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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02266979
Other study ID # AEFIIRPDstaff2014
Secondary ID
Status Completed
Phase N/A
First received September 28, 2014
Last updated November 13, 2016
Start date June 2014
Est. completion date September 2016

Study information

Verified date November 2016
Source Pontificia Universidade Católica do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- To have at least one year of experience with peritoneal dialysis

Exclusion Criteria:

- Consent withdraw

Study Design

Time Perspective: Prospective


Locations

Country Name City State
Brazil Pontificia Universidade Católica Rio Grande do Sul Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Ana Elizabeth Prado Lima Figueiredo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of activities ( direct or indirect care) performed by peritoneal dialysis nurse after focal groups a list we all activities performed by PD nurses will be prepared 6 months No
Secondary time to perform activities the time spend to perform each activities will be measured to calculate time spent with patients 6 months No
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