Arthroplasties, Hip ReplacementNCT02906033
The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes
A study testing New perioperative practice model in people with Arthroplasties, Hip Replacement and Arthroplasties, Knee Replacement, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasties, Hip Replacement, Arthroplasties, Knee Replacement
- What is being tested?
- New perioperative practice model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 1 siteFinland
- Study dates
- 12 Sep 2016to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- New perioperative practice model
- Keywords
- Surgical Procedures, Operative, Operating Rooms, Quality of Life, Surgery-related anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New perioperative practice modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | New perioperative practice model. Receives: Other: New perioperative practice model |
| Control group | No intervention | Traditional practice model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 3 months follow up
Secondary outcomes (3)
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.
Measured: Baseline and at 3 months follow-up
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.
Measured: 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
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.
Measured: Baseline and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start12 Sep 2016
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasties, Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Karlstad University
- Responsible party
- Principal investigator, Kristiina Junttila, Hospital District of Helsinki and Uusimaa
- Investigators
- Kristiina Junttila, PhD, Study director, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906033
- Sponsor's protocol ID
- TYH2014211
- Other IDs
- U1111-1185-9612
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2016
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33576579Pulkkinen 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.
PubMed 32765189
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes
- ClinicalTrials.gov ID
- NCT02906033
- Acronym / sponsor ID
- TYH2014211
- Keywords
- Surgical Procedures, Operative, Operating Rooms, Quality of Life, Surgery-related anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Collaborators
- University of Turku, Karlstad University
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: New perioperative practice modelNew perioperative practice model. |
| Control group | No intervention | –Traditional practice model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New perioperative practice modelThe 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. | Other | Intervention group |
Primary outcome
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.
3 secondary outcomes
Change in Surgery-related STATE Anxiety From Baseline to Follow-up
Time frame: Baseline and at 3 months follow-up
Quality of Perioperative Care as Experienced by Surgical Patients
Time frame: 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
Time frame: Baseline and at 3 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33576579Pulkkinen 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.
- Derived from this study: PubMed 32765189Pulkkinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiina Junttila, PhD study director
Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New perioperative practice model in people with Arthroplasties, Hip Replacement and Arthroplasties, Knee Replacement, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Follow-up in Health Related Quality of Life (time frame: Baseline and at 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906033, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.