Focus: Hospitalized Patients
Conditions
Keywords
transitions of care, reutilization, home nurse visit, focus groups, quality improvement
Brief summary
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.
Interventions
OTHERNurse 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
OTHERStandard 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.
Sponsors
Patient-Centered Outcomes Research Institute
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days Until Normalcy | 14 days post-discharge | 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). |
| Red Flags Remembered | 14 days post-discharge | 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. |
| Post Discharge Coping Difficulty Scale | 14 days post-discharge | 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. |
| Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 30 days | Occurrence(s) of an ED visit within 30 days post-discharge |
| Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization | 14 days post-discharge | 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. |
| Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge | 30 days | Occurrence(s) of an unplanned readmission within 30 days post-discharge. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 749 |
| 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. | 749 |
| Total | 1,498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | invalid consent | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Control | Home Nurse Visit |
|---|---|---|---|
| Age, Continuous | 2.0 years | 1.9 years | 2.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants | 31 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1413 Participants | 709 Participants | 704 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 9 Participants | 11 Participants |
| Length of Stay | 2 days | 2 days | 2 days |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian/Oriental or Pacific Islander | 13 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 429 Participants | 210 Participants | 219 Participants |
| Race/Ethnicity, Customized Race Other | 126 Participants | 62 Participants | 64 Participants |
| Race/Ethnicity, Customized Race Unknown/missing | 17 Participants | 8 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 909 Participants | 456 Participants | 453 Participants |
| Region of Enrollment United States | 1498 Participants | 749 Participants | 749 Participants |
| Sex: Female, Male Female | 721 Participants | 364 Participants | 357 Participants |
| Sex: Female, Male Male | 777 Participants | 385 Participants | 392 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 751 | 0 / 749 |
| serious Total, serious adverse events | 0 / 751 | 0 / 749 |
Outcome results
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.
Time frame: 30 days post-discharge
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Nurse Visit | Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge | 133 Participants |
| Control | Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge | 105 Participants |
p-value: 0.047Regression, Logistic
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).
Time frame: 14 days post-discharge
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Home Nurse Visit | Days Until Normalcy | 4.16 days |
| Control | Days Until Normalcy | 4.11 days |
p-value: 0.82censored Poisson model
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.
Time frame: 14 days post-discharge
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Nurse Visit | Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization | 132 Participants |
| Control | Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization | 110 Participants |
p-value: 0.12Regression, Logistic
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
Time frame: 30 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Nurse Visit | Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 75 Participants |
| Control | Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 54 Participants |
p-value: 0.052Regression, Logistic
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.
Time frame: 30 days
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Nurse Visit | Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge | 58 Participants |
| Control | Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge | 41 Participants |
p-value: 0.08Regression, Logistic
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.
Time frame: 14 days post-discharge
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Home Nurse Visit | Post Discharge Coping Difficulty Scale | 20.4 units on a scale |
| Control | Post Discharge Coping Difficulty Scale | 21.2 units on a scale |
p-value: 0.32Regression, Linear
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.
Time frame: 14 days post-discharge
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Home Nurse Visit | Red Flags Remembered | 1.91 units on a scale |
| Control | Red Flags Remembered | 1.61 units on a scale |
p-value: <0.01Poisson model