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Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions (ALTRA)

Primary Purpose

Acute Myocardial Infarction, Acute Coronary Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

APN-led Telemedicine

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction focused on measuring Telemedicine, Advanced Practice Nurse

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)> 30 minutes
Undergone PCI for index event
NT-Pro-BNP ≥1000 ng/L
Cinically diagnosed AMI at high risk of ventricular remodeling (STEMI or NSTEMI):

(Anterior or large inferior STEMI)

ECG changes>0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or
Presence of pathological Q waves in two or more contiguous limb leads or precordial leads.
Typical rise or fall of cardiac enzymes (cardiac troponin value exceeding the 99th percentile).
Angiographic findings of proximal/mid LAD, proximal LCX or RCA occlusion for STEMI.

(Or NSTEMI with)

Typical rise or fall of cardiac enzymes (cTn value exceeding the 99th percentile).
Peak cTnI should be >10ug/L, TnT-hs>250 ng/L or CK-MB >80 IU/L
LVEF (echocardiography) ≤ 40% or Kilip class ≥2

Exclusion Criteria:

Hypersensitivity to ticagrelor, aspirin or any excipients
Active pathological bleeding
History of intracranial haemorrhage
Infection within 6 weeks preceding the primary angioplasty, inflammatory disorders, Hepatitis, HIV, autoimmune disease or on immunosuppressive therapy
Women of childbearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period.
History of non-ischaemic cardiomyopathy or malignancy
History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)
Planned CABG within the next 6 weeks
Cardiogenic shock unable to be weaned off inotropes or IABP
Asthma or any other contraindications to beta-blockers
Arrhythmias precluding proper CMR image acquisition, including atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic ECG complexes
Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants
Significant liver impairment
Renal impairment (eGFR<45 ml min -1), end stage renal failure on renal replacement therapy
Anaemia (Hb<10 g/dL)
Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)
Participants who cannot be followed up
Participants not able or willing to consent for study

Sites / Locations

National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

APN-led Telemedicine

Usual care

Arm Description

Participants will receive APN-led Telemedicine in addition to usual care.

Participants will receive the standard of care which includes education by cardiac care nurses and face-to-face consultations.

Outcomes

Primary Outcome Measures

Readmissions Days

Cardiac and non-cardiac causes Readmission days per 1000 follow up days will be calculated using the total number of sample in that arm x follow days (i.e. 30 days in this instance) as the denominator. (Please refer to references attached)

Secondary Outcome Measures

Readmissions Days Per 1000 follow up days

Cardiac and non-cardiac causes

ED visits or unplanned self-reported doctor visits

Cardiac and non-cardiac causes

Cardiac Self-Efficacy Scale

Health Related Outcomes

Myocardial Infarction Dimension Assessment Scale

Health Related Outcomes

EuroQoL

Health Related Outcomes

Hospital Anxiety and Depression Scale

Health Related Outcomes

Full Information

NCT ID

NCT02483494

First Posted

June 23, 2015

Last Updated

August 3, 2017

Sponsor

National University Heart Centre, Singapore

Collaborators

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02483494

Brief Title

Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions

Acronym

ALTRA

Official Title

Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions and Health Related Outcomes Amongst Patients Post Acute Myocardial Infarction: ALTRA Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 8, 2015 (Actual)

Primary Completion Date

June 30, 2018 (Anticipated)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University Heart Centre, Singapore

Collaborators

National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Aim. To develop and examine the effectiveness of an APN-led telehealth rehabilitative programme as a transitional nursing therapeutic on readmission rates and health related outcomes amongst patients with Acute Myocardial Infarction (AMI) post discharge. Design. Randomized controlled trial with repeated measures. Methodology. A consecutive sampling of 172 patients with AMI will be recruited from a tertiary hospital in Singapore. Participants will be randomised into two groups. The experimental group (ALTRA) will receive APN-led telehealth rehabilitative programme upon discharge in addition to standard care. The control group will receive only standard follow-up care.

Detailed Description

Ischaemic heart disease is the third leading cause both for death and illness for hospitalisation in Singapore. Epidemiological data shows that the incidence of acute myocardial infarction (AMI) stands around 7000 plus in Singapore. In United States, nearly 20% of patients with AMI are readmitted within 30 days of discharge causing the healthcare system a huge financial burden. These readmissions have been shown to be associated with lower patient satisfaction and less inefficient healthcare. Cardiac rehabilitation has been proven to be an effective strategy in improving quality of life and reducing readmission. However, this structured programme which comprise of clinical review, education and exercise, has poor uptake rate for varied reasons. It is important that newer strategies are being explored and developed to cater to the changing needs of the patient population. One of which is to utilize telemedicine with combination of Advanced Practice Nurse delivering the care remotely. This is a substudy of IMMACULATE STUDY (NCT02468349) where more details can be found.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction, Acute Coronary Syndrome

Keywords

Telemedicine, Advanced Practice Nurse

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

APN-led Telemedicine

Arm Type

Experimental

Arm Description

Participants will receive APN-led Telemedicine in addition to usual care.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Participants will receive the standard of care which includes education by cardiac care nurses and face-to-face consultations.

