

January 23, 2025 updated by: University of Toledo Health Science Campus

Patient Perceptions of Care: The Effects of Social Determinants of Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will be conducting this study as a prospective, non-randomized quality improvement study that will look at patients 18 years of age and older who are admitted under the trauma and general surgery specialties. Patients will be identified through admission to the trauma or general surgery service or referred to surgery services.

Eligible patients will be identified and approached by the study team. Once the informed consent is completed, patients will be given a Social Determinants of Health Screening Tool, an Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Tool, and an short form health survey (SF-12) Quality of Life Questionnaire. Feedback from the Hospital Consumer Assessment of Healthcare Providers and Systems results will be given immediately to the relevant teams (nurses, doctors, etc.) to address the patient's concerns. Prior to discharge, the patients will also be given referrals to designated community resources. On day 15 (+/- 7 days) after discharge, the patients will receive a follow up phone call where they will be asked if they have utilized the Social Determinants of Health Referrals. Participants will also be given a second Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Survey at this time. On day 30 (+/- 7 days) after discharge, the patients will receive a follow up phone call where the participants will be asked if they utilized the Social Determinants of Health Referrals. Participants will also be given a second short form health survey (SF-12) Quality of Life Survey at this time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Social Determinants of Health
Intervention will be the Social Determinants of Health Referrals.
Other: Social Determinants of Health Referrals
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk
Time Frame: Within 15 days of discharge
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
Time Frame: Within 30 days of discharge
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
Time Frame: within 30 days of discharge

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Communication Between Patient and Health Care Givers Questionnaire
Time Frame: Within 15 days of discharge
patients will evaluate the communication of the hospital staff with an abbreviated hospital consumer assessment of healthcare providers and system (HCAHPS) and rate the communication. the scale is based on positive (yes) or negative (no) responses. positive (yes) correlates to 1, negative (no) correlates to a 2. This scale of total answers can range from 1 to 10. One being the worst score and 10 being the best score. Once the questionnaire was completed. The negative (no) responses are shared with hospital leadership and unit directors to improve patient/staff communication.
Within 15 days of discharge
Baseline HCAHPS Data
Time Frame: Within 15 days of discharge
Baseline data obtained for evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and systems, HCAHPS. 10 questions total. 9 based on positive (yes) and negative (no) answers. Positive response (yes) correlates to number 1. negative response (no) correlates to a number 2. The lower the score the greater the patient satisfaction with the hospital. 1 question was a hospital rating scale of 1-10 with 1 being the lowest score and 10 being the highest score. A higher score correlates to a higher patient satisfaction level. 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 ea
Within 15 days of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toledo Health Science Campus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Klepacz, MD, University of Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDOH Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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