NeoplasmsNCT02429479
Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones
A study testing Making Your Wishes Known and Standard advance care planning in people with Neoplasms and Heart Failure, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial summary
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Heart Failure, Kidney Diseases
- What is being tested?
- Making Your Wishes Known and Standard advance care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2013to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of <2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis).
- Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest)
- Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23)
- No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).
Who cannot join
- Failure on any of the above inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02120
Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.
Read the detailed description
The long-term goal is to help family caregivers of seriously ill patients be better prepared to serve as surrogate decision-makers when their loved ones can no longer make medical decisions for themselves. Research shows that family caregivers find surrogate decision-making highly stressful and emotionally burdensome, in part because they feel unprepared for surrogate decision-making. To date, no studies have determined which advance care planning (ACP) process best prepares caregivers for this role. The investigators' prior work shows that a computer-based decision aid can help patients make more informed decisions and communicate their wishes more effectively. The investigators now propose to determine if family caregivers of patients with life-threatening illnesses are better prepared for surrogate decision-making: 1) when they engage in a structured ACP process together with patients; and 2) when they use this online decision aid for ACP. This will be accomplished via a randomized, controlled trial with a 2 x 2 factorial design comprising 4 groups: Standard ACP/Patient Alone (Group 1), Decision Aid/Patient Alone (Group 2), Standard ACP/Patients and Caregivers Together (Group 3), and Decision Aid/Patients and Caregivers Together (Group 4).
- Conditions
- Neoplasms, Heart Failure, Kidney Diseases, Lung Diseases
- Being tested
- Making Your Wishes Known, Standard advance care planning
- Keywords
- Advance Care Planning, Living Will, Family Caregiver, Advance Directive, Surrogate Decision Maker, Proxy, Self-Efficacy
- Medical subject headings
- Neoplasms, Heart Failure, Kidney Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Your Wishes KnownBehavioural
Making Your Wishes Known provides tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a healthcare team.
Standard advance care planningBehavioural
This is a online simple living will form.
| Study group | Role | What they receive |
|---|---|---|
| Standard ACP/Patient Alone | Active comparator | Patients (without their family caregiver) complete a standard living will form online. Receives: Behavioral: Standard advance care planning |
| Decision Aid/Patient Alone | Experimental | Patients (without their family caregiver) complete Making Your Wishes Known, an online decision aid for advance care planning. Receives: Behavioral: Making Your Wishes Known |
| Standard ACP/Together | Active comparator | Patients and their family caregiver together complete a standard living will form online. Receives: Behavioral: Standard advance care planning |
| Decision Aid/Together | Experimental | Patients and their family caregiver together complete Making Your Wishes Known, an online decision aid for advance care planning. Receives: Behavioral: Making Your Wishes Known |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
Family caregiver self-efficacy is measured using a validated questionnaire to determine if they feel better prepared to serve as surrogates for their loved one.
Measured: 6 weeks
Secondary outcomes (5)
Accuracy of medical decisions
Family caregiver responses to treatment decisions hypothetical clinical vignettes will be compared to the decisions for the same vignettes made by their loved one. Each vignette has 6-8 associated treatment decisions; the family caregiver's response for each item will be compared with the loved one's (i.e., patient's) response, and a total concordance (i.e., number of items for which there is agreement) will be calculated.
Measured: 6 weeks
Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making
Using validated instruments and semi-structured interviews, family caregivers who have made a major medical decision on behalf of their loved one will report their level of distress, decisional conflict, satisfaction with decision, and experience with surrogate decision-making.
Measured: 1-2 years
Family caregiver knowledge
Family caregivers will complete a questionnaire that assess their knowledge of surrogate responsibilities and end-of-life medical conditions and treatments
Measured: 6 weeks - 2 years
Depth of communication
Family Caregivers are interviewed about the depth of communication with their loved one (frequency, content, helpfulness of discussions) regarding advance care planning issues.
Measured: 2 years
Satisfaction with advance care planning
Participants who complete the advance care planning interventions fill out an evaluation of the intervention using a 16-item questionnaire. This instrument comprises:
Twelve 5-point Likert-style questions on how the program presented various kinds of information; helped the user clarify values, choose a spokesperson, etc.; and helped the user document or be prepared communicate their wishes to others.
Three 10-point Likert-style questions on user overall satisfaction, with the advance directive created by the intervention, and the amount of information provided.
One open-ended item asking how the intervention was helpful.
Measured: 1st study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start1 Jun 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Brigham and Women's Hospital
- Responsible party
- Principal investigator, Benjamin H. Levi, Milton S. Hershey Medical Center
- Investigators
- Benjamin H Levi, MD PhD, Principal investigator, Penn State Milton S. Hershey Medical Center / Penn State College of MedicineMichael J Green, MD MS, Principal investigator, Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429479
- Sponsor's protocol ID
- 37476
- Other IDs
- 1R01NR012757-01A1
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2015
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will present our findings at conferences and in peer-reviewed publications, and will share our study protocol, consent forms, measures, and statistical plan with other researchers upon request.
Publications
Thiede E, Levi BH, Lipnick D, Johnson R, Seo La I, Lehman EB, Smith T, Wiegand D, Green M, Van Scoy LJ. Effect of Advance Care Planning on Surrogate Decision Makers' Preparedness for Decision Making: Results of a Mixed-Methods Randomized Controlled Trial. J Palliat Med. 2021 Jul;24(7):982-993. doi: 10.1089/jpm.2020.0238. Epub 2020 Dec 29.
