Effectiveness of the HF-ACP Website Study

Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning

This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Advance Care Planning
• Intervention / Treatment: Behavioral: HF-ACP Website

Detailed Description

Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care. Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates. Content intended for use by the general public may be too vague for those living with a chronic illness. Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP. The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• over the age of 18,
• a regular patient in our clinic,
• able to read and write English,
• familiar with the use and have access to a personal computer, email and the internet.

Exclusion Criteria:

• ineligible for participation in the trial if they do not meet the inclusion criteria described above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HF-ACP Website; The HF-ACP website leads participants through 4 e-learning modules. Each module contains 3 core elements: (1) educational content which provides information and support to help patients complete the module (2) interactive tools for documenting their thoughts and progress and (3) motivational video clips that encourage behavior change by validating participants ambivalence, suggesting strategies to help participants complete the task and to encourage and reassure participants that they can do this.	Behavioral: HF-ACP Website; Each module is broken down into weekly topics and each module takes 3-6 weeks to complete. Participants can access and review the material as often as needed as well as revisiting the information from modules they have completed.
No Intervention: Usual Care; The standard of care for advance care planning at our institution is the "Speak Up" booklet and the Power of Attorney workbook from the Attorney General's Office - Ontario. Patients randomized to the Control arm will be asked to register on a separate research portal where participants will have electronic access to both of the booklets and a link to the Speak Up online Interactive workbook. There is no specific information on HF or HF treatments. Participants in the control arm will be asked to complete the ACP using the interactive workbook. Participants in the control arm will not receive any additional communication from the research team about their progress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advance care planning completion rates	proportion of participants who complete the advance care planning process	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
advance care planning knowledge	% improvement in knowledge of advance care planning	6 months
The 5-level European Quality of Life scale	The EQ-5D-5L is a generic quality of life measure that consists of a 5-item health state assessment and a visual analog scale. The dimensions represented in the 5-item assessment include: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses to the questions can be converted to a time tradeoff utility score from 0 (represents worst possible health) to 1.0 (represents perfect health). The visual analog scale ranges from 0-100 with higher scores representing better quality of life.	6 months
Generalized Anxiety Disorder Scale (GAD-7)	The GAD-7 is a 7 item self-administered screening tool for anxiety. Scores range from 0-21 with cutoffs at 5, 10, and 15 representing mild, moderate and severe anxiety, respectively.	6 months
The Readiness to Change Scale (RCS)	The RCS is a study-specific tool based on Prochaska's algorithm for change. It categorizes participants into one of the 5 categories of readiness. The RCS will be used to measure change for the 3 discreet behaviors: (1) identifying a SDM, (2) developing the advance care plan and (3) communicating wishes to their SDM. The RCS will be used to determine if readiness is associated with ACP completion	6 months
The Patient Health Questionnaire (PHQ-9)	The PHQ -9 is a 9 item self-administered scale screening tool for depression. Scores range from 0-27 with cutoffs at 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe depression	6 months
The Perceived Stress Scale	The PSS is a 10 item self-administered scale to measure perceived stress. The scores range form 0-40 with higher scores representing greater stress.	6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Jane Maciver, RN PhD, UHN Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF-ACP website

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No