Focus: Hospitalized PatientsNCT02081846
Hospital to Home Outcomes
A study testing Nurse Home Visit in people with Focus: Hospitalized Patients, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Home Nurse Visit post discharge. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Focus: Hospitalized Patients
- What is being tested?
- Nurse Home Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2015to 30 Jun 2017
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient is under 18 years of age Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, community pediatrics, adolescent medicine, neurology or neurosurgery.
Who cannot join
- Patient to be discharged someplace other than home (e.g., residential facility, psychiatric facility)
- Patient's home residence is outside the home nursing service area
- Patient is eligible for "traditional" home nursing services
- Caregiver is non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home
Home Nurse Visit post discharge.
Read the detailed description
To identify barriers to successful transitions that are most meaningful to patients and families, and use these identified barriers to iteratively adapt an existing nurse home visit program to address these barriers. This study will also test the efficacy of a nurse home visit intervention in improving post-discharge outcomes through a randomized controlled trial.
- Conditions
- Focus: Hospitalized Patients
- Being tested
- Nurse Home Visit, Standard of Care
- Keywords
- transitions of care, reutilization, home nurse visit, focus groups, quality improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Home VisitOther
We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home
Standard of CareOther
Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside.
| Study group | Role | What they receive |
|---|---|---|
| Home Nurse Visit | Experimental | Families in this arm will receive a nurse home visit within 96 hours of discharge. Receives: Other: Nurse Home Visit |
| Control | Active comparator | This arm will receive standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge
The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization and/or any emergency department/urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and complex versus noncomplex teams) included in the model.
Measured: 30 days post-discharge
Secondary outcomes (6)
Post Discharge Coping Difficulty Scale
Post-Discharge Difficulty Coping Scale (Weiss, et. al) measured at 14 day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11 point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.
Measured: 14 days post-discharge
Days Until Normalcy
Number of days until normalcy: measured at post discharge phone call. Parents asked to recall the number of days it took to "return to a 'normal' routine" including the return to work and school (with option of not yet be back to normal).
Measured: 14 days post-discharge
Red Flags Remembered
This was measured at the 14 day post-discharge phone call survey. Parents were asked to recall "any red flags or warning signs" to indicate the "child's condition was getting worse." The number of red flags recalled could range from 0-10 depending on the template used. The template was a home visit guideline for nurses to use that was specific to the child's illness. For example, if the child had bronchiolitis the nurse would use the template "bronchiolitis/croup/pneumonia" to guide them through the visit. Higher values (i.e., the greater number of red flags remembered) represent a better outcome.
Measured: 14 days post-discharge
Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge
Occurrence(s) of an unplanned readmission within 30 days post-discharge.
Measured: 30 days
Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge
Occurrence(s) of an ED visit within 30 days post-discharge
Measured: 30 days
Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization
Occurrence(s) of 14-day unplanned healthcare utilization defined by unplanned re-hospitalization and/or any emergency/urgent care visit within 14 days or parent report of an unplanned visit to one of these places. Parent report is collected at the 14 day follow-up phone call.
Measured: 14 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start2 Feb 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Focus: Hospitalized PatientsStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Samir S Shah, MD, MSCE, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081846
- Sponsor's protocol ID
- H2O
- Status last verified
- Apr 2019
- First submitted
- 5 Mar 2014
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Solan LG, Beck AF, Brunswick SA, Sauers HS, Wade-Murphy S, Simmons JM, Shah SS, Sherman SN; H2O Study Group. The Family Perspective on Hospital to Home Transitions: A Qualitative Study. Pediatrics. 2015 Dec;136(6):e1539-49. doi: 10.1542/peds.2015-2098.
PubMed 26620060Sauers-Ford HS, Simmons JM, Shah SS; H2O Study Team. Strategies to engage stakeholders in research to improve acute care delivery. J Hosp Med. 2016 Feb;11(2):123-5. doi: 10.1002/jhm.2492. Epub 2015 Sep 28.
