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.

NCT ID: NCT06616129

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Frail Elderly Persons; Cardiac Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PRIME-Group

Group Type: EXPERIMENTAL

Geriatric assessment

Intervention Type: DIAGNOSTIC_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 conversation

Intervention Type: OTHER

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.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Geriatric assessment

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.

Intervention Type: DIAGNOSTIC_TEST

Shared decision-making conversation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Unable to read or understand Dutch

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanze University of Applied Sciences Groningen

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. dr. Mariani

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

dr. Fredrike Zwiers-Blokzijl

Role: CONTACT

f.zwiers-blokzijl@umcg.nl

+31 50 361 56 17

Milou S.H. van Dieen

Role: CONTACT

m.s.h.van.dieen@umcg.nl

Other Identifiers

RR number: 202100724

Identifier Type: -

Identifier Source: org_study_id