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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Post-discharge nurse phone call
Previous work has identified barriers to successful transitions that are most meaningful to patients and families. Investigators used these learnings to iteratively adapt an existing nurse home visit program to address these barriers, and have been studying the effectiveness of the redesigned nurse home visit in a randomized control trial (NCT02081846).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Phone Call | Experimental | Families in this arm will receive a phone call within 96 hours of discharge |
|
| Standard of Care | Active Comparator | This arm will receive standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Phone Call | Other | We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), 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, ED or 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 state) | 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Discharge Coping 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. Differences between intervention and control groups on this outcome at 14-day post-discharge are evaluated using a linear regression model with the stratification variables (census tract poverty and state of residence). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir 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 |
|---|---|---|---|
| 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. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nurse Phone Call | Families in this arm will receive a phone call within 96 hours of discharge Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home |
| FG001 | Standard of Care | 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 |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurse Phone Call | Families in this arm will receive a phone call within 96 hours of discharge Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), 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, ED or 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 state) | The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up. | 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nurse Phone Call | Families in this arm will receive a phone call within 96 hours of discharge Nurse Phone Call: We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Sucharew (Biostatistician) | Cincinnati Children's Hospital Medical Center | 513-803-1920 | heidi.sucharew@cchmc.org |
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| 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 |
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| 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 |
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|
| 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. |
|
| 14 days post-discharge |
| Number of 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 | Occurence(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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 30039161 | Background | 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. |
| 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. |
| 34330881 | Derived | Auger KA, Sucharew HJ, Simmons JM, Shah SS, Kahn RS, Beck AF; H2O Trial Study Group. Differential Impact of Home Nurse Contact After Discharge by Financial Strain, Primary Care Access, and Medical Complexity. Hosp Pediatr. 2021 Aug;11(8):791-800. doi: 10.1542/hpeds.2020-004267. |
| BG001 | Standard of Care | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Length of Stay | Length of hospital stay in days. | Median | Inter-Quartile Range | days |
|
| OG001 | Standard of Care | 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. |
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|
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| Secondary | Post-Discharge Coping 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. Differences between intervention and control groups on this outcome at 14-day post-discharge are evaluated using a linear regression model with the stratification variables (census tract poverty and state of residence). | The analysis population includes the total subjects completing the 14-day phone call survey for this outcome. Of the total randomized (966: 483 intervention, 483 control), 26 were excluded from the intervention group and 23 from the control group. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 14 days post-discharge |
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|
|
| Secondary | Number of 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 for this outcome. Of the total randomized (966: 483 intervention, 483 control), 26 were excluded from the intervention group and 23 from the control group. | Posted | Least Squares Mean | 95% Confidence Interval | days | 14 days post-discharge |
|
|
|
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| 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 for this outcome. Of the total randomized (966: 483 intervention, 483 control), 25 were excluded from the intervention group and 23 from the control group. | 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 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | Occurence(s) of an ED visit within 30 days post-discharge | The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up. | 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 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up. | Posted | Count of Participants | Participants | 14 days post-discharge |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 483 |
| 0 |
| 483 |
| EG001 | Standard of Care | 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 | 483 | 0 | 483 |
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