Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Usual care; Pressure management and Mobility program
Intervention type(s): Other; Other
Intervention description(s): Subjects 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. 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). Any equipment or services will be obtained through the usual provider agencies.; Subjects are 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 is based on an in depth home assessment performed by a registered Occupational (OT) or Physical Therapist (PT). Pressure Management Program: A qualified OT or PT will examine the subject on all in-use surfaces and observe all transfers to identify sources of friction and shear, and any strength or balance deficits, identifying what equipment/services are required to manage pressure, improve mobility, and reduce friction and shear. Mobility Program: A qualified PT will assess strength, balance, range of motion, and functional independence with transfers and other ADLs and will develop a mobility program to optimize functional independence and improve strength and balance required for safe and effective transfers. Program to be implemented within one month of this evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pressure Ulcer; Bed Sores; Bedsore; Decubitus Ulcer; Pressure Sore; Best rest; mobility; pressure management