search
Back to results

Neurology Inpatient Clinical Education Trial

Primary Purpose

Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Current standard discharge educational intervention
Personalized discharge educational intervention
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myasthenia Gravis focused on measuring clinical education

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over the age of 18
  • Must have the capacity to consent and understand the study related activities and education materials.

Exclusion Criteria:

  • Under the age of 18
  • Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study

Sites / Locations

  • Dartmouth- Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current standard education group

New personalized education group

Arm Description

A study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.

A study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.

Outcomes

Primary Outcome Measures

Patient satisfaction scores
The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2019
Last Updated
January 6, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03826056
Brief Title
Neurology Inpatient Clinical Education Trial
Official Title
Neurology Inpatient Clinical Education Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores. The investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Guillain-Barre Syndrome, Multiple Sclerosis, Seizures, Parkinsonism, Meningitis, Encephalitis, Headache, Vestibular Disorder, Spondylosis, Normal Pressure Hydrocephalus
Keywords
clinical education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution. A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
Masking
Participant
Masking Description
The patient will not be informed of whether he or she is receiving the current hospital standard or the new personalized patient education intervention. The study team member will known which intervention is being used for patient education. The intervention arm will not be blinded in the data analysis.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current standard education group
Arm Type
Active Comparator
Arm Description
A study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
Arm Title
New personalized education group
Arm Type
Experimental
Arm Description
A study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
Intervention Type
Behavioral
Intervention Name(s)
Current standard discharge educational intervention
Intervention Description
The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.
Intervention Type
Behavioral
Intervention Name(s)
Personalized discharge educational intervention
Intervention Description
The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.
Primary Outcome Measure Information:
Title
Patient satisfaction scores
Description
The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.
Time Frame
Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 18 Must have the capacity to consent and understand the study related activities and education materials. Exclusion Criteria: Under the age of 18 Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Renga, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth- Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Investigators will protect patients' identity by using identification numbers that do not correspond to any personal identification information. They will enter the survey results to the institution's safely encrypted database.

Learn more about this trial

Neurology Inpatient Clinical Education Trial

We'll reach out to this number within 24 hrs