PubMed 33373538Lipnick D, Green M, Thiede E, Smith TJ, Lehman EB, Johnson R, La IS, Wiegand D, Levi BH, Van Scoy LJ. Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis From a Randomized Controlled Trial. J Pain Symptom Manage. 2020 Dec;60(6):1117-1126. doi: 10.1016/j.jpainsymman.2020.07.001. Epub 2020 Jul 6.
PubMed 32645452Foy AJ, Levi BH, Van Scoy LJ, Bucher A, Dimmock A, Green MJ. Patient Preference to Accept Medical Treatment Is Associated with Spokesperson Agreement. Ann Am Thorac Soc. 2019 Apr;16(4):518-521. doi: 10.1513/AnnalsATS.201806-428RL. No abstract available.
PubMed 30714833
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making
- ClinicalTrials.gov ID
- NCT02429479
- Acronym / sponsor ID
- 37476
- Conditions
- Neoplasms, Heart Failure, Kidney Diseases, Lung Diseases
- Keywords
- Advance Care Planning, Living Will, Family Caregiver, Advance Directive, Surrogate Decision Maker, Proxy, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Brigham and Women's Hospital
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.
Detailed description
The long-term goal is to help family caregivers of seriously ill patients be better prepared to serve as surrogate decision-makers when their loved ones can no longer make medical decisions for themselves. Research shows that family caregivers find surrogate decision-making highly stressful and emotionally burdensome, in part because they feel unprepared for surrogate decision-making. To date, no studies have determined which advance care planning (ACP) process best prepares caregivers for this role. The investigators' prior work shows that a computer-based decision aid can help patients make more informed decisions and communicate their wishes more effectively. The investigators now propose to determine if family caregivers of patients with life-threatening illnesses are better prepared for surrogate decision-making: 1) when they engage in a structured ACP process together with patients; and 2) when they use this online decision aid for ACP. This will be accomplished via a randomized, controlled trial with a 2 x 2 factorial design comprising 4 groups: Standard ACP/Patient Alone (Group 1), Decision Aid/Patient Alone (Group 2), Standard ACP/Patients and Caregivers Together (Group 3), and Decision Aid/Patients and Caregivers Together (Group 4).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard ACP/Patient Alone | Active comparator | Behavioral: Standard advance care planningPatients (without their family caregiver) complete a standard living will form online. |
| Decision Aid/Patient Alone | Experimental | Behavioral: Making Your Wishes KnownPatients (without their family caregiver) complete Making Your Wishes Known, an online decision aid for advance care planning. |
| Standard ACP/Together | Active comparator | Behavioral: Standard advance care planningPatients and their family caregiver together complete a standard living will form online. |
| Decision Aid/Together | Experimental | Behavioral: Making Your Wishes KnownPatients and their family caregiver together complete Making Your Wishes Known, an online decision aid for advance care planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of <2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis).
- Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest)
- Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23)
- No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).
Key exclusion criteria (1 listed)
- Failure on any of the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Making Your Wishes KnownMaking Your Wishes Known provides tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a healthcare team. | Behavioural | Decision Aid/Patient Alone, Decision Aid/Together |
| Standard advance care planningThis is a online simple living will form. | Behavioural | Standard ACP/Patient Alone, Standard ACP/Together |
Primary outcome
Self-efficacy
Time frame: 6 weeks
Family caregiver self-efficacy is measured using a validated questionnaire to determine if they feel better prepared to serve as surrogates for their loved one.
5 secondary outcomes
Accuracy of medical decisions
Time frame: 6 weeks
Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making
Time frame: 1-2 years
Family caregiver knowledge
Time frame: 6 weeks - 2 years
Depth of communication
Time frame: 2 years
Satisfaction with advance care planning
Time frame: 1st study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 33373538Thiede E, Levi BH, Lipnick D, Johnson R, Seo La I, Lehman EB, Smith T, Wiegand D, Green M, Van Scoy LJ. Effect of Advance Care Planning on Surrogate Decision Makers' Preparedness for Decision Making: Results of a Mixed-Methods Randomized Controlled Trial. J Palliat Med. 2021 Jul;24(7):982-993. doi: 10.1089/jpm.2020.0238. Epub 2020 Dec 29.
- Derived from this study: PubMed 32645452Lipnick D, Green M, Thiede E, Smith TJ, Lehman EB, Johnson R, La IS, Wiegand D, Levi BH, Van Scoy LJ. Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis From a Randomized Controlled Trial. J Pain Symptom Manage. 2020 Dec;60(6):1117-1126. doi: 10.1016/j.jpainsymman.2020.07.001. Epub 2020 Jul 6.
- Derived from this study: PubMed 30714833Foy AJ, Levi BH, Van Scoy LJ, Bucher A, Dimmock A, Green MJ. Patient Preference to Accept Medical Treatment Is Associated with Spokesperson Agreement. Ann Am Thorac Soc. 2019 Apr;16(4):518-521. doi: 10.1513/AnnalsATS.201806-428RL. No abstract available.
- Individual participant dataSharing planned: Yes. We will present our findings at conferences and in peer-reviewed publications, and will share our study protocol, consent forms, measures, and statistical plan with other researchers upon request.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin H Levi, MD PhD principal investigator
Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
Michael J Green, MD MS principal investigator
Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making Your Wishes Known and Standard advance care planning in people with Neoplasms and Heart Failure, run by Milton S. Hershey Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429479, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.