Social Determinants of HealthSDOHNCT03661359
Social Determinants of Health Screening and Interventions
A study testing Social Determinants of Health Referrals in people with Social Determinants of Health and Patient Satisfaction, run by University of Toledo Health Science Campus at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Patient Satisfaction, Quality of Life
- What is being tested?
- Social Determinants of Health Referrals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo Medical Center
Toledo, Ohio, 43614
About this study
Official title: 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.
Read the 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.
- Being tested
- Social Determinants of Health Referrals
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Determinants of Health ReferralsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Determinants of Health | Experimental | Intervention will be the Social Determinants of Health Referrals. Receives: Other: Social Determinants of Health Referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: within 30 days of discharge
Secondary outcomes (2)
Communication Between Patient and Health Care Givers Questionnaire
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.
Measured: Within 15 days of discharge
Baseline HCAHPS Data
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
Measured: Within 15 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start14 May 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Klepacz, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661359
- Sponsor's protocol ID
- SDOH Study
- Acronym
- SDOH
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2018
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collection is still in early stages. Further discussion will be needed before a decision is finalized.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perceptions of Care: The Effects of Social Determinants of Health
- ClinicalTrials.gov ID
- NCT03661359
- Acronym / sponsor ID
- SDOH / SDOH Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Social Determinants of Health | Experimental | Other: Social Determinants of Health ReferralsIntervention will be the Social Determinants of Health Referrals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Social Determinants of Health ReferralsPatients 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. | Other | Social Determinants of Health |
Primary outcome
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
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.
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.
2 secondary outcomes
Communication Between Patient and Health Care Givers Questionnaire
Time frame: Within 15 days of discharge
Baseline HCAHPS Data
Time frame: Within 15 days of discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data collection is still in early stages. Further discussion will be needed before a decision is finalized.
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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.
Heather Klepacz, MD principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Determinants of Health Referrals in people with Social Determinants of Health and Patient Satisfaction, run by University of Toledo Health Science Campus 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 4 inclusion and 3 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 27 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk (time frame: Within 15 days of discharge). 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 27 Jan 2025.