Frail Elderly PersonsPRIMENCT06616129
A Study Protocol for Research Investigating How Geriatric Risk Assessment and Shared Decision-making Conversations Affect Treatment Decisions and Quality of Life in Patients Eligible for Open-heart Surgery.
A study testing Geriatric assessment and Shared decision-making conversation in people with Frail Elderly Persons and Cardiac Surgery, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly Persons, Cardiac Surgery
- What is being tested?
- Geriatric assessment and Shared decision-making conversation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2022to 31 Dec 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70 years and older
- Eligible for cardiac surgery
- Having two or more risk factors: stroke; reduced cognitive function; Chronic Obstructive Pulmonary Disease (COPD); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure.
Who cannot join
- Unable to read or understand Dutch
Trial locations and contacts
1 site in 1 country.
Milou S.H. van Dieen contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, Hanzeplein 1 9713 GZ Groningen
About this study
Official title: Preoperative RIsk Assessment and Shared Decision-Making in Patients Eligible for Cardiac Surgery (PRIME-study): a Study Protocol for a Single Center Non-randomized Prospective Trial
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization.
The main questions this study aims to answer are:
- Does PRIME consultation influence treatment recommendations?
- Does a personalized treatment plan for cardiac patients influence health-related quality of life?
- Does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)?
Participants will:
- Visit the PRIME clinic once
- Complete quality of life questionnaires twice
- Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.
Read the detailed description
The primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic.
Secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (COPD) GOLD III or IV, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/L), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (CABG, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures).
Data will be collected using several questionnaires:
- Health-related Quality of Life (the RAND-36 questionnaire)
- The Katz Index of Independence in Activities of Daily Living to assess functional status
- The Cognitive Impairment Test
- The Timed Up and Go Test
- Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients, including those receiving standard care.
- Conditions
- Frail Elderly Persons, Cardiac Surgery
- Being tested
- Geriatric assessment, Shared decision-making conversation
- Keywords
- cardiothoracic surgery, decision-making, quality of life, frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessmentDiagnostic test
At the clinic further information on the somatic, social, psychological and functional domain will be gathered by the nurse and two validated tests to map the vulnerability and resilience of the patient will be used; the Cognitive Impairment Test and the timed Up and Go Test.
Shared decision-making conversationOther
The nurse and nurse practitioner together will talk with the patient and their partner about possible treatment options as well as patients' expectations, preferences and their life in general.
During the conversation the OPT (Outcome Prioritization Tool) will be used to clarify the most important goals of treatment for the patient. The OPT exists of four universal treatment goals rated on a visual analogue scale from 0 to 100. The goals represented are: life extension, maintaining independence, reducing pain and reducing other symptoms. The goals will be explained and the patient will be asked to rate each outcome according to the trade-off principle meaning that two outcomes cannot be rated equally.
| Study group | Role | What they receive |
|---|---|---|
| PRIME-Group | Experimental | Not described Receives: Diagnostic Test: Geriatric assessment; Other: Shared decision-making conversation |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic.
After the patient is referred to the UMCG, the patients situation is discussed by the heart team, resulting in a treatment recommendation, which is documented in the electronic patient record. If the patient meets the inclusion criteria for the PRIME-study, they will also be invited to the PRIME-clinic (usually within a week). The findings from the PRIME-clinic are then discussed the same day during the heart team meeting, after which a treatment recommendation is formulated again.
A difference in treatment recommendation is noted when the initial recommendation is revised, opting for a less invasive or conservative treatment instead of open-heart surgery.
Measured: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .
Secondary outcomes (2)
Health related quality of life, SF-36
Health-related quality of life is measured using the validated SF-36 questionnaire, which consists of 36 items that assess eight health dimensions: physical functioning, role limitations due to physical health issues, role limitations due to emotional problems, social functioning, emotional well-being, energy levels and fatigue, pain, and overall perceptions of general health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health. Two composite scores can be derived from these domains: the Physical Component Score and the Mental Component Score.
Measured: From enrollment to one year after
The cost-effectiveness ratio, an analysis that combines both the EQ-5D-5L (for health gains) and the Medical Cost Questionnaire (for costs)
Both the MCQ and EQ-5D-5L will be administered at 3, 6, 9, and 12 months following the PRIME-clinic visit.
The MCQ will be used to measure the healthcare utilization. This includes both direct medical costs (such as hospitalizations, medication, and treatments) as well as indirect costs (such as productivity losses). Additionally, Quality-Adjusted Life Years (QALYs) are calculated using the EQ-5D-5L, which measures health-related quality of life.
Using these data (QALYs and costs), the cost per QALY is calculated, representing the ratio between the costs of treatment and the health gains achieved. A lower cost per QALY indicates that the treatment is more cost-effective.
Measured: From enrollment to one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start4 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly PersonsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Hanze University of Applied Sciences Groningen
- Responsible party
- Sponsor
- Investigators
- Prof. dr. Mariani, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616129
- Sponsor's protocol ID
- RR number: 202100724
- Acronym
- PRIME
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the dataset available once all data has been anonymized.
Publications
Dieen MSHV, Blokzijl F, Kuijpers M, Paans W, Bayon MA, Festen S, Dieperink W, Bouma W, Rienstra M, Mariani MA. Preoperative Risk Assessment and Shared Decision-Making in Older Patients Eligible for Cardiac Surgery: Protocol for a Non-Randomized Prospective Study. Healthcare (Basel). 2026 Jun 30;14(13):1900. doi: 10.3390/healthcare14131900.
PubMed 42450909
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative RIsk Assessment and Shared Decision-Making in Patients Eligible for Cardiac Surgery (PRIME-study): a Study Protocol for a Single Center Non-randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT06616129
- Acronym / sponsor ID
- PRIME / RR number: 202100724
- Conditions
- Frail Elderly Persons, Cardiac Surgery
- Keywords
- cardiothoracic surgery, decision-making, quality of life, frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Hanze University of Applied Sciences Groningen
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization.
The main questions this study aims to answer are:
- Does PRIME consultation influence treatment recommendations?
- Does a personalized treatment plan for cardiac patients influence health-related quality of life?
- Does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)?
Participants will:
- Visit the PRIME clinic once
- Complete quality of life questionnaires twice
- Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.
Detailed description
The primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic.
Secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (COPD) GOLD III or IV, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/L), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (CABG, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures).
Data will be collected using several questionnaires:
- Health-related Quality of Life (the RAND-36 questionnaire)
- The Katz Index of Independence in Activities of Daily Living to assess functional status
- The Cognitive Impairment Test
- The Timed Up and Go Test
- Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients, including those receiving standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIME-Group | Experimental | Diagnostic Test: Geriatric assessment, Other: Shared decision-making conversation |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 70 years and older
- Eligible for cardiac surgery
- Having two or more risk factors: stroke; reduced cognitive function; Chronic Obstructive Pulmonary Disease (COPD); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure.
Key exclusion criteria (1 listed)
- Unable to read or understand Dutch
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 |
|---|---|---|
| Geriatric assessmentAt the clinic further information on the somatic, social, psychological and functional domain will be gathered by the nurse and two validated tests to map the vulnerability and resilience of the patient will be used; the Cognitive Impairment Test and the timed Up and Go Test. | Diagnostic test | PRIME-Group |
| Shared decision-making conversationThe nurse and nurse practitioner together will talk with the patient and their partner about possible treatment options as well as patients' expectations, preferences and their life in general. During the conversation the OPT (Outcome Prioritization Tool) will be used to clarify the most important goals of treatment for the patient. The OPT exists of four universal treatment goals rated on a visual analogue scale from 0 to 100. The goals represented are: life extension, maintaining independence, reducing pain and reducing other symptoms. The goals will be explained and the patient will be asked to rate each outcome according to the trade-off principle meaning that two outcomes cannot be rated equally. | Other | PRIME-Group |
Primary outcome
The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic.
Time frame: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .
After the patient is referred to the UMCG, the patients situation is discussed by the heart team, resulting in a treatment recommendation, which is documented in the electronic patient record. If the patient meets the inclusion criteria for the PRIME-study, they will also be invited to the PRIME-clinic (usually within a week). The findings from the PRIME-clinic are then discussed the same day during the heart team meeting, after which a treatment recommendation is formulated again. A difference in treatment recommendation is noted when the initial recommendation is revised, opting for a less invasive or conservative treatment instead of open-heart surgery.
2 secondary outcomes
Health related quality of life, SF-36
Time frame: From enrollment to one year after
The cost-effectiveness ratio, an analysis that combines both the EQ-5D-5L (for health gains) and the Medical Cost Questionnaire (for costs)
Time frame: From enrollment to one year after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 42450909Dieen MSHV, Blokzijl F, Kuijpers M, Paans W, Bayon MA, Festen S, Dieperink W, Bouma W, Rienstra M, Mariani MA. Preoperative Risk Assessment and Shared Decision-Making in Older Patients Eligible for Cardiac Surgery: Protocol for a Non-Randomized Prospective Study. Healthcare (Basel). 2026 Jun 30;14(13):1900. doi: 10.3390/healthcare14131900.
- Individual participant dataSharing planned: Yes. We will make the dataset available once all data has been anonymized.
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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.
Milou S.H. van Dieen contact
Prof. dr. Mariani principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric assessment and Shared decision-making conversation in people with Frail Elderly Persons and Cardiac Surgery, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dr. Fredrike Zwiers-Blokzijl (+31 50 361 56 17, f.zwiers-blokzijl@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic. (time frame: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .). 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 NCT06616129, which also lists 1 linked publication.
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 27 Sep 2024.