Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00796042 |
| Other study ID # |
ONF-2004-SCI-SC-01 |
| Secondary ID |
ONF-2004-SCI-SC- |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
November 21, 2008 |
| Last updated |
June 4, 2012 |
| Start date |
January 2008 |
| Est. completion date |
January 2010 |
Study information
| Verified date |
June 2012 |
| Source |
University of Western Ontario, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Health CanadaCanada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial Summary
People with spinal cord injuries posses many factors that increase their risk of developing
pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury
(SCI) will experience a pressure ulcer at sometime during their life. Earlier guidelines for
the assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that
"a client who has a pressure ulcer on a seating surface should avoid sitting."
Unfortunately, this recommendation has fueled the long standing view that people with
pressure ulcers should stop using their wheelchairs and return to bed. The strength of
evidence assigned for this recommendation was Level=C reflecting the paucity of research
evidence to support this common practice. Not only do the benefits of bed rest on healing
remain to be demonstrated, there is mounting evidence that bed rest can be harmful to a
person's overall health and well being. Bed rest has been shown to be strongly associated
with complications in most body systems including respiratory, cardiovascular,
musculoskeletal, cerebrovascular, gastrointestinal, and genital-urinary. Psychosocial
complications and cognitive impacts are also well documented. Without evidence to dispel the
myth that "bed rest is best" it will be difficult to change practice and avoid many of the
secondary complications. This study is a pilot study to 1) determine whether pressure ulcers
heal faster in individuals with SCI who receive an individualized community-based, pressure
management and mobility program compared to a similar group assigned to usual care (bed
rest), 2) determine the strength of the association between the intervention
(pressure/mobility or bedrest) and wound healing, motor performance/independence and quality
of life while adjusting for motivation to regain independence, degree of caregiver burden,
and compliance with the intervention, 3) determine whether individuals with SCI who
participate in a pressure/mobility management program experience fewer secondary
complications than those who do not participate, 4) determine the cost-effectiveness of
providing a time-efficient, pressure management and mobility program compared to bed rest.
Description:
Hypothesis: Individuals with SCI who have pressure ulcers who receive an individualized,
community-based, pressure management and mobility program will have better outcomes compared
to a similar group of individuals who remain on bed rest (usual care).
Specific Objectives
1. To determine whether pressure ulcers heal faster in individuals with SCI who receive an
individualized community-based, pressure management and mobility program compared to a
similar group assigned to usual care (bed rest).
2. To determine the strength of the association between the intervention
(pressure/mobility or bedrest) and wound healing, motor performance/independence and
quality of life while adjusting for motivation to regain independence, degree of
caregiver burden, and compliance with the intervention.
3. To determine whether individuals with SCI who participate in a pressure/mobility
management program experience fewer secondary complications than those who do not
participate
4. To determine the cost-effectiveness of providing a time-efficient, pressure management
and mobility program compared to bed rest.
5. To formally evaluate our ability to successfully recruit eligible patients into the
full study.
6. To determine the barriers and facilitators to successful implementation of a pressure
management and mobility program from the perspective of the client, caregiver, and
health care provider.
7. To use our experiences individualizing pressure management and mobility programs to
develop a preceptorship/mentorship training program for community-based
pressure/mobility management that can be transferred to other regions in Ontario
through distance education.
Study Design: This pilot study is a double-blind, parallel group, randomized controlled
cross-over design that will be conducted in two centres over a 1.5 year period. Rigorous
pilot data will ensure that our intervention has sufficient potential to warrant further
investigation, will determine whether our protocol is feasible. As such, the methods and
data collection strategies laid out in this protocol are meant to mimic the full trial.
Sample population We will enroll twenty individuals with SCI living in each of the two sites
(Toronto (n=10) and London (n=10)) who have a Stage II to IV pressure ulcer(s) and meet the
eligibility criteria.
Screening assessment: A research assistant will contact volunteers who consent to
participate in the study and assess the subject's willingness to undergo a medical and wound
assessment to determine study eligibility. She/he will collect, information on SCI injury,
demographics, current level of activity, wheelchair use, and wound history. This will entail
a phone interview and home assessment and the research assistant will schedule the clinic
visit to assess eligibility. For subjects who are interested in learning more about the
study, the research assistant will schedule the clinic visit to assess eligibility.
Wound Assessment: We will arrange transportation to the wound management centre where the
subject's eligibility for study participation (see Inclusion/Exclusion criteria) will be
determined. The subject's current medical status and pressure sore(s) will be assessed by
research personnel including a qualified wound care specialist and she/he will record
detailed wound history, determine wound extent and severity, and assess the likelihood that
the wound will heal over the 8 month study period. As part of this medical screen, a blood
sample will be drawn and wound swab will be obtained and analyzed for key determinants of
healing (metabolic disorders, anemia, nutritional deficiencies, infection). From this
assessment, we will develop a treatment plan to optimize wound environment, provide
nutritional supplementation, and modify factors interfering with healing.
