Social Determinants of HealthNEEDSNCT04248738
Social Needs and Resources in the Evaluation and Enhancement of Discharge Support
A study testing NEEDS in people with Social Determinants of Health and Readiness for Hospital Discharge, run by Andrea Wallace at 1 site in United States.
Trial summary
The goal of NEEDS is to systematically identify patients' needs and resources at home to inform discharge planning by health care teams. We believe the process of conducting such an assessment during hospitalization will integrate the patient's voice and improve patient outcomes by improving the team communication… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Readiness for Hospital Discharge
- What is being tested?
- NEEDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,562 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- newly assigned to one of the participating SS or GIM teams at the University Hospital
Who cannot join
- Non-English and non-Spanish speaking
- admitted due to a primary or secondary psychiatric diagnosis
- enrolled in palliative/hospice care
- unable to communicate verbally
- resident of skilled nursing facility upon admission
- transplant patient
Show all 9Show fewer
- unfunded end stage renal disease patient
- incarcerated persons
- patients in isolation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Needs and Resources in the Evaluation and Enhancement of Discharge Support: The NEEDS Study
The goal of NEEDS is to systematically identify patients' needs and resources at home to inform discharge planning by health care teams. We believe the process of conducting such an assessment during hospitalization will integrate the patient's voice and improve patient outcomes by improving the team communication, quality of discharge planning, length of stay, post-discharge outcomes (e.g., satisfaction), and readmissions.
Read the detailed description
As much as $17 billion could be saved annually by identifying patients at risk for hospital readmission, and better supporting them during their "transitions" home. However, current interventions aiming to decrease readmissions are limited by the fact that the most frequently used risk models relying on clinical and administrative data fail to identify a significant number of patients readmitted. A potential reason for the limited power of models seeking to identify those at risk for readmission is that they fail to incorporate patientcentered factors associated with health outcomes. Research continues to document how social needs (e.g. food and housing insecurity) and supportive resources (e.g. instrumental social support) play important roles in health outcomes. Yet, while admissions assessment of social needs and supportive resources is required for JCAHO and CMS, our previous research identified that 1) conducting an assessment of patients' supportive resources (i.e. instrumental social support) reveals information important to discharge planning (e.g., living alone, poor relationships with providers) otherwise unknown by inpatient teams; 2) lack of agreement between patients and nurses regarding readiness for hospital discharge (personal status, knowledge, coping ability, and expected support) is associated with patient coping difficulties and readmissions; and 3) even in systems with dedicated discharge planners (e.g., RN case managers, LCSWs), health team members involved in discharge planning and education are frequently unaware of patients' social needs and supportive resources. These findings suggest that facilitating communication between patients, family members, and inpatient health care providers regarding patients' social needs and supportive resources will improve patient outcomes (e.g., readiness for hospital discharge, readmissions). However, we do not yet understand whether or how patients' social needs and supportive resources inform clinical decision-making, and there are concerns about incorporating such assessments into routine care without sufficient understanding of its impact on patients. Therefore, the objective of this study is to provide inpatient health care teams with information about patients' social needs and supportive resources, evaluating whether it facilitates clinical decision-making, impacts readiness for hospital discharge and, ultimately, reduces hospital readmission. We will use a pre-post design, with a segmented regression (interrupted time series) analytic approach, to test the effect of communicating results of a SocNSuppR assessment to medical and surgical inpatient teams during routine discharge planning rounds, or the NEEDS intervention. The hypothesis is the incorporation of patients' SocNSuppR information into inpatient care will result in higher and more congruent readiness for hospital discharge ratings (between patients, family caregivers, and members of the health care team) compared to patients without SocNSuppR assessment and communication. The study's specific aims are:
Specific Aim 1. To test the effect of the NEEDS intervention (assessing patients' SocNSuppR and communicating SocNSuppR to discharge teams) on patient- family caregiver- nurse- provider- outcomes.
We will compare the following pre and post intervention: (1a) patient-reported readiness for hospital discharge (primary outcome) and post-discharge coping difficulty (secondary outcome), (1b) degree of congruence among readiness for hospital discharge ratings (among patients, families, caregivers, nurses, and providers), and (1c) 7- and 30-day readmission rates.
Specific Aim 2. To test the effect of the NEEDS intervention on discharge planning processes.
We will (2a) track changes in discharge plans based on SocNSuppR qualitatively through clinical documentation, and (2b) compare documentation of designated caregiver teaching, discharges before 11am, discharges before 2pm, time from discharge order to discharge, and HCAHPS scores.
Specific Aim 3. To examine patient and provider experiences of the NEEDS intervention.
We will qualitatively examine patient- caregiver- and provider-reported barriers, facilitators and recommendations for clinical adoption of the NEEDS protocol (SocNSuppR assessment and communication).
