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Parent Understanding of Discharge Instructions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063241
Recruitment Status : Suspended (Study suspended due to Covid-19)
First Posted : August 21, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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).

Condition or disease Intervention/treatment Phase
Parent-Child Relations Other: Health Literacy-Informed Discharge Instructions Other: Provider Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 778 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Parent Understanding of Discharge Instructions
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
No Intervention: Parent: 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).
Experimental: Parent: Post-Implementation
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
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
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
20-minute long provider training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data.




Primary Outcome Measures :
  1. Parent Execution of Discharge Instructions [ Time Frame: 14 days ]
    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


Secondary Outcome Measures :
  1. Parent Understanding of Discharge Instructions [ Time Frame: 1 day (within 12 hours of hospital discharge) ]
    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.

  2. Post-Hospitalization Morbidity [ Time Frame: 45 days ]
    Unplanned 7 and 30-day post-discharge readmissions, ED visits, and doctor visits) will be assessed via parent survey and via chart review.

  3. Provider Outcomes: Baseline [ Time Frame: Baseline: Day 1 ]
    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).

  4. Provider Outcomes [ Time Frame: 45 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063241


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Alexander Glick, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04063241    
Other Study ID Numbers: 15-00072
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
health literacy