Intervention Type

Other

Intervention Name(s)

APN-led Telemedicine

Intervention Description

Allocation to experimental or Usual care is 1:1. The four study APNs will be delivering the care and have at least three years working experiences in coronary care settings. A telephonic script and study protocol is made available to ensure standardization of intervention.

Primary Outcome Measure Information:

Title

Readmissions Days

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Readmissions Days Per 1000 follow up days

Description

Cardiac and non-cardiac causes

Time Frame

6 months

Title

ED visits or unplanned self-reported doctor visits

Description

Cardiac and non-cardiac causes

Time Frame

6 months

Title

Cardiac Self-Efficacy Scale

Description

Health Related Outcomes

Time Frame

6 months

Title

Myocardial Infarction Dimension Assessment Scale

Description

Health Related Outcomes

Time Frame

6 months

Title

EuroQoL

Description

Health Related Outcomes

Time Frame

6 months

Title

Hospital Anxiety and Depression Scale

Description

Health Related Outcomes

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)> 30 minutes Undergone PCI for index event NT-Pro-BNP ≥1000 ng/L Cinically diagnosed AMI at high risk of ventricular remodeling (STEMI or NSTEMI): (Anterior or large inferior STEMI) ECG changes>0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or Presence of pathological Q waves in two or more contiguous limb leads or precordial leads. Typical rise or fall of cardiac enzymes (cardiac troponin value exceeding the 99th percentile). Angiographic findings of proximal/mid LAD, proximal LCX or RCA occlusion for STEMI. (Or NSTEMI with) Typical rise or fall of cardiac enzymes (cTn value exceeding the 99th percentile). Peak cTnI should be >10ug/L, TnT-hs>250 ng/L or CK-MB >80 IU/L LVEF (echocardiography) ≤ 40% or Kilip class ≥2 Exclusion Criteria: Hypersensitivity to ticagrelor, aspirin or any excipients Active pathological bleeding History of intracranial haemorrhage Infection within 6 weeks preceding the primary angioplasty, inflammatory disorders, Hepatitis, HIV, autoimmune disease or on immunosuppressive therapy Women of childbearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period. History of non-ischaemic cardiomyopathy or malignancy History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR) Planned CABG within the next 6 weeks Cardiogenic shock unable to be weaned off inotropes or IABP Asthma or any other contraindications to beta-blockers Arrhythmias precluding proper CMR image acquisition, including atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic ECG complexes Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants Significant liver impairment Renal impairment (eGFR<45 ml min -1), end stage renal failure on renal replacement therapy Anaemia (Hb<10 g/dL) Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders) Participants who cannot be followed up Participants not able or willing to consent for study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Koh

Phone

+65 6772 6884

karen_wl_koh@nuhs.edu.sg

First Name & Middle Initial & Last Name or Official Title & Degree

Sock Cheng Poh

Phone

+65 9772 0495

sock_cheng_poh@nuhs.edu.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Koh

Organizational Affiliation

National University Heart Centre, Singapore

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

A Mark Richards

Organizational Affiliation

National University Heart Centre, Singapore

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mark Chan

Organizational Affiliation

National University Heart Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Kent Ridge

ZIP/Postal Code

117597

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen WL Koh

Phone

67726884

karen_wl_koh@nuhs.edu.sg

First Name & Middle Initial & Last Name & Degree

Sock Cheng A Poh

sock_cheng_poh@nuhs.edu.sg

12. IPD Sharing Statement

Citations:

PubMed Identifier

14581307

Citation

Young W, Rewa G, Goodman SG, Jaglal SB, Cash L, Lefkowitz C, Coyte PC. Evaluation of a community-based inner-city disease management program for postmyocardial infarction patients: a randomized controlled trial. CMAJ. 2003 Oct 28;169(9):905-10.

Results Reference

background

PubMed Identifier

26915719

Citation

Koh KW, Wang W, Richards AM, Chan MY, Cheng KK. Effectiveness of advanced practice nurse-led telehealth on readmissions and health-related outcomes among patients with post-acute myocardial infarction: ALTRA Study Protocol. J Adv Nurs. 2016 Jun;72(6):1357-67. doi: 10.1111/jan.12933. Epub 2016 Feb 25.

Results Reference

derived

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Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions

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