Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes

March 13, 2008 updated by: State University of New York - Upstate Medical University

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • University Hospital, SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Registered Nurse staff working on inpatient study units (medicine, surgery, surgical intensive care)

Description

Inclusion Criteria:

  • employed by Upstate
  • working full or part time on study unit
  • able to attend all education sessions

Exclusion Criteria:

  • employed by temporary agency
  • not able to attend all education sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ARCC standard
RNs on unit receiving basic ARCC information with staff nurse champion
Behavioral: ARCC standard information
EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs
ARCC enhanced
RNs on unit receiving ARCC standard content plus with an EBP mentor
Behavioral: ARCC enhanced
same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation
C
RNs on the unit receiving the placebo intervention
Behavioral: Placebo
didactic education sessions on physical assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
EBP beliefs
Time Frame: baseline, week 5, week 16, week 24
baseline, week 5, week 16, week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
EBP Implementation
Time Frame: baseline, week 5, week 16, week 24
baseline, week 5, week 16, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Priscilla S Worral, PhD, RN, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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