Medication AdherencePRISMNCT07914452
Personalized Routine and Habit Integration to Support Medication Management
A study testing PRISM Arm in people with Medication Adherence, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to test a multidisciplinary care team behavioral intervention to enhance medication adherence among older adults with multiple chronic conditions (MCC). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- PRISM Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- appointment in the past 18 months in the Galter-18 primary care practice
- ≥2 cardiovascular and/or metabolic chronic conditions documented in the EHR,
- ≥5 daily medications
- poor medication adherence ≥1 cardiovascular and/or metabolic medication using validated EHR-data algorithms
- English-speaking
- ≥65 years old
Who cannot join
- severe mental illness
- dementia
- dependent on others for medication management
- have received a pharmacist-led comprehensive medication review in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mass General Brigham
Somerville, Massachusetts, 021250
Julie Lauffenburger, PharmD, PhD
About this study
Official title: A Randomized Controlled Trial of the Personalized Routine and Habit Integration to Support Medication Management Intervention (PRISM)
The objective of this study is to test a multidisciplinary care team behavioral intervention to enhance medication adherence among older adults with multiple chronic conditions (MCC). The Personalized Routine and Habit Integration to Support Medication Management (PRISM) intervention is a novel, scalable intervention delivered by pharmacists and occupational therapists (OTs) that aims to improve medication adherence by reducing regimen complexity and solidifying medication habits within daily routines. The goal of this randomized control trial is to evaluate the effectiveness and implementation of PRISM compared with enhanced usual care.
- Conditions
- Medication Adherence
- Being tested
- PRISM Arm, Enhanced Usual Care Arm
- Keywords
- Multiple Chronic Conditions
- Medical subject headings
- Medication Adherence, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM ArmBehavioural
The PRISM arm will receive three sessions: 1) comprehensive medication management session with a clinical pharmacist, 2) an in-home visit with an occupational therapist (OT), and then 3) follow up phone call with OT.
Enhanced Usual Care ArmBehavioural
The EUC arm will receive a comprehensive medication management session with a clinical pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| PRISM Arm | Experimental | The PRISM arm will receive three sessions: 1) comprehensive medication management session with a clinical pharmacist, 2) an in-home visit with an occupational therapist (OT), and then 3) follow up phone call with OT. Receives: Behavioral: PRISM Arm |
| Enhanced usual care (EUC) arm | Experimental | The EUC arm will receive a comprehensive medication management session with a clinical pharmacist. Receives: Behavioral: Enhanced Usual Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDC (Continuous) - Cardiometabolic
Medication adherence to cardio-metabolic pill-form daily medications including the following classes: ACE inhibitor, Angiotensin Receptor Blockers (ARBs), Beta-Blockers, Calcium Channel Blockers, Diuretics, Lipid-lowering, Metformin
Measured: Through 6-months post-baseline
Secondary outcomes (8)
PDC (Continuous) - All
Medication adherence to all daily prescription pill-form medications
Measured: Through 6-months post-baseline
PDC (Continuous) - Study-entering
Medication adherence to study-entering medication i.e. the medciation that was identified during the eligibility screening process as having poor medication adherence.
Measured: Through 6-months post-baseline
Medication Adherence Report Scale 10-item (MARS-10)
Self reported; medication ahderence to all prescriptoin daily medications
Measured: Through 3-months post-baseline
Regimen Knowledge (continuous)
Participant knowledge of prescribed medications, including their purpose, dosage, and administration instructions using Medication Purpose \& Dosage Identification Score (MPDS).
Measured: Through 3-months post-baseline
Regimen Complexity (continuous)
Complexity of the participant's prescribed medication regime using Medication Regimen Complexity Index (MRCI).
Measured: Through 3-months post-baseline
Daily Routine (continuous)
Daily activity patterns and routines, including the timing of activities throughout the day using a time diary.
