Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Home Nurse Visit post discharge.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Nurse Visit | Experimental | Families in this arm will receive a nurse home visit within 96 hours of discharge. |
|
| Control | Active Comparator | This arm will receive standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Home Visit | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samir S Shah, MD, MSCE | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26620060 | Background | 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. | |
| 26416164 | Background | Sauers-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. |
Not provided
Not provided
Not provided
Patients hospitalized on the hospital medicine or neurosciences services (neurology/ neurosurgery) at Cincinnati Children's Hospital Medical Center (CCHMC), a freestanding tertiary care children's hospital, between 2/2015 and 4/2016 were eligible for study recruitment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Home Nurse Visit | Families in this arm will receive a nurse home visit within 96 hours of discharge. Nurse Home Visit: 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 |
| FG001 | Control | This arm will receive standard of care. Standard of Care: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Home Nurse Visit | Families in this arm will receive a nurse home visit within 96 hours of discharge. Nurse Home Visit: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal). | Posted | Count of Participants | Participants | 30 days post-discharge |
|
enrollment to 30 days post-discharge
As this study involved minimal risk to the individuals recruited, we relied solely on caregiver report of any adverse event or serious adverse event during the study encounter (enrollment to 30 days post discharge). All-Cause Mortality was not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Nurse Visit | Families in this arm will receive a nurse home visit within 96 hours of discharge. Nurse Home Visit: 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Sucharew (Biostatistician) | Cincinnati Children's Hospital Medical Center | 513-803-1920 | heidi.sucharew@cchmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | Sep 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Sep 20, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Other | 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. |
|
| 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). |
| 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. | 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. | 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 | 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. | 14 days post-discharge |
| 26817441 | Background | Tubbs-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. |
| 27851705 | Background | Pickler 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. |
| 27471042 | Background | Beck 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. |
| 28557728 | Background | Sauers-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. |
| 29345256 | Background | Solan 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. |
| 29563237 | Background | Shah 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. |
| 29934295 | Background | Auger 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. |
| 30104421 | Background | Chang 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. |
| 30229150 | Background | Sauers-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. |
| 30039161 | Derived | Auger 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. |
| BG001 | Control | This arm will receive standard of care. Standard of Care: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Length of Stay | Length of hospital stay in days. | Median | Inter-Quartile Range | days |
|
Families in this arm will receive a nurse home visit within 96 hours of discharge.
Nurse Home Visit: 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
| OG001 | Control | This arm will receive standard of care. Standard of Care: 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. |
|
|
|
| Secondary | 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. | The analysis population includes the total subjects completing the 14-day phone call survey. Of the total randomized (1,500: 751 intervention, 749 control), 29 were excluded from the intervention group and 26 from the control group. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 14 days post-discharge |
|
|
|
|
| Secondary | 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). | The analysis population includes the total subjects completing the 14-day phone call survey with a response for the return to normalcy question. Of the total randomized (1,500: 751 intervention, 749 control), 30 were excluded from the intervention group and 26 from the control group with no data available for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | days | 14 days post-discharge |
|
|
|
|
| Secondary | 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. | The analysis population includes the total subjects completing the 14-day phone call survey. Of the total randomized (1,500: 751 intervention, 749 control), 29 were excluded from the intervention group and 26 from the control group for not completing the 14-day phone call survey. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 14 days post-discharge |
|
|
|
|
| Secondary | 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. | The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal). | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | 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 | The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal). | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | 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. | The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal). | Posted | Count of Participants | Participants | 14 days post-discharge |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 751 |
| 0 |
| 751 |
| EG001 | Control | This arm will receive standard of care. Standard of Care: 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. | 0 | 0 | 0 | 749 | 0 | 749 |
Not provided
Not provided