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Trial registered on ANZCTR


Registration number
ACTRN12616001322426
Ethics application status
Approved
Date submitted
14/08/2016
Date registered
21/09/2016
Date last updated
21/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Integrated Care Pathway for Post Stroke Patients (iCaPPS) Residing at Home in The Malaysian Community: A Cost Effectiveness Analysis
Scientific title
The Integrated Care Pathway for Post Stroke Patients (iCaPPS) Residing at Home in The Malaysian Community: An Evaluation of Impact on Quality of Life and Cost Effectiveness Analysis
Secondary ID [1] 289889 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Integrated Care Pathway for Post Stroke (iCaPPS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Stroke 299838 0
Post stroke healthcare provision for patients residing at home in the community 299839 0
Condition category
Condition code
Stroke 299757 299757 0 0
Ischaemic
Stroke 299758 299758 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post stroke patients under long term care follow up at public primary care health centres are randomised to receive either iCaPPS or conventional care.

The iCaPPS is a care pathway document, which provides an itemised checklist guide for the primary care team to provide comprehensive and coordinated delivery of long-term stroke care, using resources available in the Malaysian public healthcare system.

The iCaPPS details a task oriented checklist for each member of the primary care team which includes the Family Medicine Specialist (FMS) or Medical Officer-in-charge, the registered staff nurse or community nurse, the Community-based Rehabilitation team (which has either a Physiotherapist and/or Occupational Therapist based at the health centre). The iCaPPS also summarises the current and updated medication list, which the patient is taking.

The iCaPPS lists the tasks for each visit in detail, starting at first visit to the health centre after transfer of care from the referral hospital, all relevant assessments done and screening of stroke related complications which have to be scheduled periodically, as recommended by the Expert Panel, using current evidence based recommendations as well as best practice options tailored to available public healthcare delivery system.

The FMS will be the main coordinator of care, to administer care as per iCaPPS to the patient receiving long term stroke care at the public primary care healthcentres (i.e. baseline and at 6 months, total duration of observation per patient was 2 visits over a 6-month period).

The iCaPPS guides the primary care team at the health centre to deliver a comprehensive medical care plan, which covers:

A. Stroke risk factor management (i.e. control of hypertension, dyslipdaemia and/ or diabetes mellitus treated to targets) The FMS will be provide and coordinate treatment (where necessary) to ensure the patient receives adequate medical management for each of the co-morbid conditions and make adjustments to the medications as required.

B. The Registered Nurse or Community Nurse will be responsible to take the vital signs (e.g. Blood pressure, pulse rate, Body Mass index or Waist hip ratio) and conduct screening for complications related to stroke using validated screening tools:
a. Two Question With Help Questionnaire; TQWHQ for screening for depression (Mohd-Sidik et al, 2011)
b. Elderly Cognitive Assessment Questionnaire (ECAQ) (Kua, 1992) for patients aged 60 years and more (using cut off score of less than 5 as cognitive decline) and / or
c. Malay- Mini Mental State Examination using a cut of point of 17 and above as normal, for patients aged below 60 years (Zarina, 2007)
d. The FMS uses the symptom checklist to help identify possible swallowing abnormalities during consultation. If the patient is suspected to have swallowing abnormalities, the iCaPPS-Swallow (Copyright) algorithm designed by the expert panel to guide the primary care team to channel the patient to the nearest Speech & Language Therapy (SLT) service in the district.
e. Patients are also assessed for rehabilitation needs (either initiation for those who have been diagnosed late or continuing rehabilitation for those already referred to community rehabilitation services). The patients’ functional status will be assessed using the modified Barthel Index (MBI) (Mahoney, 1965; Shah, 1989) and the Brody & Lawton’s Instrumental Activities for Daily Living (IADL)(Brody & Lawton, 1988) questionnaire (by the trained Nurse or the Therapist based at the Healthcentres, whichever is available.). The FMS and the Therapist at the healthcentres will then coordinate the rehabilitation program using the iCaPPS-Rehabilitation (Copyright) algorithm to ensure that patients receive the optimal neurorehabiltation as necessary tailored to the individual needs.