PubMed 26416164Tubbs-Cooley HL, Pickler RH, Simmons JM, Auger KA, Beck AF, Sauers-Ford HS, Sucharew H, Solan LG, White CM, Sherman SN, Statile AM, Shah SS; H2O Study Group. Testing a post-discharge nurse-led transitional home visit in acute care pediatrics: the Hospital-To-Home Outcomes (H2O) study protocol. J Adv Nurs. 2016 Apr;72(4):915-25. doi: 10.1111/jan.12882. Epub 2016 Jan 28.
PubMed 26817441Pickler R, Wade-Murphy S, Gold J, Tubbs-Cooley H, White CM, Statile A, Hoying C, Sauers-Ford H, Shah SS, Simmons J; H2O Study Group. A Nurse Transitional Home Visit Following Pediatric Hospitalizations. J Nurs Adm. 2016 Dec;46(12):642-647. doi: 10.1097/NNA.0000000000000420.
PubMed 27851705Beck AF, Solan LG, Brunswick SA, Sauers-Ford H, Simmons JM, Shah S, Gold J, Sherman SN; H2O Study Group. Socioeconomic status influences the toll paediatric hospitalisations take on families: a qualitative study. BMJ Qual Saf. 2017 Apr;26(4):304-311. doi: 10.1136/bmjqs-2016-005421. Epub 2016 Jul 28.
PubMed 27471042Sauers-Ford HS, Gold JM, Statile AM, Tubbs-Cooley HL, Simmons JM, Shah SS, Bell K, Pfefferman C, Moore MJ, Auger KA; H2O Study Group. Improving Recruitment and Retention Rates in a Randomized Controlled Trial. Pediatrics. 2017 May;139(5):e20162770. doi: 10.1542/peds.2016-2770.
PubMed 28557728Solan LG, Beck AF, Shardo SA, Sauers-Ford HS, Simmons JM, Shah SS, Sherman SN; H2O Study Group. Caregiver Perspectives on Communication During Hospitalization at an Academic Pediatric Institution: A Qualitative Study. J Hosp Med. 2018 May;13(5):304-310. doi: 10.12788/jhm.2919.
PubMed 29345256Shah AN, Beck AF, Sucharew HJ, Litman S, Pfefferman C, Haney J, Shah SS, Simmons JM, Auger KA; H2O Study Group. Parental Adverse Childhood Experiences and Resilience on Coping After Discharge. Pediatrics. 2018 Apr;141(4):e20172127. doi: 10.1542/peds.2017-2127.
PubMed 29563237Auger KA, Simmons JM, Tubbs-Cooley HL, Sucharew HJ, Statile AM, Pickler RH, Sauers-Ford HS, Gold JM, Khoury JC, Beck AF, Wade-Murphy S, Kuhnell P, Shah SS; H2O Trial study group. Postdischarge Nurse Home Visits and Reuse: The Hospital to Home Outcomes (H2O) Trial. Pediatrics. 2018 Jul;142(1):e20173919. doi: 10.1542/peds.2017-3919.
PubMed 29934295Chang LV, Shah AN, Hoefgen ER, Auger KA, Weng H, Simmons JM, Shah SS, Beck AF; H2O Study Group. Lost Earnings and Nonmedical Expenses of Pediatric Hospitalizations. Pediatrics. 2018 Sep;142(3):e20180195. doi: 10.1542/peds.2018-0195. Epub 2018 Aug 13.
PubMed 30104421Sauers-Ford HS, Tubbs-Cooley H, Statile AM, Pickler RH, White CM, Wade-Murphy S, Gold JM, Shah SS, Simmons JM, Auger KA, Bachus J, Beck AF, Borell ML, Brunswick SA, Chang L, Heilman JA, Jabour JA, Khoury JC, Moore MJ, Sherman SN, Solan LG, Sucharew HJ, Sullivan KP. Optimizing a Nurse-led Transitional Home Visit Program in Preparation for a Randomized Control Trial. Pediatr Qual Saf. 2017 Jan 25;2(1):e012. doi: 10.1097/pq9.0000000000000012. eCollection 2017 Jan-Feb.
PubMed 30229150Auger KA, Shah SS, Tubbs-Cooley HL, Sucharew HJ, Gold JM, Wade-Murphy S, Statile AM, Bell KD, Khoury JC, Mangeot C, Simmons JM; Hospital-to-Home Outcomes Trial Study Group. Effects of a 1-Time Nurse-Led Telephone Call After Pediatric Discharge: The H2O II Randomized Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):e181482. doi: 10.1001/jamapediatrics.2018.1482. Epub 2018 Sep 4.
