Palliative CareNCT05244590
Primary Care Consultation for Patients With Palliative Care Needs
A study testing Consultation model for patients with palliative care needs in people with Palliative Care and Primary Health Care, run by University of Coimbra at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care, Primary Health Care
- What is being tested?
- Consultation model for patients with palliative care needs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Apr 2022to 3 Feb 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Refusal, at any time, to participate in the study.
- Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
- Level of disease severity requiring urgent intervention (GP clinical judgement).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- psychological symptoms burden.
- communication/practical issues.
- 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.
- Conditions
- Palliative Care, Primary Health Care
- Being tested
- Consultation model for patients with palliative care needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation model for patients with palliative care needsOther
Training in PC for GPs The training program for GPs will meet the main training needs of GPs according to our previous study and feedback from elements of the Palliative Care Study Group of the Portuguese Association of General and Family Medicine (GESPal). The training program will have a total duration of 24 hours and will consist of two modules.
Consultation model for patients Consultations will take place every 3 weeks for a total period of 12 weeks. The consultation model will be divided into five areas (Summarize clinical information, Objective symptoms' management, Assessment and coding of chronic diseases and symptoms, planning clinical approach, (other) problems/concerns) to be addressed during the assessment. The five areas were constructed to be intuitive for GPs, following the records' structure used in Portuguese primary care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | GPs' eligibility criteria
* Working in the centre health care region in Portugal.
* Authorisation of the coordinator of each GP health care unit to integrate the study.
Patients' eligibility criteria
Inclusion criteria
* Belonging to the list of patients of the recruited GPs.
* 18 years or older.
* Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V.
Exclusion Criteria
* Refusal, at any time, to participate in the study.
* Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
* Level of disease severity requiring urgent intervention (GP clinical judgement). Receives: Other: Consultation model for patients with palliative care needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
GPs enrolled will evaluate physical symptoms burden before and after the 12 week intervention.
Measured: 12 week
Secondary outcomes (3)
Impact of the intervention in patients' psychological symptoms burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
GPs enrolled will evaluate psychological symptoms burden before and after the 12 week intervention.
Measured: 12 week
Impact of the intervention in patients' communication/practical issues evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
GPs enrolled will evaluate communication/practical issues before and after the 12 week intervention.
Measured: 12 week
Impact of the intervention on 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
GPs enrolled will evaluate this variables 3 month before and 3 month after the 12 week intervention.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start27 Apr 2022
- Primary completion1 Jan 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Seiça Cardoso, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244590
- Sponsor's protocol ID
- 2007015580
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in peer-reviewed journals and presented at national and international conferences.
Publications
Seica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777.
PubMed 41612825Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epub 2024 Jan 16.
PubMed 38226491
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05244590
- Acronym / sponsor ID
- 2007015580
- Conditions
- Palliative Care, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- 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.
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.
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:
- psychological symptoms burden.
- communication/practical issues.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Consultation model for patients with palliative care needsGPs' eligibility criteria * Working in the centre health care region in Portugal. * Authorisation of the coordinator of each GP health care unit to integrate the study. Patients' eligibility criteria Inclusion criteria * Belonging to the list of patients of the recruited GPs. * 18 years or older. * Diagnosis of advanced stage neoplasm (ASN), Chronic Obstructive Pulmonary Disease (COPD) Gold III/IV, Congestive Heart Failure (CHF) NYHA III/IV, Chronic Kidney Disease (CKD) stage IV/V. Exclusion Criteria * Refusal, at any time, to participate in the study. * Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score). * Level of disease severity requiring urgent intervention (GP clinical judgement). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Refusal, at any time, to participate in the study.
- Level of understanding or execution that compromises taking part in the study and answering the IPOS patient version (evaluated using Mini Mental State Examination score).
- Level of disease severity requiring urgent intervention (GP clinical judgement).
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 |
|---|---|---|
| Consultation model for patients with palliative care needsTraining in PC for GPs The training program for GPs will meet the main training needs of GPs according to our previous study and feedback from elements of the Palliative Care Study Group of the Portuguese Association of General and Family Medicine (GESPal). The training program will have a total duration of 24 hours and will consist of two modules. Consultation model for patients Consultations will take place every 3 weeks for a total period of 12 weeks. The consultation model will be divided into five areas (Summarize clinical information, Objective symptoms' management, Assessment and coding of chronic diseases and symptoms, planning clinical approach, (other) problems/concerns) to be addressed during the assessment. The five areas were constructed to be intuitive for GPs, following the records' structure used in Portuguese primary care. | Other | Intervention |
Primary outcome
Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
Time frame: 12 week
GPs enrolled will evaluate physical symptoms burden before and after the 12 week intervention.
3 secondary outcomes
Impact of the intervention in patients' psychological symptoms burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
Time frame: 12 week
Impact of the intervention in patients' communication/practical issues evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores
Time frame: 12 week
Impact of the intervention on 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
Time frame: 12 week
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 14 Feb 2023.
- Derived from this study: PubMed 41612825Seica Cardoso C, Prazeres F, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Gomes B. Impact of a complex intervention in primary care for patients with palliative care needs in their healthcare utilization: a before-after study. Prim Health Care Res Dev. 2026 Jan 30;27:e15. doi: 10.1017/S1463423625100777.
- Derived from this study: PubMed 38226491Seica Cardoso C, Prazeres F, Oliveiros B, Nunes C, Simoes P, Aires C, Rita P, Penetra J, Lopes P, Alcobia S, Baptista S, Venancio C, Gomes B. Feasibility and effectiveness of a two-tiered intervention involving training and a new consultation model for patients with palliative care needs in primary care: A before-after study. Palliat Med. 2024 Sep;38(8):842-852. doi: 10.1177/02692163231219682. Epub 2024 Jan 16.
- Individual participant dataSharing planned: Yes. Results will be published in peer-reviewed journals and presented at national and international conferences.
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation model for patients with palliative care needs in people with Palliative Care and Primary Health Care, run by University of Coimbra at 1 site in Portugal.
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 0 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 14 Feb 2023. 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 Portugal. 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?
Impact of the intervention in patients' physical symptom burden evaluated using Integrated Palliative Outcome Scale (IPOS) - patient version's mean scores (time frame: 12 week). 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 NCT05244590, 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 14 Feb 2023.