Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03830190
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2018-12-20
Brief Title:
Cost-effectiveness of Nursing Interventions for Patients With PD
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Cost-Effectiveness of Specialized Nursing Interventions for Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE-PD
Brief Summary:
Background Current guidelines recommend that every person with Parkinsons disease PD should have access to Parkinsons Disease Nurse Specialist PDNS care Thus hospitals increasingly offer PDNS care to their patients with PD However there is currently little scientific evidence on the cost-effectiveness of PDNS care Consequently many hospitals lack the nursing capacity to offer PDNS care to all patients which creates unequal access to care and possibly avoidable disability and costs
Objective The investigators aim to study the cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages To gain more insight into the used interventions and their effects a subgroup analysis will be performed based on disease duration diagnosis made 5 5-10 or 10 years ago
Methods The investigators will perform an 18-month single-blind randomized controlled clinical trial in eight community hospitals in the Netherlands A total of 240 people with idiopathic PD that have not been treated by a PDNS over the past two years will be included independent of disease severity or duration In each hospital 30 patients will randomly be allocated in a 11 ratio to either PDNS care according to the Dutch Guideline on PDNS care or no nursing intervention continuing usual care For the allocation of participants a computer-generated list of random numbers will be used The co-primary outcome measures are Quality of Life QoL and motor symptoms Secondary outcomes include PD symptoms mobility non-motor symptoms health-related quality of life experienced quality of care self-management medication adherence caregiver quality of life coping skills and caregiver burden Data will be collected after 12 months and 18 months A healthcare utilization and productivity loss questionnaire will be completed every 3 months by both the patient and the caregiver
Hypothesis The investigators hypothesize that by offering more patients access to PDNS care QoL will increase with equal healthcare costs Increasing direct medical costs for nurse staffing will be offset by a reduced number of consultations with the general practitioner and neurologist If these outcomes are reached wide implementation of PDNS care is needed
Objective The investigators aim to study the cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages To gain more insight into the used interventions and their effects a subgroup analysis will be performed based on disease duration diagnosis made 5 5-10 or 10 years ago
Methods The investigators will perform an 18-month single-blind randomized controlled clinical trial in eight community hospitals in the Netherlands A total of 240 people with idiopathic PD that have not been treated by a PDNS over the past two years will be included independent of disease severity or duration In each hospital 30 patients will randomly be allocated in a 11 ratio to either PDNS care according to the Dutch Guideline on PDNS care or no nursing intervention continuing usual care For the allocation of participants a computer-generated list of random numbers will be used The co-primary outcome measures are Quality of Life QoL and motor symptoms Secondary outcomes include PD symptoms mobility non-motor symptoms health-related quality of life experienced quality of care self-management medication adherence caregiver quality of life coping skills and caregiver burden Data will be collected after 12 months and 18 months A healthcare utilization and productivity loss questionnaire will be completed every 3 months by both the patient and the caregiver
Hypothesis The investigators hypothesize that by offering more patients access to PDNS care QoL will increase with equal healthcare costs Increasing direct medical costs for nurse staffing will be offset by a reduced number of consultations with the general practitioner and neurologist If these outcomes are reached wide implementation of PDNS care is needed
Detailed Description:
1 Background The Parkinsons Disease Nurse Specialist PDNS can fulfill a pivotal role in the multidisciplinary team of people with PD The PDNS was introduced in 1989 in the United Kingdom to bridge the gap between medical management and the unique personal needs of patients To obtain greater uniformity in care delivery by a PDNS and to facilitate the efficacy of nursing care in PD the Dutch Guideline Nursing care in Parkinsons disease was published in 2016 The main roles of the PDNS are clearly described in the Guideline and include 1 providing information education and instruction 2 supporting the patient and caregiver in the promotion of self-management 3 supporting psychosocial care questions 4 prevention 5 specialized diagnostic strategies and therapeutic nursing interventions and 6 multidisciplinary collaboration
Based on expert opinion from healthcare professionals the Dutch guideline advises that every person with PD could benefit from PDNS care including those in early-stage disease where delivery of information education about medication compliance and support in self-management are critical So far only three studies have evaluated PDNS care and they have found inconsistent results Overall they indicate that PDNS care may improve patient wellbeing physical functioning and general health status and reduce anxiety and depression but definite conclusions could not be drawn Moreover there is little evidence that shows that quality of life actually improves with PDNS care and to date no studies have been performed that evaluated the cost-effectiveness of PDNS care
Currently most hospitals in The Netherlands offer PDNS care since it is advised in the Dutch Multidisciplinary Guideline However many centers still lack the nursing capacity to offer PDNS care to all patients because the scientific evidence is inconclusive This situation creates an undesirable inequality in access to care and presumably leads to avoidable disability and costs eg from early admissions to nursing homes or crisis admissions to the hospital Therefore the investigators aim to study the cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD
