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.

NCT06616129 | Recruiting

• 1 other identifier: RR number: 202100724
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Persons; Cardiac Surgery

Keywords

cardiothoracic surgery; decision-making; quality of life; frailty

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  From enrollment to one year after

Study Arms (2)

PRIME-Group

EXPERIMENTAL

Diagnostic Test: Geriatric assessment; Other: Shared decision-making conversation

Control Group

NO INTERVENTION

Interventions

Geriatric assessment 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.

PRIME-Group

Shared decision-making conversation 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.

PRIME-Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to read or understand Dutch

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Hanze University of Applied Sciences Groningen: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, Hanzeplein 1 9713 GZ Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. dr. Mariani

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr. Fredrike Zwiers-Blokzijl

CONTACT

+31 50 361 56 17; f.zwiers-blokzijl@umcg.nl

Milou S.H. van Dieen

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: April 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will be made available after it has been published.
• Access Criteria: The data will be available on reasonable request.

Locations

NL (1)