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

NCT02906033 | Completed Results

• 2 other identifiers: TYH2014211U1111-1185-9612
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 1

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).

Conditions

Arthroplasties, Hip Replacement; Arthroplasties, Knee Replacement

Keywords

Surgical Procedures, Operative; Operating Rooms; Quality of Life; Surgery-related anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

Intervention group

EXPERIMENTAL

New perioperative practice model.

Other: New perioperative practice model

Control group

NO INTERVENTION

Traditional practice model.

Interventions

New perioperative practice model OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital District of Helsinki and Uusimaa: lead
• University of Turku: collaborator
• Karlstad University: collaborator

Study Sites (1)

Peijas Hospital / Helsinki University Hospital

Vantaa, Finland

Location

Related Publications (2)

• 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.

  PMID: 33576579 DERIVED

• 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.

  PMID: 32765189 DERIVED

Results Point of Contact

• Title: MNSc Maria Pulkkinen
• Organization: Helsinki University Hospital

maria.pulkkinen@hus.fi

+358 50 427 2678

Study Officials

• Kristiina Junttila, PhD

  Hospital District of Helsinki and Uusimaa

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research Center

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: September 12, 2016
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)