ACP in Older Patients With Multimorbidity: a Randomized Pilot

NCT04856202 | Unknown

• 1 other identifier: NL72101.078.20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale A recent study into the patient perspective of patients with multiple chronic conditions in the Netherlands underlines the strain multimorbidity can put on people. Most patients would appreciate more coordination from and communication with their care providers. This call for better coordination of needs and preferences ties into the concept of Advance Care Planning (ACP). ACP is a structured process of communication in which patients and physicians discuss and, if applicable, document health preferences and goals of patients regarding their last phase in life. Most ACP studies have been performed amongst older, terminally ill patients with the main aim of establishing patients' preferences before they lose capacity. We want to investigate the potential of ACP to increase patient empowerment in a population of competent patients with multimorbidity, who are not necessarily in their last phase of life. The distribution of healthcare expenditure among the population requiring care is skewed. In the Netherlands the top-10% most cost incurring patients account for 68% of expenditure. Many of these patients receive unnecessary or ineffective care, with a recent study estimating preventable spending at 10%. High-Need High-Cost patients comprise a very heterogeneous group, yet one common denominator explaining high cost is the high prevalence of multiple chronic conditions. Both overtreatment and conflicting treatment are legitimate concerns within this population. As multimorbidity and frailty increase with age, the older patient with multimorbidity is especially at risk. Targeted care programmes have been developed under the assumption that better coordination will lead to a reduction in healthcare utilization. However, although care might be identified as preventable or inefficient from a medical point of view, this is not necessarily the case from a patient perspective. We are interested how patients experience such care and thereby if better coordination would indeed lead to a reduction in utilization. Because ACP supports patients in timely recognition and better expression of their needs and preferences, we hypothesize that care will address those needs and preferences more adequately, which will result in improved patient assessment of care. We further hypothesize that patient empowerment will enable better planning of care and decision making, which can result in less unwanted or preventable interventions. As a consequence healthcare utilization might decrease. However, another possibility is that rather than leading to a decrease, improved empowerment may lead to an increase in utilization because care which is deemed superfluous from a medical perspective might not be perceived as such by patients. Objective The primary objective of our pilot study is to assess the feasibility of a formal Randomized Controlled Trial. Our secondary pilot objectives are to collect data on patient experience of healthcare, patient engagement, cost-effectiveness, and other data that might inform the design of a full-scale RCT. Study design Randomized pilot study Study population Patients over 65 years of age with polypharmacy, multimorbidity and multiple hospitalizations and/or ER admissions in the past year Intervention One of the most well-researched ACP programmes is the Respecting Choices Programme. In this programme, a trained facilitator encourages patients to reflect on their goals, values and beliefs, to discuss and document their future choices, and to appoint a surrogate decision maker. The programme was translated to the Dutch context in previous studies in the nursing home setting and oncology care. Patients randomized to receive ACP will have two meetings with a trained facilitator within two months. Main study parameters/endpoints Primary: trial-feasibility is defined as the successful inclusion of 50 patients in total, timely administration of the intervention in 25 patients, adherence to follow-up procedures and identification of problems or barriers during recruitment, inclusion, intervention administration and follow-up. Secondary: main outcome for cost-effectiveness is total duration and number of hospital admissions, as a proxy for both costs and effects (iMCQ). In order to inform a future cost-effectiveness analysis (CEA), data on health-related quality of life (EQ5D-5L) will also be collected. Our outcomes for patient assessment of care and patient empowerment are the PACIC questionnaire, the ACP Engagement Survey and the appointment of a surrogate decision maker and/or the documentation of advance directives.

Conditions

Advance Care Planning; Multimorbidity; Old Age; Debility; Health Economics; Quality of Life; Patient Empowerment; Patient Satisfaction

Keywords

ACP; Advance Care Planning; Health Economics; Quality of Life; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Number of successfully included patients

  Aim is to include 50 patients in total with a timely administration of the ACP intervention in 25

  12 months

• Number of patients in which follow-up procedures were fully adhered to

  Aim is to include 50 patients in total with a follow-up of twelve months

  12 months

• Number of problems or barriers during pilot

  Identification of problems or barriers during recruitment, inclusion, intervention administration and follow-up

  12 months

Secondary Outcomes (1)

• Patient assessment of care as assessed by Patient Assessment of Care for Chronic Conditions (PACIC)

  12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

A trained facilitator will schedule two facilitated Respecting Choices interviews with the patient and preferably, if the patient agrees, in the presence of a caregiver or relative.

Behavioral: Advance Care Planning interview

Control

NO INTERVENTION

Care as usual

Interventions

Advance Care Planning interview BEHAVIORAL

The facilitator will clarify the patients' preferences, asking specific questions regarding personal goals, including religious and cultural beliefs. The facilitator will discuss life supporting treatments that might be applicable to the patient and encourage the patient to weigh up personal benefits and burdens. Treatments may include: invasive therapy (such as chemotherapy or dialysis), hospitalization, resuscitation, ventilation, artificial nutrition or hydration and administration of antibiotics. The patient will also be encouraged to identify specific situations that are likely to improve or diminish his or her quality of life. The facilitator will assist the patient in documenting their wishes, including the assignment of a health care proxy.

Also known as: Respecting Choices interview

Intervention

Eligibility Criteria

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

You may qualify if:

• Polypharmacy (i.e. use of ≥ 5 medications for longer than six months)
• ≥ 2 hospitalizations, day clinic admissions and/or individual ER admissions in the last 12 months
• Charlson Comorbidity Index (CCI) of ≥ 5 (unadjusted for age)
• Written informed consent to participate

You may not qualify if:

• Unable to complete questionnaire or interview in Dutch
• Less than 6 months anticipated life expectancy
• Serious cognitive impairment (MMSE score \< 16)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, North Holland, 3000CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Frailty; Patient Participation; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized pilot study

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 23, 2021
• Study Start: May 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)