Clinical trial NCT04063241: Parent Understanding of Discharge Instructions
Official title: Parent Understanding of Discharge Instructions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parent-Child Relations
Keywords: health literacy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 264
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Parent Execution of Discharge Instructions
timeFrame: 14 days
Secondary outcomes:
measure: Parent Understanding of Discharge Instructions
timeFrame: 1 day (within 12 hours of hospital discharge)
measure: Post-Hospitalization Morbidity
timeFrame: 45 days
measure: Provider Outcomes: Baseline
timeFrame: Baseline: Day 1
measure: Provider Outcomes
timeFrame: 45 days
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alexander Glick, MD
role: PRINCIPAL_INVESTIGATOR
References: