Trial Outcomes & Findings for The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes (NCT NCT02906033)

Last Updated: 2021-12-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

517 participants

Primary outcome timeframe

Baseline and at 3 months follow up

Results posted on

2021-12-06

Participant Flow

Excluded due to general anesthesia: N=64

Participant milestones

Participant milestones
Measure	Intervention Group New perioperative practice model. 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.	Control Group Traditional practice model.
Baseline STARTED	231	222
Baseline 15 D at Baseline	211	189
Baseline STATE at Baseline	199	190
Baseline TRAIT at Baseline	194	189
Baseline COMPLETED	194	189
Baseline NOT COMPLETED	37	33
Follow-up STARTED	194	189
Follow-up 15 D at Follow-up	151	135
Follow-up STATE at Follow-up	154	135
Follow-up TRAIT at Follow-up	148	127
Follow-up COMPLETED	148	127
Follow-up NOT COMPLETED	46	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group New perioperative practice model. 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.	Control Group Traditional practice model.
Baseline Protocol Violation	37	33
Follow-up Lost to Follow-up	46	62

Baseline Characteristics

Enrolled participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=231 Participants New perioperative practice model. 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.	Control Group n=222 Participants Traditional practice model.	Total n=453 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 10.41 • n=5 Participants • Enrolled participants	68.0 years STANDARD_DEVIATION 10.48 • n=7 Participants • Enrolled participants	67.0 years STANDARD_DEVIATION 10.44 • n=5 Participants • Enrolled participants
Sex: Female, Male Female	146 Participants n=5 Participants	139 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	83 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	231 Participants n=5 Participants	222 Participants n=7 Participants	453 Participants n=5 Participants
Region of Enrollment Finland	231 participants n=5 Participants	222 participants n=7 Participants	453 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 3 months follow up

Outcome measures

Outcome measures
Measure	Intervention Group n=151 Participants New perioperative practice model. 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.	Control Group n=135 Participants Traditional practice model.
Change From Baseline to Follow-up in Health Related Quality of Life	0.059 score on a scale Interval 0.036 to 0.081	0.055 score on a scale Interval 0.031 to 0.078

SECONDARY outcome

Timeframe: Baseline and at 3 months 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=154 Participants New perioperative practice model. 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.	Control Group n=135 Participants Traditional practice model.
Change in Surgery-related STATE Anxiety From Baseline to Follow-up	-4.91 score on a scale Interval -8.02 to -1.79	-5.21 score on a scale Interval -8.47 to -1.95

SECONDARY outcome

Timeframe: One-point measurement on the day of discharge (on average on the 3rd day after surgery)

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=219 Participants New perioperative practice model. 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.	Control Group n=217 Participants Traditional practice model.
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Staff characteristics"	4.89 score on a scale Interval 4.84 to 4.94	4.83 score on a scale Interval 4.75 to 4.9
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Encouragement"	4.61 score on a scale Interval 4.49 to 4.72	4.56 score on a scale Interval 4.42 to 4.7
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Pain management"	4.85 score on a scale Interval 4.78 to 4.91	4.83 score on a scale Interval 4.76 to 4.89
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Technical skills"	4.95 score on a scale Interval 4.92 to 4.98	4.90 score on a scale Interval 4.84 to 4.95
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Information"	4.61 score on a scale Interval 4.47 to 4.74	4.58 score on a scale Interval 4.44 to 4.71
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Respect"	4.87 score on a scale Interval 4.8 to 4.94	4.76 score on a scale Interval 4.68 to 4.85
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Environment"	4.79 score on a scale Interval 4.71 to 4.87	4.81 score on a scale Interval 4.74 to 4.88
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Temperature management"	4.90 score on a scale Interval 4.84 to 4.96	4.95 score on a scale Interval 4.92 to 4.99
Quality of Perioperative Care as Experienced by Surgical Patients Sum variable "Process"	4.71 score on a scale Interval 4.6 to 4.82	4.51 score on a scale Interval 4.35 to 4.68

SECONDARY outcome

Timeframe: Baseline and at 3 months 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=148 Participants New perioperative practice model. 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.	Control Group n=127 Participants Traditional practice model.
Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up	-0.76 score on a scale Interval -3.54 to 2.02	-2.05 score on a scale Interval -4.98 to 0.88

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MNSc Maria Pulkkinen

Helsinki University Hospital

Phone: +358 50 427 2678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place