- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266979
Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs
November 13, 2016 updated by: Ana Elizabeth Prado Lima Figueiredo
As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework of nursing professionals is essential to ensure the safety and quality of patient care.
To achieve such goals actions are needed to evaluate the variety of tasks and performance specific to each area in nursing profession.
The National Agency for Health Surveillance (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1 to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based on any evidence, and same apply to other Latin-American countries.
Objective: To determine the appropriate nurse: patient ratio for peritoneal dialysis unit.
Method: This research will be developed in two phases.
The first with an observational design with descriptive and qualitative approach.
There will be a focus group with experts in the field, to defined the activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a list of activities.
A time-orientated score will be created.
In the second stage a cross-sectional quantitative approach will be used.
To apply the instrument from by direct observation of activities performed by nurses during their workday.
With the instrument activities will be timed and the overall time of each nursing activity will be determined by multiplying the time spent by the total number of patients.
It is expected tat this strategy will increase time on treatment and/or decrease dropout rates, by developing an easy test/ formula application to determine the correct ratio according to the peritoneal dialysis program.
This tool will provide better outcomes for patients as well as allow for growth of peritoneal dialysis programs with qualified assistance and patient safety.
Study Overview
Status
Completed
Conditions
Detailed Description
Research question:
Can a time-oriented score system and expert consensus be applied to PD to develop an easy and repeatable system to evaluate work load for peritoneal dialysis nurses to achieve the best outcomes and allow for planned growth of the unit?
Study Type
Observational
Enrollment (Actual)
10
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
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90.619-900
- Pontificia Universidade Católica Rio Grande do Sul
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Renal nurses, master and PhD nurse experts in peritoneal dialysis to develop a list of activities to be timed
Description
Inclusion Criteria:
- To have at least one year of experience with peritoneal dialysis
Exclusion Criteria:
- Not applicable
- Consent withdraw
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
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of activities ( direct or indirect care) performed by peritoneal dialysis nurse
Time Frame: 6 months
|
after focal groups a list we all activities performed by PD nurses will be prepared
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to perform activities
Time Frame: 6 months
|
the time spend to perform each activities will be measured to calculate time spent with patients
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ana E Figueiredo, RN, PhD, Pontificia Universidade Católica do Rio Grande do Sul
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
June 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
September 28, 2014
First Submitted That Met QC Criteria
October 13, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 13, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEFIIRPDstaff2014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.