Musculoskeletal DiseasesNPPNCT02543307
Effects of Nurse-led Patient Pathways
A study testing Nurse-led Patient Pathways in people with Musculoskeletal Diseases, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
Objectives: This quasi-experimental pre-post-study investigated the effect of newly developed Nurse-led Patient Pathways (NPP) designed to improve patients', and health care professionals' as well as institutional outcomes. Intervention: In the IG patients were cared for under the three newly developed NPP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Nurse-led Patient Pathways
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- surgical patients hospitalized for total hip arthroplasty, exploration and decompression of the spinal cord, and rotator cuff reconstruction,
- age 18 years or older,
- German speaking (oral and written),
- consents to the use of patient data (chart review),
- give informed consent (patient survey)
- patients that had cognitive deficits such that they were unable to provide informed consent
Show all 12Show fewer
- nurses (survey and interview)
- age 18 years or older,
- works on one of the two study units
- give informed consent
- directly involved in patients care
- give informed consent
Who cannot join
- inclusion criteria will be not met
- other health care professionals
- inclusion criteria will be not met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality and Process Improvement Using Nurse-led Patient Pathways in an Orthopedic Hospital
Objectives: This quasi-experimental pre-post-study investigated the effect of newly developed Nurse-led Patient Pathways (NPP) designed to improve patients', and health care professionals' as well as institutional outcomes.
Intervention: In the IG patients were cared for under the three newly developed NPP. NPP are characterized by four principles: evidence-based nursing, patient and family centered care, comprehensive discharge planning beyond hospital discharge and nurses' responsibility for patients' processes. The principles support and strengthen patient and family preferences as well as formalize nursing activities, and therefore contribute to process transparency in relation to other health care professionals.
Outcomes: Primary Outcomes were defined as quality of nursing care (nursing care index, NCI), and patient satisfaction (patient satisfaction with nursing care quality, PSNCQ). Secondary outcomes were defined as 1) nursing work environment (nursing work index revised, NWI-R; and nursing workplace quality, NWQ), and 2) institutional-related costs (length of hospital stay, LOS; nursing time and nursing costs). Additionally, nurses' and other health care professionals' experiences of intervention translation will be explored.
Read the detailed description
In Switzerland, the hospitalization rate of patients with musculoskeletal disorders has increased within the last decade. For example, recent data shows that Switzerland had the highest rate of hip replacement surgery in Europe. Due to the introduction of diagnosis related groups in Switzerland, there is increased pressure to reduce length of hospital stay and increase economic efficiency.
To achieve the required economic efficiency, there is a trend towards standardization of care delivery processes, often in the form of care pathways. The European Pathway Association has defined care pathways as a complex intervention. Pathways should incorporate evidence based care, best practices and patient expectations. As such, care pathways depend on communication and coordination between team members, patients and families, as well as defined roles and sequenced activities.
However, care pathways are often criticized for their organization-driven focus, the lack of a patient centered perspective or missing a holistic approach to care. Therefore, the Balgrist University Hospital and the Zurich University of Applied Sciences developed NPP to enhance patients', and health care professionals' as well as institutional outcomes.
Method: A quasi-experimental prospective study with a pre-post sample design will be conducted. Usual care will be given in the control group (Pre) and compared with a group of patients that were assigned to NPP (Post). The study will be conducted on the two largest orthopedic units at the Balgrist University Hospital, a highly specialized center in musculoskeletal care, located in the Canton of Zurich.
- A convenience sample will be recruited, consisting of 558 surgical patients hospitalized for total hip arthroplasty, exploration and decompression of the spinal cord, and rotator cuff reconstruction. Demographic, clinical data as well as data to measure quality of nursing care, patient satisfaction, and costs will be obtained,
- A sample of 38 nurses will be recruited, which are working on the two units. Demographic data and data to measure nursing work environment will be contained,
- Additionally, a sample of 6 nurses and 5 other health care professionals' (directly involved in patients care) will be recruited to explore experiences of intervention translation within 2 focus group sessions.
The quantitative data analyses will be performed using statistical tests appropriate to the sample size, measurement level, distribution and the independence of variables. For group control appropriate tests for independent groups were used in respect to provision of necessary assumptions. Statistically significance was set on Alpha .05 with undirected hypothesis testing, if necessary correction for multiple testing will be included. Qualitative data analysis will be performed using content analysis.