2 Study design The NICE-PD study is an 18-month single-blind randomized controlled clinical trial that will be performed in eight community hospitals in the Netherlands A total of 240 people with PD will be included 120 in each group and equally distributed over the participating hospitals The investigators have selected hospitals where due to lack of sufficient PDNS staff only a proportion of PD patients currently has access to PDNS care This provides the investigators with a unique opportunity to identify patients who at present have no access to PDNS care and to randomize them within hospitals at the patient level between PDNS care and no nursing intervention
Eligible patients will be allocated randomly to either PDNS care or usual care in a 11 ratio using a computer-generated list of random numbers To ascertain an equal representation of patients the investigators will stratify for disease duration according to pre-defined subgroups ie disease duration 5 years 5-10 years and 10 years The PDNS intervention will be carried out according to the Dutch Guideline Nursing care in PD A blinded researcher will perform the clinical assessments at baseline t0 after 12 months t1 and after 18 months t2 Patients and caregivers will also be asked to complete a set of questionnaires at t0 t1 and t2 Finally every three months patients and their caregivers will complete an online questionnaire about healthcare utilization costs and productivity loss
3 Intervention
The PDNS intervention will be performed according to the Dutch Guideline Nursing care in PD published in 2015 The intervention is not standardized but tailored to the patients and caregivers needs This includes the following
Assessment of individual care needs of people with PD and their caregivers The PDNS performs a specific nursing assessment related to the medical physical psychological and social domains
Development of a patient-centered treatment plan that supports the patient and caregiver in self-management The PDNS composes a multidisciplinary plan based on the results of the individual assessment and as prioritized by the patient and caregiver shared decision making The treatment plan is developed according to the national self-management framework
Specific nursing interventions The intervention varies across disease stages and is tailored to the specific problems and needs of individual patients and their caregivers The Guideline on PDNS care describes general- and specific nursing interventions General interventions consist of providing information and education disease management eg considering advanced treatment options such as DBS and monitoring eg of caregiver burden Specific nursing interventions are described for the following areas mental functions fatigue sleep urogenital functions sexuality medication adherence orthostatic hypotension caregiver burden coping mobility self-management and dietary issues table 2 provides examples of such interventions
Collaboration with other healthcare professionals The PDNS stimulates and supports multidisciplinary collaboration between healthcare professionals based on the individual patient-centered treatment plan The PDNS also plays a pivotal role in the timely referral to other healthcare professionals
The PDNS will keep a pre-defined electronic study report according to a structured format for each PD patient documenting the individual care needs present symptoms performed interventions and changes in the individual care plan This report will be started at the initial assessment and updated at every follow-up contact with the patient eg at the outpatient clinic during a telephone consultation or at a home visit This data will be purposefully collected for a possible process analysis at the end of the study
Patients will have regular contact with their PDNS about the progress and realization of the personal goals both during face-to-face contacts and by telephone and sometimes during additional home visits The frequency and type of contact will be optimized for each patient depending on disease stage and individual patient needs The Guideline on PDNS care advises that each patient has a minimum of one contact with the PDNS each year Currently in the Netherlands patients are seen on average twice a year by their PDNS with an additional two interim telephone consultations per year
The control group will receive ongoing usual care which is otherwise comparable but without a nursing intervention This involves regular consultations with a neurologist in their own community hospital typically 2-4 times per year depending on patient preferences and health status In addition control patients will have no other restrictions considering any other medical treatments eg by a psychologist or social worker Importantly many important elements of care including in particular the treating neurologist remain comparable between the two intervention arms because of the randomization at patient level within hospitals
4 Clinical assessments At baseline t1 and t2 all patients will visit their own hospital for the study assessments which are performed by a blinded researcher PDQ-39 MDS-UPDRS and TUG Furthermore the patients and their caregivers will complete additional home questionnaires In addition every three months patients will receive a questionnaire at home regarding healthcare utilization costs and productivity loss over the past three months Caregivers will complete a cost questionnaire including healthcare utilization costs and productivity loss specifically related to caregiver burden Patients can choose if they want to fill out digital or paper questionnaires
5 Data analysis The economic evaluation investigates alongside the clinical trial the value for money of full implementation of the PDNS into PD care from a societal and healthcare perspective The investigators will take all relevant costs into account The cost-effectiveness timeframe adheres to the clinical study protocol and evaluates cost-effectiveness up to 18 months after randomization Cost will be measured using a healthcare utilization questionnaire eg including medical consultations hospital admissions medication travel costs etc and a questionnaire measuring productivity loss while working of both patients and caregivers Per item of healthcare consumption standard cost-prices will be determined using the guideline for performing economic evaluations If standardized prices are not available full cost prices will be determined using activity based costing Costs will be analyzed using a mixed model approach or a general linear model approach with a gamma distribution using a log link to account for possible skewness of the cost data