Measured: Through 3-months post-baseline
Medication Habits (continuous)
The extent to which medication-taking is performed automatically as a habitual behavior using Self-Report Behavioral Automaticity Index (SRBAI).
Measured: Through 3-months post-baseline
Problem Solving Skills (continuous)
Participant ability to identify, address, and learn from problems affecting medication-taking and health management using Health Problem-Solving Scale (HPSS).
Measured: Through 3-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
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 Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914452
- Sponsor's protocol ID
- 2026P001972
- Other IDs
- 5P30AG064199-08
- Acronym
- PRISM
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Personalized Routine and Habit Integration to Support Medication Management Intervention (PRISM)
- ClinicalTrials.gov ID
- NCT07914452
- Acronym / sponsor ID
- PRISM / 2026P001972
- Conditions
- Medication Adherence
- Keywords
- Multiple Chronic Conditions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- 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 objective of this study is to test a multidisciplinary care team behavioral intervention to enhance medication adherence among older adults with multiple chronic conditions (MCC). The Personalized Routine and Habit Integration to Support Medication Management (PRISM) intervention is a novel, scalable intervention delivered by pharmacists and occupational therapists (OTs) that aims to improve medication adherence by reducing regimen complexity and solidifying medication habits within daily routines. The goal of this randomized control trial is to evaluate the effectiveness and implementation of PRISM compared with enhanced usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM Arm | Experimental | Behavioral: PRISM ArmThe PRISM arm will receive three sessions: 1) comprehensive medication management session with a clinical pharmacist, 2) an in-home visit with an occupational therapist (OT), and then 3) follow up phone call with OT. |
| Enhanced usual care (EUC) arm | Experimental | Behavioral: Enhanced Usual Care ArmThe EUC arm will receive a comprehensive medication management session with a clinical pharmacist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- appointment in the past 18 months in the Galter-18 primary care practice
- ≥2 cardiovascular and/or metabolic chronic conditions documented in the EHR,
- ≥5 daily medications
- poor medication adherence ≥1 cardiovascular and/or metabolic medication using validated EHR-data algorithms
- English-speaking
Key exclusion criteria (4 listed)
- severe mental illness
- dementia
- dependent on others for medication management
- have received a pharmacist-led comprehensive medication review in the last 6 months
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 |
|---|---|---|
| PRISM ArmThe PRISM arm will receive three sessions: 1) comprehensive medication management session with a clinical pharmacist, 2) an in-home visit with an occupational therapist (OT), and then 3) follow up phone call with OT. | Behavioural | PRISM Arm |
| Enhanced Usual Care ArmThe EUC arm will receive a comprehensive medication management session with a clinical pharmacist. | Behavioural | Enhanced usual care (EUC) arm |
Primary outcome
PDC (Continuous) - Cardiometabolic
Time frame: Through 6-months post-baseline
Medication adherence to cardio-metabolic pill-form daily medications including the following classes: ACE inhibitor, Angiotensin Receptor Blockers (ARBs), Beta-Blockers, Calcium Channel Blockers, Diuretics, Lipid-lowering, Metformin
8 secondary outcomes
PDC (Continuous) - All
Time frame: Through 6-months post-baseline
PDC (Continuous) - Study-entering
Time frame: Through 6-months post-baseline
Medication Adherence Report Scale 10-item (MARS-10)
Time frame: Through 3-months post-baseline
Regimen Knowledge (continuous)
Time frame: Through 3-months post-baseline
Regimen Complexity (continuous)
Time frame: Through 3-months post-baseline
Daily Routine (continuous)
Time frame: Through 3-months post-baseline
Medication Habits (continuous)
Time frame: Through 3-months post-baseline
Problem Solving Skills (continuous)
Time frame: Through 3-months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM Arm in people with Medication Adherence, run by Brigham and Women's Hospital 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Lauffenburger, PharmD, PhD (857-282-1962, jlauffenburger@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDC (Continuous) - Cardiometabolic (time frame: Through 6-months post-baseline). 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 3 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.