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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00635869
Other study ID # 5199
Secondary ID
Status Completed
Phase N/A
First received March 7, 2008
Last updated March 13, 2008
Start date September 2005
Est. completion date August 2006

Study information

Verified date March 2008
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
ARCC standard information
EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs
ARCC enhanced
same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation
Placebo
didactic education sessions on physical assessment

Locations

Country Name City State
United States University Hospital, SUNY Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EBP beliefs baseline, week 5, week 16, week 24 No
Secondary EBP Implementation baseline, week 5, week 16, week 24 No
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