Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions

NCT ID: NCT02483494

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-08
• Study Completion Date: 2018-06-30

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.

Conditions

Acute Myocardial Infarction; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

APN-led Telemedicine

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

Group Type: EXPERIMENTAL

APN-led Telemedicine

Intervention Type: OTHER

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.

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

APN-led Telemedicine

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

National University Heart Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Karen Koh

Assistant Director of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Koh

Role: PRINCIPAL_INVESTIGATOR

National University Heart Centre, Singapore

A Mark Richards

Role: STUDY_CHAIR

National University Heart Centre, Singapore

Mark Chan

Role: PRINCIPAL_INVESTIGATOR

National University Heart Centre, Singapore

Locations

National University Hospital

Kent Ridge, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Karen Koh

Role: CONTACT

karen_wl_koh@nuhs.edu.sg

+65 6772 6884

Sock Cheng Poh

Role: CONTACT

sock_cheng_poh@nuhs.edu.sg

+65 9772 0495

Facility Contacts

Karen WL Koh

Role: primary

karen_wl_koh@nuhs.edu.sg

67726884

Sock Cheng A Poh

Role: backup

sock_cheng_poh@nuhs.edu.sg

References

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.

Reference Type: BACKGROUND

PMID: 14581307 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26915719 (View on PubMed)

Other Identifiers

RG2013/03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014\00793

Identifier Type: -

Identifier Source: org_study_id