Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-03
Brief Title:
Decision Support on End-of-life Care Planning in Older Adults
Sponsor:
National Taipei University of Nursing and Health Sciences
Organization:
National Taipei University of Nursing and Health Sciences
Study Overview
Official Title:
Effects of a Decision Support Intervention on End-of-life Care Planning in Chinese Older Adults With Advanced Disease and Their Family Members A Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Does a PDA improve the process of a person to make decisions on EOL care
2 Does a PDA improve the readiness of a person to join advance care planning ACP communication
3 Does a person make an advance directive after using a PDA
Participants in this study will
1 Be randomly assigned to one of two groups
2 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
3 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
Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care the readiness of a person to join ACP communication and the chance to make an advance directive
1 Does a PDA improve the process of a person to make decisions on EOL care
2 Does a PDA improve the readiness of a person to join advance care planning ACP communication
3 Does a person make an advance directive after using a PDA
Participants in this study will
1 Be randomly assigned to one of two groups
2 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
3 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
Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care the readiness of a person to join ACP communication and the chance to make an advance directive
Detailed Description:
I Research Background
Chronic Obstructive Pulmonary Disease COPD is a progressive life-limiting condition and one of the leading causes of death globally and locallyMacPherson et al 2013 Patients with COPD experience increasing symptom burden as the disease progresses resulting in repeated episodes of exacerbation and hospital admissionsSapey Stockley 2006 However they and their family members are generally unprepared for the health changes and the perceived sudden changes often lead to care incongruent with patients preferences compromised quality of life and mistrust towards the healthcare team Despite the projected disease progression interventions or mechanisms to discuss end-of-life EOL care have not been systematically introduced in the management of COPD Momen et al 2012
Advance care planning ACP aims to support people to plan for EOL and communicate their care wishes with family and the healthcare team before they lose mental capacity Rietjens et al 2017 ACP is gaining increased attention from the public However studies have shown that patients and their family members were unprepared for ACP due to unrealistic expectations towards medical treatments and cultural taboos of discussing death-related issuesChan et al 2018 Cheng et al 2019 Conventional ACP interventions have positive but limited effects on empowering patients or EOL care decision-making Studies reporting the effects of ACP on patients readiness decisional conflict and the concordance between care preferences and the EOL care provided are mixed Bravo et al 2016 Cohen et al 2019 Michael et al 2022
Decision aids have been developed as tools to support patients in making informed and preference-sensitive treatment decisions with some explicitly for ACPCardona-Morrell et al 2017 Elwyn et al 2006 A Cochrane review found that decision aids are effective in reducing decisional conflict clarifying personal values increasing decision-making behaviours and improving patient-doctor communicationStacey et al 2017 However the effects of a locally-adapted disease-specific decision aid for COPD on decision-making are lacking
II Research Objectives
This study aims to assess the effectiveness of PDA in improving the understanding of ACP and EOL medical care among individuals diagnosed with Chronic COPD The specific research objectives are as follows
1 Assess the practicality of implementing PDAs for individuals with COPD
2 Evaluate the thoroughness with which PDA address the needs of COPD patients
3 Determine COPD patients acceptance of PDA
4 Assess the practicality of the research measurement tools
5 Evaluate the effectiveness of strategies for recruiting participants
6 Examine participant completion rates and analyse dropout causes
7 Explore the experiences of participants using the PDA
III Research Methodology
I Research Design
This 12-month study adopts a mixed-methods approach incorporating the following procedures
1 Quantitative Survey We will conduct a single-blinded randomised controlled trial RCT to assess the interventions efficacy and impact systematically
2 Qualitative Interviews Semi-structured interviews will gather detailed insights into participants experiences and perceptions regarding ACP EOL treatment and their interactions with the PDA
II Study Population Location and Sample Size
1 Location The study targets individuals diagnosed with Chronic Obstructive Pulmonary Disease COPD in the northern community of Taiwan Recruitment will occur across various settings including community care points nursing homes and neighbourhood activity centres
