PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

About three in 10 patients do not go to the pharmacy to get the medicine their doctor has prescribed. Some researchers believe that better communication between patients, doctors, and pharmacists may make it more likely that patients will fill their prescription medicines.

Project Purpose

In this project, researchers tried to figure out why patients do not get their blood pressure medicine. Researchers also created and tested an online guide to help patients make the decision to pick up their blood pressure medicine.

Methods

First, researchers talked to patients, primary care providers, and pharmacists. They asked questions about why patients choose not to get the blood pressure medicines their doctors have prescribed.

The researchers summarized the information from the discussions. They then used it to make an online guide that provided information about high blood pressure and why it is important to pick up and use blood pressure medicine prescribed by a doctor.

Then the researchers tested the online guide in a study with 232 patients. The patients had all dropped off prescriptions for blood pressure medicine at a pharmacy but had not come back to pick them up.

The researchers randomly assigned the 232 patients to three groups. The researchers gave the first group a brochure with information about high blood pressure. Patients in the second group participated in an interview about their views on high blood pressure and taking medications to treat it. Patients in the third group participated in the interview and received the new online guide created by the research team.

After 30 days, the researchers checked pharmacy records to see if the patients had picked up their blood pressure medicine. The researchers compared how many patients in each of the three groups ended up picking up their blood pressure medicine.

Findings

In the discussions, the researchers found several things that might make patients more likely to get their blood pressure medicine, including:

• Patients’ trust in their doctors
• Patients and doctors making healthcare decisions together about how to treat high blood pressure

Doctors and patients liked the idea of having an online guide to help patients understand the importance of getting their medicine. However, in each of the three groups, about the same number of patients picked up their prescriptions; the patients who used the online guide did not pick up their medicine more often than patients in the other groups.

Limitations

This was a small study, and it may not have had enough patients to allow researchers to tell if there were true differences among the three groups. Some people who did not pick up their medicine right away may have picked it up after the study ended. Compared with study participants, people who were not in the study might have different reasons for not getting their medicine.

Conclusions

In the interviews, the researchers learned that patients may be more likely to get their blood pressure medicine when they and their doctors communicate well and work together to make decisions. The researchers found that the group that used the online guide did not get their medicine more often than the other groups.

Sharing the Results

The researchers made the online guide used in this study available on multiple websites. It is available here.

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

Medication nonadherence is prevalent. Although most research about understanding and improving medication adherence has focused on prescription drug use following drug initiation, about 28 percent of patients fail to fill the initial prescription for a new medication. This less well-studied phenomenon is known as primary medication nonadherence. Reframing the initial prescribing event as a time for collaborative discussion between patient and provider, with a shared focus on the patient’s treatment preferences and desired outcomes, can create an opportunity to improve primary medication adherence (PMA).

Project Purpose

In this project, researchers assessed the factors associated with primary medication nonadherence to develop and test a decision support tool for PMA to antihypertensive medications.

Study Design

Researchers conducted four focus groups with 26 patients, three focus groups with 15 primary care providers, and two focus groups with retail pharmacists. Based on the findings from the group discussions, the research team developed a decision support tool through an iterative review process involving the research team and collaborators. The tool then was tested in a pilot randomized controlled trial (RCT).

Participants, Interventions, Settings, and Outcomes

The pilot study involved 232 patients who did not pick up a prescription for a new antihypertensive medication within 14 days of the initial fill date at the pharmacy. Patients with primary medication nonadherence were identified by the research team’s retail pharmacy research partner.

Patients with primary medication nonadherence were randomized into three study groups. The control group received an American Heart Association informational brochure regarding hypertension. Patients in the interview-only group participated in a 30–45 minute interview, and the interview plus decision aid group also received the decision support tool.

The main outcome was defined as a patient’s successful pick-up of any antihypertensive medication during the 30-day follow-up period.

Data Sources

Prescription drug-related baseline characteristics and the PMA outcome were provided by the research team’s retail pharmacy partner.

Data Analysis

Focus groups. Three members of the research team marked and provisionally labeled transcribed recordings and notes of the focus groups by key themes using standard qualitative methodologies. The team then discussed and modified these labels, which became the basis for a coding scheme in which each key theme was defined and illustrated with relevant quotations. Using the agreed-upon coding scheme, the same three team members independently coded notes and transcripts to identify components to include in the shared decision-making tool. Coded results were analyzed using NVivo.

Pilot RCT. The research team calculated the cumulative risk of PMA in each group and compared the cumulative incidence between the study groups using unadjusted chi-square tests. In an intent to treat (ITT) analysis, in which all study patients were included regardless of whether they completed the control survey or participated in an interview, follow-up began on the date of randomization. In an as treated analysis, analyses were restricted to (1) control group patients who returned the survey, with follow-up beginning on the date of the survey’s arrival to the research team; and (2) interview only and interview plus decision aid patients who completed interviews, with follow-up beginning on the dates of the completed interviews. All analyses were completed using SAS 9.1.

Findings

The major themes or findings from the focus group discussions were that a trusting patient–provider relationship and shared decision-making support tool to address the challenges of PMA to antihypertensive medications are attributes that might enhance PMA. Both patients and providers welcomed using decision support tools to improve PMA, but most providers were less confident about their abilities to integrate these tools into practice.

In the pilot RCT, among patients with initial primary nonadherence to an antihypertensive medication, a decision support tool was not effective in improving PMA. In the ITT analysis, there were no significant differences in the risk of PMA in the interview only group (RR = 0.67; 95% CI, 0.42–1.04) or the interview plus decision aid group (RR = 0.88; 0.60–1.31) compared with the control group.

Limitations

The self-selected participants in the focus groups may have held particularly strong views that were not representative of the larger patient population with incomplete PMA. It is likely that these patients represent those individuals with the highest barriers to PMA.

As a pilot study testing the decision aid, the analyses were not powered to detect differences in the outcomes between groups. Patients were identified as primary nonadherents using a standard prescription drug claims-based definition. However, 35 percent of all patients subsequently filled an antihypertensive prescription within 30 days, which did not differ across study groups. This finding suggests that the claims-based definition of primary nonadherence is time sensitive and likely does not have sufficient specificity to identify patients for an intervention. Access to qualitative information about why patients did not fill a prescription initially would improve specificity and could help decrease time delays in implementing the intervention.

Conclusions

Findings provide preliminary evidence of the utility and potential effectiveness of decision support tools for PMA to antihypertensive medications. Although the focus group discussions highlight the need for enhanced patient–provider communication and the potential role of using shared decision making, the results from the pilot RCT did not indicate that the tool had a large effect on improving PMA, which may reflect challenges in evaluating such interventions. These challenges include the logistical hurdles to implement the interventions rapidly and lack of translation between their efficacy and adherence outcomes. Decision support tools may have the potential to be useful strategies to improve PMA, but the barriers to evaluating and implementing these interventions should be studied further.