HealthyNCT00680368

Resident Supervision Index: Assessing Feasibility and Validity

An observational study of Healthy, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 97 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Dec 2008
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Residents

Who may be able to join

Males and females
Ages 18 and older

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357

Other trials in United States

About this study

RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for content validity, test-retest reliability, and construct validity.

Read the detailed description

RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for test-retest reliability and construct validity.

METHODOLOGY: Trained interviewers administered the Index during face-to-face and in-clinic interviews with 60 consenting resident physicians and their 37 consenting attending physicians to descsribe the care they provided to 143 patients at the outpatient clinics involving 148 clinical encounters at the Loma Linda VA Medical Center.

For each encounter, data comes from administering the Resident Supervision Index to the resident and attending. Baseline data describing each subject (attending physicians and resident physicians) came from face-to-face interviews.

Test-retest reliability is assessed by re-administering the Index to residents for within 24 hours of the encounter. Concurrent validity is assessed by re-administering the Index to the attending physician responsible for the patient's care.

CLINICAL RELATIONSHIPS: The study will help our understanding of how residents at VA medical centers receive training and are supervised for the purpose of both education and patient outcomes.

IMPACT/SIGNIFICANCE: The instrument is planned for future studies to assess the association between resident supervision and training outcomes, clinical workload, patient outcomes, quality of care, and care costs.

Conditions: Healthy
Keywords: Feasibility, Supervision, Assessing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00680368
Study group	Role	What they receive
Residents and Attending Physicians		This group contains the residents and the attending physicians who consented to participate in the study. They participated in a survey administered by a research assistant. Both physician resident and attending physicians were administered the survey twice within 24-hours and their test-retest responses were compared for reliability. Responses to attending and resident physicians covering the care for the patient and clinical care encounter were compared for accuracy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.
Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.
Measured: 24-hours

Secondary outcomes (2)

Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians
Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.
Measured: 24 hours
Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians
Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Dec 2008

First posted20 May 2008 (estimated)
Study startMar 2008
Primary completionDec 2008
Study completionDec 2008

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 HealthyStudies 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
Observational model: Case only
Time perspective: Prospective
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00680368
Sponsor's protocol ID: SHP 08-164
Status last verified: Aug 2014
First submitted: 16 May 2008
Last updated: 28 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cannon GW, Keitz SA, Holland GJ, Chang BK, Byrne JM, Tomolo A, Aron DC, Wicker AB, Kashner TM. Factors determining medical students' and residents' satisfaction during VA-based training: findings from the VA Learners' Perceptions Survey. Acad Med. 2008 Jun;83(6):611-20. doi: 10.1097/ACM.0b013e3181722e97.
PubMed 18520472
Kashner TM, Henley SS, Golden RM, Byrne JM, Keitz SA, Cannon GW, Chang BK, Holland GJ, Aron DC, Muchmore EA, Wicker A, White H. Studying the effects of ACGME duty hours limits on resident satisfaction: results from VA learners' perceptions survey. Acad Med. 2010 Jul;85(7):1130-9. doi: 10.1097/ACM.0b013e3181e1d7e3.
PubMed 20592508
Byrne JM, Kashner M, Gilman SC, Aron DC, Cannon GW, Chang BK, Godleski L, Golden RM, Henley SS, Holland GJ, Kaminetzky CP, Keitz SA, Kirsh S, Muchmore EA, Wicker AB. Measuring the intensity of resident supervision in the department of veterans affairs: the resident supervision index. Acad Med. 2010 Jul;85(7):1171-81. doi: 10.1097/ACM.0b013e3181d5a954.
PubMed 20305532
Kashner TM, Byrne JM, Henley SS, Golden RM, Aron DC, Cannon GW, Chang BK, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: theoretical approach. J Grad Med Educ. 2010 Mar;2(1):8-16. doi: 10.4300/JGME-D-09-00083.1.
PubMed 21975879
Kashner TM, Byrne JM, Chang BK, Henley SS, Golden RM, Aron DC, Cannon GW, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: empirical approach. J Grad Med Educ. 2010 Mar;2(1):17-30. doi: 10.4300/1949-8357-2.1.17.
PubMed 21975880

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Resident Supervision Index: Assessing Feasibility and Validity
ClinicalTrials.gov ID: NCT00680368
Acronym / sponsor ID: SHP 08-164
Conditions: Healthy
Keywords: Feasibility, Supervision, Assessing
Study type: Observational
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Mar 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 20 May 2008 (estimated)
Results: Posted 16 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for test-retest reliability and construct validity.

