HIV InfectionsNCT00678600
Study of Provider Computer Alerts Designed to Improve Delivery of HIV Care
A study testing Standard (static) Computer Alerts and Enhanced Computer Alerts in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Standard (static) Computer Alerts and Enhanced Computer Alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Followed in the Massachusetts General Hospital HIV clinic.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts
The purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts.
Read the detailed description
This study will compare the effectiveness of standard and enhanced care alerts in HIV infected participants at Massachusetts General Hospital in Boston, Massachusetts.
Participants will be a part of this study for 4 years or until they are no longer followed at Massachusetts General Hospital. Participants will be assigned randomly to one of two arms. Participants assigned to Arm 1 will receive standard care, involving standard provider alerts which will be posted on the participant's health record. Participants assigned to Arm 2 will receive enhanced care, involving improved functionality. Experimental informatics-based provider alerts and support systems will be used to develop a pilot system designed to optimize delivery of HIV clinical care.
All participants will be monitored for new laboratory toxicities, suboptimal follow up, and virologic failure at their normally scheduled appointments.
- Conditions
- HIV Infections
- Being tested
- Standard (static) Computer Alerts, Enhanced Computer Alerts
- Keywords
- Informatics, Alerts, Toxicity, Virologic failure, Suboptimal follow up
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard (static) Computer AlertsOther
Static Computer Alerts on Patient's EMR webpage.
Enhanced Computer AlertsOther
Population level and asynchronous alerts with enhanced functionality
| Study group | Role | What they receive |
|---|---|---|
| Standard (static) Computer Alerts | Active comparator | Participants in this arm will be assigned to standard care. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Provider computer alerts will be posted on the participant's electronic health record summary page. Receives: Other: Standard (static) Computer Alerts |
| Enhanced Computer Alerts | Experimental | Participants in this arm will be assigned to the enhanced alert arm. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Providers will receive population and asynchronous computer alerts with improved functionality. Receives: Other: Enhanced Computer Alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD4 count
Measured: Throughout study
Secondary outcomes (2)
Time to repeat laboratory testing
Measured: Throughout study
Time to follow up appointment
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Harvard Medical School (HMS and HSDM), Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Gregory K Robbins, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678600
- Sponsor's protocol ID
- 1K01AI062435
- Other IDs
- K01AI062435
- Status last verified
- Nov 2013
- First submitted
- 13 May 2008
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Robbins GK, Lester W, Johnson KL, Chang Y, Estey G, Surrao D, Zachary K, Lammert SM, Chueh HC, Meigs JB, Freedberg KA. Efficacy of a clinical decision-support system in an HIV practice: a randomized trial. Ann Intern Med. 2012 Dec 4;157(11):757-66. doi: 10.7326/0003-4819-157-11-201212040-00003.
PubMed 23208165
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts
- ClinicalTrials.gov ID
- NCT00678600
- Acronym / sponsor ID
- 1K01AI062435
- Conditions
- HIV Infections
- Keywords
- Informatics, Alerts, Toxicity, Virologic failure, Suboptimal follow up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Harvard Medical School (HMS and HSDM), Massachusetts General Hospital
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 May 2008 (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.
The purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts.
Detailed description
This study will compare the effectiveness of standard and enhanced care alerts in HIV infected participants at Massachusetts General Hospital in Boston, Massachusetts.
Participants will be a part of this study for 4 years or until they are no longer followed at Massachusetts General Hospital. Participants will be assigned randomly to one of two arms. Participants assigned to Arm 1 will receive standard care, involving standard provider alerts which will be posted on the participant's health record. Participants assigned to Arm 2 will receive enhanced care, involving improved functionality. Experimental informatics-based provider alerts and support systems will be used to develop a pilot system designed to optimize delivery of HIV clinical care.
All participants will be monitored for new laboratory toxicities, suboptimal follow up, and virologic failure at their normally scheduled appointments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard (static) Computer Alerts | Active comparator | Other: Standard (static) Computer AlertsParticipants in this arm will be assigned to standard care. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Provider computer alerts will be posted on the participant's electronic health record summary page. |
| Enhanced Computer Alerts | Experimental | Other: Enhanced Computer AlertsParticipants in this arm will be assigned to the enhanced alert arm. Participants will be monitored for new laboratory toxicity, suboptimal follow up, and virologic failure. Providers will receive population and asynchronous computer alerts with improved functionality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV infected
- Followed in the Massachusetts General Hospital HIV clinic.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard (static) Computer AlertsStatic Computer Alerts on Patient's EMR webpage. | Other | Standard (static) Computer Alerts |
| Enhanced Computer AlertsPopulation level and asynchronous alerts with enhanced functionality | Other | Enhanced Computer Alerts |
Primary outcome
Change in CD4 count
Time frame: Throughout study
2 secondary outcomes
Time to repeat laboratory testing
Time frame: Throughout study
Time to follow up appointment
Time frame: Throughout study
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 20 Nov 2013.
- Results publication: PubMed 23208165Robbins GK, Lester W, Johnson KL, Chang Y, Estey G, Surrao D, Zachary K, Lammert SM, Chueh HC, Meigs JB, Freedberg KA. Efficacy of a clinical decision-support system in an HIV practice: a randomized trial. Ann Intern Med. 2012 Dec 4;157(11):757-66. doi: 10.7326/0003-4819-157-11-201212040-00003.
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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.
Gregory K Robbins, MD MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard (static) Computer Alerts and Enhanced Computer Alerts in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 0 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 20 Nov 2013. 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?
Change in CD4 count (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678600, which also lists 1 linked publication.
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 20 Nov 2013.