Supplement to Hospital to Home Outcomes

Hospitalized Patients Clinical Trial

— Supplement  

Official title:

Supplement to Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224130
• Other study ID #: H2O Supplement
• Status: Completed
• Phase: N/A
• Start date: May 11, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-discharge nurse phone call

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient is under 18 years of age

• Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, ,community pediatrics, or adolescent medicine.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hospitalized Patients

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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). pii: e20173919. doi: 10.1542/peds.2017-3919. Erratum in: Pediatrics. 2019 Mar 29;:. — View Citation

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. — View Citation

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). pii: e20180195. doi: 10.1542/peds.2018-0195. Epub 2018 Aug 13. — View Citation

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. — View Citation

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). pii: e20162770. doi: 10.1542/peds.2016-2770. — View Citation

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. — View Citation

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. — View Citation

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). pii: e20172127. doi: 10.1542/peds.2017-2127. — View Citation

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. — View Citation

Solan LG, Beck AF, Shardo SA, Sauers-Ford HS, Simmons JM, Shah SS, Sherman SN; H20 Study Group. Caregiver Perspectives on Communication During Hospitalization at an Academic Pediatric Institution: A Qualitative Study. J Hosp Med. 2018 Jan 18;13(5):304-311. doi: 10.12788/jhm.2919. [Epub ahead of print] — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	30 days post-discharge
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).	14 days post-discharge
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).	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.	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.	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	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.	14 days post-discharge