Parent Understanding of Discharge Instructions

NYU Langone Health

Status: Terminated

Conditions: Parent-Child Relations

Treatments: Other: Health Literacy-Informed Discharge Instructions; Other: Provider Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04063241

15-00072

Details and patient eligibility

About

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).

Full description

In this study, investigators seek to address gaps in the knowledge base related to pediatric post-hospitalization morbidity in 3 phases: first (Phase A) by examining the understanding and execution of post-hospitalization discharge instructions in the context of low HL, second (Phase B) by beginning to develop a low literacy discharge plan template to enhance and standardize provider counseling, and third (Phase C) by examining the effects of the intervention. The focus will be on those at greatest risk for low HL and poor outcomes, families from low SES backgrounds. Investigators therefore propose a prospective study (Phase A) to:

AIM 1. Examine associations between HL and parent execution of inpatient discharge instructions (overall and 4 key domains: medication management, follow-up, diet/activity restrictions, and concerning symptoms to act on;.

Hypothesis: Low HL will be adversely associated with execution (overall/individual domains).

AIM 2. Examine the role of understanding in the relationship between HL and parent execution of inpatient discharge instructions. a) Examine associations between HL and understanding (overall and 4 key domains). b) Examine the degree to which understanding mediates the relationship between HL and execution (overall and individual domains).

Hypothesis: Low HL will be adversely associated with understanding and its individual domains. The relationship between HL and execution will be partially mediated by understanding.

AIM 3 (Exploratory). Explore the role and mechanism through which low HL is related to post-hospitalization morbidity (as defined by readmissions, ED use, or unplanned doctor visits) by examining a) the association between HL and post-hospitalization morbidity, and b) the degree to which the relationship between HL and post-hospitalization morbidity occurs through overall understanding and execution.

Preliminary data from Phase A showed that >80% of parents make ≥1 error related to hospital discharge instructions. Notably, 30% of parents made medication errors, 20% missed >1 follow-up appointment, and 70% were not aware of concerning symptoms that should prompt medical attention. Findings from Phase A will be used to inform development of (Phase B) and to examine the efficacy of (Phase C) interventions to reduce post-hospitalization morbidity through a HL-informed approach as recommended by the Institute of Medicine. This work will build on a longstanding program of research and intervention development in this area by the study team.

The specific aims for Phases B and C are to:

AIM 4. Design a health literacy-informed discharge plan template tool to address domains of medication management, follow-up appointments, concerning symptoms to act on, and diet/activity restrictions.

AIM 5. Explore the efficacy of the tool in improving parent understanding and execution of discharge instructions (e.g. medication errors, appointment attendance, actions related to concerning symptoms, diet/activity restrictions).

Hypothesis: Parents will demonstrate improved understanding/execution of discharge instructions.

AIM 6. Explore the feasibility and utility of the tool with providers and parents.

Hypothesis: Providers/parents will find the tool to be easy to use and helpful.

Enrollment: 264 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Parent

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Inclusion Criteria:

• Pediatric resident at NYU School of Medicine

Exclusion Criteria:

• None

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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264 participants in 3 patient groups

Parent: Pre-implementation

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Health Literacy-Informed Discharge Instructions

Provider

Other group

Description:

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.

Treatment:

Other: Provider Training