- Being tested
- NEEDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEEDSBehavioural
NEEDS intervention includes assessing patients' social needs and resources (SocNSuppR) and communicating those SocNSuppR to discharge teams
| Study group | Role | What they receive |
|---|---|---|
| SocNSuppR | Experimental | Inpatient teams systematically provided with information about patients' social needs and supportive resources. Receives: Behavioral: NEEDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness for Hospital Discharge Scale (RHDS)
Comparison of baseline and intervention average score on the Readiness for Hospital Discharge Scale, analyzed at the unit and hospital level. There are 8 questions on the RHDS, each scored from 0-10, with 0 indicating not being ready for discharge at all and 10 indicating being totally ready for discharge. Higher scores indicate better outcomes. The RHDS is administered to patients and the clinical care teams at the time that the patient receives the green light for discharge.
Measured: The RHDS is administered to all patients and clinical care team members for three months prior to the introduction of the intervention (baseline) and also during the 3-month intervention.
Secondary outcomes (1)
Post-Discharge Coping Difficulty Scale (PDCDS)
Comparison of baseline and intervention average score on the Post-Discharge Coping Difficulty Scale, analyzed at the unit and hospital level. There are 10 questions on the RHDS, each scored from 0-10, with 0 indicating no difficulty coping with life after discharge and 10 indicating a great deal of difficulty coping. Higher scores indicate worse outcomes. The RHDS is only administered to patients.
Measured: The PDCDS is administered to all patients for three months prior to the introduction of the intervention (baseline) and also during the 3-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start4 Feb 2020
- Primary completion28 Jul 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Wallace
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Andrea Wallace, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248738
- Sponsor's protocol ID
- 00126445
- Acronym
- NEEDS
- Status last verified
- Aug 2022
- First submitted
- 27 Jan 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallace AS, Park S, Guo JW, Johnson EP, Elliott M, Elmore CE, Bristol AA. Reconsidering risk: instrumental social support and 30-day utilization after discharge. Health Aff Sch. 2025 Sep 4;3(10):qxaf178. doi: 10.1093/haschl/qxaf178. eCollection 2025 Oct.
PubMed 41079423Wallace AS, Raaum SE, Johnson EP, Presson AP, Allen CM, Elliott M, Bristol AA, Elmore CE. Impact of COVID-19 visitation policies and hospital capacity on discharge readiness in medicine patients. Discov Health Syst. 2023;2(1):45. doi: 10.1007/s44250-023-00060-8. Epub 2023 Nov 30.
PubMed 38045443Schmutz KE, Wallace AS, Bristol AA, Johnson EP, Raaum SE. Hospital Discharge During COVID-19: The Role of Social Resources. Clin Nurs Res. 2022 May;31(4):724-732. doi: 10.1177/10547738221075760. Epub 2022 Feb 15.
PubMed 35168380
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Needs and Resources in the Evaluation and Enhancement of Discharge Support: The NEEDS Study
- ClinicalTrials.gov ID
- NCT04248738
- Acronym / sponsor ID
- NEEDS / 00126445
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,562 participants (actual)
- Lead sponsor
- Andrea WallaceUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of NEEDS is to systematically identify patients' needs and resources at home to inform discharge planning by health care teams. We believe the process of conducting such an assessment during hospitalization will integrate the patient's voice and improve patient outcomes by improving the team communication, quality of discharge planning, length of stay, post-discharge outcomes (e.g., satisfaction), and readmissions.
Detailed description
As much as $17 billion could be saved annually by identifying patients at risk for hospital readmission, and better supporting them during their "transitions" home. However, current interventions aiming to decrease readmissions are limited by the fact that the most frequently used risk models relying on clinical and administrative data fail to identify a significant number of patients readmitted. A potential reason for the limited power of models seeking to identify those at risk for readmission is that they fail to incorporate patientcentered factors associated with health outcomes. Research continues to document how social needs (e.g. food and housing insecurity) and supportive resources (e.g. instrumental social support) play important roles in health outcomes. Yet, while admissions assessment of social needs and supportive resources is required for JCAHO and CMS, our previous research identified that 1) conducting an assessment of patients' supportive resources (i.e. instrumental social support) reveals information important to discharge planning (e.g., living alone, poor relationships with providers) otherwise unknown by inpatient teams; 2) lack of agreement between patients and nurses regarding readiness for hospital discharge (personal status, knowledge, coping ability, and expected support) is associated with patient coping difficulties and readmissions; and 3) even in systems with dedicated discharge planners (e.g., RN case managers, LCSWs), health team members involved in discharge planning and education are frequently unaware of patients' social needs and supportive resources. These findings suggest that facilitating communication between patients, family members, and inpatient health care providers regarding patients' social needs and supportive resources will improve patient outcomes (e.g., readiness for hospital discharge, readmissions). However, we do not yet understand whether or how patients' social needs and supportive resources inform clinical decision-making, and there are concerns about incorporating such assessments into routine care without sufficient understanding of its impact on patients. Therefore, the objective of this study is to provide inpatient health care teams with information about patients' social needs and supportive resources, evaluating whether it facilitates clinical decision-making, impacts readiness for hospital discharge and, ultimately, reduces hospital readmission. We will use a pre-post design, with a segmented regression (interrupted time series) analytic approach, to test the effect of communicating results of a SocNSuppR assessment to medical and surgical inpatient teams during routine discharge planning rounds, or the NEEDS intervention. The hypothesis is the incorporation of patients' SocNSuppR information into inpatient care will result in higher and more congruent readiness for hospital discharge ratings (between patients, family caregivers, and members of the health care team) compared to patients without SocNSuppR assessment and communication. The study's specific aims are:
Specific Aim 1. To test the effect of the NEEDS intervention (assessing patients' SocNSuppR and communicating SocNSuppR to discharge teams) on patient- family caregiver- nurse- provider- outcomes.
