Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244590
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2022-02-04
Brief Title:
Primary Care Consultation for Patients With Palliative Care Needs
Sponsor:
University of Coimbra
Organization:
University of Coimbra
Study Overview
Official Title:
Development and Evaluation of a Mix-method Intervention Involving Training and a New Consultation Model for Patients With Palliative Care Needs in Primary Care - Before-After Study
Status:
COMPLETED
Status Verified Date:
2023-02
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:
None
Brief Summary:
Introduction General practitioners provide health care in the community managing patients and families longitudinally and there is some evidence that when they are involved in caring for people with palliative care needs alongside specialists palliative care delivery may be more efficient The investigators aim to determine the impact of a mix-method intervention involving training in PC and a new consultation model for patients with palliative care needs in primary care
Methods and analysis A before-after study will be conducted in the centre health care region of Portugal The study will involve 53 patients with palliative care needs from the list of patients of the GPs who accept to collaborate with the project The mix-method intervention will consist of 1 training in palliative care and 2 application of a newly developed consultation model for use in the primary care setting and consisting of medical consultation every 3 weeks for a period of 12 weeks The primary outcome is physical symptom burden evaluated by the Integrated Palliative Outcome Scale IPOS patient version Secondary outcomes include psychological symptoms and communicationpractical issues IPOS number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services
Methods and analysis A before-after study will be conducted in the centre health care region of Portugal The study will involve 53 patients with palliative care needs from the list of patients of the GPs who accept to collaborate with the project The mix-method intervention will consist of 1 training in palliative care and 2 application of a newly developed consultation model for use in the primary care setting and consisting of medical consultation every 3 weeks for a period of 12 weeks The primary outcome is physical symptom burden evaluated by the Integrated Palliative Outcome Scale IPOS patient version Secondary outcomes include psychological symptoms and communicationpractical issues IPOS number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services
Detailed Description:
Study aim
The investigators aim to develop apply and evaluate a mix-method intervention involving training in PC and a new consultation model in primary care for patients with PC needs
Primary objective
To determine the impact of the intervention on the physical symptom burden for patients
Secondary objectives
To determine the impact of the intervention on
1 psychological symptoms burden
2 communicationpractical issues
3 some determinants of health care service use number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services
Study design
Before-after study
Study procedures
GPs working in the centre health care region in Portugal will be asked to collaborate with the project
GPs will receive a training program on PC built based on our previous study with GPs where the investigators identified the role of GPs in the PC setting and their training needs in PC They will also receive training on how to apply the new consultation model
Each GP will be asked to recruit patients with PC needs from their own list of patients using a protocol developed for that purpose Each patient recruited will receive a medical consultation every 3 weeks for a period of 12 weeks In both the first and last medical consultations each GP will ask patients to complete the Integrated Palliative Outcome Scale IPOS patient version
The study will integrate a pilot evaluation involving the first two patients of each GP so that the consultation model can be improved according to the collected feedback
The investigators intend to assess whether our mix-method intervention can improve the physical symptom burden of patients with PC needs after a 12-week intervention
Sample size
Sample size was calculated for the main outcome physical symptom burden measured using the IPOS considering the two time points baseline and 12 weeks after The effect of the intervention will be measured by the difference between the two means tested using t-test for paired samples A sample size of 53 patients is estimated considering a power of 80 a type I error of 5 and a medium effect size of 0513 and accommodating a 50 loss of patients at follow-up UCSF Clinical Translational Science Institute - Sample Size Calculators available at httpwwwsample-sizenet Given that the prevalence of patients with PC needs in primary care is 8 to 1434 and that in Portugal each GP has on average 1600 to 1900 patients in their list it is estimated that each GP will have around 128 patients with PC needs in their list Considering the involvement of 8-10 GPs in the study the planned sample size is feasible Included GPs will be asked to recruit patients until the planned sample size is reached around 6 patients per GP
Data collection
The following variables will be collected by the main researcher about the GPs participating in the study age sex years of clinical practice type of primary care unit in which they work environment rural or urban and previous training in PC