The investigators will use a PD-specific quality of life measure PDQ-39 and a generic health-related quality of life scale EQ5D to evaluate the quality of the health status of patients The potential difference in Quality-Adjusted Life Years QALYs measured with the EQ5D will be analyzed with a regression approach The investigators will use a linear mixed model with repeated measurements to test for differences in quality of life measured with the PDQ-39 between both groups The same analysis will be used to measure differences between groups in the secondary outcome measures The investigators will include study center as a random effect and fixed effects for group time and the interaction between group and time Each of the outcomes will be included as dependent variable Statistical analyses will be performed based on the intention-to-treat principle
Besides the overall cost-effectiveness evaluation the investigators will perform a pre-planned subgroup analysis based on disease duration diagnosis made 5 years 5-10 years or 10 years ago to obtain more insight into the nursing interventions used in each disease stage and the effects of PDNS care in these different groups of patients This subgroup analysis will be performed because for example for the more severely affected patients the nursing intervention is expected to become more intensive and possibly more effective but also more expensive When different patterns of this kind are found this should be investigated further in future trials that are powered adequately to address such group differences
6 Discussion The investigators hypothesize that offering PDNS care will lead to higher quality of life with equal healthcare costs Increasing direct medical costs for nurse staffing are expected to be offset by a reduced number of telephone consultations with the general practitioner and neurologist These short-term goals are the focus of the present NICE-PD proposal In addition to the short-term effects the investigators also expect long-term benefits which are out of scope of the present project Examples of potential long-term benefits include a reduction in the number of nursing home admissions and fewer emergency visits to the hospital which would lead to a substantial cost reduction
In conclusion this study will generate new insights into the cost-effectiveness of specialized PD nursing interventions for people with PD If positive results are found a large shift in the organization of PD care is needed to warrant equal access to PDNS care for every person with PD
Based on expert opinion from healthcare professionals the Dutch guideline advises that every person with PD could benefit from PDNS care including those in early-stage disease where delivery of information education about medication compliance and support in self-management are critical So far only three studies have evaluated PDNS care and they have found inconsistent results Overall they indicate that PDNS care may improve patient wellbeing physical functioning and general health status and reduce anxiety and depression but definite conclusions could not be drawn Moreover there is little evidence that shows that quality of life actually improves with PDNS care and to date no studies have been performed that evaluated the cost-effectiveness of PDNS care
Currently most hospitals in The Netherlands offer PDNS care since it is advised in the Dutch Multidisciplinary Guideline However many centers still lack the nursing capacity to offer PDNS care to all patients because the scientific evidence is inconclusive This situation creates an undesirable inequality in access to care and presumably leads to avoidable disability and costs eg from early admissions to nursing homes or crisis admissions to the hospital Therefore the investigators aim to study the cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD
2 Study design The NICE-PD study is an 18-month single-blind randomized controlled clinical trial that will be performed in eight community hospitals in the Netherlands A total of 240 people with PD will be included 120 in each group and equally distributed over the participating hospitals The investigators have selected hospitals where due to lack of sufficient PDNS staff only a proportion of PD patients currently has access to PDNS care This provides the investigators with a unique opportunity to identify patients who at present have no access to PDNS care and to randomize them within hospitals at the patient level between PDNS care and no nursing intervention
Eligible patients will be allocated randomly to either PDNS care or usual care in a 11 ratio using a computer-generated list of random numbers To ascertain an equal representation of patients the investigators will stratify for disease duration according to pre-defined subgroups ie disease duration 5 years 5-10 years and 10 years The PDNS intervention will be carried out according to the Dutch Guideline Nursing care in PD A blinded researcher will perform the clinical assessments at baseline t0 after 12 months t1 and after 18 months t2 Patients and caregivers will also be asked to complete a set of questionnaires at t0 t1 and t2 Finally every three months patients and their caregivers will complete an online questionnaire about healthcare utilization costs and productivity loss
3 Intervention
The PDNS intervention will be performed according to the Dutch Guideline Nursing care in PD published in 2015 The intervention is not standardized but tailored to the patients and caregivers needs This includes the following
Assessment of individual care needs of people with PD and their caregivers The PDNS performs a specific nursing assessment related to the medical physical psychological and social domains
Development of a patient-centered treatment plan that supports the patient and caregiver in self-management The PDNS composes a multidisciplinary plan based on the results of the individual assessment and as prioritized by the patient and caregiver shared decision making The treatment plan is developed according to the national self-management framework
Specific nursing interventions The intervention varies across disease stages and is tailored to the specific problems and needs of individual patients and their caregivers The Guideline on PDNS care describes general- and specific nursing interventions General interventions consist of providing information and education disease management eg considering advanced treatment options such as DBS and monitoring eg of caregiver burden Specific nursing interventions are described for the following areas mental functions fatigue sleep urogenital functions sexuality medication adherence orthostatic hypotension caregiver burden coping mobility self-management and dietary issues table 2 provides examples of such interventions
