Treatment results and patient satisfaction: an evaluation of care for cardiovascular disease by specialized nurses (nurse practitioners) and physicians using multiple research methods
| ISRCTN | ISRCTN18138025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18138025 |
| Sponsor | PMU Salzburg |
| Funder | Medbase AG |
- Submission date
- 14/02/2026
- Registration date
- 26/02/2026
- Last edited
- 23/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Primary care in Switzerland is facing major challenges. The population is ageing, and more people are living with chronic diseases such as heart and cardiovascular conditions. At the same time, there is a growing shortage of general practitioners. Almost half of current primary care doctors are over 55 years old, and many do not yet have a successor for their practice. To meet future healthcare needs, the number of general practitioners would need to increase significantly in the coming years.
Innovative care models may help address this problem. One such model involves specially trained nurses called Nurse Practitioners (NPs). Nurse Practitioners have advanced academic training and work closely with doctors. In many countries, they already provide safe and effective care, particularly for people with long-term conditions.
However, in Switzerland there is still limited scientific evidence directly comparing care provided by Nurse Practitioners with traditional doctor-led care. This study aims to close this gap.
The main goal of the study is to evaluate whether care provided by Nurse Practitioners for patients with chronic cardiovascular diseases is as effective and safe as usual care provided by doctors. We will compare medical outcomes, healthcare use, and patient satisfaction between the two models of care.
Who can participate?
Adults (18 years and older) who are receiving care for a chronic cardiovascular condition (such as high blood pressure, coronary heart disease or heart failure) at one of the participating Medical Centers may be eligible.
People cannot take part if they are:
Under 18 years of age
In an unstable acute medical condition (e.g. acute heart problems or severe shortness of breath)
Severely cognitively impaired or unable to give informed consent
Pregnant
Living with a terminal illness
Taking part in another clinical study at the same time
What does the study involve?
The study lasts 12 months.
Participants are randomly assigned (by computer) to one of two groups:
Nurse Practitioner group: Care is mainly provided by a Nurse Practitioner, working closely with doctors.
Standard care group: Care is provided by a doctor as usual.
Random assignment means neither the patient nor the healthcare team can choose the group.
During the 12 months, participants will attend their usual medical appointments (typically two main visits as part of routine care). No extra clinic visits are required for the study.
At these visits, we will:
Measure blood pressure, pulse, height and weight
Record laboratory results (e.g. cholesterol and kidney function), taken as part of routine care
Document the number of consultations, referrals and hospital stays
After 12 months, some participants will be invited to take part in a voluntary 30-minute telephone interview to talk about their experiences and satisfaction with care.
What are the possible benefits and risks of participating?
Possible benefits:
Participants are unlikely to receive a direct personal benefit. However, the results may help improve future care for patients with cardiovascular diseases in Switzerland.
Possible risks or disadvantages:
The study does not involve new medications or experimental treatments. All care follows established medical standards. There are no additional medical risks beyond usual primary care.
Blood tests are part of routine care and may cause minor discomfort or bruising. The optional telephone interview may take around 30 minutes and could feel slightly time-consuming.
Where is the study run from?
The study is conducted at Medbase Medical Centers in:
Eglisau (ZH)
Zurich-Wiedikon (ZH)
Winterthur (ZH)
Wil (SG)
Wattwil (SG)
The study is part of a doctoral project at Paracelsus Medical Private University (PMU), Salzburg.
When is the study starting and how long is it expected to run for?
The study is planned to start in 2026. Recruitment and follow-up are expected to continue for approximately 12 months per participant. The overall study duration is expected to be several years, including data analysis and reporting.
Who is funding the study?
The study is conducted as part of a doctoral research project by Anne-Marie Schirmer at PMU Salzburg.
There is no direct external funding. Medbase AG supports the study by providing the necessary infrastructure and access to patients within its Medical Centers.
Who is the main contact?
Anne-Marie Schirmer, Nurse Practitioner, PhD candidate
anne-marie.schirmer@stud.pmu.ac.at
annemarie.schirmer@medbase.ch
anne.schirmer95@gmail.com
Contact information
Principal investigator, Public
Greifenseestrasse 31
Zürich
8050
Switzerland
 ORCID ID |
0009-0005-0150-183X |
|---|---|
| Phone | +41 764966382 |
| anne-marie.schirmer@stud.pmu.ac.at |
Scientific
Strubergasse 21
Salzburg
5020
Austria
| Phone | +43 662 2420 |
|---|---|
| nadja.nestler@pmu.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Basic science, Health services research |
| Scientific title | Treatment outcomes and patient satisfaction in cardiovascular disease – a clinical evaluation of primary care by nurse practitioners and physicians – a mixed-methods study |
| Study objectives | |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Cardiovascular patients |
| Intervention | The research project follows an explanatory sequential mixed-method design (Creswell & Plano Clark, 2018). This means that quantitative data are collected first and subsequently deepened and explained through qualitative insights. Phase 1: Quantitative sub-study (RCT) A randomized controlled trial will be conducted over a period of 12 months. Patients with chronic cardiovascular diseases will be randomly assigned to one of two groups via software: Intervention group (NP model): Patients are primarily managed by a Nurse Practitioner. Control group (standard model): Patients remain in conventional physician-led care. Parameters assessed: Clinical outcomes: Blood pressure (systolic/diastolic), lipid levels (LDL-C), renal function (eGFR/creatinine), height, weight, BMI. Process indicators: Number of consultations (consultation frequency), frequency of referrals to cardiology, as well as number and duration of hospitalizations. Phase 2: Qualitative sub-study Subsequently, semi-structured interviews will be conducted with patients to further explore and contextualize the statistical findings. The focus will be on subjective satisfaction and the quality of the therapeutic relationship (Lincoln & Guba, 1985). |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 10/05/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Diagnosed or suspected cardiovascular disease 3. Confirmed cardiovascular diagnosis (ICD-10 I10–I15, I20–I25, I50, E78) and/or 3.1. Documented medical history and/or use of cardiovascular-related medication (e.g., antihypertensive agents, statins) and/or 3.2. Clinically justified suspicion of cardiovascular disease with an indication for cardiological evaluation, particularly in the presence of: Self-measured blood pressure values ≥ 135/85 mmHg Exertional dyspnea Stable chest tightness |
| Key exclusion criteria | 1. Unstable acute conditions (e.g., cardiac decompensation, acute angina pectoris, or dyspnea) 2. Severe cognitive impairment 3. Inability to provide informed consent 4. Terminal illness 5. Current pregnancy 6. Concurrent participation in another clinical trial 7. Age under 18 years |
| Date of first enrolment | 31/03/2026 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
23/03/2026: Ethics approval field updated.
23/02/2026: Trial's existence confirmed by swissethics
