Interdisciplinary CommunicationMED-COMMNCT00574990
Minimizing Harm From ADEs by Improving Nurse-Physician Communication
An observational study of Interdisciplinary Communication and Management, Medication Therapy, run by US Department of Veterans Affairs at 3 sites in United States.
Trial summary
The purpose of this research study is to examine the clinical processes of care involved with the sharing and communicating of medication management information in the inpatient setting between nurses, pharmacists and physicians. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Interdisciplinary Communication, Management, Medication Therapy
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to Sep 2009
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: VA Physicians, Nurses, and Pharmacists had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
Who may be able to join
- Providers who are working in the VA on the inpatient setting, including pharmacists, nurses, and physicians.
Who cannot join
- Staff who have worked at the VA less than 1 year.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Medical Center, Asheville
Asheville, North Carolina, 28805
Salt Lake City
Salt Lake City, Utah, 84148
VA Medical Center, San Francisco
San Francisco, California, 94121
About this study
The purpose of this research study is to examine the clinical processes of care involved with the sharing and communicating of medication management information in the inpatient setting between nurses, pharmacists and physicians. The study is unique in that few studies have examined communication content and processes in depth and in relation to specific clinical care. The study will be conducted in two phases. The first phase involves using three focus groups across three sites (a total of nine) each involving between 6-8 individuals to examine perceptions regarding role and procedures associated with medication management. The focus group discussions will be tape-recorded and analyzed using qualitative methods. The information gleaned will assist us in identifying patterns of problems in enhancing the sharing of information, to develop better measures for assessing communication as well as designing effective interventions to enhance communication.
In the second phase of the study, 400 2-4 hour time slots will be randomly selected over about a 5-week period for nursing staff and 500 events over a 6-week period for physicians to conduct ethnographic observations during which specific communication events will be recorded and coded. Every effort will be made to minimize interruptions during clinical care. This research has not been done in terms of medication management content in the inpatient setting (non-ICU).
Read the detailed description
Background:
Medication management is a complex clinical task. It requires substantial collaboration and coordination between physicians, nurses and pharmacists. Addressing ineffective communication has been identified by the Institute of Medicine as a high priority. Ineffective communication regarding medication management coordination can result in increased medication errors, rates of adverse drug events (ADEs), delays in treating adverse drug events and less effective treatment. ADEs are frequent in hospitalized patients, ranging from less than 3% to over 32%. The purpose of this study was to evaluate communication patterns associated with medication management between providers, physicians and pharmacists in the inpatient setting.
Objectives:
Specific Aim 1. Assess clinicians' beliefs and concerns regarding the role of communication in preventing, detecting and managing ADEs in elderly inpatients (focus groups).
Specific Aim 2. Evaluate and characterize communication events between VA nurses, physicians and pharmacists in an inpatient medicine setting (ethnographic observation).
Methods:
Phase 1: Focus Groups Design: The design of this study was qualitative and used focus group methodology.
Settings: Three VA sites that differed in size, location and academic affiliation were selected.
Participants: Three focus groups were conducted at each site (one each of pharmacists, nurses and physicians). A total of 19 nurses, 16 pharmacists and 13 doctors participated.
Phase 2: Observation Design: The design of this study was quantitative and descriptive. Settings: Two inpatient units at the VA Salt Lake City Health Care System (medicine and telemetry).
Participants: Twelve residents were selected randomly from each of the 4 medical teams, 19 nurses were selected randomly from the two in-patient medicine wards, and 8 clinical pharmacists (the total number of clinical pharmacists available) agreed to participate.
Status:
All data have been collected and initial analyses has been completed.
- Keywords
- Interdisciplinary Communication, Safety Management, Management, Medication Therapy, Cooperative Behavior, Drug Therapy Management, Physician Nurse Relationships, Side Effects, Hospital Information Systems, Documentation, Quality Assurance, Health Care
- Medical subject headings
- Cooperative Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VA Physicians | VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. | |
| VA Nurses | VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. | |
| VA Pharmacists | VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Rate for Communication Events
Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.
Measured: 6 months
Secondary outcomes (1)
Overall Involvement in Conversation by Roles
The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionSep 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for Interdisciplinary CommunicationStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charlene R Weir, PhD RN, Principal investigator, Salt Lake City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574990
- Sponsor's protocol ID
- NRI 05-275
- Acronym
- MED-COMM
- Status last verified
- May 2015
- First submitted
- 12 Dec 2007
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Flaherty JH, Shay K, Weir C, Kamholz B, Boockvar KS, Shaughnessy M, Shapiro R, Gordon S, Stein J, Rudolph JL; VA Delirium Working Group. The development of a mental status vital sign for use across the spectrum of care. J Am Med Dir Assoc. 2009 Jul;10(6):379-80. doi: 10.1016/j.jamda.2009.04.001. No abstract available.
