a telerehabilitation intervention for persons with …...spinal cord injury (sci), particular...

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SCI BRIEF REPORT A Telerehabilitation Intervention for Persons with Spinal Cord Dysfunction ABSTRACT Houlihan BV, Jette A, Paasche-Orlow M, Wierbicky J, Ducharme S, Zazula J, Cuevas P, Friedman RH, Williams S: A telerehabilitation intervention for persons with spinal cord dysfunction. Am J Phys Med Rehabil 2011;90:00Y00. Pressure ulcers and depression are common preventable conditions secondary to a spinal cord dysfunction. However, few successful, low-cost preventive ap- proaches have been identified. We have developed a dynamic automated tele- phone calling system, termed Care Call, to empower and motivate people with spinal cord dysfunction to improve their skin care, seek treatment for depression, and appropriately use the healthcare system. Herein, we describe the design and development of Care Call, its novel features, and promising preliminary results of our pilot testing. Voice quality testing showed that Care Call was able to understand all voice characteristics except very soft-spoken speech. Importantly, pilot study subjects felt Care Call could be particularly useful for people who are depressed, those with acute injury, and those without access to quality care. The results of a randomized controlled trial currently underway to evaluate Care Call will be available in 2011. Key Words: Spinal Cord Injuries, Telemedicine, Pressure Ulcer, Depression P ressure ulcers and depression are common preventable secondary condi- tions for people with spinal cord dysfunction (SCD). Unfortunately, diagnosis and/or treatment of secondary conditions is often delayed. 1Y4 This can under- mine rehabilitation and have a significant impact on a person’s quality-of-life and his/her healthcare costs. 5Y8 A patient’s self-care behavior can impact the onset and severity of secondary conditions after an SCD. Pressure ulcers, for example, can be prevented through the use of patient education. 9 Depression can be improved and successfully managed if a patient receives treatment. 10 Nonetheless, persons with SCD do not generally receive the necessary follow-up care 11 that could promote self- management behaviors. Patients report various obstacles to complying with self-care management and annual follow-up evaluations, including cost, trans- portation, time, and reluctance to seek treatment, 12 such that they are not being successfully encouraged to prevent or seek treatment for pressure ulcers and depression. Interventions to promote healthy behaviors, which can in turn prevent secondary conditions, are typically resource intensive. 13,14 Telerehabilitation and Authors: Bethlyn Vergo Houlihan, MSW, MPH Alan Jette, PhD, PT Michael Paasche-Orlow, MD, MA, MPH Jane Wierbicky, RN Stan Ducharme, PhD Judi Zazula, MS, OTR/L Penelope Cuevas, MD Robert H. Friedman, MD Steve Williams, MD Affiliations: From the Department of Health Policy & Management (BVH) and the Health & Disability Research Institute (AJ), Boston University School of Public Health; Section of General Internal Medicine, Department of Medicine (MP-O, PC, RHF), and the Department of Physical Medicine and Rehabilitation (SD, SW), Boston University School of Medicine; and the New England Regional Spinal Cord Injury Center (BVH, JW, JZ, SW) and Rehabilitation Medicine (SD), Boston Medical Center, Massachusetts. Correspondence: All correspondence and requests for reprints should be addressed to: Bethlyn Vergo Houlihan, MSW, MPH, New England Regional SCI Center, Boston Medical Center, 732 Harrison Ave, F511, Boston, MA 02118. Disclosures: Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article. Supported by Centers for Disease Control and Prevention grant 5R01DD000155, Department of Health and Human Services. Presented in poster format (portions of content) at the Spinal Cord Injury Contemporary Forums Conference, Orlando, FL, 2009; the American Congress of Rehabilitation Medicine Annual Conference, Denver, CO, 2009; and the International Spinal Cord Society Annual Meeting, Florence, Italy, 2009. 0894-9115/11/9003-0000/0 American Journal of Physical Medicine & Rehabilitation Copyright * 2011 by Lippincott Williams & Wilkins DOI: 10.1097/PHM.0b013e31820b140f www.ajpmr.com Telerehabilitation in Spinal Cord Dysfunction 1 Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