For the iCaPPS arm, each visit will take up a total of 45 minutes, i.e. a 30-minute consultation with the FMS (A), and 15-minutes for screening with Registered Nurse or Community Nurse or Therapist (whichever is applicable) (B and C).

In conventional care arm: post stroke patients are managed by FMS' for their stroke risk factors (i.e. hypertension, diabetes mellitus and/or dyslipdaemia alone), as per a consultation with the physician. There is no local guideline, which the primary care doctors can refer to in cases where rehabilitation should be initiated or continued or even a pathway to review for its effectiveness. The FMS are not trained in principles of neurorehabilitation or rehabilitation per se, and at best, are not aware on how to monitor or coordinate rehabilitation for stroke patients at community level.

Patients are observed at baseline and at 6 months, as per the iCaPPS arm. The FMS or Therapist at the healthcentres does not routinely assess functional status of post stroke patients unless they are officially for referred for intervention or evaluation, similarly for swallowing disorders. FMS' on the average take up 20-25 minutes per patient per consultation.

Intention to treat analysis was employed, with last observation carried forward for patients who did not turn up for appointments despite 2 reminders / call back.

The researchers (i.e. Family Medicine Specialists) are blinded to the intervention (i.e. iCaPPS or conventional care). Assignment of type of intervention was done at healthcentres level.
Intervention code [1] 295576 0
Treatment: Other
Comparator / control treatment
Conventional Care for post stroke patients at primary care healthcentres usually follow the Non Communicable Disease clinic protocol, i.e. follow up for control of blood pressure, diabetes and dyslipidaemia. The rehabilitation of post stroke care is not coordinated as this service is mainly run by the supportive health services at the healthcentre. Primary care physicians in general are not exposed or trained in rehabilitation of post stroke patients at community level.
Control group
Active

Outcomes
Primary outcome [1] 299269 0
Change in quality of life (EQ5D scores)
Timepoint [1] 299269 0
From baseline up to 6 months of intervention with the iCaPPS or continue conventional care
Secondary outcome [1] 327122 0
Blood pressure. This outcome is assessed by sphygmomanometry.
Timepoint [1] 327122 0
6 months post commencement of intervention.
Secondary outcome [2] 327123 0
Glycaemic control, HbA1C. This outcome was assessed by serum assay and medical record review.
Timepoint [2] 327123 0
6 months post commencement of intervention.
Secondary outcome [3] 327124 0
Lipid level changes. This outcome was assessed by serum assay and medical record review.
Timepoint [3] 327124 0
6 months post commencement of intervention.

Eligibility
Key inclusion criteria
1. Age 18 years and above
2. Any type of stroke diagnosed clinically by Neurologist / Physician and / or confirmed radiologically
3. At least 6 months or more after first or recurrent stroke episode
4. Completed acute stroke treatment and discharged from hospital
5. Completed acute stroke treatment and referred for long term stroke care at community health centres
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with Transient Ischaemic Attack (TIA)
2. Patients with traumatic brain injury
3. Patients with isolated nerve palsies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a cluster randomised controlled trial.Allocation concealment was done at health centre level- i.e. central randomisation, where all post stroke patients at the selected health centre would be assigned to either iCaPPS or conventional care
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was done using coin toss method, to assign which health centre would manage post stroke patients either with iCaPPS or conventional care
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome of this study was the quality of life of the post stroke patients managed either by iCaPPS or conventional care. The secondary outcomes were the clinical outcomes resulting from the care program.

For this study, the working hypotheses used were:

1. The use of iCaPPS to manage post stroke patients at primary care level had a positive impact on the quality of life (QoL) of the patients compared to conventional care.
2. Managing post stroke patients at public primary care with the iCaPPS programme was more cost effective compared with conventional care practices.

