Evidence-Based MedicineNCT00635869
Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes
An observational study of Evidence-Based Medicine and Physician-Nurse Relations, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evidence-Based Medicine, Physician-Nurse Relations
- What is being tested?
- ARCC standard information and ARCC enhanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2006
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Registered Nurse staff working on inpatient study units (medicine, surgery, surgical intensive care)
Who may be able to join
- employed by Upstate
- working full or part time on study unit
- able to attend all education sessions
Who cannot join
- employed by temporary agency
- not able to attend all education sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital, SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims are to test the feasibility of study methods and reliability and validity of questionnaires.
This study is designed as a three-group randomized clinical trial with repeated measures. Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention (didactic content and environmental prompts, but not related to EBP; placebo). The interventions will be implemented over an estimated 14 weeks, including a 4-week training period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two ARCC intervention units will develop.
Baseline information and questionnaires will be collected from nurses at the start of the study, and again at completion of the intervention phase. Outcome data will be collected from nurses approximately 10 weeks after implementation of the ARCC interventions are completed (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be collected from physicians working with study unit nurses as well as from the nurses. Patient satisfaction data will not be separately collected in this study, but will include use of unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level and institutional RN turnover will be tracked monthly during the entire study period and will be compared across units at the same time as well as compared within each study over time (i.e., unit retention during those same months in the previous year). Costs of each EBP intervention will be tracked during the study and compared descriptively. Survey data will be analyzed using analysis of variance statistics. Questionnaires will be tested for reliability and construct validity. Because this is a pilot study, statistically significant differences are not expected, however, effect sizes will be calculated
- Conditions
- Evidence-Based Medicine, Physician-Nurse Relations
- Being tested
- ARCC standard information, ARCC enhanced, Placebo
- Keywords
- evidence based practice beliefs, evidence based practice implementation, evidence based practice knowledge, nurse physician collaboration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCC standard informationBehavioural
EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs
ARCC enhancedBehavioural
same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation
PlaceboBehavioural
didactic education sessions on physical assessment
| Study group | Role | What they receive |
|---|---|---|
| ARCC standard | RNs on unit receiving basic ARCC information with staff nurse champion Receives: Behavioral: ARCC standard information | |
| ARCC enhanced | RNs on unit receiving ARCC standard content plus with an EBP mentor Receives: Behavioral: ARCC enhanced | |
| C | RNs on the unit receiving the placebo intervention Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBP beliefs
Measured: baseline, week 5, week 16, week 24
Secondary outcomes (1)
EBP Implementation
Measured: baseline, week 5, week 16, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence-Based MedicineStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Priscilla S Worral, PhD, RN, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635869
- Sponsor's protocol ID
- 5199
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes
- ClinicalTrials.gov ID
- NCT00635869
- Acronym / sponsor ID
- 5199
- Conditions
- Evidence-Based Medicine, Physician-Nurse Relations
- Keywords
- evidence based practice beliefs, evidence based practice implementation, evidence based practice knowledge, nurse physician collaboration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Mar 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 primary aim of this pilot study is to evaluate the effects of two variations of the ARCC Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims are to test the feasibility of study methods and reliability and validity of questionnaires.
This study is designed as a three-group randomized clinical trial with repeated measures. Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention (didactic content and environmental prompts, but not related to EBP; placebo). The interventions will be implemented over an estimated 14 weeks, including a 4-week training period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two ARCC intervention units will develop.
Baseline information and questionnaires will be collected from nurses at the start of the study, and again at completion of the intervention phase. Outcome data will be collected from nurses approximately 10 weeks after implementation of the ARCC interventions are completed (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be collected from physicians working with study unit nurses as well as from the nurses. Patient satisfaction data will not be separately collected in this study, but will include use of unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level and institutional RN turnover will be tracked monthly during the entire study period and will be compared across units at the same time as well as compared within each study over time (i.e., unit retention during those same months in the previous year). Costs of each EBP intervention will be tracked during the study and compared descriptively. Survey data will be analyzed using analysis of variance statistics. Questionnaires will be tested for reliability and construct validity. Because this is a pilot study, statistically significant differences are not expected, however, effect sizes will be calculated
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARCC standard | – | Behavioral: ARCC standard informationRNs on unit receiving basic ARCC information with staff nurse champion |
| ARCC enhanced | – | Behavioral: ARCC enhancedRNs on unit receiving ARCC standard content plus with an EBP mentor |
| C | – | Behavioral: PlaceboRNs on the unit receiving the placebo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Registered Nurse staff working on inpatient study units (medicine, surgery, surgical intensive care)
Key inclusion criteria (3 listed)
- employed by Upstate
- working full or part time on study unit
- able to attend all education sessions
Key exclusion criteria (2 listed)
- employed by temporary agency
- not able to attend all education sessions
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 |
|---|---|---|
| ARCC standard informationEBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs | Behavioural | ARCC standard |
| ARCC enhancedsame as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation | Behavioural | ARCC enhanced |
| Placebodidactic education sessions on physical assessment | Behavioural | C |
Primary outcome
EBP beliefs
Time frame: baseline, week 5, week 16, week 24
1 secondary outcome
EBP Implementation
Time frame: baseline, week 5, week 16, week 24
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 14 Mar 2008.
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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.
Priscilla S Worral, PhD, RN principal investigator
State University of New York - Upstate Medical University
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 Evidence-Based Medicine and Physician-Nurse Relations, run by State University of New York - Upstate Medical University 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 3 inclusion and 2 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 14 Mar 2008. 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?
EBP beliefs (time frame: baseline, week 5, week 16, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2008.