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Page 1: A Telerehabilitation Intervention for Persons with …...spinal cord injury (SCI), particular attention in telerehabilitation interventions has been paid to us-ing telephone contact

SCI

BRIEF REPORT

A Telerehabilitation Intervention forPersons with Spinal Cord Dysfunction

ABSTRACT

Houlihan BV, Jette A, Paasche-Orlow M, Wierbicky J, Ducharme S, Zazula J,

Cuevas P, Friedman RH, Williams S: A telerehabilitation intervention for persons

with spinal cord dysfunction. Am J Phys Med Rehabil 2011;90:00Y00.

Pressure ulcers and depression are common preventable conditions secondary

to a spinal cord dysfunction. However, few successful, low-cost preventive ap-

proaches have been identified. We have developed a dynamic automated tele-

phone calling system, termed Care Call, to empower and motivate people with

spinal cord dysfunction to improve their skin care, seek treatment for depression,

and appropriately use the healthcare system. Herein, we describe the design and

development of Care Call, its novel features, and promising preliminary results of

our pilot testing. Voice quality testing showed that Care Call was able to understand

all voice characteristics except very soft-spoken speech. Importantly, pilot study

subjects felt Care Call could be particularly useful for people who are depressed,

those with acute injury, and those without access to quality care. The results of

a randomized controlled trial currently underway to evaluate Care Call will be

available in 2011.

Key Words: Spinal Cord Injuries, Telemedicine, Pressure Ulcer, Depression

Pressure ulcers and depression are common preventable secondary condi-tions for people with spinal cord dysfunction (SCD). Unfortunately, diagnosisand/or treatment of secondary conditions is often delayed.1Y4 This can under-mine rehabilitation and have a significant impact on a person’s quality-of-lifeand his/her healthcare costs.5Y8

A patient’s self-care behavior can impact the onset and severity of secondaryconditions after an SCD. Pressure ulcers, for example, can be prevented throughthe use of patient education.9 Depression can be improved and successfullymanaged if a patient receives treatment.10 Nonetheless, persons with SCD donot generally receive the necessary follow-up care11 that could promote self-management behaviors. Patients report various obstacles to complying withself-care management and annual follow-up evaluations, including cost, trans-portation, time, and reluctance to seek treatment,12 such that they are not beingsuccessfully encouraged to prevent or seek treatment for pressure ulcers anddepression.

Interventions to promote healthy behaviors, which can in turn preventsecondary conditions, are typically resource intensive.13,14 Telerehabilitation and

Authors:Bethlyn Vergo Houlihan, MSW, MPHAlan Jette, PhD, PTMichael Paasche-Orlow, MD, MA, MPHJane Wierbicky, RNStan Ducharme, PhDJudi Zazula, MS, OTR/LPenelope Cuevas, MDRobert H. Friedman, MDSteve Williams, MD

Affiliations:From the Department of Health Policy& Management (BVH) and the Health& Disability Research Institute (AJ),Boston University School of PublicHealth; Section of General InternalMedicine, Department of Medicine(MP-O, PC, RHF), and the Departmentof Physical Medicine and Rehabilitation(SD, SW), Boston University Schoolof Medicine; and the New EnglandRegional Spinal Cord Injury Center(BVH, JW, JZ, SW) and RehabilitationMedicine (SD), Boston MedicalCenter, Massachusetts.

Correspondence:All correspondence and requests forreprints should be addressed to:Bethlyn Vergo Houlihan, MSW, MPH,New England Regional SCI Center,Boston Medical Center, 732 HarrisonAve, F511, Boston, MA 02118.

Disclosures:Financial disclosure statements havebeen obtained, and no conflicts ofinterest have been reported by theauthors or by any individuals in controlof the content of this article. Supportedby Centers for Disease Control andPrevention grant 5R01DD000155,Department of Health andHuman Services. Presented in posterformat (portions of content) at theSpinal Cord Injury ContemporaryForums Conference, Orlando, FL,2009; the American Congress ofRehabilitation Medicine AnnualConference, Denver, CO, 2009; andthe International Spinal Cord SocietyAnnual Meeting, Florence, Italy, 2009.

