Automated Communication ToolsPhase 3NCT01397253
Virtual Continuity and Its Impact on Complex Hospitalized Patients' Care
A Phase 3 study testing Automated communication tools in people with Automated Communication Tools and Complex Medical Patients, run by University of Pittsburgh at 1 site in United States.
Trial summary
Communication between physicians caring for a patient in the hospital and that patient's primary care provider is less than optimal, and can lead to diminished health care quality and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Automated Communication Tools, Complex Medical Patients
- What is being tested?
- Automated communication tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Are admitted to UPMC Presbyterian General Medicine, Geriatrics, Cardiology, or Surgery inpatient services;
- Are 18 years of age or older;
- Are currently receiving 5 or more medications;
- Have 2 or more comorbid conditions present, defined using the Elixhauser comorbidity system (Med Care 1998;36:8-27 and Med Care. 2005 Nov; 43(11): 1130-9 ). These comorbidities are: congestive heart failure, cardiac arrhythmias, valvular disease, pulmonary circulation disorders, peripheral vascular disorders, hypertension, paralysis, other neurologic disorders, chronic pulmonary disease, diabetes uncomplicated, diabetes complicated, hypothyroidism, renal failure, liver disease, peptic ulcer disease excluding bleeding, AIDS/HIV disease, lymphoma, metastatic cancer, solid tumor without metastasis, rheumatoid arthritis/collagen vascular diseases, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, blood loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression
- Have a Primary Care Physician who has outpatient data included on EPIC electronic health record.
Who cannot join
- Are admitted to critical care units;
- Are admitted from skilled nursing facilities;
- Have dementia;
- Were previously enrolled in the study
- Are organ transplant recipients
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213-2582
About this study
Communication between physicians caring for a patient in the hospital and that patient's primary care provider is less than optimal, and can lead to diminished health care quality and safety. This project will lead to better communication between physicians and could decrease medication errors that tend to occur as the patient goes from hospital to home.
Read the detailed description
Communication between physicians caring for hospitalized patients and those patients' primary care providers (PCPs) is often suboptimal. Hospital-based information systems can improve communication by automating information exchange between hospital physicians and PCPs, and perhaps, as a result, improve the quality and safety of health care. MedTrak, the University of Pittsburgh Medical Center (UPMC) electronic physician communication tool, has proven successful and is poised to move forward with an initiative the investigators call virtual continuity, allowing PCPs to follow their patients electronically if they cannot do so physically. Virtual continuity will include: emails to PCPs triggered by clinical events with embedded links to electronic medical record data and communication portals, medication lists electronically delivered to PCPs at admission and discharge, and immediate PCP notification of discharge with pertinent clinical details. To evaluate virtual continuity, the investigators will examine the frequency of discharge medication errors in complex medical patients using a pre-post study design of virtual continuity compared to usual communication. Medication errors will be ascertained using accepted methods. The investigators will also investigate differences in rehospitalization, post discharge emergency department visit and PCP follow up rates. The IT cost of implementing and maintaining the virtual continuity intervention will also be assessed. Virtual continuity will allow PCPs to participate more directly in the care of their hospitalized patients. Improved communication could lead to higher-quality patient care and greater patient care safety for hospitalized patients with complex medical problems.
- Being tested
- Automated communication tools
- Keywords
- Automated Communication Tools, Medication errors, PCP communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated communication toolsOther
Automated communication tools will include:
- PCP notification of patient admission and location
- Data on medications begun on admission
- Automated alerts on changes in patient status and location while the patient is hospitalized
- Links to the EMR and to hospital physician contact information on all email alerts
- Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
- Automatic reporting to PCPs of test results pending at discharge
- Electronic delivery of final discharge summaries
| Study group | Role | What they receive |
|---|---|---|
| (Usual) MedTrak system of PCP notification | No intervention | MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital. |
| Automated communication tools | Experimental | An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP. Receives: Other: Automated communication tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Errors at Hospital Discharge
Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.
Measured: Approximately 1-30 days
Secondary outcomes (1)
Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.
Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.
Measured: Within 30 post-discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Automated Communication ToolsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Kenneth J Smith, MD, MS, Principal investigator, University of Pittsburgh Medical Center, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397253
- Sponsor's protocol ID
- 3130920
- Status last verified
- Mar 2015
- First submitted
- 15 Jul 2011
- Last updated
- 16 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Halasyamani L, Kripalani S, Coleman E, Schnipper J, van Walraven C, Nagamine J, Torcson P, Bookwalter T, Budnitz T, Manning D. Transition of care for hospitalized elderly patients--development of a discharge checklist for hospitalists. J Hosp Med. 2006 Nov;1(6):354-60. doi: 10.1002/jhm.129.
PubMed 17219528Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007 Sep;2(5):314-23. doi: 10.1002/jhm.228.
PubMed 17935242Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007 Feb 28;297(8):831-41. doi: 10.1001/jama.297.8.831.
PubMed 17327525Coleman EA, Boult C; American Geriatrics Society Health Care Systems Committee. Improving the quality of transitional care for persons with complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):556-7. doi: 10.1046/j.1532-5415.2003.51186.x. No abstract available.
