Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201812678880960 Date of Approval: 13/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intervention study of Nursing Process
Official scientific title Assessing the effect of integrated nursing process on the outcome of care of children with pneumonia in Dar es Salaam: A quasi experimental study
Brief summary describing the background and objectives of the trial Background: Pneumonia is one of the major causes of death of children worldwide and most prevalent in the low resource settings particularly sub-Saharan Africa. According to WHO (2013) pneumonia and malaria are the leading causes of child mortality in Tanzania. Pneumonia alone is responsible for 20% of total mortality among postnatal (1 – 59 months) children and Tanzania is ranked among the 15 countries with the highest estimated number of deaths due to clinical pneumonia (Rudan, Boschi-Pinto, Biloglav, Mulholland, & Campbell, 2008). Evidence that implementing nursing process while providing care to patients is associated with better patients’ outcomes as compared with the traditional task-based care approach is limited. However, available literature suggest that, patients who receive care under individualized plan have better outcomes (Lion & Mangione-smith, 2014). The objective of our study is to determine the effect of training and integration of nursing process to the nursing care of children with pneumonia on patient outcomes and length of hospital stay at Temeke and Amana Regional Referral hospitals in Dar es Salaam
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ISNP
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Pneumonia
Purpose of the trial Nursing care based on implementation of nursing process
Anticipated trial start date 12/01/2015
Actual trial start date 16/02/2015
Anticipated date of last follow up 23/04/2015
Actual Last follow-up date 07/05/2015
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 327
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training and implementation of nursing process in caring for children with pneumonia Training for nurses was conducted for one week before implementation began time for implementation of nursing process for every child was variable. Each child received care under nursing process for as long as he / she stayed in the ward. The intervention protocol for the intervention hospital comprise of training of nurses and guidance to enable them to implement the nursing process in the care of children recruited under the study. The training involved training workshops to provide knowledge and skills in utilizing nursing process in routine care of children. The training followed a competence-based approach through clearly outlining the learning outcomes. The training consisted of a two-modules. The first focused on knowledge on the Nursing Process framework. The second was a practical module that focused on developing nurses’ skills on integrating nursing process in the care of children practically. We divided each module into 2 sessions. Each session lasted for two (2) hours. All nurses working in the pediatric wards were involved in the training to ensure that they could all implement the nursing process. Hands-on activities with integration of problem-based approach, individual exercises, case studies, and discussions were employed to maximize acquisition of knowledge and skills of implementing nursing process in the care of patients. This approach is described to have good results for adult learning (Fidishun, 2005; Noor, Harun, & Aris, 2012). All the training sessions will be facilitated by the PI. The implementation part involved integration of the nursing process in care of the children with pneumonia. Nurses in the intervention hospital were supplied with nursing process forms for them to implement the nursing process while caring for children. The forms were simplified and comprised sections and charts for nurses to chart their assessment data; use their critical thinking to formulate and chart their nursing care plans for their patients on daily basis. The PI also supplied the learning materials for reference during implementation and provided consultative support to nurses to help them address any emerging challenges on the course of implementation. 147
Control Group Usual care For as long as the child was admitted in the ward Usual care was based on task based care approach. Non implementation of nursing process was a usual nursing care for both two hospitals before the intervention study began. Usual care was defined as care of patients based on assigned tasks. Largely the tasks were based on orders by the physicians during ward round or as tasks assigned by the nurse leader at the beginning of the shift. 180 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The parent/guardian admitted with child must consent for the child to participate in the study. The child must be diagnosed with pneumonia by the attending physician based on history and presentation of signs on examination. The main clinical signs the physicians assessment data must indicate are: presence of cough, dyspnea, age-specific WHO-defined tachypnea, and pleurisy as the hallmark signs as was suggested by (Prasad, 2013; Wingerter, Bachur, Monuteaux, & Neuman, 2012). Chest radiography indicative of a confirmatory test will not be included as a diagnosing criterion because it is not done routinely in Tanzania. Along with parent’s/ care giver’s consent, older children of age 8-12 will have to give an assent for them to take part in the study. Has been diagnosed of pneumonia but has a comorbid medical/surgical condition that would confound the outcome; such as pneumonia and HIV or pneumonia and malaria Died within one hour after admission. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/02/2015 Muhimbili University of Health and Allied Sciences Institutional Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
United Nations Road, Dar es Salaam Dar es Salaam 0255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality rate of children defined as proportion of children who dies after one hour of admission during the study period per total number of children enrolled in the study One hour after the child is admitted until the child is discharged or dies
Secondary Outcome Length of hospital stay defined as number of days the child spent in the ward before discharge One hour after the child is admitted the day that the child is discharged
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Amana Regional Referral Hospitals Ilala district Dar es Salaam United Republic of Tanzania
Temeke Regional Referral Hospital Temeke district Dar es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Dodoma University of Dodoma Dodoma 0255 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhimbili University of Health and Allied Sciences Kalenga street, United Nations Road Dar es Salaam 0255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Dr. German H. Leyna School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences. Dar es Salaam 65004 United Republic of Tanzania
Mr. Menti Ndile School of Nursing, Muhimbili University of Health and Allied Sciences Dar es Salaam 65004 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Golden Mwakibo Masika gmwakibo@yahoo.co.uk +255717813222 College of Health Sciences, University of Dodoma
City Postal code Country Position/Affiliation
Dodoma 0255 United Republic of Tanzania Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Menti Ndile mentlast@yahoo.co.uk +255714890015 Muhimbili University of Health and Allied Sciences
City Postal code Country Position/Affiliation
Dar es Salaam 0255 United Republic of Tanzania Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Germana H. Leyna gleyna@muhas.ac.tz +255782847320 Muhimbili University of Health and Allied Sciences
City Postal code Country Position/Affiliation
Dar es Salaam 0255 United Republic of Tanzania Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The overall mean length of hospital stay was 3.97 (SD = 1.5) days, and 27 deaths occurred. We found that being hospitalized in the intervention hospital was associated with staying for one day less than being hospitalized in the control hospital (better coefficient = -0.69, 95% CI = -1.00, -0.38). Less mortality rate was observed in the intervention compared to the control hospital, but the difference was not statistically significant. 13/12/2018 13/12/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks No link is available, the protocol was not published
Changes to trial information