0894-9115/11/9003-0000/0American Journal of PhysicalMedicine & RehabilitationCopyright * 2011 by LippincottWilliams & Wilkins

DOI: 10.1097/PHM.0b013e31820b140f

www.ajpmr.com Telerehabilitation in Spinal Cord Dysfunction 1

Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

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related technologies are a promising strategy that,if successful, could improve the quality and reducethe cost of secondary prevention.15 For persons withspinal cord injury (SCI), particular attention intelerehabilitation interventions has been paid to us-ing telephone contact and video monitoring for theprevention and management of pressure ulcers.16,17

However, because telerehabilitation interventionshave not been evaluated, few successful, low-costapproaches that prevent secondary conditions havebeen identified18,19; such a system could bring notonly substantial long-term cost savings but also en-hanced quality-of-life of people with SCD.

With this goal in mind, we have developedCare CallVan innovative telerehabilitation inter-vention system designed to empower and motivatepeople with SCD to improve their skin care andmental health. The system does not replace face-to-face health care, rather, it supplements a clinician’srole in long-term management after SCD. Care Callhas the potential to help significant numbers ofpeople after an SCD using a low-risk, low-cost ap-proach that could be used for long-term patientmonitoring and service provision. If efficacious,this intervention could be offered by clinicians topatients across multiple settings. Herein, we de-scribe the design, development, and initial pilottesting of the Care Call intervention, with the ul-timate goal of informing the final interventionprotocol for an initial randomized controlled trial(RCT) now underway.

METHODSDescription of the Care Call Technology

The Care Call intervention is delivered from theTelephone-Linked Computer System (TLC),20 an au-tomated, interactive conversation system that speakswith a digitized human voice.21 TLC, which func-tions as an at-home monitor, educator, and coun-selor for reinforcing or changing health-relatedbehaviors, has been used to screen and monitor nu-merous diseases22Y27 and has been applied to im-portant health-related behaviors.28 Clinical trialsshow TLC to improve medication adherence,29 in-crease exercise among the general13 and elderlypopulations,30 decrease the degree of dyspnea forpeople with chronic obstructive pulmonary dis-ease,31 and improve eating habits32 and lower serumcholesterol levels through dietary changes.31

TLC uses an interactive voice response systemto generate digitized speech over the telephone, aspeech recognition software, a conversation controlsystem that directs the content and flow of indi-

vidual TLC conversations with users, and a databasemanagement system for storing user informationand call logs. It is a call-in and call-out system; thatis, users can call (from any telephone) at any timeand the system will also call the user according toan adaptive scheduling protocol that reflects howwell a person is doing with his/her self-care. If thesystem initiates a call and no contact is made, itwill leave a message for the person to call TLC andwill call again according to a call schedule protocol.TLC automatically produces reports on utilizationstatistics to assist in system operation, interventionevaluation, and patient monitoring.

Design of the Care Call InterventionThe target population for the Care Call inter-

vention consists of persons with SCD who use awheelchair at least 6 hrs a day. For the Care Callclinical trial, further exclusion criteria were devel-oped, including having nontraumatic SCI diagnoseswith fast progression (amyotrophic lateral sclerosis,postpolio, and metastatic disease of the spine),having severe major depression, and having a stageIII or greater pressure ulcer. In practice, the ap-propriateness of Care Call for subgroups meetingthese exclusion criteria would need to be evaluatedon an individual basis.

We designed the Care Call intervention to (1)screen for pressure ulcers and depressive symp-toms, (2) educate about the prevention of depres-sion and pressure ulcers and the appropriate use ofheath care services, and (3) alert a nurse tele-rehabilitation coordinator (NTC), when appropri-ate, for direct medical or mental health attention.Furthermore, we hypothesized a secondary goal,that Care Call would improve community integra-tion and quality-of-life. Each of these goals is beingevaluated in the RCT. An interdisciplinary team ofrehabilitation professionals developed the content,design, and overall functionality of the Care Callsystem.

