Focus of Study is on Graduate Medical Education SupervisionNCT03318198
The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
A study testing Enhanged Attending Supervision in people with Focus of Study is on Graduate Medical Education Supervision, run by Massachusetts General Hospital.
Trial summary
Randomized cross over trial investigating the effect of intensive attending supervision of residents caring for inpatients on the medical service on both patient safety and educational outcomes. Hypothesis: increased attending supervision would improve patient safety and resident education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of Study is on Graduate Medical Education Supervision
- What is being tested?
- Enhanged Attending Supervision
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 2017
- 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
- Teaching attending on the medicine service at Massachusetts General Hospital
- Resident physician on the medical service at Massachusetts General Hospital
Who cannot join
- Faculty unable to complete both control and intervention arms of the study.
- Faculty unwilling to participate
- Residents unwilling to participate
About this study
Randomized cross over trial investigating the effect of intensive attending supervision of residents caring for inpatients on the medical service on both patient safety and educational outcomes. Hypothesis: increased attending supervision would improve patient safety and resident education.
Read the detailed description
Background While the relationship between resident work hours and patient safety has been extensively studied, little research has evaluated the role of attending supervision on patient safety and education.
Investigators conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Secondary safety outcomes included deaths and transfers to the intensive care unit. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.
- Being tested
- Enhanged Attending Supervision, Standard of Care
- Keywords
- Graduate Medical Education, Attending Supervision of Residents, Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanged Attending SupervisionOther
Attendings were randomized at the start of the study to begin in the enhanced supervision arm where they attended resident work rounds. They then crossed over to the control arm where they did not attend work rounds. The outcomes were assessed between the two periods during which the attending participated in the study; attending work rounds vs. not attending work rounds.
Standard of CareOther
Attendings participated directly in new patient rounds but did not see patients previously known to the team with the residents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Attendings on the interventional arm attended daily work rounds with the resident teams in addition to established work rounds on the previously admitted patients on the care team. Receives: Other: Enhanged Attending Supervision |
| Control Arm | Placebo comparator | Attendings crossed over to the control arm in which they did not attend work rounds with the team and only say new admissions with the resident team. This was usual care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome
Using a previously validated protocol (PMID:24871238) to assess these outcomes, five research nurses reviewed the medical records, formal incident reports from the hospital incident-reporting system, daily pharmacy reports, pharmacy paging logs and solicited reports from nurses working on the study units and noted any adverse events or near misses. Four physician investigators, blinded to attending and intervention, classified each suspected incident as an adverse event, near miss or exclusion (an incident determined to be neither a medical error or adverse event). Physician reviewers further classified all adverse events as preventable or non-preventable. Medical Error rates are reports as number of events per 1,000 patient days
Measured: 9 months
Resident Engagement on Rounds: Educational Outcome
Time motion study of the amount of time residents and faculty speak during rounds. Time was measured by a research assistant using a Microsoft access program embedded on an IPAD that recorded length of time. Time measurement outcomes are reported in minutes
Measured: 9 months
Secondary outcomes (3)
Resident and Faculty Perception of Education, Educational Outcome
A 20 question survey based on prior literature (PMID: 25340363) asking about resident and faculty experience with different levels of faculty supervision. The survey questions each were followed by a 5 point scale with a range from strongly agree, agree, neutral, disagree to strongly disagree. Strongly agree represents a better outcome. There were no subscales.
Measured: 9 months
Deaths, Patient Safety Outcome
Hospital collected data on the number of medical patients who died during the study
Measured: 9 months
Transfers to the Intensive Care Unit, Patient Safety Outcome
Hospital collected data on the number of medical patients who were transferred to the intensive care unit
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study startSep 2015
- Primary completionJun 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focus of Study is on Graduate Medical Education SupervisionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Finn, Massachusetts General Hospital
- Investigators
- Kathleen Finn, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318198
- Sponsor's protocol ID
- 2015D005158
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data and results from the study are listed to the research personnel associated with the study.
Publications
Biondi EA, Varade WS, Garfunkel LC, Lynn JF, Craig MS, Cellini MM, Shone LP, Harris JP, Baldwin CD. Discordance between resident and faculty perceptions of resident autonomy: can self-determination theory help interpret differences and guide strategies for bridging the divide? Acad Med. 2015 Apr;90(4):462-71. doi: 10.1097/ACM.0000000000000522.
PubMed 25340363Starmer AJ, O'Toole JK, Rosenbluth G, Calaman S, Balmer D, West DC, Bale JF Jr, Yu CE, Noble EL, Tse LL, Srivastava R, Landrigan CP, Sectish TC, Spector ND; I-PASS Study Education Executive Committee. Development, implementation, and dissemination of the I-PASS handoff curriculum: A multisite educational intervention to improve patient handoffs. Acad Med. 2014 Jun;89(6):876-84. doi: 10.1097/ACM.0000000000000264.