We will compare the following pre and post intervention: (1a) patient-reported readiness for hospital discharge (primary outcome) and post-discharge coping difficulty (secondary outcome), (1b) degree of congruence among readiness for hospital discharge ratings (among patients, families, caregivers, nurses, and providers), and (1c) 7- and 30-day readmission rates.
Specific Aim 2. To test the effect of the NEEDS intervention on discharge planning processes.
We will (2a) track changes in discharge plans based on SocNSuppR qualitatively through clinical documentation, and (2b) compare documentation of designated caregiver teaching, discharges before 11am, discharges before 2pm, time from discharge order to discharge, and HCAHPS scores.
Specific Aim 3. To examine patient and provider experiences of the NEEDS intervention.
We will qualitatively examine patient- caregiver- and provider-reported barriers, facilitators and recommendations for clinical adoption of the NEEDS protocol (SocNSuppR assessment and communication).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SocNSuppR | Experimental | Behavioral: NEEDSInpatient teams systematically provided with information about patients' social needs and supportive resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- newly assigned to one of the participating SS or GIM teams at the University Hospital
Key exclusion criteria (9 listed)
- Non-English and non-Spanish speaking
- admitted due to a primary or secondary psychiatric diagnosis
- enrolled in palliative/hospice care
- unable to communicate verbally
- resident of skilled nursing facility upon admission
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 |
|---|---|---|
| NEEDSNEEDS intervention includes assessing patients' social needs and resources (SocNSuppR) and communicating those SocNSuppR to discharge teams | Behavioural | SocNSuppR |
Primary outcome
Readiness for Hospital Discharge Scale (RHDS)
Time frame: The RHDS is administered to all patients and clinical care team members for three months prior to the introduction of the intervention (baseline) and also during the 3-month intervention.
Comparison of baseline and intervention average score on the Readiness for Hospital Discharge Scale, analyzed at the unit and hospital level. There are 8 questions on the RHDS, each scored from 0-10, with 0 indicating not being ready for discharge at all and 10 indicating being totally ready for discharge. Higher scores indicate better outcomes. The RHDS is administered to patients and the clinical care teams at the time that the patient receives the green light for discharge.
1 secondary outcome
Post-Discharge Coping Difficulty Scale (PDCDS)
Time frame: The PDCDS is administered to all patients for three months prior to the introduction of the intervention (baseline) and also during the 3-month intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 41079423Wallace AS, Park S, Guo JW, Johnson EP, Elliott M, Elmore CE, Bristol AA. Reconsidering risk: instrumental social support and 30-day utilization after discharge. Health Aff Sch. 2025 Sep 4;3(10):qxaf178. doi: 10.1093/haschl/qxaf178. eCollection 2025 Oct.
- Derived from this study: PubMed 38045443Wallace AS, Raaum SE, Johnson EP, Presson AP, Allen CM, Elliott M, Bristol AA, Elmore CE. Impact of COVID-19 visitation policies and hospital capacity on discharge readiness in medicine patients. Discov Health Syst. 2023;2(1):45. doi: 10.1007/s44250-023-00060-8. Epub 2023 Nov 30.
- Derived from this study: PubMed 35168380Schmutz KE, Wallace AS, Bristol AA, Johnson EP, Raaum SE. Hospital Discharge During COVID-19: The Role of Social Resources. Clin Nurs Res. 2022 May;31(4):724-732. doi: 10.1177/10547738221075760. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEEDS in people with Social Determinants of Health and Readiness for Hospital Discharge, run by Andrea Wallace 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 1 inclusion and 9 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 19 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Readiness for Hospital Discharge Scale (RHDS) (time frame: The RHDS is administered to all patients and clinical care team members for three months prior to the introduction of the intervention (baseline) and also during the 3-month intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248738, which also lists 3 linked publications.
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 19 Aug 2022.