Assignment of subjects to study groups: Following wound assessment, we will randomize ten
eligible subjects from each study centre (London and Toronto) who meet eligibility criteria
using the Zelen method whereby randomization to treatment group occurs prior to subject
consent for participation. Those subjects allocated to intervention group will be asked to
consent to participation in a randomized trial comparing usual care to a pressure management
and mobility program. They will be informed that they have been randomized to receive the
pressure management and mobility program. Those subjects allocated to usual care will be
asked to consent to participate in a long-term prospective natural history study to document
the effects of bed rest in individuals who have SCI and pressure wounds. This method of
randomization reduces the considerable risk of producing a biased estimate of the effect of
treatment since patients assigned to usual care are likely to feel that other study
participants are receiving better care (despite the lack of evidence to support this
notion). This method of blinding the patient is especially important in trials with
subjective and self-report outcome measures.
Using data obtained from the assessment at the wound centre, the randomization scheme will
be stratified according to two key determinants of healing; wound severity (Stage of
pressure ulcer II, III, IV); 2) and the presence or absence of 2 or more abnormal blood
values to ensure that the potential confounding affect on wound healing is equally dispersed
between treatment groups. Randomization will take place using the 24-hour web-based
randomization system at the Fowler Kennedy Methods Centre. The computer will provide the
caller with a group allocation to usual care or to the pressure management and mobility
program.
Group 1: Usual Care: Subjects who are randomized to usual care will be encouraged to
implement the standard wound care protocol that is consistent with the National (CAWC)and
Provincial (RNAO) best practice guidelines for the treatment of pressures ulcers. This wound
care program will be customized to subject's needs based on the results of the assessment
performed by the wound care specialist. It will address medical, psychological, and
nutritional factors interfering with wound healing and optimize the wound environment. A
registered dietitian will review blood values associated with nutritional status and make
recommendations for dietary changes. Wherever possible, implementation of this wound care
program will be coordinated with the subjects' current health care team and appropriate
referrals to home care agencies or specialists will be initiated where needed. Subjects
assigned to this group will continue their current level of activity (bed rest). For the
purpose of this study we have defined bed rest as a significant reduction in patient's
normal activity level that involves more than 12 hours per day in bed. Any equipment or
services will be obtained through the usual provider agencies and documented as part of the
associated wait times. All study subjects who volunteer to participate in this screening
process will receive a written report that summarizes the findings of these assessments.
Included in this report will be an explanation of factors that interfere with healing and
recommendations of how to modify home or wound environment to promote wound closure and
limit current and future problems with skin integrity. Provided the study subject is in
agreement, we will relay this information to health care professionals and administrators
involved in the subject's circle of care.
Group 2: Individualized, Community-based, Pressure management and Mobility program: Subjects
allocated to this group will be provided with the same customized wound care program as the
usual care group and a pressure management and mobility program that is customized to the
individual's needs. This program will be based on an in depth home environmental
assessment(s) performed by a registered Occupational (OT) and/or Physical Therapist (PT)
trained as part of the research study and will be implemented within one month of
randomization.
Pressure Management program: A qualified OT or PT will examine the subject on all in-use
surfaces including bed, toilet/commode, and shower chair, conduct a detailed wheelchair
assessment including pressure mapping technology (X3 Pressure Mapping System, (Xsensor
Technology Corporation, Calgary, Canada) and observe all transfers on and off all surfaces
to identify sources of friction and shear, and any strength or balance deficits. The subject
will be asked to record their activity level by completing a diary to record daily
activities over a three day period including all surfaces used, duration on each surface and
the number and type of transfers completed throughout the day. From this detailed 1-2 hour
home assessment, the OT/PT apprentice will identify what equipment and services are required
to manage pressure, improve mobility, and reduce friction and shear. Through collaboration
with sponsoring company's (Waverly Glen, Shoppers Home Health, and The Roho Group). This
program might include rental or purchase and installation of necessary equipment or
supplies, modification of existing equipment, and follow up to provide required
re-adjustments.
Mobility Program: We will contract services of a qualified Physical Therapist to assess
strength, balance, range of motion, and functional independence with transfers and other
ADLs. The subject will be asked to perform activities to classify their current level of
functional independence using the FIM motor scale (FIM). Based on the results of this
assessment she/he will develop a mobility program to optimize functional independence and
improve strength and balance required for safe and effective transfers and bed mobility
including educating the individual and their caregivers how to move with minimal injury to
their skin. Depending on the complexity of the mobility program, delivery of this customized
mobility program may involve training of the existing, community-based Personal Support
Workers (PSW)s or other aids to assist with transfers, supervise strengthening and balance
exercises on a regular basis.
