Clinical trial NCT01739803: Behavioral Contract Adherence Intervention
Official title: Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Keywords: Immunosuppressant therapy adherence
Quality of life
Economic outcomes
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.


Eligibility criteria: Inclusion Criteria:

* renal transplant recipient
* at least 21 years of age
* receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus
* be at least one year post-transplant
* obtain immunosuppressant therapy from Avella Specialty Pharmacy for at least one year prior to study enrollment and during the study period

Exclusion Criteria:

* pregnant
* prisoner
* institutionalized
* unable to give informed consent

Primary outcomes:
measure: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period
timeFrame: 12 months
Secondary outcomes:
measure: Health-related Quality of Life (HQoL)
timeFrame: 12 months
measure: Days in Hospital
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Pharmacy
state: Arizona
Study officials:
affiliation: University of Tennessee College of Pharmacy
name: Marie A Chisholm-Burns, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chisholm-Burns MA, Erickson SR, Spivey CA, Gruessner RW, Kaplan B. Concurrent validity of kidney transplant questionnaire in US renal transplant recipients. Patient Prefer Adherence. 2011;5:517-22. doi: 10.2147/PPA.S24261. Epub 2011 Oct 13.
citation: Chisholm-Burns MA, Erickson SR, Spivey CA, Kaplan B. Health-related quality of life and employment among renal transplant recipients. Clin Transplant. 2012 May-Jun;26(3):411-7. doi: 10.1111/j.1399-0012.2011.01541.x. Epub 2011 Oct 28.
citation: Chisholm-Burns MA, Spivey CA, Graff Zivin J, Lee JK, Sredzinski E, Tolley EA. Improving outcomes of renal transplant recipients with behavioral adherence contracts: a randomized controlled trial. Am J Transplant. 2013 Sep;13(9):2364-73. doi: 10.1111/ajt.12341. Epub 2013 Jul 2.
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.