Parent-Child RelationsNCT04063241
Parent Understanding of Discharge Instructions
A study testing Health Literacy-Informed Discharge Instructions and Provider Training in people with Parent-Child Relations, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Health Literacy-Informed Discharge Instructions and Provider Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 2 Apr 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- Pediatric resident at NYU School of Medicine
Who cannot join
- 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
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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).
Read the 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.
- Conditions
- Parent-Child Relations
- Being tested
- Health Literacy-Informed Discharge Instructions, Provider Training
- Keywords
- health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy-Informed Discharge InstructionsOther
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.
Provider TrainingOther
20-minute long provider training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Provider Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (4)
Parent Understanding of Discharge Instructions
Understanding will be measured in person or by phone after discharge education by the inpatient team but before parents begin administering scheduled home medications (T1b). Parents will be administered a structured survey. Actual understanding of medications, follow-up appointments, diet and activity restrictions, and concerning symptoms to monitor will be assessed. Questions will also include parent self-perceived understanding (including self-perceived understanding of medications, follow-up appointments, time of, diet and activity restrictions, and concerning symptoms). Subjects will rate their agreement with these statements on a 5 Point Likert Scale (Strongly Disagree to Strongly Agree). The adult version of this questionnaire has been validated and was later adapted for pediatric parents; we further modified this tool to include additional topics and to make it more easily understandable for parents with low literacy.
Measured: 1 day (within 12 hours of hospital discharge)
Post-Hospitalization Morbidity
Unplanned 7 and 30-day post-discharge readmissions, ED visits, and doctor visits) will be assessed via parent survey and via chart review.
Measured: 45 days
Provider Outcomes: Baseline
Survey at enrollment: Assessments include provider knowledge/attitudes/practices relating to counseling at the time of hospital discharge (assessment instrument modified from survey used in previous research study performed by this team).
Measured: Baseline: Day 1
Provider Outcomes
Follow-up survey: Providers who used the health-literacy informed tool at least once will be interviewed at the end of the study. Assessments include provider knowledge/attitudes/practices as well as perceived ease of use, utility, and barriers to use of the low literacy web-based intervention.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start16 Jul 2019
- Primary completion12 Mar 2020
- Study completion2 Apr 2020
Why it stopped: After initially being suspended in the setting of the COVID-19 pandemic, the study was then terminated due to lack of funding and staffing to complete it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Glick, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063241
- Sponsor's protocol ID
- 15-00072
- Status last verified
- May 2024
- First submitted
- 19 Aug 2019
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Requests should be directed to alexander.glick@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.