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Clinical Trials/NCT02906033
NCT02906033
Completed
Not Applicable

The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes

Hospital District of Helsinki and Uusimaa1 site in 1 country517 target enrollmentSeptember 12, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasties, Hip Replacement
Sponsor
Hospital District of Helsinki and Uusimaa
Enrollment
517
Locations
1
Primary Endpoint
Change From Baseline to Follow-up in Health Related Quality of Life
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of the study is to improve the surgical patients' care process. The objective is to explore the effect of a new perioperative practice model on 1) patient outcomes (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes (organizational engagement), and 3) organization outcomes (timeline of surgical care process).

Detailed Description

Study design: A longitudinal untreated control group design with pre- and posttests will be followed. Setting and sampling: The study will be conducted at the Helsinki University Hospital; more specifically at the operating department K of the Peijas Hospital. The randomized patient sampling will include voluntary adult surgical patients undergoing a hip or a knee replacement procedure. The patients will be recruited during their preoperative visit (approx. 2-3 weeks prior to the operation), and an informed consent will be obtained. Approximately 12-16 patients per day are scheduled for the preoperative visits, summing up to 60-80 recruitments per week. A control group (Group A) and an experimental (intervention) group (Group B) will be formed. The sample size was checked with power analysis (2 sided test) with the following parameters: value for α = 0.05, value for power 0.8, and value for common standard deviation 0.1. The sample size for both groups (A and B) was set at 175. Considering the potential drop-out, approx. 30%, the final sample size was determined to be 245 per group. The randomization will be performed by an independent third party (i.e., nurses at the preoperative clinic). The eligible patients will draw one of two cards; one indicating that an invitation to participate the study will be given to them, and the other being empty. Patients for the Group A will be recruited on the first week and the patients for the Group B on the second week. This pattern will be repeated until the desired amount of patients is recruited. This stratification will ensure that the two groups will not be contaminated in the ward where the post-operative visits will be carried out. Data collection and instruments: The patient data will be collected with 1) The Good Perioperative Nursing Care Scale developed by Leinonen and Leino-Kilpi (2001); 2) 15D; a generic, 15-dimensional, self-administered instrument for measuring health related quality of life among adults, developed by professor Sintonen; and 3) STAI, The State-Trait Anxiety Inventory; a definitive instrument for measuring anxiety in adults developed by Dr. Spielberger. The following demographic data from the participants will be collected: age, gender, diagnosis, procedure, and ASA-classification. Intervention: Traditionally during the intra- and postoperative phases of surgical care, the patient is cared for by several nurses; i.e. by an anesthetic nurse in the operating room and by a recovery room nurse in the Post Anesthesia Care Unit (PACU). Furthermore, the pre- and postoperative visits to the surgical patients are rare in Finland; mainly due to resources and new surgical processes where patients arrive to the hospital in the morning of the scheduled procedure. Basically, the new perioperative practice model denotes that the one and same nurse will meet the patient at his/her arrival to the operating department, and will care for the patient both in the operating room and in the PACU. Thus, the nursing care in the operating room and in the PACU remains the same, but will be organized in a new way which focuses on the patient centered individual care and the continuity of care. Furthermore, the same nurse will visit the patient at the surgical unit on the first postoperative day. A uniform content for the postoperative visits will be defined to ensure consistency of the intervention. The nurse will ask the patients if they have any questions or concerns regarding the procedure, how they have experienced their perioperative care, what they very satisfied with and what they would have desired to be different or would expect in the future from their care. The main aim of the visits is to meet the patient as an individual with individual needs and desires. According to the previous research results this new way to allocate personnel did not cause additional resource needs and did not in any way harm the care of other patients who did not participate in the study. Data analysis: Descriptive, inferential and advanced statistical analyses will be used.

Registry
clinicaltrials.gov
Start Date
September 12, 2016
End Date
December 21, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital District of Helsinki and Uusimaa
Responsible Party
Principal Investigator
Principal Investigator

Kristiina Junttila

Director of Nursing Research Center

Hospital District of Helsinki and Uusimaa

Eligibility Criteria

Inclusion Criteria

  • the patient has been scheduled for a primary elective hip or a knee replacement procedure under spinal anesthesia
  • the patient is 18 years of age or older
  • the patient is able to participate in the study either in Finnish or Swedish
  • the patient is able to give his/her written consent to participate the study
  • the patient is willing to participate the study
  • the patients operation time is scheduled on Monday through Thursday in the operating department K in the Peijas hospital

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change From Baseline to Follow-up in Health Related Quality of Life

Time Frame: Baseline and at 3 months follow up

The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The 15 dimensions are: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental functioning, discomfort and symptoms, depression, distress, vitality, and sexual activity The respondent chooses one of the five levels for each dimension that best describes his or her state of health at present moment; the best level is 1 and the worst is 5. The single index score (15D score), representing the overall HRQoL on a 0-1 scale (1=full health, 0=being dead). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group.

Secondary Outcomes

  • Change in Surgery-related STATE Anxiety From Baseline to Follow-up(Baseline and at 3 months follow-up)
  • Quality of Perioperative Care as Experienced by Surgical Patients(One-point measurement on the day of discharge (on average on the 3rd day after surgery))
  • Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up(Baseline and at 3 months follow-up)

Study Sites (1)

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