Chronic Renal FailureNCT02266979
Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs
An observational study of Chronic Renal Failure, run by Ana Elizabeth Prado Lima Figueiredo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Sep 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Renal nurses, master and PhD nurse experts in peritoneal dialysis to develop a list of activities to be timed
Who may be able to join
- To have at least one year of experience with peritoneal dialysis
Who cannot join
- Not applicable
- Consent withdraw
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontificia Universidade Católica Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90.619-900
About this study
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.
Read the 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?
- Conditions
- Chronic Renal Failure
- Keywords
- peritoneal dialysis, nursing staff, nursing activities, Personnel Downsizing
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
time to perform activities
the time spend to perform each activities will be measured to calculate time spent with patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Elizabeth Prado Lima Figueiredo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Elizabeth Prado Lima Figueiredo, Pontificia Universidade Católica do Rio Grande do Sul
- Investigators
- Ana E Figueiredo, RN, PhD, Principal investigator, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266979
- Sponsor's protocol ID
- AEFIIRPDstaff2014
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs
- ClinicalTrials.gov ID
- NCT02266979
- Acronym / sponsor ID
- AEFIIRPDstaff2014
- Conditions
- Chronic Renal Failure
- Keywords
- peritoneal dialysis, nursing staff, nursing activities, Personnel Downsizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ana Elizabeth Prado Lima FigueiredoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Oct 2014 (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.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Renal nurses, master and PhD nurse experts in peritoneal dialysis to develop a list of activities to be timed
Key inclusion criteria (1 listed)
- To have at least one year of experience with peritoneal dialysis
Key exclusion criteria (2 listed)
- Not applicable
- Consent withdraw
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
time to perform activities
Time frame: 6 months
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 15 Nov 2016.
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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.
Ana E Figueiredo, RN, PhD principal investigator
Pontificia Universidade Católica do Rio Grande do Sul
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 Chronic Renal Failure, run by Ana Elizabeth Prado Lima Figueiredo at 1 site in Brazil.
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 1 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 15 Nov 2016. 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 Brazil. 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?
number of activities ( direct or indirect care) performed by peritoneal dialysis nurse (time frame: 6 months). 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 15 Nov 2016.