Breast NeoplasmsPhase 2NCT00355381
Evaluating Patient Information Prescriptions
A Phase 2 study testing Information Services (IRx) in people with Breast Neoplasms and Premature Birth, run by Johns Hopkins University at 1 site in United States.
Trial summary
Research shows that patient satisfaction with medical care correlates strongly with how satisfied they are with the ease of getting information from their providers regarding their medical condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Premature Birth
- What is being tested?
- Information Services (IRx)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2009
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Breast Cancer: None
- Neonatal Intensive Care: Parents with infants whose SNAP mortality >= 80%(J Pediatr. 2001 Jan;138(1):92-100)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Evaluating Patient Information Prescriptions in Different Service Environments
Research shows that patient satisfaction with medical care correlates strongly with how satisfied they are with the ease of getting information from their providers regarding their medical condition. Although the Internet is a wonderful source of information for patients, research has shown that, unmediated, it comprises a potential quagmire of information poorly matched to users needs. Providers typically do not have enough time to fulfill all of their patients' information needs. One strategy to meeting the patient's information needs is to introduce librarians trained and experienced in consumer health information services into the relationship between the patient and the provider. One recently described tactic is for providers to provide information the way they of provide treatment-through an information prescription (IRx) filled by a librarian. The librarian fills the prescription by offering information services tailored to the needs of individual patients. At Johns Hopkins, we have piloted such a tactic, and in this project, extend and evaluate it. The research hypothesis is that provision of an IRx will improve patient satisfaction, provider knowledge and attitudes regarding patient information needs, and the efficiencies of care.
Read the 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.
- Conditions
- Breast Neoplasms, Premature Birth
- Being tested
- Information Services (IRx)
- Keywords
- Information Services, Randomized Controlled Trials, Medical Records Systems, Computerized, Internet, Librarians, Breast Neoplasms, Patient Satisfaction, Health Personnel, Costs and Cost Analysis, Premature Birth
- Medical subject headings
- Breast Neoplasms, Premature Birth, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information Services (IRx)Behavioural
Also called Information prescriptions or IRx
Information services tailored to the needs of individual patients. The information prescription (IRx)or service is defined for this study as a combination of: 1)An evidence-based web site for use by patients and their families; 2) A reference interview and assistance in locating relevant general information in response to patient information needs; 3) Documentation of the questions and the information service provided in response to these in the patient's Electronic Patient Record for review by providers as needed; and, 4) Triage of patient's/parents clinical questions to providers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Measured: 4 years
Secondary outcomes (1)
provider perceptions and behavior will be assessed;costs entailed and resources utilized will be assessed;how the intervention (information services) generalizes across service environments
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startSep 2004
- Primary completionApr 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Nancy K Oliver, MLS, Principal investigator, Johns Hopkins School of MedicineKathleen B Oliver, MLS, MPH, Study director, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355381
- Sponsor's protocol ID
- JHU 04-09-03-01
- Other IDs
- 1R01LM008143
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2006
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Information Prescriptions in Different Service Environments
- ClinicalTrials.gov ID
- NCT00355381
- Acronym / sponsor ID
- JHU 04-09-03-01
- Conditions
- Breast Neoplasms, Premature Birth
- Keywords
- Information Services, Randomized Controlled Trials, Medical Records Systems, Computerized, Internet, Librarians, Breast Neoplasms, Patient Satisfaction, Health Personnel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Library of Medicine (NLM)
- Study start
- Sep 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that patient satisfaction with medical care correlates strongly with how satisfied they are with the ease of getting information from their providers regarding their medical condition. Although the Internet is a wonderful source of information for patients, research has shown that, unmediated, it comprises a potential quagmire of information poorly matched to users needs. Providers typically do not have enough time to fulfill all of their patients' information needs. One strategy to meeting the patient's information needs is to introduce librarians trained and experienced in consumer health information services into the relationship between the patient and the provider. One recently described tactic is for providers to provide information the way they of provide treatment-through an information prescription (IRx) filled by a librarian. The librarian fills the prescription by offering information services tailored to the needs of individual patients. At Johns Hopkins, we have piloted such a tactic, and in this project, extend and evaluate it. The research hypothesis is that provision of an IRx will improve patient satisfaction, provider knowledge and attitudes regarding patient information needs, and the efficiencies of care.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Breast Cancer: None
- Neonatal Intensive Care: Parents with infants whose SNAP mortality >= 80%(J Pediatr. 2001 Jan;138(1):92-100)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information Services (IRx)Also: Information prescriptions or IRxInformation services tailored to the needs of individual patients. The information prescription (IRx)or service is defined for this study as a combination of: 1)An evidence-based web site for use by patients and their families; 2) A reference interview and assistance in locating relevant general information in response to patient information needs; 3) Documentation of the questions and the information service provided in response to these in the patient's Electronic Patient Record for review by providers as needed; and, 4) Triage of patient's/parents clinical questions to providers. | Behavioural | – |
Primary outcome
Patient Satisfaction
Time frame: 4 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy K Oliver, MLS principal investigator
Johns Hopkins School of Medicine
Kathleen B Oliver, MLS, MPH study director
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Information Services (IRx) in people with Breast Neoplasms and Premature Birth, run by Johns Hopkins University 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 2 inclusion and 2 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 23 Oct 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient Satisfaction (time frame: 4 years). 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 23 Oct 2018.