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Not yet recruitingNCT07914452PRISMUpdated Nov 3, 2026

Personalized Routine and Habit Integration to Support Medication Management

An interventional study of PRISM Arm and Enhanced Usual Care Arm in Medication Adherence, sponsored by Brigham and Women's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Medication Adherence

Keywords

  • Multiple Chronic Conditions
03

In context

Medication Adherence

937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 768 interventional studies indexed under Medication Adherence.

Browse Medication Adherence studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. appointment in the past 18 months in the Galter-18 primary care practice
  2. ≥2 cardiovascular and/or metabolic chronic conditions documented in the EHR,
  3. ≥5 daily medications
  4. poor medication adherence ≥1 cardiovascular and/or metabolic medication using validated EHR-data algorithms
  5. English-speaking
  6. ≥65 years old

Exclusion criteria

Exclusion Criteria:

  1. severe mental illness
  2. dementia
  3. dependent on others for medication management
  4. have received a pharmacist-led comprehensive medication review in the last 6 months
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    PRISM Arm

    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.

    Behavioral: PRISM Arm

  • Experimental
    Enhanced usual care (EUC) arm

    The EUC arm will receive a comprehensive medication management session with a clinical pharmacist.

    Behavioral: Enhanced Usual Care Arm

Interventions

  • BehavioralPRISM Arm

    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.

  • BehavioralEnhanced Usual Care Arm

    The EUC arm will receive a comprehensive medication management session with a clinical pharmacist.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Through 6-months post-baseline

Secondary outcomes

  1. PDC (Continuous) - All

    Medication adherence to all daily prescription pill-form medications

    Time frame: Through 6-months post-baseline

  2. 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.

    Time frame: Through 6-months post-baseline

  3. Medication Adherence Report Scale 10-item (MARS-10)

    Self reported; medication ahderence to all prescriptoin daily medications

    Time frame: Through 3-months post-baseline

  4. Regimen Knowledge (continuous)

    Participant knowledge of prescribed medications, including their purpose, dosage, and administration instructions using Medication Purpose \& Dosage Identification Score (MPDS).

    Time frame: Through 3-months post-baseline

  5. Regimen Complexity (continuous)

    Complexity of the participant's prescribed medication regime using Medication Regimen Complexity Index (MRCI).

    Time frame: Through 3-months post-baseline

  6. Daily Routine (continuous)

    Daily activity patterns and routines, including the timing of activities throughout the day using a time diary.

    Time frame: Through 3-months post-baseline

  7. Medication Habits (continuous)

    The extent to which medication-taking is performed automatically as a habitual behavior using Self-Report Behavioral Automaticity Index (SRBAI).

    Time frame: Through 3-months post-baseline

  8. 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).

    Time frame: Through 3-months post-baseline

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Study locations

1 site
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Feb 2028, 12 months later.

Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 12 months is below that.

Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartEst.
Feb 2027
Primary completionEst.
Feb 2028
CompletionEst.
May 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07914452
Responsible party
Julie Lauffenburger (Associate Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Nov 3, 2026
Start date
Feb 2027 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Julie Lauffenburger, PharmD, PhD
Contact
jlauffenburger@bwh.harvard.edu
857-282-1962

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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