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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04248738
Other study ID # 00126445
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2020
Est. completion date August 16, 2022

Study information

Verified date August 2022
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, quality of discharge planning, length of stay, post-discharge outcomes (e.g., satisfaction), and readmissions.


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).


Recruitment information / eligibility

Status Completed
Enrollment 4562
Est. completion date August 16, 2022
Est. primary completion date July 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - newly assigned to one of the participating SS or GIM teams at the University Hospital Exclusion Criteria: - 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 - unfunded end stage renal disease patient - incarcerated persons - patients in isolation

Study Design


Intervention

Behavioral:
NEEDS
NEEDS intervention includes assessing patients' social needs and resources (SocNSuppR) and communicating those SocNSuppR to discharge teams

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Andrea Wallace Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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. 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.
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