The following variables will be collected by each GP about the patients participating in the study using a paper form age sex education marital status rural or urban environment main diagnosis and comorbidities and IPOS patient version scores GPs will also collect by searching patients medical records number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services referring to 12-week pre intervention and 12-week post intervention A 12-week timeframe for evaluating resource use before and after the intervention was chosen to assess how these variables behaved over a period equal to that of the intervention Each form will be pseudo-anonymized by assigning a code so that only each GP will be able to identify which patient each form belongs to
Statistical analysis
Data analysis will be performed using SPSS v 27 Categorical variables will be described by frequencies absolutes and relatives Normally distributed continuous variables will be summarized by mean and standard deviation Ordinal and non-normally distributed continuous variables will be represented by median and interquartile interval The normality of the distributions will be assessed by observation of the respective QQ-plots
To compare the difference of the two moments baseline and 12 weeks after a t-test for paired samples or a Wilcoxon test will be used Statistical significance will be set at p005
The investigators aim to develop apply and evaluate a mix-method intervention involving training in PC and a new consultation model in primary care for patients with PC needs
Primary objective
To determine the impact of the intervention on the physical symptom burden for patients
Secondary objectives
To determine the impact of the intervention on
1 psychological symptoms burden
2 communicationpractical issues
3 some determinants of health care service use number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services
Study design
Before-after study
Study procedures
GPs working in the centre health care region in Portugal will be asked to collaborate with the project
GPs will receive a training program on PC built based on our previous study with GPs where the investigators identified the role of GPs in the PC setting and their training needs in PC They will also receive training on how to apply the new consultation model
Each GP will be asked to recruit patients with PC needs from their own list of patients using a protocol developed for that purpose Each patient recruited will receive a medical consultation every 3 weeks for a period of 12 weeks In both the first and last medical consultations each GP will ask patients to complete the Integrated Palliative Outcome Scale IPOS patient version
The study will integrate a pilot evaluation involving the first two patients of each GP so that the consultation model can be improved according to the collected feedback
The investigators intend to assess whether our mix-method intervention can improve the physical symptom burden of patients with PC needs after a 12-week intervention
Sample size
Sample size was calculated for the main outcome physical symptom burden measured using the IPOS considering the two time points baseline and 12 weeks after The effect of the intervention will be measured by the difference between the two means tested using t-test for paired samples A sample size of 53 patients is estimated considering a power of 80 a type I error of 5 and a medium effect size of 0513 and accommodating a 50 loss of patients at follow-up UCSF Clinical Translational Science Institute - Sample Size Calculators available at httpwwwsample-sizenet Given that the prevalence of patients with PC needs in primary care is 8 to 1434 and that in Portugal each GP has on average 1600 to 1900 patients in their list it is estimated that each GP will have around 128 patients with PC needs in their list Considering the involvement of 8-10 GPs in the study the planned sample size is feasible Included GPs will be asked to recruit patients until the planned sample size is reached around 6 patients per GP
Data collection
The following variables will be collected by the main researcher about the GPs participating in the study age sex years of clinical practice type of primary care unit in which they work environment rural or urban and previous training in PC
The following variables will be collected by each GP about the patients participating in the study using a paper form age sex education marital status rural or urban environment main diagnosis and comorbidities and IPOS patient version scores GPs will also collect by searching patients medical records number of consultations for acute disease both in the health care unit and emergency department number of hospitalizations and referrals to hospital health care services referring to 12-week pre intervention and 12-week post intervention A 12-week timeframe for evaluating resource use before and after the intervention was chosen to assess how these variables behaved over a period equal to that of the intervention Each form will be pseudo-anonymized by assigning a code so that only each GP will be able to identify which patient each form belongs to
Statistical analysis
Data analysis will be performed using SPSS v 27 Categorical variables will be described by frequencies absolutes and relatives Normally distributed continuous variables will be summarized by mean and standard deviation Ordinal and non-normally distributed continuous variables will be represented by median and interquartile interval The normality of the distributions will be assessed by observation of the respective QQ-plots
To compare the difference of the two moments baseline and 12 weeks after a t-test for paired samples or a Wilcoxon test will be used Statistical significance will be set at p005
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