Decision Support on End-of-life Care Planning in Older Adults

NCT06314035 | Not Yet Recruiting

• 1 other identifier: CIC2023003
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to test the effects of a patient decision aid (PDA) on planning for end-of-life (EOL) care among older adults with COPD. The main questions it aims to answer are:

1. 1.Does a PDA improve the process of a person to make decisions on EOL care?
2. 2.Does a PDA improve the readiness of a person to join advance care planning (ACP) communication?
3. 3.Does a person make an advance directive after using a PDA?
4. 4.Be randomly assigned to one of two groups.
5. 5.In the experimental group, participants will receive two 60-minute interactive consultations over four weeks, using a PDA to help clarify values and preferences for future medical care. A guidebook summarising these future care options will be provided.
6. 6.In the control group, participants will receive two 60-minute sessions on lifestyle modification and self-care management over four weeks using a guidebook with coaching. A guidebook summarising general health information will be provided.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; advance care planning; decision aid; readiness

Outcome Measures

Primary Outcomes (1)

• Patients' decisional conflict regarding EOL care

  It will be measured using the SURE test to reflect the quality of the decision-making process. This test is derived from the Decisional Conflict Scale. It contains four items that measure uncertainty, inadequate knowledge, unclear values and inadequate support and resources. It is corresponding to the conceptual framework of this study. The response format will be dichotomous (0 = no, 1 = yes), with a higher score indicating a higher level of decisional conflict.

  Before intervention, after intervention and 3-month followup.

Secondary Outcomes (6)

• Patients' confidence level regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and medical doctors.

  Before intervention, after intervention and 3-month followup.

• Patients' readiness for ACP

  Before intervention, after intervention and 3-month followup.

• Participant's completion of an Advance Directive (AD)

  Before intervention, 3-month followup

• Participants' understanding of the PDA

  After intervention and 3-month followup.

• Participant's subjective clarity of content, comfort during reading and viewing, and the usefulness of the information of the PDA.

  After intervention and 3-month followup.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in experimental group will receive a COPD Decision Support Tool (PDA intervention).

Other: COPD Patient Decision Aid

Attention Control Placebo Group

PLACEBO COMPARATOR

Participants in the attention control placebo group will receive a general health coaching intervention. Dose and time similar to experimental group.

Other: General Health Coaching Intervention

Interventions

COPD Patient Decision Aid OTHER

Participants in this group will receive two 60-minute intervention sessions in one month. The COPD PDA consists of three main parts: The first component, clinical counselling, guides the participants in reviewing the common EOL scenarios. The second component, an evidence-based decision aid, is presented as an option grid in a booklet and a video to provide information about outcome probabilities of various treatment options and survival estimates in a balanced and unbiased manner. The information is presented in plain language for laypersons. The third component, decision coaching, introduces the concept of ACP and guides deliberation through value clarification.

Also known as: Experimental Group

Experimental Group

General Health Coaching Intervention OTHER

The participants in the control group will receive two 60-minute health coaching sessions developed by the PI for another project as an attention placebo control. Trained research personnel will use the same amount of interaction time and similar formats to avoid threats to the study's internal validity. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes. The trained research personnel will give the guidebook consisting of general self-management advice to participants in this group.

Also known as: Attention Control Placebo Group

Attention Control Placebo Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years (inclusive) or older.
• Diagnosed with Chronic Obstructive Pulmonary Disease (COPD) by a physician.
• Normal cognitive function.
• Ability to communicate in Mandarin or Cantonese.
• Willingness to participate in the study.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Chinese University of Hong Kong: collaborator

Related Publications (18)

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  BACKGROUND

• Barbetta C, Allgar V, Maddocks M, Ribeiro C, Wilcock A, Currow DC, Phillips J, Johnson MJ. Australia-modified Karnofsky Performance Scale and physical activity in COPD and lung cancer: an exploratory pooled data analysis. BMJ Support Palliat Care. 2022 Dec;12(e6):e759-e762. doi: 10.1136/bmjspcare-2019-001869. Epub 2019 Jul 11.

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jenny Lai, DN

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Lai, DN

CONTACT

02-2822-7101; chingting@ntunhs.edu.tw

Helen Chan, PhD

CONTACT

39438099; helencyl@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their group assignment. The personnel administering the interventions will not be blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 15, 2024
• Study Start: March 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share