CLINICAL RELATIONSHIPS: The study will help our understanding of how residents at VA medical centers receive training and are supervised for the purpose of both education and patient outcomes.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Residents and Attending Physicians	–	–This group contains the residents and the attending physicians who consented to participate in the study. They participated in a survey administered by a research assistant. Both physician resident and attending physicians were administered the survey twice within 24-hours and their test-retest responses were compared for reliability. Responses to attending and resident physicians covering the care for the patient and clinical care encounter were compared for accuracy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Residents

Key inclusion criteria (2 listed)

Males and females
Ages 18 and older

Key exclusion criteria (1 listed)

None

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

Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.
Time frame: 24-hours
Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.

2 secondary outcomes

Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians
Time frame: 24 hours
Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians
Time frame: 24 hours

Results and safety

Results posted to the registry on 16 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	112	97

Primary outcome: Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.

Time frame: 24-hours. Number (95% Confidence Interval). Unit: Intraclass Correlation Coefficient

Measure	Physician Residents and Attending Physicians n = 97
Value	.69 (.57 to .78)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected during the 3-months when subjects were interviewed only.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 75 (0%)	0 of 75 (0%)	Not reported

Limitations and caveats (from the sponsor): Single site study limiting generalizability of findings

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18520472Cannon GW, Keitz SA, Holland GJ, Chang BK, Byrne JM, Tomolo A, Aron DC, Wicker AB, Kashner TM. Factors determining medical students' and residents' satisfaction during VA-based training: findings from the VA Learners' Perceptions Survey. Acad Med. 2008 Jun;83(6):611-20. doi: 10.1097/ACM.0b013e3181722e97.
Background: PubMed 20592508Kashner TM, Henley SS, Golden RM, Byrne JM, Keitz SA, Cannon GW, Chang BK, Holland GJ, Aron DC, Muchmore EA, Wicker A, White H. Studying the effects of ACGME duty hours limits on resident satisfaction: results from VA learners' perceptions survey. Acad Med. 2010 Jul;85(7):1130-9. doi: 10.1097/ACM.0b013e3181e1d7e3.
Results publication: PubMed 20305532Byrne JM, Kashner M, Gilman SC, Aron DC, Cannon GW, Chang BK, Godleski L, Golden RM, Henley SS, Holland GJ, Kaminetzky CP, Keitz SA, Kirsh S, Muchmore EA, Wicker AB. Measuring the intensity of resident supervision in the department of veterans affairs: the resident supervision index. Acad Med. 2010 Jul;85(7):1171-81. doi: 10.1097/ACM.0b013e3181d5a954.
Results publication: PubMed 21975879Kashner TM, Byrne JM, Henley SS, Golden RM, Aron DC, Cannon GW, Chang BK, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: theoretical approach. J Grad Med Educ. 2010 Mar;2(1):8-16. doi: 10.4300/JGME-D-09-00083.1.
Results publication: PubMed 21975880Kashner TM, Byrne JM, Chang BK, Henley SS, Golden RM, Aron DC, Cannon GW, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: empirical approach. J Grad Med Educ. 2010 Mar;2(1):17-30. doi: 10.4300/1949-8357-2.1.17.

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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.

Terrell Michael Kashner, PhD JD MPH principal investigator

VA Loma Linda Healthcare System, Loma Linda, CA

Dale S. Cannon, PhD principal investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by US Department of Veterans Affairs 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 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 28 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2014). 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?

Intraclass Correlation Coefficient Between Physician Resident and Attending Physician. (time frame: 24-hours). 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 NCT00680368, 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 28 Apr 2015.