Parent Understanding of Discharge Instructions

NCT04063241 | Terminated

• 1 other identifier: 15-00072
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this work is to identify strategies to reduce preventable pediatric post-hospitalization morbidity. In this study, investigators seek to address gaps in the knowledge base related to pediatric post-hospitalization morbidity by examining the understanding and execution of post-hospitalization discharge instructions in the context of low health literacy (HL).

Conditions

Parent-Child Relations

Keywords

health literacy

Outcome Measures

Primary Outcomes (1)

• Parent Execution of Discharge Instructions

  Execution will be assessed at three time points. The first assessment (T2) will take place in person, within the first two weeks of discharge, to coincide with a follow-up appointment if possible or at another convenient time for the parent. At this time point, execution will be assessed via structured survey and b) observed dosing assessment. Surveys will include information about execution of instructions related to medications (dose and adherence), follow up appointments (attendance), concerning symptoms, and restrictions. The electronic health record will also be reviewed to determine if appointments were attended

  14 days

Secondary Outcomes (4)

• Parent Understanding of Discharge Instructions

  1 day (within 12 hours of hospital discharge)

• Post-Hospitalization Morbidity

  45 days

• Provider Outcomes: Baseline

  Baseline: Day 1

• Provider Outcomes

  45 days

Study Arms (3)

Parent: Pre-implementation

NO INTERVENTION

Parents in the pre-implementation group will receive standard care: verbal counseling by the doctor/nurse using text-based instructions they have prepared (not standardized).

Parent: Post-Implementation

EXPERIMENTAL

Doctors and nurses will be able to customize the web-based disease-specific instructions with the research team's help. They will reference these instructions as they perform discharge counseling and will give parents a copy of the instructions to refer to at home.

Other: Health Literacy-Informed Discharge Instructions

Provider

OTHER

Baseline measures will be assessed for providers. They will then take part in a 20-minute training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data. At the end of the study, assessments will be performed for those who use the health literacy-informed tool at least once during the study period.

Other: Provider Training

Interventions

Health Literacy-Informed Discharge Instructions OTHER

Web-based disease-specific instruction sheets that will be printed with the research team's help. Providers will reference these instructions as they perform discharge counseling and will give parents a copy of the instructions to refer to at home.

Parent: Post-Implementation

Provider Training OTHER

20-minute long provider training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data.

Provider

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caregiver of child ≤12 years old
• Primary caregiver of child discharged on ≥1 daily medication
• Primarily speaks and reads English or Spanish (by report).

You may not qualify if:

• Parent of child not discharged home (e.g. transferred to another facility\<18 years old
• Vision difficulty (\<20/50 corrected; Rosenbaum screener)
• Self-reported parent hearing difficulty
• Provider
• Pediatric resident at NYU School of Medicine
• None

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Alexander Glick, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parents: Phase A (Pre-implementation): Parents in the pre-implementation group will receive standard care: verbal counseling by the doctor/nurse using text-based instructions they have prepared (not standardized). Phase A was completed as an observational study. Phase B (Implementation): Provider training (see below) Phase C (Post-implementation): Doctors and nurses will customize the web-based disease-specific instructions with the research team's help. They will reference these instructions as they perform discharge counseling and will give parents a copy of the instructions. Providers: Pediatric residents knowledge, attitudes, and practices will be assessed at baseline. They will then take part in a 20-minute training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data. Assessments will be performed for those who use the health literacy-informed tool at least once during the study period.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: July 16, 2019
• Primary Completion: March 12, 2020
• Study Completion: April 2, 2020
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)