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Transition to Adult Health CareNCT02480660

Adolescent to Adult-Oriented Health Care Transition Survey: Study of a Video-Based Educational Intervention

A study testing Educational Video in people with Transition to Adult Health Care, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To understand the baseline knowledge on the transition of care to adult providers in hospitalized adolescent patients and to test if an educational intervention given during an inpatient stay in a medium size academic pediatric hospital affects perception of knowledge, attitudes and participation in… Read more about this study

Who is it for?
Ages 15 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Transition to Adult Health Care
What is being tested?
Educational Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteUnited States
Study dates
Nov 2013to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

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 15 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • All subjects admitted to Golisano Children's Hospital from 15 to 25 years old except those defined by exclusion criteria

Who cannot join

  • Critically ill, as defined as being ICU patients;
  • Patients with acute psychosis;
  • Patients boarding within the pediatric hospital admitted to an adult hospital service;
  • Patients who have previously viewed the video;
  • Intellectually disabled;
  • Non -English speaking subjects and patients who have previously participated in the study.
  • For patients with an intellectual disability investigators will defer to the parents' judgment whether the patient can complete the surveys independently.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Golisano Children's Hospital at Strong

    Rochester, New York, 14642

Other trials in United States

About this study

Purpose: To understand the baseline knowledge on the transition of care to adult providers in hospitalized adolescent patients and to test if an educational intervention given during an inpatient stay in a medium size academic pediatric hospital affects perception of knowledge, attitudes and participation in transition planning.

Primary Research Question: Will a video-based educational intervention in an academic pediatric hospital affect perception of knowledge, attitudes and participation in transition planning to adult oriented health care of the hospitalized adolescent?

Secondary Research Question: What is the baseline experience of the hospitalized adolescent in key elements of transitioning to adult oriented health care?

Read the detailed description

Purpose: To understand the baseline knowledge on the transition of care to adult providers in hospitalized adolescent patients and to test if an educational intervention given during an inpatient stay in a medium size academic pediatric hospital affects perception of knowledge, attitudes and participation in transition planning.

Aim 1: To determine the effect of viewing a video-based educational intervention in an academic pediatric hospital affect perception of knowledge, attitudes and participation in transition planning to adult oriented health care of the hospitalized adolescent.

Aim 2: To describe the baseline experience and knowledge base of hospitalized adolescents regarding key elements of transitioning to adult-oriented health care.

CHARACTERISTICS OF THE RESEARCH POPULATION

  1. Number of subjects: There will be approximately 140 subjects assuming approximately 50% attrition by the third survey.
  2. Gender of Subjects: Subjects of either gender will be part of the study. Discrepancies in gender will be related to the patient population at the time of the study enrollment.
  3. Age of Subjects: The age range will be 15 to 25 years old.
  4. Racial and Ethnic Origin: There will be no enrollment restrictions based on race. It is expected that the racial distribution of our study population will mirror that of the inpatient pediatric patient population.

Methods and Procedures:

The purpose of the study will be achieved by surveying all eligible subjects admitted to the children's hospital. Eligible patients will be identified by the daily unit census in the children's hospital, excluding the patients outlined under exclusion criteria. Informed consent will be obtained from their parents and patients will assent to participate in the study. Personal health information and contact information will be collected with parents present by study investigator prior to randomization of subjects and will be stored separately from other survey data stored in a secure database on a password protected computer. All paper files will be kept in a locked office.

  1. At the time of enrollment patients will be stratified by age for block randomization in order to have balanced intervention and control groups. The age groups will be 15-16 year old control or intervention group vs 17 years old and greater control or intervention group. Both groups will be asked to complete three surveys during the course of the study; in terms of education, the control groups will receive standard care education while the intervention group will view an educational video on transition from adolescent to adult oriented health care. All subjects will be oriented to the use of the Get Well Network in order to access the surveys via SurveyMonkey© (Palo Alto, CA). The first survey will consist of 40 questions. A number of first survey questions were obtained and modified from the web questionnaire of 2007 Survey of Adult Transition and Health (SATH) from Department of Health and Human Services, Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA). Other questions from the Health-Care, Self Determination questionnaire packets relating to treatment self-regulation and perceived competence have been modified to focus on independence in health care management.
  2. After completing the first survey the intervention group subject will then be prompted via an embedded html link within the survey to watch a seven minute educational video.
  3. Prior to discharge from the hospital, participants in both groups will be asked to complete a second survey assessing willingness to prepare for the transition to adult oriented medical care, and actions taken during the hospital stay. Possible actions include taking a tour of an adult unit, discussing health insurance changes with a social worker, asking for a copy of a sample medical summary or requesting information about adult primary care and/or specialty providers. Patients will be given a reminder in person or via Facebook, phone, text or e-mail to complete the second survey via SurveyMonkey.
  4. Approximately 4 weeks after hospital discharge a reminder via Facebook, phone, text or e-mail will be sent to complete the third survey via SurveyMonkey©. If the subject does not have access to the internet, then the survey will be administered by phone.

