Hospitalized Patients
Conditions
Keywords
transitions of care, reutilization, nurse phone call
Brief summary
Post-discharge nurse phone call
Detailed 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).
Interventions
OTHERNurse 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
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, 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
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, 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of 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 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. 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). |
| Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 30 days | Occurence(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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 483 |
| 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. | 482 |
| Total | 965 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | consent issue | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Standard of Care | Nurse Phone Call |
|---|---|---|---|
| Age, Continuous | 2.4 years | 2.4 years | 2.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 20 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 931 Participants | 461 Participants | 470 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Length of Stay | 2 days | 2 days | 2 days |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian/Oriental or Pacific Islander | 14 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Black or African American | 219 Participants | 102 Participants | 117 Participants |
| Race/Ethnicity, Customized Race Other | 110 Participants | 61 Participants | 49 Participants |
| Race/Ethnicity, Customized Race Unknown/missing | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 620 Participants | 311 Participants | 309 Participants |
| Region of Enrollment United States | 965 Participants | 482 Participants | 483 Participants |
| Sex: Female, Male Female | 460 Participants | 214 Participants | 246 Participants |
| Sex: Female, Male Male | 505 Participants | 268 Participants | 237 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 / 483 | 0 / 483 |
| serious Total, serious adverse events | 0 / 483 | 0 / 483 |
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, 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)
Time frame: 30 days post-discharge
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nurse Phone Call | Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge | 77 Participants |
| Standard of Care | Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge | 63 Participants |
p-value: 0.21Regression, Logistic
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).
Time frame: 14 days post-discharge
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nurse Phone Call | Number of Days Until Normalcy | 3.9 days |
| Standard of Care | Number of Days Until Normalcy | 4.2 days |
p-value: 0.24censored 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 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nurse Phone Call | Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization | 71 Participants |
| Standard of Care | Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization | 72 Participants |
p-value: 0.92Regression, Logistic
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
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nurse Phone Call | Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 35 Participants |
| Standard of Care | Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge | 35 Participants |
p-value: 0.998Regression, 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 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nurse Phone Call | Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge | 32 Participants |
| Standard of Care | Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge | 27 Participants |
p-value: 0.5Regression, Logistic
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).
Time frame: 14 days post-discharge
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nurse Phone Call | Post-Discharge Coping Scale | 14.3 units on a scale |
| Standard of Care | Post-Discharge Coping Scale | 15.2 units on a scale |
p-value: 0.31Regression, 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 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nurse Phone Call | Red Flags Remembered | 1.8 units on a scale |
| Standard of Care | Red Flags Remembered | 1.5 units on a scale |
p-value: <0.01Poisson model