We hypothesized that the NPP-group (post) will be experienced higher quality of nursing care and increased patient satisfaction, without an increase in health care costs. Secondary outcomes will be enhanced work environment for the nurses.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Nurse-led Patient Pathways
- Keywords
- Hip Replacement, Spinal Diseases, Rotator Cuff Reconstruction, Nursing, Nurse-led, Pathways, Patient Satisfaction, Quality of Nursing Care
- Medical subject headings
- Musculoskeletal Diseases, Spinal Diseases, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Patient PathwaysProcedure or surgery
The NPP include a comprehensive needs and goal assessment. Patients appreciated written information provided at an early stage of their hospital stay that helped to prepare them for discharge. The NPP continue with pre- and post-operative patient care, and conclude with a newly implemented follow-up phone call after hospital discharge. Nursing interventions were presented in a checklist format, based on scientific and clinical evidence. The NPP were developed with regard to patient and family centered goals and objectives and were explicitly emphasized in the NPP. NPP guided the nursing care plan. Nurses act as advocates for patients' interests. Therefore NPPs represent a means to formalize these nursing activities and contribute to transparency in relation to other health professionals.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Patient Pathways | Experimental | Patients were cared for under the three NPP developed for the orthopedic populations: NPP-1) patients with total hip arthroplasty; NPP-2) exploration and decompression of the spinal cord; and NPP-3) rotator cuff reconstruction. NPP are characterized by four principles: evidence-based nursing, patient and family centred care, comprehensive discharge planning beyond hospital discharge and nurses' responsibility for patients' processes. The principles support and strengthen patient and family preferences as well as formalize nursing activities, and therefore contribute to process transparency in relation to other health care professionals. Aims: to improve patients' and health care professionals' as well as institutional outcomes. Receives: Procedure: Nurse-led Patient Pathways |
| Standard usual nursing care | No intervention | Patients in the control group will receive usual nursing care, which is based on the institutional principles and standards of care for surgical patients. Based on the type of surgery and assessment of the nurse the nursing process is used to care for the patients. The nurses will be ending their activities with discharge of the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nursing Care Index (NCI) between pre and post intervention group
The NCI was used to measure the quality of nursing care. The self-developed instrument included 35 items with yes/no-answers for each item. Data will be generated from entries in the patient's electronic clinical record. The total NCI-score was calculated by computing the average value of all mean values of the subscales. NCI-scores could range between zero (lowest quality) and one (highest quality). Six subscales will be used in order to reflect the key principles of NPPs (Initial Pain Assessment, Needs and Goal Assessment, Family Centred Care, Care Planning, Post-surgical Care, Discharge Planning).
Measured: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
Change in Patient Satisfaction with Nursing Care Quality (PSNCQ) between pre and post intervention group
The PSNCQ Questionnaire was used to measure the patient satisfaction with nursing care quality. The 19-item instrument is a validated and common used instrument in clinical settings to measure patient satisfaction. The patients evaluated key areas of nursing care during their hospital stay on a 5-point Likert in terms of whether the quality was excellent (5 points), very good, good, fair or poor (1 point). The maximum value (5) reflected a high level of satisfaction and the lowest value (1) indicated a deep dissatisfaction with the nursing performance. Data were collected using a survey mailed to the patients within the first week after discharge. For the first 84 patients in the control group survey was not possible because data collection took place more than one week after discharge.
Measured: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
Secondary outcomes (3)
Change in nursing work environment (nursing work index revised, NWI-R) between pre and post intervention group
The NWI-R is a validated and common instrument in clinical settings to measure the quality of nursing work environment. The NWI-R includes 51 items that are rated on a 4-point Likert (strongly agree (4 points), agree, disagree, strongly disagree (1 point). The total NWI-R-score will be calculated by computing the average over all 51 items. NWI-R-scores could range between 0 (dissatisfaction with nursing work environment) and 1 (satisfaction with nursing work environment). Three NWI-R subscales are included (Leadership \& Development, Resources \& Autonomy, and Cooperation \& Competence).
Measured: Data will be gathered ones for the control group close before implementation of the NPP, and ones after 8 month of implementation of NPP.
Change in nursing work environment (nursing workplace quality, NWQ) between pre and post intervention group
The NWQ Questionnaire is a self-developed instrument to measure the quality of nursing work environment in a shorter version, based on characteristics of magnet hospitals. The NWQ Questionnaire includes 8 items that are rated on a visual analog scale (strongly agree (100 points) and strongly disagree (0 points). The total NWQ-score will be calculated by computing the average over all 8 items. NWI-R-scores could range between 0 (dissatisfaction with nursing work environment) and 100 (satisfaction with nursing work environment).
