Behavioral Contract Adherence Intervention

NCT01739803 | Completed Results DMC

• 1 other identifier: 7R01DK081347-04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation

Keywords

Immunosuppressant therapy adherence; Quality of life; Economic outcomes

Outcome Measures

Primary Outcomes (1)

• Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period

  Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows: 1 - \[(Days Between Refills - Total Days Supply)/Days Between Refills\] = Adherence Rate for Quarterly Time Period At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period.

  12 months

Secondary Outcomes (2)

• Health-related Quality of Life (HQoL)

  12 months

• Days in Hospital

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral contract intervention

Behavioral: Behavioral Contract

Control Group

NO INTERVENTION

No intervention

Interventions

Behavioral Contract BEHAVIORAL

Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Arizona College of Pharmacy

Tucson, Arizona, 85721, United States

Location

Related Publications (4)

• 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.

  PMID: 22114465 BACKGROUND

• 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.

  PMID: 22032257 BACKGROUND

• 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.

  PMID: 23819827 RESULT

• 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.

  PMID: 36094829 DERIVED

Limitations and Caveats

Did not include attention control group. Did not employ multiple study pharmacists to perform intervention. Limitations of pharmacy refill records: accuracy may be affected by dosage changes, do not indicate if drug actually consumed as prescribed.

Results Point of Contact

• Title: Marie Chisholm-Burns
• Organization: University of Tennessee College of Pharmacy

mchisho3@uthsc.edu

901-448-7141

Study Officials

• Marie A Chisholm-Burns, PharmD

  University of Tennessee College of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 7, 2014
• Results First Posted: February 7, 2014

Record last verified: 2013-12

Locations

US (1)