Social IsolationDC PROMISNCT02041585
Discharge Functional Status and Rehospitalization in the Elderly
An observational study of Social Isolation and Depression, run by Northwestern University at 1 site in United States.
Trial summary
The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement Information System Study) is a study to see the effect of patients' social, physical and mental function on their health after hospital discharge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Social Isolation, Depression, Anxiety
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2014
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: General medical service inpatient hospitalist service population, aged greater than or equal to 65
Who may be able to join
- patients cared for on the inpatient general medical and surgical services at Northwestern Memorial Hospital (NMH)
- age upon admission ≥65 years
- anticipated disposition to home at discharge or within two weeks of discharge
Who cannot join
- previous hospitalization within 30 days
- in-hospital death
- transfer to another inpatient facility at the time of discharge
- non-English language fluency
- hospital medicine attending attestation that patient is not competent or clinically stable to participate
- Mini-cog evaluation consistent with dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: The Contribution of Low Physical Function, Emotional Function and Social Support to Rehospitalization Risk Among Older Adults
The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement Information System Study) is a study to see the effect of patients' social, physical and mental function on their health after hospital discharge.
Read the detailed description
Background:
Rehospitalization within 30 days of discharge is observed in approximately 19% of Medicare Fee for Service patients following discharge. Risk factors including medical comorbidity and discharge process quality have been identified as contributing to this outcome, however the possibility that patient level social and functional characteristics has not been equally investigated.
Procedural summary:
Patients will be recruited at the time of discharge. Participation in the study will include three surveys (one at the time of discharge, one within 72-96 hours after discharge and one thirty days after discharge) about functional status. The survey will inquire about function in six domains: physical function, depression, anxiety, cognition, social isolation, instrumental social support. The initial survey will be conducted in person at the hospital bedside by a research team member. The second and third surveys will be conducted by telephone within 72 to 96 day hours of discharge. Survey responses will be collected by direct patient response into tablet computer hardware.
Recruitment:
The research team (PI or RA) will identify candidates for recruitment based on conversation with the hospital case management staff and hospitalist physicians at the time of daily interdisciplinary care rounds. Inclusion criteria are age greater than or equal to 65 and anticipated return to home-based care at discharge or within two weeks of discharge. Exclusion criteria are non-English speaking language status, inability to complete interview based on sensory limitations, Mini-Cog evaluation consistent with dementia, or physician caregiver recommendation that patient not be enrolled.
Risk:
Participation in this study will not involve any physical risk beyond that of every day life. Risk will be minimized as no invasive interventions will be used. The possibility of psychological stress exists as individuals participate in interviews and complete survey items designed to test performance. Subjects may feel embarrassed to report areas of functional limitation.
Risk of emotional harm will be minimized through the supportive presence of the PI and/or RA at the time of data collection and the use of geriatric appropriate strategies for interviewing. The patient will only be approached with hospital physician recommendation.
Data Safety Primary data will be de-identified and carefully maintained in a locked area.
- Conditions
- Social Isolation, Depression, Anxiety, Debility
- Keywords
- Hospital Readmission, Social Isolation and Hospital Readmission, Age and Hospital Readmission, Functional Status and Hospital Readmission, Charlson Score and Hospital Readmission, Length of Stay and Hospital Readmission
- Medical subject headings
- Social Isolation, Depression, Anxiety Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elder discharge cohort | There will be no intervention in this observational survey research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day rehospitalization
Rehospitalization is an important clinical quality/healthcare utilization measure. In this study it will be measured using patient report of rehospitalization collected via telephone followup.
Measured: Measured at 30 days following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Hansen, Northwestern University
- Investigators
- Luke Hansen, MD, MHS, Principal investigator, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041585
- Sponsor's protocol ID
- DCPROMIS
- Acronym
- DC PROMIS
- Status last verified
- Mar 2023
- First submitted
- 15 Jan 2014
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Low Physical Function, Emotional Function and Social Support to Rehospitalization Risk Among Older Adults
- ClinicalTrials.gov ID
- NCT02041585
- Acronym / sponsor ID
- DC PROMIS / DCPROMIS
- Conditions
- Social Isolation, Depression, Anxiety, Debility
- Keywords
- Hospital Readmission, Social Isolation and Hospital Readmission, Age and Hospital Readmission, Functional Status and Hospital Readmission, Charlson Score and Hospital Readmission, Length of Stay and Hospital Readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Jan 2014 (estimated)
- 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 DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement Information System Study) is a study to see the effect of patients' social, physical and mental function on their health after hospital discharge.
Detailed description
Background:
Rehospitalization within 30 days of discharge is observed in approximately 19% of Medicare Fee for Service patients following discharge. Risk factors including medical comorbidity and discharge process quality have been identified as contributing to this outcome, however the possibility that patient level social and functional characteristics has not been equally investigated.
Procedural summary:
Patients will be recruited at the time of discharge. Participation in the study will include three surveys (one at the time of discharge, one within 72-96 hours after discharge and one thirty days after discharge) about functional status. The survey will inquire about function in six domains: physical function, depression, anxiety, cognition, social isolation, instrumental social support. The initial survey will be conducted in person at the hospital bedside by a research team member. The second and third surveys will be conducted by telephone within 72 to 96 day hours of discharge. Survey responses will be collected by direct patient response into tablet computer hardware.
Recruitment:
The research team (PI or RA) will identify candidates for recruitment based on conversation with the hospital case management staff and hospitalist physicians at the time of daily interdisciplinary care rounds. Inclusion criteria are age greater than or equal to 65 and anticipated return to home-based care at discharge or within two weeks of discharge. Exclusion criteria are non-English speaking language status, inability to complete interview based on sensory limitations, Mini-Cog evaluation consistent with dementia, or physician caregiver recommendation that patient not be enrolled.
Risk:
Participation in this study will not involve any physical risk beyond that of every day life. Risk will be minimized as no invasive interventions will be used. The possibility of psychological stress exists as individuals participate in interviews and complete survey items designed to test performance. Subjects may feel embarrassed to report areas of functional limitation.
Risk of emotional harm will be minimized through the supportive presence of the PI and/or RA at the time of data collection and the use of geriatric appropriate strategies for interviewing. The patient will only be approached with hospital physician recommendation.
Data Safety Primary data will be de-identified and carefully maintained in a locked area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elder discharge cohort | – | –There will be no intervention in this observational survey research. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- General medical service inpatient hospitalist service population, aged greater than or equal to 65
Key inclusion criteria (3 listed)
- patients cared for on the inpatient general medical and surgical services at Northwestern Memorial Hospital (NMH)
- age upon admission ≥65 years
- anticipated disposition to home at discharge or within two weeks of discharge
Key exclusion criteria (6 listed)
- previous hospitalization within 30 days
- in-hospital death
- transfer to another inpatient facility at the time of discharge
- non-English language fluency
- hospital medicine attending attestation that patient is not competent or clinically stable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 day rehospitalization
Time frame: Measured at 30 days following hospital discharge
Rehospitalization is an important clinical quality/healthcare utilization measure. In this study it will be measured using patient report of rehospitalization collected via telephone followup.
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 6 Mar 2023.
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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.
Luke Hansen, MD, MHS principal investigator
Northwestern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Isolation and Depression, run by Northwestern University 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 3 inclusion and 6 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 6 Mar 2023. 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?
30 day rehospitalization (time frame: Measured at 30 days following hospital discharge). 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 6 Mar 2023.