Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05244590 |
| Other study ID # |
2007015580 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2022 |
| Est. completion date |
February 3, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
University of Coimbra |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 communication/practical 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.
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. communication/practical 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 0.513, and accommodating a 50% loss of patients at
follow-up (UCSF Clinical & Translational Science Institute - Sample Size Calculators,
available at http://www.sample-size.net). Given that the prevalence of patients with PC needs
in primary care is 8% to 14%3,4 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
p<0.05.