2 Sample Size We have determined the required sample size for this study based on prior research conducted by our team on severe disease patients and their families concerning ACP in community settings Chan et al 2018 The primary objective is to evaluate decisional conflicts regarding EOL care measured through SURE test scores with effect sizes Cohens d of 026 and 047 at one and six months respectively Chan et al 2018 Factoring in a 35 dropout rate as observed in our previous ACP studies Bell et al 2018 Chan et al 2018 Julious 2005 and using the empirical rule the study necessitates 120 participants equating to 60 individuals per group
3 Subject Recruitment The research team will partner with community care points nursing homes and neighbourhood activity centres in the northern region of Taiwan The Principal Investigator PI will obtain approval from the leaders of these facilities to conduct the study and to place recruitment posters Social workers or nurses at these community centres will initially screen for eligibility and manage the registration process
III Informed consent randomisation and blinding
1 Informed Consent Trained research personnel will evaluate participants eligibility according to the inclusion criteria Before any intervention the research team will explain the informed consent form to the participants ensuring they fully understand its contents Following this the team will ask participants to sign the consent form
2 Randomisation and Blinding This study will adopt a single-blind random allocation approach Before the commencement of the research activities a computer-generated randomisation process will allocate participants to either the experimental or control group A designated individual Personnel C who will have no involvement in the recruitment or the delivery of interventions will manage this allocation process The allocation outcomes will be sealed in envelopes strictly accessible only to the research team Trained research personnel A will administer the experimental interventions Trained research personnel B will administer the control interventions Trained Research Personnel who administer the interventions will not be blind to the participants group assignments Participants will be blinded regarding their group allocation to maintain the studys integrity
IV Data collection
1 Demographic and past medical history at baseline Demographic data including age sex education marital status religious beliefs and living status of the patients and their family carers will be collected Charlson Comorbidity Index will be used to quantify comorbidity and the Australia-modified Karnofsky Performance Scale will be used to assess the patients functional ability Barbetta et al 2019
2 The outcomes will be measured using Chinese validated instruments at baseline 1 and 3 months post-allocation The repeated-measure design will enable us to examine the short- and long-term intervention effects
V Data Analysis
1 Quantitative data analysis will be conducted using will be conducted using SPSS 260 IBM Armonk NY USA for statistical analysis Descriptive statistical methods will summarise the characteristics of participants and study outcomes One-way between-group ANOVA will be employed to compare the differences in continuous outcomes between the two study groups The significance level will be set at 005
2 Qualitative data analysis will be conducted using thematic and content analysis methods Recordings from qualitative interviews will be transcribed verbatim coded and analysed Qualitative findings will be compared and integrated with the quantitative survey results to provide a more comprehensive research conclusion
Chronic Obstructive Pulmonary Disease COPD is a progressive life-limiting condition and one of the leading causes of death globally and locallyMacPherson et al 2013 Patients with COPD experience increasing symptom burden as the disease progresses resulting in repeated episodes of exacerbation and hospital admissionsSapey Stockley 2006 However they and their family members are generally unprepared for the health changes and the perceived sudden changes often lead to care incongruent with patients preferences compromised quality of life and mistrust towards the healthcare team Despite the projected disease progression interventions or mechanisms to discuss end-of-life EOL care have not been systematically introduced in the management of COPD Momen et al 2012
Advance care planning ACP aims to support people to plan for EOL and communicate their care wishes with family and the healthcare team before they lose mental capacity Rietjens et al 2017 ACP is gaining increased attention from the public However studies have shown that patients and their family members were unprepared for ACP due to unrealistic expectations towards medical treatments and cultural taboos of discussing death-related issuesChan et al 2018 Cheng et al 2019 Conventional ACP interventions have positive but limited effects on empowering patients or EOL care decision-making Studies reporting the effects of ACP on patients readiness decisional conflict and the concordance between care preferences and the EOL care provided are mixed Bravo et al 2016 Cohen et al 2019 Michael et al 2022
Decision aids have been developed as tools to support patients in making informed and preference-sensitive treatment decisions with some explicitly for ACPCardona-Morrell et al 2017 Elwyn et al 2006 A Cochrane review found that decision aids are effective in reducing decisional conflict clarifying personal values increasing decision-making behaviours and improving patient-doctor communicationStacey et al 2017 However the effects of a locally-adapted disease-specific decision aid for COPD on decision-making are lacking