Measured: Data will be gathered ones for the control group close before implementation of the NPP, and ones after 8 month of implementation of NPP.
Change in institutional-related costs (length of hospital stay, LOS; nursing time and nursing costs).
Data related to costs were collected using 1) length of stay in days, retrieved from patients' clinical record entries (based on date of admission and date of discharge), 2) nursing time for patient care in minutes, and 3) costs of nursing care per case in Swiss franc (CHF), provided by the comptroller department using data from the LEP® method, a workload measurement system for the healthcare system. Higher values will be indicated higher institutional-related costs.
Measured: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital, Ebnet-Foundation, Swiss Association Balgrist
- Responsible party
- Principal investigator, Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences
- Investigators
- Lorenz Imhof, Prof Dr, Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543307
- Sponsor's protocol ID
- P270248_151704
- Other IDs
- 2011_0248
- Acronym
- NPP
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Process Improvement Using Nurse-led Patient Pathways in an Orthopedic Hospital
- ClinicalTrials.gov ID
- NCT02543307
- Acronym / sponsor ID
- NPP / P270248_151704
- Conditions
- Musculoskeletal Diseases
- Keywords
- Hip Replacement, Spinal Diseases, Rotator Cuff Reconstruction, Nursing, Nurse-led, Pathways, Patient Satisfaction, Quality of Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Balgrist University Hospital, Ebnet-Foundation, Swiss Association Balgrist
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: This quasi-experimental pre-post-study investigated the effect of newly developed Nurse-led Patient Pathways (NPP) designed to improve patients', and health care professionals' as well as institutional outcomes.
Intervention: In the IG patients were cared for under the three newly developed NPP. NPP are characterized by four principles: evidence-based nursing, patient and family centered care, comprehensive discharge planning beyond hospital discharge and nurses' responsibility for patients' processes. The principles support and strengthen patient and family preferences as well as formalize nursing activities, and therefore contribute to process transparency in relation to other health care professionals.
Outcomes: Primary Outcomes were defined as quality of nursing care (nursing care index, NCI), and patient satisfaction (patient satisfaction with nursing care quality, PSNCQ). Secondary outcomes were defined as 1) nursing work environment (nursing work index revised, NWI-R; and nursing workplace quality, NWQ), and 2) institutional-related costs (length of hospital stay, LOS; nursing time and nursing costs). Additionally, nurses' and other health care professionals' experiences of intervention translation will be explored.
Detailed description
In Switzerland, the hospitalization rate of patients with musculoskeletal disorders has increased within the last decade. For example, recent data shows that Switzerland had the highest rate of hip replacement surgery in Europe. Due to the introduction of diagnosis related groups in Switzerland, there is increased pressure to reduce length of hospital stay and increase economic efficiency.
To achieve the required economic efficiency, there is a trend towards standardization of care delivery processes, often in the form of care pathways. The European Pathway Association has defined care pathways as a complex intervention. Pathways should incorporate evidence based care, best practices and patient expectations. As such, care pathways depend on communication and coordination between team members, patients and families, as well as defined roles and sequenced activities.
However, care pathways are often criticized for their organization-driven focus, the lack of a patient centered perspective or missing a holistic approach to care. Therefore, the Balgrist University Hospital and the Zurich University of Applied Sciences developed NPP to enhance patients', and health care professionals' as well as institutional outcomes.
Method: A quasi-experimental prospective study with a pre-post sample design will be conducted. Usual care will be given in the control group (Pre) and compared with a group of patients that were assigned to NPP (Post). The study will be conducted on the two largest orthopedic units at the Balgrist University Hospital, a highly specialized center in musculoskeletal care, located in the Canton of Zurich.
- A convenience sample will be recruited, consisting of 558 surgical patients hospitalized for total hip arthroplasty, exploration and decompression of the spinal cord, and rotator cuff reconstruction. Demographic, clinical data as well as data to measure quality of nursing care, patient satisfaction, and costs will be obtained,
- A sample of 38 nurses will be recruited, which are working on the two units. Demographic data and data to measure nursing work environment will be contained,
- Additionally, a sample of 6 nurses and 5 other health care professionals' (directly involved in patients care) will be recruited to explore experiences of intervention translation within 2 focus group sessions.
The quantitative data analyses will be performed using statistical tests appropriate to the sample size, measurement level, distribution and the independence of variables. For group control appropriate tests for independent groups were used in respect to provision of necessary assumptions. Statistically significance was set on Alpha .05 with undirected hypothesis testing, if necessary correction for multiple testing will be included. Qualitative data analysis will be performed using content analysis.