The hypotheses were proposed based on the design of the iCaPPS that was comprehensive, scheduled to screen and intervene for long-term stroke complications. The iCaPPS required less visits to the health centre for the patient and the caregiver.

Based on this hypothesis, the formula used for sample size calculation for two-group experimental study by Lemeshow (1990) (Lemeshow et al. 1990) was employed to estimate the number of stroke patients to be recruited.

The formula that was used to calculate the sample size is listed below:

N= 2 delta squared (Z alpha + Z beta) squared / A squared

Where N is the required sample size, delta squared is estimated standard deviation (SD), Z alpha and Z beta are unit normal deviates corresponding to the level of significance of a and type II error B, and A is the size of between group difference desired to be detected after the intervention. Z alpha = 1.96 for a of 0.05, while Z beta =0.84 for a power rate of 80% and 1.28 for a power rate of 90%.

Considering the constraints in resources for this study, a power rate of 80% was used to calculate sample for each variable. There was difficulty in trying to locate similar studies, which evaluated the outcomes of a primary care based post stroke service in the community. Hence, studies, which assessed quality of life on patients residing in the community at least six months post stroke, and utilised any outpatient facilities was used as guide to calculate sample size of subjects (Darlington et al, 2007)

The desired group difference in mean EQ5D index scores was generally estimated at a rate of 15% (Adamchak 2000) as per the study by Darlingto et al (2007).
Based on the calculation, a minimum sample of 65 subjects in each arm was required for the study. No allowances were made for dropout rates because intention-to-treat analysis was decided.


For assessment of quality of life:
EQ5D utility weights were converted from the descriptive data, and comparisons were made between baseline scores and at six-months, using Mann Whitney tests and intention-to-treat analysis. The changes in scores distribution were also calculated to show the proportions of patients who improved, in status quo or no changes and deteriorated. Distribution of impacts across the measured dimensions was also explored to determine which aspect of the daily life was most affected.

Subsequently, since there were no references available at the time of study to evaluate the clinical outcomes for a primary care led post stroke service in the community, no calculations were made to determine on the sample size were required for the secondary clinical outcomes or the economic evaluation portion of this study.

For clinical outcomes:
A descriptive summary of the clinical parameters was reported. Quantitative data were analysed descriptively using Statistical Package for Social Sciences (Registered Trademark) (IBM-SPSS) version 20.0 (New York, 2011). Baseline mean (SD) or median (IQR) scores were compared against scores at 6 months after follow-up, using paired t-tests or Mann Whitney test. Intention to treat analysis was used to prevent biasness introduced by missing data and patient drop-out rates (i.e patients who did not turn up on scheduled review visit date). For patients who missed the final assessment, the ‘last observation carried forward’ method was used.

For economic evaluation (cost effectiveness analysis):Two costing methods were combined in this study, the step-down and activity-based-costing (ABC) methods based on the iCaPPS. Some cost components were costed using the step down method while the remainder employed the ABC. All were added up to provide the total cost.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2012
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
30/06/2013
Sample size
Target
130
Accrual to date
Final
151
Recruitment outside Australia
Country [1] 8094 0
Malaysia
State/province [1] 8094 0
Kedah, Pulau Pinang & Seberang Perai, Wilayah Persekutuan, Pahang.

