## Protocol Section
### Identification Module
**NCT ID:** NCT02429479

**Brief Title:** Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones

**Official Title:** Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making

#### Organization Study ID Info
**ID:** 37476
#### Organization
**Class:** OTHER
**Full Name:** Milton S. Hershey Medical Center
#### Secondary ID Infos
**ID:** 1R01NR012757-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01NR012757-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2021-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-26

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2013-06-01

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2015-04-29
**Type:** ESTIMATED
**Study First Submit Date:** 2015-04-24
**Study First Submit QC Date:** 2015-04-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Nursing Research (NINR)

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Milton S. Hershey Medical Center

#### Responsible Party

**Investigator Affiliation:** Milton S. Hershey Medical Center

**Investigator Full Name:** Benjamin H. Levi

**Investigator Title:** Co-PI

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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 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).

### Conditions Module

**Conditions:**

- Neoplasms

- Heart Failure

- Kidney Diseases

- Lung Diseases

**Keywords:**

- Advance Care Planning

- Living Will

- Family Caregiver

- Advance Directive

- Surrogate Decision Maker

- Proxy

- Self-Efficacy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 285

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients (without their family caregiver) complete a standard living will form online.

**Intervention Names:**

- Behavioral: Standard advance care planning

**Label:** Standard ACP/Patient Alone

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients (without their family caregiver) complete Making Your Wishes Known, an online decision aid for advance care planning.

**Intervention Names:**

- Behavioral: Making Your Wishes Known

**Label:** Decision Aid/Patient Alone

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Patients and their family caregiver together complete a standard living will form online.

**Intervention Names:**

- Behavioral: Standard advance care planning

**Label:** Standard ACP/Together

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** Patients and their family caregiver together complete Making Your Wishes Known, an online decision aid for advance care planning.

**Intervention Names:**

- Behavioral: Making Your Wishes Known

**Label:** Decision Aid/Together

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Decision Aid/Patient Alone

- Decision Aid/Together

**Description:** 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.

**Name:** Making Your Wishes Known

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Standard ACP/Patient Alone

- Standard ACP/Together

**Description:** This is a online simple living will form.

**Name:** Standard advance care planning

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Self-efficacy

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** Accuracy of medical decisions

**Time Frame:** 6 weeks

**Description:** 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.

**Measure:** Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making

**Time Frame:** 1-2 years

**Description:** Family caregivers will complete a questionnaire that assess their knowledge of surrogate responsibilities and end-of-life medical conditions and treatments

**Measure:** Family caregiver knowledge

**Time Frame:** 6 weeks - 2 years

**Description:** Family Caregivers are interviewed about the depth of communication with their loved one (frequency, content, helpfulness of discussions) regarding advance care planning issues.

**Measure:** Depth of communication

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Satisfaction with advance care planning

**Time Frame:** 1st study visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 18 years of age or older
2. 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).
3. 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)
4. Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score \>23)
5. No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).

Exclusion Criteria:

* Failure on any of the above inclusion criteria.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Brigham & Women's Hospital

**State:** Massachusetts

**Zip:** 02120

**Location 2:**

**City:** Hershey

**Country:** United States

**Facility:** Penn State Milton S. Hershey Medical Center / Penn State College of Medicine

**State:** Pennsylvania

**Zip:** 17033

#### Overall Officials

**Official 1:**

**Affiliation:** Penn State Milton S. Hershey Medical Center / Penn State College of Medicine

**Name:** Benjamin H Levi, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Penn State Milton S. Hershey Medical Center / Penn State College of Medicine

**Name:** Michael J Green, MD MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Researchers who provide a methodologically sound proposal/request for these data.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** July 1, 2023 - June 30, 2026

### References Module

#### References

**Citation:** 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.

**PMID:** 33373538

**Citation:** Lipnick 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.

**PMID:** 32645452

**Citation:** Foy 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.

**PMID:** 30714833

#### See Also Links

**Label:** This is the website for the intervention arm advance care planning decision aid.

**URL:** https://www.makingyourwishesknown.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M9421

- Name: Heart Failure

- Relevance: LOW

- As Found: Unknown

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000007674

- Term: Kidney Diseases

### Misc Info Module

- Version Holder: 2024-05-24