The content of the Care Call intervention isbased on the Transtheoretical Model33 and SocialCognitive Theory,34 as well as on the heuristics ofexperienced counselors. The Transtheoretical Modelposits that people at different stages of readiness tomake a desired behavioral change will respond todifferent counseling messages. A fundamental pre-cept in the Social Cognitive Theory is that individ-uals use self-referent thought to mediate betweenknowledge and behavior, which allows them toevaluate their own experiences and thought pro-cesses.35 Through the process of self-evaluation,

2 Houlihan et al. Am. J. Phys. Med. Rehabil. & Vol. 90, No. 3, March 2011

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individuals may alter their own thinking about theirabilities and the outcomes of their actions and sub-sequently alter their behavior.

Care Call targets pressure ulcers and depression,in particular, because of their prominence for peoplewith SCD and their preventability through self-management. The prevalence of pressure ulcers ina community-based sample of individuals with SCDis estimated at 33%.36 Patient education is generallyconsidered paramount for proper prevention ofpressure ulcers.36 The percentage of adults withdisabilities who reported that feelings of depressionkept them from being active was three times that ofthe general population, 28% compared with 7%,respectively.15 Research has shown that TLC tech-nology has been able to successfully change healthbehavior and disease outcomes.13,20,23,32,37 Althoughthere is little research on using TLC to prevent ortreat depression, screening for another sensitivemental health issue, substance use, has proven ef-fective using TLC.25 In addition, several randomizedtrials over the last decade have demonstrated thattelehealth interventions can decrease depressionseverity.38,39

General Description of Care CallThe Care Call scripts are organized into modules

and integrate information relative to three targetedareas: skin care, depression and wellness, andhealthcare utilization. Although most content isdelivered by computer voice, the system also hasrecorded vignettes from people with SCD andrecorded comments from healthcare professionals.Throughout each module, users are referred to localcommunity and informational resources via theCare Call Resource Book (see below).

The Skin Care Module assesses and monitorsold and new skin problems, trains users in skin care,and assesses and monitors risk factors such as in-continence and equipment needs. Care Call reviewsbarriers to skin care adherence to offer specificencouragement and advice.34 To provide individu-alized messages, the system is adapted based on datacollected at baseline (e.g., history of pressure ulcers,consistency of sensation, and level of paralysis) andon responses in previous calls.

The Depression and Wellness Module screens,monitors, and educates users on depression andadjustment. For those with existing untreated de-pression, Care Call provides education and en-couragement to improve their understanding andmanagement of depression. The system assessessatisfaction with treatment and promotes adher-ence. Care Call also has a wellness track for de-

creasing depression in which participants areassessed; educated about exercise, sleep habits, andalcohol use; and offered a brief relaxation exercisethat can be done at any time.

As part of the depression track, a ‘‘Self-harmProtocol’’ was developed for use when a subjectendorsed thoughts of hurting himself/herself withinthe past 2 wks. When used, a follow-up script wouldbe immediately implemented (by Care Call, theNTC, or field staff) to assess a subject’s risk of self-harm. If the subject was found to be at immediaterisk of self-harm, the system or Care Call staff wouldpage an on-call clinical psychologist with the sub-ject’s status. The clinical psychologist would thenreply within 1 hr to assess the situation and contractfor safety, when appropriate. Otherwise, subjectswould be counseled that if they ever began to feellike they could hurt themselves, they should goto the emergency department, and they would beprovided with a national hotline number. In allcases, the NTC follows up within 48 hrs to see howa subject is doing.

The Health Care Utilization Module tracks eachperson’s medical and mental health appointments.Because seeking treatment to prevent these prob-lems is paramount, Care Call both reviews withusers logistical factors before a healthcare visit andcoaches them in communicating with a providerduring a visit. If users miss an appointment, CareCall assesses barriers and offers recommendationsto overcome them.

Care Call integrates audiotaped vignettes fromactual patients with SCD. We recorded interviewswith nine key informants with SCD to illustrate tipsand personal experiences on all three modulartopics. The key informants represented a range ofSCDs (including multiple sclerosis and SCI) andethnic/racial backgrounds (seven white non-His-panic, two black; five men, four women). Users hearat least one audio clip per call, with relevant audioclips embedded throughout. Additional vignettesprovide advice from SCD clinicians.

