- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00355381
Evaluating Patient Information Prescriptions
Evaluating Patient Information Prescriptions in Different Service Environments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this research is to evaluate IRx, to provide enough data so care organizations can decide whether to implement this in their own environment.
To that end, our specific aims are:
- To evaluate the impact of IRx on patients. We are performing a randomized clinical trial, comparing IRx with standard provision of information. The primary outcome is patient satisfaction.
- To evaluate the impact of IRx on providers. As part of the trial, provider perceptions and behavior will be assessed.
- To evaluate the impact of IRx on the health-care system. As part of the trial, costs entailed and resources utilized will be assessed.
- To evaluate how IRx generalizes across service environments. The trial will be performed in two environments: adult breast cancer and neonatal intensive care.
At the heart of this proposal are the randomized clinical trials. In each, patients in both intervention and control groups will receive standard clinical care in their clinic visits. Patients randomized to the intervention group will receive information services from a specially trained librarian; patients in the control groups will receive routine, current information provision. For Aim 1, immediately after their clinic visits and four weeks later, all participants will report their satisfaction on a survey that include measures of patient-provider communication. For Aim 2, participating providers are surveyed for their perceptions of information needs being met and about patient-provider interaction. For Aim 3, costs of care and costs of providing the IRx environment will be tabulated.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Breast Cancer: any new patient seen in Johns Hopkins medical oncology for Breast Cancer
- Neonatal Intensive care:Biological mothers (or consenting guardians) of premature infants born and admitted or transferred in to Johns Hopkins Hospital or Bayview Medical Center neonatal intensive care units.
Exclusion Criteria:
- Breast Cancer: None
- Neonatal Intensive Care: Parents with infants whose SNAP mortality >= 80%(J Pediatr. 2001 Jan;138(1):92-100)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Satisfaction
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
provider perceptions and behavior will be assessed;costs entailed and resources utilized will be assessed;how the intervention (information services) generalizes across service environments
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy K Oliver, MLS, Johns Hopkins School of Medicine
- Study Director: Kathleen B Oliver, MLS, MPH, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JHU 04-09-03-01
- 1R01LM008143 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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