Medication AdherencePACTNCT00848224
Improving Adherence to Pharmacological Treatment
A study testing systems-based and pharmacist-mediated program in people with Medication Adherence, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the National Cholesterol… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- systems-based and pharmacist-mediated program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- was between 30 and 85 years of age;
- had known CHD, defined as the presence of at least one coronary lesion at coronary angiography of >50%.
Who cannot join
- was unable or unwilling to give informed consent;
- had a history of intolerance to two or more statin drugs;
- planned to move out of the area within one year of recruitment;
- had a poor prognosis such that life expectancy was thought to be <5 years;
- had a psychiatric illness which limited ability to participate; or
- had no telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
The overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.
Read the detailed description
Patients were randomly assigned to a usual care condition which consisted of patients provided with usual care only, or to the Special Intervention (SI) condition. The intervention was implemented and coordinated by pharmacists, who utilized for tracking and communication the Lotus Notes®-based system that was developed for the project.
- Conditions
- Medication Adherence
- Being tested
- systems-based and pharmacist-mediated program
- Keywords
- coronary heart disease, lipid lowering medication, NCEP guidelines
- Medical subject headings
- Medication Adherence, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systems-based and pharmacist-mediated programBehavioural
Also called Patient-centered counseling
Patients in the SI were seen by a study pharmacists prior to discharge to establish a relationship with the patient, explain the pharmacist's role in the study, provide education about all discharge medications and a medication card listing all medications and their manner of use, and set the framework for the follow-up telephone calls. Patients received pharmacist-delivered adherence counseling telephone contacts that took place at two weeks following discharge, and at months 1, 3, 6, and 9 oriented towards assisting patients to remain adherent to prescribed lipid-lowering and other medications, and also towards ensuring that all patients were either documented to be at the LDL-C goal, or were assisted to reach the goal by facilitating the scheduling of repeat lipid measurement as needed and providing information, guidelines and prompts to the patient's physician or nurse practitioner.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Not described Receives: Behavioral: systems-based and pharmacist-mediated program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl.
Measured: One year
Secondary outcomes (1)
Proportion of prescribed lipid-lowering medication taken by patients as measured by a continuous multiple-interval (CMA) measure of medication availability based on pharmacy records.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startSep 2000
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Ira S Ockene, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848224
- Sponsor's protocol ID
- HL66786
- Acronym
- PACT
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT00848224
- Acronym / sponsor ID
- PACT / HL66786
- Conditions
- Medication Adherence
- Keywords
- coronary heart disease, lipid lowering medication, NCEP guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2000
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.
Detailed description
Patients were randomly assigned to a usual care condition which consisted of patients provided with usual care only, or to the Special Intervention (SI) condition. The intervention was implemented and coordinated by pharmacists, who utilized for tracking and communication the Lotus Notes®-based system that was developed for the project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Behavioral: systems-based and pharmacist-mediated program |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- was between 30 and 85 years of age;
- had known CHD, defined as the presence of at least one coronary lesion at coronary angiography of >50%.
Key exclusion criteria (6 listed)
- was unable or unwilling to give informed consent;
- had a history of intolerance to two or more statin drugs;
- planned to move out of the area within one year of recruitment;
- had a poor prognosis such that life expectancy was thought to be <5 years;
- had a psychiatric illness which limited ability to participate; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systems-based and pharmacist-mediated programAlso: Patient-centered counselingPatients in the SI were seen by a study pharmacists prior to discharge to establish a relationship with the patient, explain the pharmacist's role in the study, provide education about all discharge medications and a medication card listing all medications and their manner of use, and set the framework for the follow-up telephone calls. Patients received pharmacist-delivered adherence counseling telephone contacts that took place at two weeks following discharge, and at months 1, 3, 6, and 9 oriented towards assisting patients to remain adherent to prescribed lipid-lowering and other medications, and also towards ensuring that all patients were either documented to be at the LDL-C goal, or were assisted to reach the goal by facilitating the scheduling of repeat lipid measurement as needed and providing information, guidelines and prompts to the patient's physician or nurse practitioner. | Behavioural | 2 |
Primary outcome
The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl.
Time frame: One year
1 secondary outcome
Proportion of prescribed lipid-lowering medication taken by patients as measured by a continuous multiple-interval (CMA) measure of medication availability based on pharmacy records.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira S Ockene, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systems-based and pharmacist-mediated program in people with Medication Adherence, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.