Lastly, Care Call offers users the opportunitythroughout to speak with the NTC and alerts theNTC to contact the user for follow-up on importantissues that are identified. The main role of the NTCis to respond to Care Call alerts in a timely manner,providing appropriate referral, resources, and/oraction steps for users. Care Call does not act as anemergency responder to medical situations or dis-pense medical advice; the NTC provides an impor-tant triage role to further ascertain the needs ofeach Care Call user beyond the limitations of au-tomated technology. The NTC uses a Web-based

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tracking form to document the length, content, andoutcome of each contact with a user. We developedthree levels of alerts for problems identified in CareCall: emergent (e.g., new skin problem), urgent(e.g., equipment problem), and routine (e.g., oldproblem that user wants to discuss with NTC).When an emergent medical problem is identified,Care Call directs users to contact their physicianimmediately or go to the emergency departmentor call 911. For urgent matters, Care Call tells usersto see their physician as soon as possible and to ask

for proper contact information for urgent medicalproblems at their next office visit (Figs. 1 and 2).

One of the major companions to Care Call is aResource Book that all users receive at enrollment.Care Call and the NTC use this book in each en-counter with participants. The Resource Bookincludes both local resources and informationalresources for topics like medical supplies, mentaland physical health providers, and personal careassistants. Included within the Resource Book is aset of user-friendly forms created by the research

FIGURE 1 Screenshot of the demo version of the Alert Manager, a Web-based tool for the nurse telerehabilitationcoordinator, showing all active alerts (using mock data; mock names have been deleted).

FIGURE 2 Screenshot of active alerts for an individual mock subject in the demo version of the Alert Manager.

4 Houlihan et al. Am. J. Phys. Med. Rehabil. & Vol. 90, No. 3, March 2011

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team which Care Call reviews to help a user preparefor upcoming office visits to a health provider.

A Care Call EncounterA Care Call user typically engages with Care

Call weekly by receiving a call from TLC at an ap-pointed time. Alternatively, a user may call into thesystem at any time to do their regular weekly call,report a new problem, hear the relaxation exercise,or leave a message for the NTC or technical staff.A typical conversation lasts 5 to 20 mins, depend-ing on the patient’s condition. After a uniquepassword is entered, Care Call greets a user and apredetermined sequence of modules is delivered,as illustrated in Figure 3.

After an initial inquiry into any new skin pro-blems, users hear different contents and questionsin each call. User responses from previous encoun-ters and the current encounter shape ensuingquestions and feedback, such that content varies foreach user and within each encounter. Throughoutthe entire conversation, Care Call alerts the NTCas needed and offers relevant patient audio clips, aswell as tips from Care Call.

Pilot TestingWe used three types of testing in Care Call’s

development, the results of which have shaped both

the final intervention and the clinical trial researchprotocol. The first was voice quality testing, whichevaluates Care Call’s ability to process various voicecharacteristics specific to our target population.Participants in the voice quality testing includedfive people with notable voice characteristics (ven-tilator use, pseudobulbar affect, dysarthria, soft-spoken speech, and stuffy nose) and one person withno notable voice characteristics. Testing the feasi-bility of Care Call for differing voice qualities wascrucial for informing the criteria for participationin the clinical trial.

The second approach was pilot testing a betaversion of the Care Call system with nine peoplewith SCD to garner consumer feedback on contentand to uncover any logic errors or technical diffi-culties. The Care Call team then revised the betaversion of the Care Call system to create a finalversion for the trial. Subjects participated in sixcalls focusing on different scripts of the Care Callsystem and provided feedback during an in-depthinterview.

All pilot testing procedures followed the ap-proved protocol of the Boston University MedicalCampus Institutional Review Board, conductedin accordance with the Declaration of the WorldMedical Association. Informed consent was ob-tained from all pilot participants.

FIGURE 3 Flow diagram depicting the architecture of Care Call.