PubMed 30039161
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home
- ClinicalTrials.gov ID
- NCT02081846
- Acronym / sponsor ID
- H2O
- Conditions
- Focus: Hospitalized Patients
- Keywords
- transitions of care, reutilization, home nurse visit, focus groups, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Home Nurse Visit post discharge.
Detailed description
To identify barriers to successful transitions that are most meaningful to patients and families, and use these identified barriers to iteratively adapt an existing nurse home visit program to address these barriers. This study will also test the efficacy of a nurse home visit intervention in improving post-discharge outcomes through a randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Nurse Visit | Experimental | Other: Nurse Home VisitFamilies in this arm will receive a nurse home visit within 96 hours of discharge. |
| Control | Active comparator | Other: Standard of CareThis arm will receive standard of care. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient is under 18 years of age Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, community pediatrics, adolescent medicine, neurology or neurosurgery.
Key exclusion criteria (4 listed)
- Patient to be discharged someplace other than home (e.g., residential facility, psychiatric facility)
- Patient's home residence is outside the home nursing service area
- Patient is eligible for "traditional" home nursing services
- Caregiver is non-English speaking
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 |
|---|---|---|
| Nurse Home VisitWe will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home | Other | Home Nurse Visit |
| Standard of CareControl patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside. | Other | Control |
Primary outcome
Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge
Time frame: 30 days post-discharge
The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization and/or any emergency department/urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and complex versus noncomplex teams) included in the model.
6 secondary outcomes
Post Discharge Coping Difficulty Scale
Time frame: 14 days post-discharge
Days Until Normalcy
Time frame: 14 days post-discharge
Red Flags Remembered
Time frame: 14 days post-discharge
Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge
Time frame: 30 days
Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge
Time frame: 30 days
Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization
Time frame: 14 days post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26620060Solan LG, Beck AF, Brunswick SA, Sauers HS, Wade-Murphy S, Simmons JM, Shah SS, Sherman SN; H2O Study Group. The Family Perspective on Hospital to Home Transitions: A Qualitative Study. Pediatrics. 2015 Dec;136(6):e1539-49. doi: 10.1542/peds.2015-2098.
- Background: PubMed 26416164Sauers-Ford HS, Simmons JM, Shah SS; H2O Study Team. Strategies to engage stakeholders in research to improve acute care delivery. J Hosp Med. 2016 Feb;11(2):123-5. doi: 10.1002/jhm.2492. Epub 2015 Sep 28.
- Background: PubMed 26817441Tubbs-Cooley HL, Pickler RH, Simmons JM, Auger KA, Beck AF, Sauers-Ford HS, Sucharew H, Solan LG, White CM, Sherman SN, Statile AM, Shah SS; H2O Study Group. Testing a post-discharge nurse-led transitional home visit in acute care pediatrics: the Hospital-To-Home Outcomes (H2O) study protocol. J Adv Nurs. 2016 Apr;72(4):915-25. doi: 10.1111/jan.12882. Epub 2016 Jan 28.
- Background: PubMed 27851705Pickler R, Wade-Murphy S, Gold J, Tubbs-Cooley H, White CM, Statile A, Hoying C, Sauers-Ford H, Shah SS, Simmons J; H2O Study Group. A Nurse Transitional Home Visit Following Pediatric Hospitalizations. J Nurs Adm. 2016 Dec;46(12):642-647. doi: 10.1097/NNA.0000000000000420.
- Background: PubMed 27471042Beck AF, Solan LG, Brunswick SA, Sauers-Ford H, Simmons JM, Shah S, Gold J, Sherman SN; H2O Study Group. Socioeconomic status influences the toll paediatric hospitalisations take on families: a qualitative study. BMJ Qual Saf. 2017 Apr;26(4):304-311. doi: 10.1136/bmjqs-2016-005421. Epub 2016 Jul 28.
