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. (PRIME)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Frail Elderly Persons
• Intervention / Treatment: Diagnostic test: Geriatric assessment; Other: Shared decision-making conversation

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dr. Fredrike Zwiers-Blokzijl; Phone Number: +31 50 361 56 17; Email: f.zwiers-blokzijl@umcg.nl
• Study Contact Backup: Name: Milou S.H. van Dieen; Email: m.s.h.van.dieen@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, Hanzeplein 1 9713 GZ Groningen
    • Recruiting
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: PRIME-Group	Diagnostic test: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to one year after

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Hanze University of Applied Sciences Groningen
• Investigators: Principal Investigator: Prof. dr. Mariani, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; frailty; cardiothoracic surgery; decision-making
• Other Study ID Numbers: RR number: 202100724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make the dataset available once all data has been anonymized.
• IPD Sharing Time Frame: The protocol will be made available after it has been published.
• IPD Sharing Access Criteria: The data will be available on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No