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The final stage involved quality control testingto evaluate the final version of the Care Call inter-vention being deployed for the randomized con-trolled clinical trial, primarily for wording changesor technical errors. Three members of the devel-opment team assumed the identities of mocksubjects with differing baseline characteristics. Areport of unexplored areas of the system was dis-tributed several times as the testing continued toguide testers in which untested pathways to followwith their responses. Pilot testing allowed the de-velopment team to address any possible issues be-fore starting the trial.

RESULTSThe results of the voice quality testing showed

that Care Call was able to understand all voice char-acteristics except very soft-spoken speech. In par-ticular, the TLC system had difficulty hearing andunderstanding the responses of a soft-spoken user.After inquiring twice without being able to under-stand one of the response options provided, thesystem stated that there were technical difficultiesand discontinued the call, per protocol. Voice qualityresults confirmed that the study could enroll sub-jects with a wide range of voice quality.

In the beta test, pilot study subjects found CareCall to be an acceptable intervention overall. Theyfelt that Care Call could be useful particularly forpeople who were depressed, those with a new injury(SCI), and those without access to quality care.Several subjects mentioned repetition of informa-tion but recognized at the same time how this couldbe helpful for those with limited education in, forexample, the topic of skin breakdown. Because oftheir feedback, we staggered content from weekto week to shorten call times and modified contentto acknowledge individual differences in perceivedneed for various recommendations. For instance,one pilot study subject felt that heel protectors didnot apply to him/her and thus did not like that CareCall would continue to suggest use of them andinquire about obtaining them. Care Call was mod-ified to include shoes as heel protectors while inthe wheelchair and to have the nurse follow up witha user rather than having Care Call repeatedlypromote the use of heel protectors.

Lastly, our quality control testing uncoveredsome logic problems in the scripts and identifiedcontent sequences that needed modification tomaintain the utmost sensitivity to the varying cir-cumstances of individuals in the clinical trial. Forinstance, a member of our research team first re-

ported having two new skin problems and was thenasked about the location of each. She imagined oneon either side of her buttocks, yet Care Call did notspecifically probe for this. When asking more abouteach skin problem, Care Call referred to each asbeing on the buttocks without differentiation be-tween the right or the left buttock cheek. This lineof questioning was confusing to the user, who didnot know which problem to report on first.

Clinical experience suggested that most likely,skin problems on the same area of the body wouldbe similar in cause and nature. Barring a total re-write of this script and its logic, this issue was re-solved most efficiently by adding a question withsome instruction to users as follows: ‘‘Are youhaving a skin problem in just one area or in morethan one area? If you’re having problems on bothsides of your body, for example both knees, countthat as one area.’’ Care Call was also revised tosubsequently ask users if they had more than oneskin problem in a particular area (in this case, thebuttocks) to report on the worst skin problem, thusrelieving any confusion or need for differentiation.

In terms of modifying content for sensitivityto individual differences, there was consensus thatlanguage needed to be softened related to feedbackand education on adherence to skin care. Testcallers felt that the weekly repetition of this contentwas reinforcement enough, such that the languageitself should be less forceful, asking users if theywould be willing to try to do more in the weekahead, rather than stating that they should. Thischange also allowed Care Call to be sensitive to thepotential individual circumstances that might pre-vent a user from proper skin care, such as illnessor a death in the family.

DISCUSSIONThe Care Call telerehabilitation approach de-

scribed in this article uses a ubiquitous instrument(the telephone) and, if shown to be efficacious, hasthe potential for widespread dissemination at lowcost. Although automated, TLC programs can suc-cessfully emulate the educational and behavioralcontent, support, and conversational style of ahuman professional.20,21,40 Research to date hasshown that TLC technology in other disease areashas been able to successfully change health behaviorand disease outcomes.31 The preliminary results ofour pilot testing are encouraging. The results of thevoice quality testing showed that Care Call was ableto understand all voice characteristics except verysoft-spoken speech. This problem could, in some

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cases, be alleviated with coaching via three-waycalling on required voice volume levels. Ventilatoruse was not a problem, and the TLC system was ableto appropriately confirm responses for the userwith a stuffy nose and cough. And, importantly, pilotstudy subjects felt that Care Call could be usefulparticularly for people who are depressed, those witha new SCI, and those without access to quality care.

