Text Messages for Liver Transplant Recipients
Condition: Medication Adherence; Liver Transplant Disorder
Study type: Interventional

Summary: 
      Although medical advancements have enabled children experiencing liver transplants to live
      longer, medical management post-transplant is ongoing and complex. Many findings underscore
      adolescents as being a particularly vulnerable population, with rates of nonadherence being
      four times higher than in adults. This pilot study aims to explore the feasibility and impact
      of a brief text-messaging intervention in a randomized controlled trials (N = 50). We have
      three primary aims: 1) Study patient satisfaction with and utilization of this intervention
      in order to better understand feasibility and acceptability; 2) Investigate the effects of
      this intervention on medication adherence, healthcare utilization, and health status; and 3)
      Examine potential effects of the intervention on the physician-patient relationship,
      motivation for adherence, and other variables.
    

Detailed description: 
      The proposed randomized control pilot study will be based at the Liver Transplant Clinic at
      CHLA. Approximately 25 participants will be randomly assigned to the intervention arm,
      whereas 25 participants will be assigned to treatment as usual (TAU), for a total sample size
      of N = 50. As there are approximately 90 patients who meet inclusion criteria currently in
      care, recruiting 50 for this study is feasible. The intervention will last for six months.
      During this time, participants in the intervention arm will receive a brief text-message on
      their cell-phones whenever laboratory blood tests indicate that immunosuppressant medications
      are within the expected range. This will primarily be measured via trough levels of
      calcineurin inhibitors, but will also take into account complete blood count, comprehensive
      metabolic panel, and magnesium level results, as reviewed by the transplant physician. The
      purpose of these text messages is to alert participants that physicians are indeed checking
      participant liver levels and recognizing when participants are putting in the work to keep
      themselves healthy. Multiple standardized text messages will be created so that participants
      do not receive identical ones each time. An example text message may include "Your liver
      levels have been checked and look good. The effort you are putting into taking your meds
      shows!" Participants in the TAU arm will not receive any text messages.If trough levels or
      any other study measure indicates possible nonadherence, nonadherence will still be addressed
      by their physicians, social work, or whatever is indicated per clinic standard of care.
      Furthermore, additional psychosocial or medical support will not be withheld from patients
      whose labs indicate nonadherence for either the intervention or TAU arms.

      All participants will complete questionnaires at four points: Baseline, mid-way through the
      intervention period (three-months), immediately after the conclusion of the intervention
      (six-months), and three months post-intervention. Participants will complete self-report
      measures assessing medication adherence (Visual Analogue Scale), participants' sense of trust
      in their medical providers (Trust in Physician Scale) and motivation for medication adherence
      (Rollnick's Readiness Ruler). In addition, participants will complete self-reported measures
      of anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), and
      socioeconomic status (Family Affluence Scale II). Several variables will also be abstracted
      from the electronic medical record, from one year prior to study enrollment to one year post
      study enrollment. At the end of the intervention, participants will complete an exit survey
      assessing its feasibility and acceptability. They will be asked to discuss which components
      of the intervention were most helpful, so this information can be used for possible
      dismantling study approaches in the future. Twenty-five participants will also be randomly
      selected and asked to participate in a 30-60 minute telephone interview in order to assess
      feasibility and acceptability of the study, as well as gain their insight regarding
      potentially helpful future interventions. Medical or psychosocial support will not be
      withheld from patients who drop out of the study or do not complete study measures. All data
      will be collected via Redcap, a HIPAA-compliant on-line platform that will allow participants
      to complete measures securely on-line at home.
    

Intervention name(s): Praise Text Messages
Intervention type(s): Behavioral
Intervention description(s): Texting messages with praise content, to positive reinforce medication adherence
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Care Provider)
Primary purpose: Supportive Care