PubMed 19560714Vogelsmeier A, Pepper GA, Oderda L, Weir C. Medication reconciliation: A qualitative analysis of clinicians' perceptions. Res Social Adm Pharm. 2013 Jul-Aug;9(4):419-30. doi: 10.1016/j.sapharm.2012.08.002. Epub 2012 Oct 23.
PubMed 23089295
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Harm From ADEs by Improving Nurse-Physician Communication
- ClinicalTrials.gov ID
- NCT00574990
- Acronym / sponsor ID
- MED-COMM / NRI 05-275
- Keywords
- Interdisciplinary Communication, Safety Management, Management, Medication Therapy, Cooperative Behavior, Drug Therapy Management, Physician Nurse Relationships, Side Effects, Hospital Information Systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 9 Jun 2015
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 research study is to examine the clinical processes of care involved with the sharing and communicating of medication management information in the inpatient setting between nurses, pharmacists and physicians. The study is unique in that few studies have examined communication content and processes in depth and in relation to specific clinical care. The study will be conducted in two phases. The first phase involves using three focus groups across three sites (a total of nine) each involving between 6-8 individuals to examine perceptions regarding role and procedures associated with medication management. The focus group discussions will be tape-recorded and analyzed using qualitative methods. The information gleaned will assist us in identifying patterns of problems in enhancing the sharing of information, to develop better measures for assessing communication as well as designing effective interventions to enhance communication.
In the second phase of the study, 400 2-4 hour time slots will be randomly selected over about a 5-week period for nursing staff and 500 events over a 6-week period for physicians to conduct ethnographic observations during which specific communication events will be recorded and coded. Every effort will be made to minimize interruptions during clinical care. This research has not been done in terms of medication management content in the inpatient setting (non-ICU).
Detailed description
Background:
Medication management is a complex clinical task. It requires substantial collaboration and coordination between physicians, nurses and pharmacists. Addressing ineffective communication has been identified by the Institute of Medicine as a high priority. Ineffective communication regarding medication management coordination can result in increased medication errors, rates of adverse drug events (ADEs), delays in treating adverse drug events and less effective treatment. ADEs are frequent in hospitalized patients, ranging from less than 3% to over 32%. The purpose of this study was to evaluate communication patterns associated with medication management between providers, physicians and pharmacists in the inpatient setting.
Objectives:
Specific Aim 1. Assess clinicians' beliefs and concerns regarding the role of communication in preventing, detecting and managing ADEs in elderly inpatients (focus groups).
Specific Aim 2. Evaluate and characterize communication events between VA nurses, physicians and pharmacists in an inpatient medicine setting (ethnographic observation).
Methods:
Phase 1: Focus Groups Design: The design of this study was qualitative and used focus group methodology.
Settings: Three VA sites that differed in size, location and academic affiliation were selected.
Participants: Three focus groups were conducted at each site (one each of pharmacists, nurses and physicians). A total of 19 nurses, 16 pharmacists and 13 doctors participated.
Phase 2: Observation Design: The design of this study was quantitative and descriptive. Settings: Two inpatient units at the VA Salt Lake City Health Care System (medicine and telemetry).
Participants: Twelve residents were selected randomly from each of the 4 medical teams, 19 nurses were selected randomly from the two in-patient medicine wards, and 8 clinical pharmacists (the total number of clinical pharmacists available) agreed to participate.
Status:
All data have been collected and initial analyses has been completed.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VA Physicians | – | –VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. |
| VA Nurses | – | –VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. |
| VA Pharmacists | – | –VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- VA Physicians, Nurses, and Pharmacists had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
Key inclusion criteria (1 listed)
- Providers who are working in the VA on the inpatient setting, including pharmacists, nurses, and physicians.
Key exclusion criteria (1 listed)
- Staff who have worked at the VA less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Rate for Communication Events
Time frame: 6 months
Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.
1 secondary outcome
Overall Involvement in Conversation by Roles
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19560714Flaherty JH, Shay K, Weir C, Kamholz B, Boockvar KS, Shaughnessy M, Shapiro R, Gordon S, Stein J, Rudolph JL; VA Delirium Working Group. The development of a mental status vital sign for use across the spectrum of care. J Am Med Dir Assoc. 2009 Jul;10(6):379-80. doi: 10.1016/j.jamda.2009.04.001. No abstract available.
- Results publication: PubMed 23089295Vogelsmeier A, Pepper GA, Oderda L, Weir C. Medication reconciliation: A qualitative analysis of clinicians' perceptions. Res Social Adm Pharm. 2013 Jul-Aug;9(4):419-30. doi: 10.1016/j.sapharm.2012.08.002. Epub 2012 Oct 23.
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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.
Charlene R Weir, PhD RN principal investigator
Salt Lake City
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interdisciplinary Communication and Management, Medication Therapy, run by US Department of Veterans Affairs at 3 sites 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 1 inclusion and 1 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 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 9 Jun 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?
Incident Rate for Communication Events (time frame: 6 months). 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 NCT00574990, which also lists 2 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 9 Jun 2015.