Trial Outcomes & Findings for Behavioral Contract Adherence Intervention (NCT NCT01739803)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

12 months

Results posted on

2014-02-07

Participant Flow

RTRs were enrolled between January 2010 and September 2011 and followed for one year (the study or intervention period). All active participants completed the study by September 2012; however, refill records were collected for three months following the end of the study period to calculate a follow-up (post-intervention) adherence rate.

Inclusion criteria: (a) at least 21 years of age; (b) at least one year post-transplant to allow for stabilization of the prescribed IST regimen; (c) receive an immunosuppressant regimen that contains oral tacrolimus or cyclosporine; and (d) obtain their IST from Avella for at least one year prior to study enrollment and during the study period.

Participant milestones

Participant milestones
Measure	Intervention Group Behavioral contract intervention. Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated. The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence	Control Group No intervention. The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence "packet" consisting of adherence-focused educational pamphlets and a pillbox
Overall Study STARTED	76	74
Overall Study COMPLETED	67	68
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group Behavioral contract intervention. Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated. The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence	Control Group No intervention. The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence "packet" consisting of adherence-focused educational pamphlets and a pillbox
Overall Study Lost to Follow-up	9	6

Baseline Characteristics

Behavioral Contract Adherence Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=76 Participants Behavioral contract intervention	Control Group n=74 Participants No intervention	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	52.78 years STANDARD_DEVIATION 13.55 • n=5 Participants	51.32 years STANDARD_DEVIATION 13.69 • n=7 Participants	52.06 years STANDARD_DEVIATION 13.59 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	74 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intention to treat, as per protocol

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=76 Participants Behavioral contract intervention	Control Group n=74 Participants No intervention
Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period	0.88 medication possession ratio (proportion) Standard Deviation 0.17	0.81 medication possession ratio (proportion) Standard Deviation 0.18

SECONDARY outcome

Timeframe: 12 months

The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting "no problems," "some problems," and "extreme problems." A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.

Outcome measures

Outcome measures
Measure	Intervention Group n=67 Participants Behavioral contract intervention	Control Group n=68 Participants No intervention
Health-related Quality of Life (HQoL)	0.84 units on a scale Standard Deviation 0.17	0.85 units on a scale Standard Deviation 0.18

SECONDARY outcome

Timeframe: 12 months

We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit. Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period.

Outcome measures

Outcome measures
Measure	Intervention Group n=67 Participants Behavioral contract intervention	Control Group n=68 Participants No intervention
Days in Hospital	51 percentage of participants 0.22	29 percentage of participants 0.99

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie Chisholm-Burns

University of Tennessee College of Pharmacy

Phone: 901-448-7141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place