Clinical trial NCT02906033: The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes
Official title: The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasties, Hip Replacement
Arthroplasties, Knee Replacement
Keywords: Surgical Procedures, Operative
Operating Rooms
Quality of Life
Surgery-related anxiety
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Karlstad University
First posted: 2016-09-19
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

* None

Primary outcomes:
measure: Change From Baseline to Follow-up in Health Related Quality of Life
timeFrame: Baseline and at 3 months follow up
Secondary outcomes:
measure: Change in Surgery-related STATE Anxiety From Baseline to Follow-up
timeFrame: Baseline and at 3 months follow-up
measure: Quality of Perioperative Care as Experienced by Surgical Patients
timeFrame: One-point measurement on the day of discharge (on average on the 3rd day after surgery)
measure: Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up
timeFrame: Baseline and at 3 months follow-up
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Peijas Hospital / Helsinki University Hospital
Study officials:
affiliation: Hospital District of Helsinki and Uusimaa
name: Kristiina Junttila, PhD
role: STUDY_DIRECTOR
References:
citation: Pulkkinen M, Jousela I, Sintonen H, Engblom J, Salantera S, Junttila K. A randomized clinical trial of a new perioperative practice model on anxiety and health-related quality of life in arthroplasty patients. Nurs Open. 2021 Jul;8(4):1593-1605. doi: 10.1002/nop2.776. Epub 2021 Feb 12.
citation: Pulkkinen M, Jousela I, Engblom J, Salantera S, Junttila K. The effect of a new perioperative practice model on length of hospital stay and on the surgical care process in patients undergoing hip and knee arthroplasty under spinal anesthesia: a randomized clinical trial. BMC Nurs. 2020 Jul 31;19:73. doi: 10.1186/s12912-020-00465-3. eCollection 2020.