II Research Objectives
This study aims to assess the effectiveness of PDA in improving the understanding of ACP and EOL medical care among individuals diagnosed with Chronic COPD The specific research objectives are as follows
1 Assess the practicality of implementing PDAs for individuals with COPD
2 Evaluate the thoroughness with which PDA address the needs of COPD patients
3 Determine COPD patients acceptance of PDA
4 Assess the practicality of the research measurement tools
5 Evaluate the effectiveness of strategies for recruiting participants
6 Examine participant completion rates and analyse dropout causes
7 Explore the experiences of participants using the PDA
III Research Methodology
I Research Design
This 12-month study adopts a mixed-methods approach incorporating the following procedures
1 Quantitative Survey We will conduct a single-blinded randomised controlled trial RCT to assess the interventions efficacy and impact systematically
2 Qualitative Interviews Semi-structured interviews will gather detailed insights into participants experiences and perceptions regarding ACP EOL treatment and their interactions with the PDA
II Study Population Location and Sample Size
1 Location The study targets individuals diagnosed with Chronic Obstructive Pulmonary Disease COPD in the northern community of Taiwan Recruitment will occur across various settings including community care points nursing homes and neighbourhood activity centres
2 Sample Size We have determined the required sample size for this study based on prior research conducted by our team on severe disease patients and their families concerning ACP in community settings Chan et al 2018 The primary objective is to evaluate decisional conflicts regarding EOL care measured through SURE test scores with effect sizes Cohens d of 026 and 047 at one and six months respectively Chan et al 2018 Factoring in a 35 dropout rate as observed in our previous ACP studies Bell et al 2018 Chan et al 2018 Julious 2005 and using the empirical rule the study necessitates 120 participants equating to 60 individuals per group
3 Subject Recruitment The research team will partner with community care points nursing homes and neighbourhood activity centres in the northern region of Taiwan The Principal Investigator PI will obtain approval from the leaders of these facilities to conduct the study and to place recruitment posters Social workers or nurses at these community centres will initially screen for eligibility and manage the registration process
III Informed consent randomisation and blinding
1 Informed Consent Trained research personnel will evaluate participants eligibility according to the inclusion criteria Before any intervention the research team will explain the informed consent form to the participants ensuring they fully understand its contents Following this the team will ask participants to sign the consent form
2 Randomisation and Blinding This study will adopt a single-blind random allocation approach Before the commencement of the research activities a computer-generated randomisation process will allocate participants to either the experimental or control group A designated individual Personnel C who will have no involvement in the recruitment or the delivery of interventions will manage this allocation process The allocation outcomes will be sealed in envelopes strictly accessible only to the research team Trained research personnel A will administer the experimental interventions Trained research personnel B will administer the control interventions Trained Research Personnel who administer the interventions will not be blind to the participants group assignments Participants will be blinded regarding their group allocation to maintain the studys integrity
IV Data collection
1 Demographic and past medical history at baseline Demographic data including age sex education marital status religious beliefs and living status of the patients and their family carers will be collected Charlson Comorbidity Index will be used to quantify comorbidity and the Australia-modified Karnofsky Performance Scale will be used to assess the patients functional ability Barbetta et al 2019
2 The outcomes will be measured using Chinese validated instruments at baseline 1 and 3 months post-allocation The repeated-measure design will enable us to examine the short- and long-term intervention effects
V Data Analysis
1 Quantitative data analysis will be conducted using will be conducted using SPSS 260 IBM Armonk NY USA for statistical analysis Descriptive statistical methods will summarise the characteristics of participants and study outcomes One-way between-group ANOVA will be employed to compare the differences in continuous outcomes between the two study groups The significance level will be set at 005
2 Qualitative data analysis will be conducted using thematic and content analysis methods Recordings from qualitative interviews will be transcribed verbatim coded and analysed Qualitative findings will be compared and integrated with the quantitative survey results to provide a more comprehensive research conclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None