We hypothesized that the NPP-group (post) will be experienced higher quality of nursing care and increased patient satisfaction, without an increase in health care costs. Secondary outcomes will be enhanced work environment for the nurses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Patient Pathways | Experimental | Procedure: Nurse-led Patient PathwaysPatients were cared for under the three NPP developed for the orthopedic populations: NPP-1) patients with total hip arthroplasty; NPP-2) exploration and decompression of the spinal cord; and NPP-3) rotator cuff reconstruction. NPP are characterized by four principles: evidence-based nursing, patient and family centred care, comprehensive discharge planning beyond hospital discharge and nurses' responsibility for patients' processes. The principles support and strengthen patient and family preferences as well as formalize nursing activities, and therefore contribute to process transparency in relation to other health care professionals. Aims: to improve patients' and health care professionals' as well as institutional outcomes. |
| Standard usual nursing care | No intervention | –Patients in the control group will receive usual nursing care, which is based on the institutional principles and standards of care for surgical patients. Based on the type of surgery and assessment of the nurse the nursing process is used to care for the patients. The nurses will be ending their activities with discharge of the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- nurses (survey and interview)
- directly involved in patients care
- give informed consent
Key exclusion criteria (3 listed)
- other health care professionals
- inclusion criteria will be not met
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 |
|---|---|---|
| Nurse-led Patient PathwaysThe NPP include a comprehensive needs and goal assessment. Patients appreciated written information provided at an early stage of their hospital stay that helped to prepare them for discharge. The NPP continue with pre- and post-operative patient care, and conclude with a newly implemented follow-up phone call after hospital discharge. Nursing interventions were presented in a checklist format, based on scientific and clinical evidence. The NPP were developed with regard to patient and family centered goals and objectives and were explicitly emphasized in the NPP. NPP guided the nursing care plan. Nurses act as advocates for patients' interests. Therefore NPPs represent a means to formalize these nursing activities and contribute to transparency in relation to other health professionals. | Procedure or surgery | Nurse-led Patient Pathways |
Primary outcome
Change in Nursing Care Index (NCI) between pre and post intervention group
Time frame: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
The NCI was used to measure the quality of nursing care. The self-developed instrument included 35 items with yes/no-answers for each item. Data will be generated from entries in the patient's electronic clinical record. The total NCI-score was calculated by computing the average value of all mean values of the subscales. NCI-scores could range between zero (lowest quality) and one (highest quality). Six subscales will be used in order to reflect the key principles of NPPs (Initial Pain Assessment, Needs and Goal Assessment, Family Centred Care, Care Planning, Post-surgical Care, Discharge Planning).
Change in Patient Satisfaction with Nursing Care Quality (PSNCQ) between pre and post intervention group
Time frame: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
The PSNCQ Questionnaire was used to measure the patient satisfaction with nursing care quality. The 19-item instrument is a validated and common used instrument in clinical settings to measure patient satisfaction. The patients evaluated key areas of nursing care during their hospital stay on a 5-point Likert in terms of whether the quality was excellent (5 points), very good, good, fair or poor (1 point). The maximum value (5) reflected a high level of satisfaction and the lowest value (1) indicated a deep dissatisfaction with the nursing performance. Data were collected using a survey mailed to the patients within the first week after discharge. For the first 84 patients in the control group survey was not possible because data collection took place more than one week after discharge.
3 secondary outcomes
Change in nursing work environment (nursing work index revised, NWI-R) between pre and post intervention group
Time frame: Data will be gathered ones for the control group close before implementation of the NPP, and ones after 8 month of implementation of NPP.
Change in nursing work environment (nursing workplace quality, NWQ) between pre and post intervention group
Time frame: Data will be gathered ones for the control group close before implementation of the NPP, and ones after 8 month of implementation of NPP.
Change in institutional-related costs (length of hospital stay, LOS; nursing time and nursing costs).
Time frame: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
Related trials for Musculoskeletal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Lorenz Imhof, Prof Dr principal investigator
Zurich University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Patient Pathways in people with Musculoskeletal Diseases, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 12 inclusion and 3 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 7 Sep 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Nursing Care Index (NCI) between pre and post intervention group (time frame: Pre-data will be gathered over an eight month period for the control group. After a 4-month break for the implementation of the NPP, the 10-month post-data collection period for the NPP-group will be started.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2015.