## Protocol Section
### Identification Module
**NCT ID:** NCT02266979

**Brief Title:** Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs

**Official Title:** Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs

#### Organization Study ID Info
**ID:** AEFIIRPDstaff2014
#### Organization
**Class:** OTHER
**Full Name:** Pontificia Universidade Católica do Rio Grande do Sul
### Status Module
#### Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Start Date
**Date:** 2014-06

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2014-10-17
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-28
**Study First Submit QC Date:** 2014-10-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ana Elizabeth Prado Lima Figueiredo

#### Responsible Party

**Investigator Affiliation:** Pontificia Universidade Católica do Rio Grande do Sul

**Investigator Full Name:** Ana Elizabeth Prado Lima Figueiredo

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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?

### Conditions Module

**Conditions:**

- Chronic Renal Failure

**Keywords:**

- peritoneal dialysis

- nursing staff

- nursing activities

- Personnel Downsizing

### Design Module

#### Design Info

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** after focal groups a list we all activities performed by PD nurses will be prepared

**Measure:** number of activities ( direct or indirect care) performed by peritoneal dialysis nurse

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** the time spend to perform each activities will be measured to calculate time spent with patients

**Measure:** time to perform activities

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Not applicable
* Consent withdraw

**Healthy Volunteers:** True

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Pontificia Universidade Católica Rio Grande do Sul

**State:** Rio Grande do Sul

**Zip:** 90.619-900

#### Overall Officials

**Official 1:**

**Affiliation:** Pontificia Universidade Católica do Rio Grande do Sul

**Name:** Ana E Figueiredo, RN, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: Chronic Renal Failure

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Misc Info Module

- Version Holder: 2024-05-24
