Study to Determine Appropriate Nurse: Patient Ratios in P... | NCT02266979

Studies
Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs

NCT02266979

Sponsor

Ana Elizabeth Prado Lima Figueiredo

Status

Completed

Last Update Posted

Nov 15, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Chronic Renal Failure

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 28, 2014

First Submission Date that Met QC Criteria

Oct 13, 2014

First Posted Date

Oct 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana Elizabeth Prado Lima Figueiredo, Professor, Pontificia Universidade Católica do Rio Grande do SulSponsor-Investigator

Lead Sponsor

Ana Elizabeth Prado Lima FigueiredoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
time to perform activities	the time spend to perform each activities will be measured to calculate time spent with patients	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To have at least one year of experience with peritoneal dialysis

Exclusion Criteria:

Not applicable
Consent withdraw

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Renal nurses, master and PhD nurse experts in peritoneal dialysis to develop a list of activities to be timed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana E Figueiredo, RN, PhD	Pontificia Universidade Católica do Rio Grande do Sul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidade Católica Rio Grande do Sul		Porto Alegre	Rio Grande do Sul	90.619-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided