- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661359
Social Determinants of Health Screening and Interventions (SDOH)
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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Toledo, Ohio, United States, 43614
- University of Toledo Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Social Determinants of Health
Intervention will be the 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.
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What is the study measuring?
Primary Outcome Measures
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
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Within 15 days of discharge
|
|
Patients Who Filled Out Community Service Questionnaires
Time Frame: Within 30 days of discharge
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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
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.
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Within 15 days of discharge
|
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Baseline HCAHPS Data
Time Frame: Within 15 days of discharge
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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
Investigators
- Principal Investigator: Heather Klepacz, MD, University of Toledo
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
Other Study ID Numbers
- SDOH Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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