A retrospective chart review will be performed to record each subject's type of health insurance and chronic illness based on the medical chart from the current hospitalization. Comparison will be made between the patient's awareness of his underlying chronic illness and compared with health care providers' documentation of underlying chronic illness.

Data Analysis and Monitoring Data will be statistically analyzed using descriptive statistics such as mean and standard deviation, chi square testing and regression analysis. Excel, SPSS and SAS will be used for statistical calculations. Dr. Keely Dwyer-Matzky , the principal investigator will be responsible for ensuring the privacy of the data. Since there is minimal risk a data and safety monitoring plan is not necessary.

Data Storage and Confidentiality

SurveyMonkey© is a confidential proprietary survey tool that collates quantitative data and written comments into convenient reports. SurveyMonkey© uses Secure Sockets Layer (SSL) technology, which protects user information through both server authentication and data encryption, ensuring that user data is safe, secure, and available only to authorized persons. Investigators will protect all health identifiers. Data downloaded from SurveyMonkey© will be maintained on electronic files on a secure server with password protection. Only authorized researchers will have access to the data. University of Rochester Office of Human Subjects or research regulatory groups may review these records.

Being tested
Educational Video
Keywords
Hospitalized, adolescents, knowledge, transition, educational intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational VideoBehavioural

    The video highlights key elements found in the existing literature critical for transition including understanding and taking charge of their health, creating a medical summary, learning more about health insurance, introducing the idea of organizing a health care transition team and creating a plan. The video also educates patients on the opportunities to take a tour of an adult floor, talk with social workers and learn more about adult providers during their hospital stay.

Study groups in NCT02480660
Study groupRoleWhat they receive
Video Intervention GroupExperimentalSubjects will be randomized to intervention group where participants will be asked to watch a 7 minute educational video.
Receives: Behavioral: Educational Video
Control GroupNo interventionSubjects will be randomized to control group ( no intervention) and receive standard of educational care on adolescent to adult oriented health care transitions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure the number of subjects who showed a positive change in perception of transition knowledge in survey responses pre and post intervention

    Will measure primary outcomes using likert scales ( eg very interested, somewhat interested, not very interested and not interested) Will compare pre and post intervention in intervention group and will compare intervention group to control group pre and post intervention.

    Measured: 2 years

  2. Measure the number of subjects who showed a positive change in attitudes about transition in survey responses pre and post intervention.

    Will measure primary outcomes using likert scales ( eg very interested, somewhat interested, not very interested and not interested) Will compare pre and post intervention in intervention group and will compare intervention group to control group pre and post intervention.

    Measured: 2 years

  3. Measure the number of subjects who showed a positive change in participation in transition planning in survey responses pre and post intervention

    Will measure primary outcomes using likert scales ( eg very interested, somewhat interested, not very interested and not interested) Will compare pre and post intervention in intervention group and will compare intervention group to control group pre and post intervention.

    Measured: 2 years

Secondary outcomes (1)
  1. Measure the number of subjects who had a positive baseline survey response in hospital experience

    Will measure secondary outcome measures using likert scales ( eg very interested, somewhat interested, not very interested and not interested) Will compare all respondents based on age, race, gender, special health care need, health insurance and education level.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480660
Sponsor's protocol ID
RSRB00044255
Status last verified
Jun 2015
First submitted
1 May 2015
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Video in people with Transition to Adult Health Care, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the number of subjects who showed a positive change in perception of transition knowledge in survey responses pre and post intervention (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.

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