Collaboration with other healthcare professionals The PDNS stimulates and supports multidisciplinary collaboration between healthcare professionals based on the individual patient-centered treatment plan The PDNS also plays a pivotal role in the timely referral to other healthcare professionals
The PDNS will keep a pre-defined electronic study report according to a structured format for each PD patient documenting the individual care needs present symptoms performed interventions and changes in the individual care plan This report will be started at the initial assessment and updated at every follow-up contact with the patient eg at the outpatient clinic during a telephone consultation or at a home visit This data will be purposefully collected for a possible process analysis at the end of the study
Patients will have regular contact with their PDNS about the progress and realization of the personal goals both during face-to-face contacts and by telephone and sometimes during additional home visits The frequency and type of contact will be optimized for each patient depending on disease stage and individual patient needs The Guideline on PDNS care advises that each patient has a minimum of one contact with the PDNS each year Currently in the Netherlands patients are seen on average twice a year by their PDNS with an additional two interim telephone consultations per year
The control group will receive ongoing usual care which is otherwise comparable but without a nursing intervention This involves regular consultations with a neurologist in their own community hospital typically 2-4 times per year depending on patient preferences and health status In addition control patients will have no other restrictions considering any other medical treatments eg by a psychologist or social worker Importantly many important elements of care including in particular the treating neurologist remain comparable between the two intervention arms because of the randomization at patient level within hospitals
4 Clinical assessments At baseline t1 and t2 all patients will visit their own hospital for the study assessments which are performed by a blinded researcher PDQ-39 MDS-UPDRS and TUG Furthermore the patients and their caregivers will complete additional home questionnaires In addition every three months patients will receive a questionnaire at home regarding healthcare utilization costs and productivity loss over the past three months Caregivers will complete a cost questionnaire including healthcare utilization costs and productivity loss specifically related to caregiver burden Patients can choose if they want to fill out digital or paper questionnaires
5 Data analysis The economic evaluation investigates alongside the clinical trial the value for money of full implementation of the PDNS into PD care from a societal and healthcare perspective The investigators will take all relevant costs into account The cost-effectiveness timeframe adheres to the clinical study protocol and evaluates cost-effectiveness up to 18 months after randomization Cost will be measured using a healthcare utilization questionnaire eg including medical consultations hospital admissions medication travel costs etc and a questionnaire measuring productivity loss while working of both patients and caregivers Per item of healthcare consumption standard cost-prices will be determined using the guideline for performing economic evaluations If standardized prices are not available full cost prices will be determined using activity based costing Costs will be analyzed using a mixed model approach or a general linear model approach with a gamma distribution using a log link to account for possible skewness of the cost data
The investigators will use a PD-specific quality of life measure PDQ-39 and a generic health-related quality of life scale EQ5D to evaluate the quality of the health status of patients The potential difference in Quality-Adjusted Life Years QALYs measured with the EQ5D will be analyzed with a regression approach The investigators will use a linear mixed model with repeated measurements to test for differences in quality of life measured with the PDQ-39 between both groups The same analysis will be used to measure differences between groups in the secondary outcome measures The investigators will include study center as a random effect and fixed effects for group time and the interaction between group and time Each of the outcomes will be included as dependent variable Statistical analyses will be performed based on the intention-to-treat principle
Besides the overall cost-effectiveness evaluation the investigators will perform a pre-planned subgroup analysis based on disease duration diagnosis made 5 years 5-10 years or 10 years ago to obtain more insight into the nursing interventions used in each disease stage and the effects of PDNS care in these different groups of patients This subgroup analysis will be performed because for example for the more severely affected patients the nursing intervention is expected to become more intensive and possibly more effective but also more expensive When different patterns of this kind are found this should be investigated further in future trials that are powered adequately to address such group differences
6 Discussion The investigators hypothesize that offering PDNS care will lead to higher quality of life with equal healthcare costs Increasing direct medical costs for nurse staffing are expected to be offset by a reduced number of telephone consultations with the general practitioner and neurologist These short-term goals are the focus of the present NICE-PD proposal In addition to the short-term effects the investigators also expect long-term benefits which are out of scope of the present project Examples of potential long-term benefits include a reduction in the number of nursing home admissions and fewer emergency visits to the hospital which would lead to a substantial cost reduction
In conclusion this study will generate new insights into the cost-effectiveness of specialized PD nursing interventions for people with PD If positive results are found a large shift in the organization of PD care is needed to warrant equal access to PDNS care for every person with PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None