- Background: PubMed 28557728Sauers-Ford HS, Gold JM, Statile AM, Tubbs-Cooley HL, Simmons JM, Shah SS, Bell K, Pfefferman C, Moore MJ, Auger KA; H2O Study Group. Improving Recruitment and Retention Rates in a Randomized Controlled Trial. Pediatrics. 2017 May;139(5):e20162770. doi: 10.1542/peds.2016-2770.
- Background: PubMed 29345256Solan LG, Beck AF, Shardo SA, Sauers-Ford HS, Simmons JM, Shah SS, Sherman SN; H2O Study Group. Caregiver Perspectives on Communication During Hospitalization at an Academic Pediatric Institution: A Qualitative Study. J Hosp Med. 2018 May;13(5):304-310. doi: 10.12788/jhm.2919.
- Background: PubMed 29563237Shah AN, Beck AF, Sucharew HJ, Litman S, Pfefferman C, Haney J, Shah SS, Simmons JM, Auger KA; H2O Study Group. Parental Adverse Childhood Experiences and Resilience on Coping After Discharge. Pediatrics. 2018 Apr;141(4):e20172127. doi: 10.1542/peds.2017-2127.
- Background: PubMed 29934295Auger KA, Simmons JM, Tubbs-Cooley HL, Sucharew HJ, Statile AM, Pickler RH, Sauers-Ford HS, Gold JM, Khoury JC, Beck AF, Wade-Murphy S, Kuhnell P, Shah SS; H2O Trial study group. Postdischarge Nurse Home Visits and Reuse: The Hospital to Home Outcomes (H2O) Trial. Pediatrics. 2018 Jul;142(1):e20173919. doi: 10.1542/peds.2017-3919.
- Background: PubMed 30104421Chang LV, Shah AN, Hoefgen ER, Auger KA, Weng H, Simmons JM, Shah SS, Beck AF; H2O Study Group. Lost Earnings and Nonmedical Expenses of Pediatric Hospitalizations. Pediatrics. 2018 Sep;142(3):e20180195. doi: 10.1542/peds.2018-0195. Epub 2018 Aug 13.
- Background: PubMed 30229150Sauers-Ford HS, Tubbs-Cooley H, Statile AM, Pickler RH, White CM, Wade-Murphy S, Gold JM, Shah SS, Simmons JM, Auger KA, Bachus J, Beck AF, Borell ML, Brunswick SA, Chang L, Heilman JA, Jabour JA, Khoury JC, Moore MJ, Sherman SN, Solan LG, Sucharew HJ, Sullivan KP. Optimizing a Nurse-led Transitional Home Visit Program in Preparation for a Randomized Control Trial. Pediatr Qual Saf. 2017 Jan 25;2(1):e012. doi: 10.1097/pq9.0000000000000012. eCollection 2017 Jan-Feb.
- Derived from this study: PubMed 30039161Auger KA, Shah SS, Tubbs-Cooley HL, Sucharew HJ, Gold JM, Wade-Murphy S, Statile AM, Bell KD, Khoury JC, Mangeot C, Simmons JM; Hospital-to-Home Outcomes Trial Study Group. Effects of a 1-Time Nurse-Led Telephone Call After Pediatric Discharge: The H2O II Randomized Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):e181482. doi: 10.1001/jamapediatrics.2018.1482. Epub 2018 Sep 4.
Related trials for Focus: Hospitalized Patients
Recruiting
A Study Of Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Active, not recruitingObservational study
Effect of a Focused Point-of-care Ultrasonography Screening Protocol in Hospitalized Patients
Heart Failure, Congestive, Renal Failure Acute Chronic
Active, not recruitingObservational study
Establishment of Reference Limits for Blood Lactate Levels in Intensive Care Patients With a Particular Focus on Age and Sex
Lactate, Sepsis
RecruitingObservational study
Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods)
Malnutrition
RecruitingPhase 2
Psilocybin for Hospitalized Patients with Treatment-resistant Depression
Treatment Resistant Depression
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.
Samir S Shah, MD, MSCE principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Home Visit in people with Focus: Hospitalized Patients, run by Children's Hospital Medical Center, Cincinnati 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 4 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 16 Apr 2019. 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 29 Mar 2019). 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?
Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge (time frame: 30 days post-discharge). 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 NCT02081846, which also lists 12 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 16 Apr 2019.