Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study
Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study
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.
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.
Inclusion Criteria:

 -  Adults (18-80 yrs) with a spinal cord injury (SCI) resulting in quadriplegia or
 paraplegia

 -  Stage II-IV pressure ulcer located anywhere on the body that is likely to heal over
 the 6 month study period.

 -  Requires a wheelchair for locomotion

 -  Able to travel to local wound centre to undergo detailed wound and medical assessment
 that includes blood analysis and wound culture.

 -  Provides consent to access relevant medical records.

 -  Able to adhere with study protocol, pressure management and mobility program, wound
 care protocol, and evaluation procedures for 8 month study period.

 Exclusion Criteria:

 -  Unable to achieve adequate pressure relief using available resources provided by
 research study.

 -  Stage IV deep pressure sore +/- osteomyelitis that requires surgical closure.

 -  Medically unstable or has or any other medical condition that would prevent the
 individual from sitting in wheelchair for at least 2 hours (e.g. Orthostatic
 hypotension).

 -  Has a limited life expectancy that is not sufficient to complete the study.