Training of "OT/PT Apprentices" using Distance education methods: technologies A distance
education model will be used to build knowledge, skills and behaviours about pressure
management and rehabilitation of motor function that is needed in community based therapists
- called "OT/PT Apprentices". Two therapists (OT and PT) per site will be selected and
trained to implement an individualized pressure management program for people with SCI who
are living in the community. They will first attend a 2 day workshop provided by L Norton
and P Houghton. Information learned in this session will be reinforced using a
preceptorship/mentorship model together with hands-on experience with subjects enrolled in
the research study. This will begin with joint home visits with Norton and/or Houghton who
will directly supervise their assessments. Subsequently, the OT/PT apprentices will perform
home assessments independently and relay their findings (pressure map, room dimensions,
video clips of subject transfers) electronically. Norton and Houghton will also be available
by mobile phone should any questions arise during the assessments. Computer based distance
learning technology (WebCT) will be used to access key articles & resources, and participate
in asynchronous and synchronous discussion groups between instructors (Houghton & Norton)
and Apprentices (n=4 OT or PTs). This form of eductation is know to will help foster
clinical reasoning skills22-24 needed to problem solve many of the roadblocks that are
anticipated with program implementation. This education program will be modified and
improved throughout the study in accordance with therapist feedback and needs as identified
and will inform our sixth and seventh objective.
Data & Statistical Analysis Primary Objective 1 - Wound Healing: We will calculate the
percentage reduction in wound surface area for each subject by subtracting the initial wound
surface area from the surface area measured at the primary endpoint - 5 months post
randomization -following 3 months of the pressure management and mobility program
(intervention group) or bed rest (usual care group). We will calculate the mean percentage
reduction in wound surface by treatment group and determine whether the difference between
groups is statistically significant using a t-test. Further, we will use an analysis of
co-variance (where baseline wound surface area is entered as the covariate, wound surface
area at 5 months is the dependent variable and treatment group is the independent variable)
to determine whether there is statistically significant difference in the healing of
pressure ulcers in individuals who receive the pressure management and mobility program
compared to a similar group on bed rest, while controlling for the baseline surface area.
Objective 2 - Motor Function and Quality of Life: Similar to the analysis described above,
we will use an analysis of co-variance (where the baseline measurement is entered as the
covariate, the post-randomization (5 months) measure is the dependent variable and treatment
group is the independent variable) to determine whether there is statistically significant
difference in the quality of life (SF-12, Cardiff Wound Impact Questionnaire) in individuals
who receive the pressure management and mobility program compared to a similar group on bed
rest, while controlling for the baseline score. We will produce a plot to express the change
in quality of life and function by time and assess whether the trajectory of change is
different by group using a repeated measures analysis of covariance. As this is a pilot
study, we expect to be underpowered to make statistical conclusions regarding the size of
the treatment effect with confidence. However, if an important between-groups difference
(20% of the minimally important difference (MID)) is contained within the 95% confidence
intervals around the mean difference between groups, we will conclude that a larger study is
warranted. We will provide the proportion of individuals in each group who achieve their
goals as laid out in the COPM at baseline, calculate the odds of obtaining desired goals in
the pressure management/mobility program compared to usual care and assess whether the
difference in proportions is significant using a Fisher's Exact Test. As this is a pilot
study, the study will be underpowered to confidently examine the strength of the association
between motivation, caregiver burden and compliance on between-group differences. Thus, we
will conduct an exploratory analysis using univariate regression methods to provide a
preliminary estimate of the magnitude of the association so that we can formulate informed a
priori hypotheses about the relationships between outcomes and multiple potential predictor
variables that we will have sufficient power to test formally as part of the full study.
Objective 3 - Secondary Complications We will report the proportion of patients who
experience adverse events by group. Adverse events will be considered any of those
conditions known to commonly occur with bed rest.
Objective 4 - Cost Effectiveness: We will conduct an economic analysis to compare usual care
with a pressure management/mobility program in terms of incremental cost per
quality-adjusted life-year (QALY) gained from the Ministry of Health and societal
perspective. The time horizon of the economic evaluation will be 8 months. To determine the
8 month direct and indirect costs associated with each alternative, resource utilization,
productivity losses, informal care and out of pocket expenditures collected at baseline and
at months 2, 5, and 8 will be valued using public and private sources (e.g. Ontario Schedule
of Benefits for Physician Services, manufacturers). In order to calculate QALYs, utilities
derived from the EQ-5D questionnaire will be weighted by time spent in health states.
Regression analyses will be used in calculating QALYs to adjust for any potential
differences in baseline utility values between the 2 groups.
Objective 5 Subject Recruitment: To inform our fifth objective, we will report the number of
eligible patients from each source and calculate the proportion of eligible patients who are
willing to participate in the study.
Objectives 6 and 7 Experiences: We will review diaries of subjects, caregivers, and
therapists to optimize and streamline delivery of this program. Utilization of the methods
centre as a remote, web-based, data management system will be informed by feedback from
research personnel. The distance education program will be modified and improved throughout
the study in accordance with "OT/PT apprentices" suggestions and needs.
Other known NCT identifiers