Funding & Sponsors
Funding source category [1] 294302 0
University
Name [1] 294302 0
Universiti Kebangsaan Malaysia (a.k.a The National University of Malaysia)
Country [1] 294302 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Medical Research & Innovation Secretariat
Faculty of Medicine
UKM Medical Centre
Jalan Yaacob Latiff
56000 Cheras, Kuala Lumpur
Malaysia
Country
Malaysia
Secondary sponsor category [1] 293142 0
None
Name [1] 293142 0
Address [1] 293142 0
Country [1] 293142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295722 0
Medical Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 295722 0
Ethics committee country [1] 295722 0
Malaysia
Date submitted for ethics approval [1] 295722 0
20/12/2011
Approval date [1] 295722 0
28/12/2011
Ethics approval number [1] 295722 0
UKM-GUP-2011-327
Ethics committee name [2] 295723 0
Medical Ethics Research Council, Ministry of Health, Malaysia
Ethics committee address [2] 295723 0
Ethics committee country [2] 295723 0
Malaysia
Date submitted for ethics approval [2] 295723 0
20/12/2011
Approval date [2] 295723 0
27/04/2012
Ethics approval number [2] 295723 0
NMRR-11-1074-10358
Ethics committee name [3] 295724 0
Institute for Health Management (IHM)
Ethics committee address [3] 295724 0
Ethics committee country [3] 295724 0
Malaysia
Date submitted for ethics approval [3] 295724 0
20/12/2011
Approval date [3] 295724 0
12/04/2012
Ethics approval number [3] 295724 0
10358

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1023 1023 0 0
/AnzctrAttachments/371265-Ethical Approval for iCaPPS vs CC Trial .pdf (Ethics approval)
Attachments [2] 1024 1024 0 0
/AnzctrAttachments/371265-Phd Proposal Dec 2011 final.doc (Protocol)
Attachments [3] 1025 1025 0 0
/AnzctrAttachments/371265-Pt Info Sheet .docx (Participant information/consent)
Attachments [4] 1026 1026 0 0
/AnzctrAttachments/371265-APSC2016ABS-PSD.pdf (Publication)
Attachments [5] 1030 1030 0 0
/AnzctrAttachments/371265-THE ISPOR HEALTH CARE RESEARCH INDEX - Details.pdf (Publication)
Attachments [6] 1031 1031 0 0
/AnzctrAttachments/371265-ISPOR 2016.pdf (Publication)

Contacts
Principal investigator
Name 68118 0
Prof Dato' Dr Syed Mohamed Aljunid
Address 68118 0
Professor and Chair
Department of Health Policy & Management
Faculty of Public Health
Kuwait University

Professor of Health Economics and Public Health Medicine
International Centre for Casemix and Clinical Coding
Faculty of Medicine
Universiti Kebangsaan Malaysia
56000 Cheras
Kuala Lumpur, Malaysia
Country 68118 0
Malaysia
Phone 68118 0
+603 9184 6986
Fax 68118 0
+603 2050 2629
Email 68118 0
saljunid@gmail.com
Contact person for public queries
Name 68119 0
Dr Aznida Firzah Abdul Aziz
Address 68119 0
Department of Family Medicine
14th Floor, Preclinical Block
UKM Medical Centre
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
Country 68119 0
Malaysia
Phone 68119 0
+603 9145 6117
Fax 68119 0
+603 9145 9479
Email 68119 0
draznida@ppukm.ukm.edu.my
Contact person for scientific queries
Name 68120 0
Dr Aznida Firzah Abdul Aziz
Address 68120 0
Department of Family Medicine
14th Floor, Preclinical Block
UKM Medical Centre
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
Country 68120 0
Malaysia
Phone 68120 0
+603 9145 6117
Fax 68120 0
+603 9145 9479
Email 68120 0
draznida@ppukm.ukm.edu.my

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe adaptation and validation of the satisfaction with stroke care questionnaire (Homesat) (SASC10-My™) for use in public primary healthcare facilities caring for long- term stroke survivors residing at home in the community2020https://doi.org/10.1186/s12955-020-01450-9
Dimensions AIThe integrated care pathway for managing post stroke patients (iCaPPS©) in public primary care Healthcentres in Malaysia: impact on quality adjusted life years (QALYs) and cost effectiveness analysis2020https://doi.org/10.1186/s12877-020-1453-z
N.B. These documents automatically identified may not have been verified by the study sponsor.