The results of an RCT evaluating the Care Callintervention will be available in 2011. The final in-tervention protocol was shaped in important waysby pilot testing the results. In the trial, interventionsubjects receive weekly calls for 6 mos. Because ofpilot testing, we were able to decrease the lengthof calls by removing some marginal content andstaggering modules across calls. For instance, weremoved most of a script that attempted to assesspossible bowel leakage problems in detail because wefound that this problem is so individualized that it isbetter to ask generally about whether the problemexists and then let the NTC follow up to further as-sess and make appropriate recommendations andreferrals. We also ended up staggering modules todecrease call length from 30 mins to 15 mins, onaverage, with some individual variation based onchoosing to hear optional content and/or need forfollow-up from previously identified issues.

Different types of follow-up care have been de-veloped to fill the gap in the continuum of rehabil-itative care, especially for people with lifelong healthneeds, such as people with SCD. A systematic reviewof the literature in 2005 on follow-up care for peoplewith SCI in the community showed that the mostimportant methods have been telemedicine, out-patient consulting hours, home visits, or a combi-nation of methods.16 Because the quality of thesestudies was generally low, the authors were not ableto draw conclusions as to the effect of these follow-upinterventions on secondary conditions or long-termcosts of care. Another systematic review of the lit-erature in 2006 on preventing pressure ulcersshowed that there were few well-designed RCTs fol-lowing standardized criteria and providing data oncost-effectiveness,41 suggesting that more need tobe developed. As technology continues to advance,experts and clinicians are looking to the field oftelehealth to fill this gap.14 These technologies offeraccessibility to potentially highly effective behaviorchange interventions at low cost. For instance, theTLC-Hypertension trial was the first telehealthchronic disease application to be evaluated in arandomized clinical trial, involving 267 elderly,poorly controlled hypertensive patients. Mean ad-justed diastolic blood pressure decreased signifi-

cantly; 69% of TLC users rated TLC in the upperquartile of satisfaction on a visual analog scale,whereas the cost per patient user for 6 mos of usewas $32.50.29

There are limitations to TLC technology andthe Care Call intervention that must be noted. First,because TLC is an automated system, technicalerrors of varying kinds can occur (e.g., the systemdoes not always recognize the user’s responses oraccept responses that it is not prepared to hear). Toaddress this, technical staff needs to be availableto assist users, and all calls should be logged lineby line on a server to record any errors in detail forproper follow-up. In addition, the system is limitedto the conversational pathways that were designed;it cannot truly take each individual user’s situationinto account or discuss any topic that the user isinterested in pursuing. This means that Care Callmay be advocating for a certain behavior that isnot appropriate or not perceived to be relevant toa particular user. The system includes statementsto explain these limitations, but users may stillultimately be frustrated at times. The extent towhich this limits the impact of the system is anempirical question about which we will learn fromour clinical trial.

CONCLUSIONCare Call is designed to reduce the incidence

and severity of secondary conditions such as pressureulcers and depression, to be relevant across multipleconsumer settings, and to facilitate long-term mon-itoring. The system is a low-risk, inexpensive inter-vention that could be widely disseminated. Resultsof pilot testing of Care Call demonstrated the inter-vention’s feasibility for a wide variety of voice quali-ties and its general acceptability by consumers, withsome minor content and logic changes. Pilot testingalso allowed the team to uncover important contentand logic changes that improved the system. Thesefindings resulted in a stronger intervention andprotocol for the clinical trial of Care Call.

Experience from the RCT will establish ifpeople with SCD will use the Care Call system andif the intervention will successfully promote self-management in a cost-effective manner.

ACKNOWLEDGMENTS

We acknowledge Dr Dave Rosenblum andMercedes Martinez for their contribution to thedesign and development of the Care Call interven-tion; Sippy Olarsch and Kelsey Williams for assist-ing with the development of the Web-based tools;

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and the Medical Systems Information Unit team fortechnical guidance and support throughout.

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