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

Arthroplasties, Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906033
• Other study ID #: TYH2014211
• Secondary ID: U1111-1185-9612
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: October 2021
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• None

Related Conditions & MeSH terms

• Arthroplasties, Hip Replacement
• Arthroplasties, Knee Replacement

Intervention

Other:
• New perioperative practice model
The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery.

Locations

Country	Name	City	State
Finland	Peijas Hospital / Helsinki University Hospital	Vantaa

Sponsors (3)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa	Karlstad University, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Follow-up in Health Related Quality of Life	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.	Baseline and at 3 months follow up
Secondary	Change in Surgery-related STATE Anxiety From Baseline to Follow-up	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes.; This instrument is composed of STATE and TRAIT scales, each of which has twenty items. The STATE items evoke feelings on a 4-point Likert scale, with responses ranging from 1 (not at all) to 4 (very much). The TRAIT items evoke how the respondent feels in general on a frequency scale ranging from 1 (hardly ever) to 4 (almost always). The scores of both STATE and TRAIT scales range from 20 to 80 scores.; According to the raw score, anxiety is classified as low (20-39), moderate (40-59) or high (60-80). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group.	Baseline and at 3 months follow-up
Secondary	Quality of Perioperative Care as Experienced by Surgical Patients	Good Perioperative Nursing Care Scale is a constructed questionnaire which contains 36 statements measuring the quality of care, which are summarized into nine quality categories (sum variables/subscales): Pain management (n=5 statements), Temperature maintenance (n=2), Technical skills (n=4), Information (n=6), Encouragement (n= 3), Respect (n= 3), Staff characteristics (n= 5), Environment (n= 6) and Process (n= 2).; The quality statements are answered with a five-point Likert scale (fully agree, 5 points - fully disagree, 1 point) with a neutral option "neither agree nor disagree" and an option "cannot evaluate this aspect". The value of each averaged sum variable/subscale varies from 1 to 5. In the analysis, the responses of "cannot evaluate this aspect" were excluded. The better the mean value is, the more positive experience the participant has of the quality of care.	One-point measurement on the day of discharge (on average on the 3rd day after surgery)
Secondary	Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes.; This instrument is composed of STATE and TRAIT scales, each of which has twenty items. The STATE items evoke feelings on a 4-point Likert scale, with responses ranging from 1 (not at all) to 4 (very much). The TRAIT items evoke how the respondent feels in general on a frequency scale ranging from 1 (hardly ever) to 4 (almost always). The scores from both STATE and TRAIT scales range from 20 to 80 scores.; According to the raw score, anxiety is classified as low (20-39), moderate (40-59) or high (60-80). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group.	Baseline and at 3 months follow-up