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NCT ID: NCT04856202 Recruiting - Quality of Life Clinical Trials

ACP in Older Patients With Multimorbidity: a Randomized Pilot

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03105713 Recruiting - Surgery Clinical Trials

Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery

PASC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures. A safety checklist for patients to use has been developed and validated for use in surgical patients. In a Stepped Wedge Cluster RCT effects of patients using their own checklists to avoid preventable patient harm are examined. The project will re-use existing health and personal data collected from patient records and patient reported data as outcome measures. A consortium of all relevant stakeholders and users participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The important project partners are information and communications technology companies (Helse-Vest IKT and CheckWare service delivery), general practitioners, and national and international research partners leading in the field of patient safety, implementation science and health economics.