AzTrials
AzTrials

Cardiovascular DiseaseNCT01876173

Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

A study testing Patient Decision Aid for an ICD (primary prevention, non-CRT) in people with Cardiovascular Disease and Sudden Cardiac Death, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Disease, Sudden Cardiac Death
What is being tested?
Patient Decision Aid for an ICD (primary prevention, non-CRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteCanada
Study dates
Jun 2012to Dec 2014
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

  • Referred for consideration of an ICD(non-CRT)for a primary prevention indication
  • English speaking
  • able to provide informed consent

Who cannot join

  • unable to understand the decision aid due to a language barrier or visual impairment
  • referred for secondary prevention indication

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton Health Sciences

    Hamilton, Ontario, L8P 2X2

Other trials in Canada

About this study

Official title: Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Definitive evidence has established the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice guidelines define the criteria to determine patient ICD candidacy for primary prevention. However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and risks of an ICD can become complex, particularly when competing mortality risks are present. Research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. In Canada, there is no clear framework to support patients' decision-making in the context of ICD treatment options. Decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions.

Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.

Being tested
Patient Decision Aid for an ICD (primary prevention, non-CRT)
Keywords
Sudden cardiac death, implantable cardioverter defibrillator, decision aid
Medical subject headings
Cardiovascular Diseases, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Decision Aid for an ICD (primary prevention, non-CRT)Behavioural

    Also called PtDA

    The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.

Study groups in NCT01876173
Study groupRoleWhat they receive
Patient Decision Aid for an ICD (primary prevention, non-CRT)ExperimentalThe intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.
Receives: Behavioral: Patient Decision Aid for an ICD (primary prevention, non-CRT)
Usual careNo interventionThe control group will not receive the patient decision aid prior to consultation with the physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.

    Development of the decision aid will be guided by the Ottawa Decision Support Framework (ODSF). Evaluation will include the Decision Aid Acceptability questionnaire comprised of 10 items including comprehensibility, balance of presentation of information, and overall suitability.

    Measured: Phase 1-2 (1- year)

Secondary outcomes (7)

  1. Pilot RCT (feasibility)

    In this feasibility RCT, the feasibility regarding processes (referral and recruitment rates, consent), key to the success of a larger study will be assessed. This includes successful delivery of the decision aid in an efficient manner, the monitoring of resources (budget), and study management (trial coordination, human resources). We will assess the proportion of patients who complete the decision aid, quality questionnaires, and missing data.

    Measured: Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)

  2. Decision quality measures

    Decision quality, the extent to which patients' decisions are informed (knowledge) and values based (values, preferences, decisional conflict).

    Measured: Pre consultation (baseline visit)

  3. Decisional Conflict Scale (DCS)

    The Decisional Conflict Scale measures a person's perception of the difficulty in making a decision, the extent to which they feel uncertain about treatment options, are knowledgeable about the risks and benefits of options, clear about personal values, and supported in decision making. The scale has good test-retest reliability (Cronbach's alpha coefficients > 0.78) and predictive validity.

    Measured: Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)

  4. Sure Test

    The Sure Test is a 4 item decisional conflict screening tool designed for use in clinical practice. The Sure Test is embedded in the decision aid (intervention group).

    Measured: Pre-consultation - baseline visit

  5. The Center for Epidemiologic Studies Depression Scale (CES-D)

    The CES-D has 20 items that measure depressive symptoms. The CES-D has good reliability and validity across community and clinical settings. Associations between depressive symptoms and decision choice will be assessed.

    Measured: Pre consultation - baseline visit (intervention and usual care)

  6. Preparation for Decision Making scale

    The Preparation for Decision Making Scale has 10 categorical items assessing the usefulness of the decision aid in preparing patients to communicate with a health professional.

    Measured: Post consultation - up to two weeks post baseline visit (intervention group)

  7. The Medical Outcomes Trust Short Form (SF-36v2)

    The SF-36 is a reliable and valid generic health related quality of life scale (HRQL) comprised of 36 items. Associations between HRQL and decision choice will be undertaken.

    Measured: Pre consultation - baseline visit (intervention and usual care)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2014
  4. Study completionDec 2014

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01876173
Sponsor's protocol ID
12-214
Other IDs
119449 Grant number
Status last verified
Mar 2016
First submitted
30 May 2013
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Carroll SL, Stacey D, McGillion M, Healey JS, Foster G, Hutchings S, Arthur HM, Browne G, Thabane L. Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 Nov 21;3:49. doi: 10.1186/s40814-017-0189-9. eCollection 2017.

    PubMed 29201388

  • Carroll SL, McGillion M, Stacey D, Healey JS, Browne G, Arthur HM, Thabane L. Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. Trials. 2013 Oct 22;14:346. doi: 10.1186/1745-6215-14-346.

    PubMed 24148851

Questions about this trial

What is this clinical trial studying?

A study testing Patient Decision Aid for an ICD (primary prevention, non-CRT) in people with Cardiovascular Disease and Sudden Cardiac Death, run by McMaster University at 1 site in Canada.

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 3 inclusion and 2 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation. (time frame: Phase 1-2 (1- year)). 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 NCT01876173, which also lists 2 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 17 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in