PubMed 12657079Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Med Care. 2005 Mar;43(3):246-55. doi: 10.1097/00005650-200503000-00007.
PubMed 15725981
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Continuity and Its Impact on Complex Hospitalized Patients' Care
- ClinicalTrials.gov ID
- NCT01397253
- Acronym / sponsor ID
- 3130920
- Keywords
- Automated Communication Tools, Medication errors, PCP communication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 25 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Communication between physicians caring for a patient in the hospital and that patient's primary care provider is less than optimal, and can lead to diminished health care quality and safety. This project will lead to better communication between physicians and could decrease medication errors that tend to occur as the patient goes from hospital to home.
Detailed description
Communication between physicians caring for hospitalized patients and those patients' primary care providers (PCPs) is often suboptimal. Hospital-based information systems can improve communication by automating information exchange between hospital physicians and PCPs, and perhaps, as a result, improve the quality and safety of health care. MedTrak, the University of Pittsburgh Medical Center (UPMC) electronic physician communication tool, has proven successful and is poised to move forward with an initiative the investigators call virtual continuity, allowing PCPs to follow their patients electronically if they cannot do so physically. Virtual continuity will include: emails to PCPs triggered by clinical events with embedded links to electronic medical record data and communication portals, medication lists electronically delivered to PCPs at admission and discharge, and immediate PCP notification of discharge with pertinent clinical details. To evaluate virtual continuity, the investigators will examine the frequency of discharge medication errors in complex medical patients using a pre-post study design of virtual continuity compared to usual communication. Medication errors will be ascertained using accepted methods. The investigators will also investigate differences in rehospitalization, post discharge emergency department visit and PCP follow up rates. The IT cost of implementing and maintaining the virtual continuity intervention will also be assessed. Virtual continuity will allow PCPs to participate more directly in the care of their hospitalized patients. Improved communication could lead to higher-quality patient care and greater patient care safety for hospitalized patients with complex medical problems.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Usual) MedTrak system of PCP notification | No intervention | –MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital. |
| Automated communication tools | Experimental | Other: Automated communication toolsAn enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are admitted to UPMC Presbyterian General Medicine, Geriatrics, Cardiology, or Surgery inpatient services;
- Are 18 years of age or older;
- Are currently receiving 5 or more medications;
- Have 2 or more comorbid conditions present, defined using the Elixhauser comorbidity system (Med Care 1998;36:8-27 and Med Care. 2005 Nov; 43(11): 1130-9 ). These comorbidities are: congestive heart failure, cardiac arrhythmias, valvular disease, pulmonary circulation disorders, peripheral vascular disorders, hypertension, paralysis, other neurologic disorders, chronic pulmonary disease, diabetes uncomplicated, diabetes complicated, hypothyroidism, renal failure, liver disease, peptic ulcer disease excluding bleeding, AIDS/HIV disease, lymphoma, metastatic cancer, solid tumor without metastasis, rheumatoid arthritis/collagen vascular diseases, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, blood loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression
- Have a Primary Care Physician who has outpatient data included on EPIC electronic health record.
Key exclusion criteria (5 listed)
- Are admitted to critical care units;
- Are admitted from skilled nursing facilities;
- Have dementia;
- Were previously enrolled in the study
- Are organ transplant recipients
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 |
|---|---|---|
| Automated communication toolsAutomated communication tools will include: * PCP notification of patient admission and location * Data on medications begun on admission * Automated alerts on changes in patient status and location while the patient is hospitalized * Links to the EMR and to hospital physician contact information on all email alerts * Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP * Automatic reporting to PCPs of test results pending at discharge * Electronic delivery of final discharge summaries | Other | Automated communication tools |
Primary outcome
Medication Errors at Hospital Discharge
Time frame: Approximately 1-30 days
Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.
1 secondary outcome
Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.
Time frame: Within 30 post-discharge from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17219528Halasyamani L, Kripalani S, Coleman E, Schnipper J, van Walraven C, Nagamine J, Torcson P, Bookwalter T, Budnitz T, Manning D. Transition of care for hospitalized elderly patients--development of a discharge checklist for hospitalists. J Hosp Med. 2006 Nov;1(6):354-60. doi: 10.1002/jhm.129.
- Background: PubMed 17935242Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007 Sep;2(5):314-23. doi: 10.1002/jhm.228.
- Background: PubMed 17327525Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007 Feb 28;297(8):831-41. doi: 10.1001/jama.297.8.831.
- Background: PubMed 12657079Coleman EA, Boult C; American Geriatrics Society Health Care Systems Committee. Improving the quality of transitional care for persons with complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):556-7. doi: 10.1046/j.1532-5415.2003.51186.x. No abstract available.
- Background: PubMed 15725981Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Med Care. 2005 Mar;43(3):246-55. doi: 10.1097/00005650-200503000-00007.
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.
Kenneth J Smith, MD, MS principal investigator
University of Pittsburgh Medical Center, University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Automated communication tools in people with Automated Communication Tools and Complex Medical Patients, run by University of Pittsburgh 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 5 inclusion and 5 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 16 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Errors at Hospital Discharge (time frame: Approximately 1-30 days). 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 NCT01397253, which also lists 5 linked publications.
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 16 Apr 2015.