NCT03826056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

January 30, 2019

Last Update Submit

January 6, 2022

Conditions

Keywords

clinical education

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

Current standard education group

ACTIVE COMPARATOR

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.

Behavioral: Current standard discharge educational intervention

New personalized education group

EXPERIMENTAL

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.

Behavioral: Personalized discharge educational intervention

Interventions

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.

Current standard education group

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.

New personalized education group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth- Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Myasthenia GravisGuillain-Barre SyndromeMultiple SclerosisSeizuresParkinsonian DisordersMeningitisEncephalitisHeadacheVestibular DiseasesSpondylosisHydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPolyradiculoneuropathyDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSNeurologic ManifestationsSigns and SymptomsBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNeuroinflammatory DiseasesPainLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHydrocephalus

Study Officials

  • Vijay Renga, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

February 1, 2019

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

January 11, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

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.

Locations