PubMed 24871238Finn KM, Metlay JP, Chang Y, Nagarur A, Yang S, Landrigan CP, Iyasere C. Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):952-959. doi: 10.1001/jamainternmed.2018.1244.
PubMed 29868877
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
- ClinicalTrials.gov ID
- NCT03318198
- Acronym / sponsor ID
- 2015D005158
- Keywords
- Graduate Medical Education, Attending Supervision of Residents, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
Randomized cross over trial investigating the effect of intensive attending supervision of residents caring for inpatients on the medical service on both patient safety and educational outcomes. Hypothesis: increased attending supervision would improve patient safety and resident education.
Detailed description
Background While the relationship between resident work hours and patient safety has been extensively studied, little research has evaluated the role of attending supervision on patient safety and education.
Investigators conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Secondary safety outcomes included deaths and transfers to the intensive care unit. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Other: Enhanged Attending SupervisionAttendings on the interventional arm attended daily work rounds with the resident teams in addition to established work rounds on the previously admitted patients on the care team. |
| Control Arm | Placebo comparator | Other: Standard of CareAttendings crossed over to the control arm in which they did not attend work rounds with the team and only say new admissions with the resident team. This was usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Teaching attending on the medicine service at Massachusetts General Hospital
- Resident physician on the medical service at Massachusetts General Hospital
Key exclusion criteria (3 listed)
- Faculty unable to complete both control and intervention arms of the study.
- Faculty unwilling to participate
- Residents unwilling to participate
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 |
|---|---|---|
| Enhanged Attending SupervisionAttendings were randomized at the start of the study to begin in the enhanced supervision arm where they attended resident work rounds. They then crossed over to the control arm where they did not attend work rounds. The outcomes were assessed between the two periods during which the attending participated in the study; attending work rounds vs. not attending work rounds. | Other | Intervention Arm |
| Standard of CareAttendings participated directly in new patient rounds but did not see patients previously known to the team with the residents. | Other | Control Arm |
Primary outcome
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome
Time frame: 9 months
Using a previously validated protocol (PMID:24871238) to assess these outcomes, five research nurses reviewed the medical records, formal incident reports from the hospital incident-reporting system, daily pharmacy reports, pharmacy paging logs and solicited reports from nurses working on the study units and noted any adverse events or near misses. Four physician investigators, blinded to attending and intervention, classified each suspected incident as an adverse event, near miss or exclusion (an incident determined to be neither a medical error or adverse event). Physician reviewers further classified all adverse events as preventable or non-preventable. Medical Error rates are reports as number of events per 1,000 patient days
Resident Engagement on Rounds: Educational Outcome
Time frame: 9 months
Time motion study of the amount of time residents and faculty speak during rounds. Time was measured by a research assistant using a Microsoft access program embedded on an IPAD that recorded length of time. Time measurement outcomes are reported in minutes
3 secondary outcomes
Resident and Faculty Perception of Education, Educational Outcome
Time frame: 9 months
Deaths, Patient Safety Outcome
Time frame: 9 months
Transfers to the Intensive Care Unit, Patient Safety Outcome
Time frame: 9 months
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 2017.
- Background: PubMed 25340363Biondi EA, Varade WS, Garfunkel LC, Lynn JF, Craig MS, Cellini MM, Shone LP, Harris JP, Baldwin CD. Discordance between resident and faculty perceptions of resident autonomy: can self-determination theory help interpret differences and guide strategies for bridging the divide? Acad Med. 2015 Apr;90(4):462-71. doi: 10.1097/ACM.0000000000000522.
- Background: PubMed 24871238Starmer AJ, O'Toole JK, Rosenbluth G, Calaman S, Balmer D, West DC, Bale JF Jr, Yu CE, Noble EL, Tse LL, Srivastava R, Landrigan CP, Sectish TC, Spector ND; I-PASS Study Education Executive Committee. Development, implementation, and dissemination of the I-PASS handoff curriculum: A multisite educational intervention to improve patient handoffs. Acad Med. 2014 Jun;89(6):876-84. doi: 10.1097/ACM.0000000000000264.
- Derived from this study: PubMed 29868877Finn KM, Metlay JP, Chang Y, Nagarur A, Yang S, Landrigan CP, Iyasere C. Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):952-959. doi: 10.1001/jamainternmed.2018.1244.
- Individual participant dataSharing planned: No. The data and results from the study are listed to the research personnel associated with the study.
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.
Kathleen Finn, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Enhanged Attending Supervision in people with Focus of Study is on Graduate Medical Education Supervision, run by Massachusetts General Hospital.
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 3 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 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT03318198, which also lists 3 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 23 Oct 2017.