Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial

BMJ Open, 2016 · DOI: 10.1136/bmjopen-2015-010350 · Published: March 1, 2016

Spinal Cord Injury Rehabilitation Public Health

Simple Explanation

This study aims to assess whether a low-cost, community-based care model can help prevent serious complications and reduce mortality among people with spinal cord injuries (SCI) in Bangladesh after they leave the hospital. The study involves providing regular telephone support and a few home visits from healthcare professionals to SCI patients in the intervention group, while the control group receives standard care without regular contact. The primary goal is to determine if this community-based care model can lower the rate of death from all causes within two years compared to standard care alone.

Study Duration

5 years

Participants

410 wheelchair-dependent people with recent SCI

Evidence Level

Level 1: Pragmatic randomised controlled trial

Key Findings

1
The primary hypothesis is that the community-based model of care will be more effective than standard care in reducing all-cause mortality at 2 years.
2
The secondary hypotheses are that the community-based model of care will be more effective than standard care in decreasing the burden of complications, decreasing the prevalence and severity of pressure ulcers, decreasing depression, improving quality of life, improving independence and increasing participation.
3
In addition, it is hypothesised that the community-based model of care will be cost-effective from a health provider perspective.

Research Summary

The CIVIC trial aims to evaluate the effectiveness and cost-effectiveness of a community-based care model for wheelchair-dependent individuals with SCI in Bangladesh after hospital discharge. The study employs a pragmatic randomised controlled trial, comparing an intervention group receiving telephone-based support and home visits to a control group receiving standard care. The primary outcome is all-cause mortality at 2 years, with secondary outcomes including burden of complications, pressure ulcer prevalence and severity, depression, quality of life, independence, and participation.

Practical Implications

Inexpensive Care Models

The results of this trial will have implications for the development of inexpensive models of care for people with spinal cord injury and possibly also other causes of physical disability in low- and middle-income countries.

Healthcare Service Provision

Evidence of effectiveness and cost-effectiveness will have widespread implications for provision of health services for people with SCI and other conditions that cause serious disability in low-income and middle-income countries.

Community-Based Care

Findings could promote the adoption of similar community-based care models in other low-resource settings to improve outcomes for individuals with SCI.

Study Limitations

1
The trial is being conducted from one specialised spinal cord injury unit in Bangladesh, which may not be representative of all people with spinal cord injury or hospitals in low-income and middle-income countries.
2
The healthcare provider perspective in the cost-effectiveness analysis is limited and does not capture all costs borne by people with SCI or society.
3
Bangladesh does not have a death registry so the date of death will be conﬁrmed by interviewing next of kin or carers at 2 years.

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