- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06605807
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions: Aim 3
The goal of this pilot clinical trial is to learn if providing a clinical decision framework for managing older adults chronic conditions during hospitalization to inpatient clinicians improves clinicians' ability to individualize chronic condition prescribing decisions for hospitalized older adults (65 and older). The main questions it aims to answer are:
- Will the clinical decision framework lead to clinicians having greater confidence to individualize discharge prescribing?
- Will clinicians using the framework discharge make fewer changes to hospitalized older adults with home diabetes and hypertension medications than they did prior to receiving the framework?
- Will older adult patients of participating clinicians will report fewer gaps in understanding of medication changes after the clinician is exposed to the framework?
Researchers will compare participating clinician survey responses and prescribing records from before and after an educational session presenting the clinical decision framework.
Participants will be asked to
- Attend a one-time educational session on the clinical decision framework
- Complete 2 electronic surveys, one before and one following the educational session.
- Agree for researchers to contact their patients, in order for patients to complete a one-time phone survey about changes made to home medications during hospitalization and quality of communication from the hospital team.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ella Hileman-Kaplan, BA
- Phone Number: 206-733-0880
- Email: prescribingwiselylab@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
-
Contact:
- Ella Hileman-Kaplan, BA
- Phone Number: 206-733-0880
- Email: prescribingwiselylab@pitt.edu
-
Principal Investigator:
- Timothy S Anderson, MD, MAS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Clinician Participants:
Inclusion Criteria:
- Attending clinicians who practice on the general medicine or hospital medicine service at UPMC Presbyterian, UPMC Montefiore, UPMC Shadyside, UPMC Mercy, or UPMC Magee-Women's Hospital campuses.
- Practicing on the general medicine or hospital medicine service. This population may include physicians with training in general internal medicine, hospital medicine, family practice, internal medicine subspecialities, as well as advance practice clinicians.
Exclusion Criteria:
- Anticipating leaving current clinical position within next 3 months
- Less than 4 weeks of inpatient attending service scheduled within 3 months of recruitment
Patient Participants:
Inclusion Criteria:
- Adult aged 65 years or older who are hospitalized under the care of a participating clinician and discharged home.
- Eligible patients must recieve at least one cardiometabolic medication change at hospital discharge (can include new medication starts, stops, or dose changes). Cardiometabolic medications include any class of antihypertensive, lipid lowering, anti-platelet, or glucose lowering medications regardless of indication for use.
Exclusion Criteria:
- Incapacity for informed consent / unable to answer survey questions due to cognitive impairment
- Enrolled in hospice care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinician Participants
All clinician participants will undergo the same intervention, an educational session providing a clinical decision framework for managing older adults' chronic conditions during hospitalization.
|
All clinicians will attend an educational session where they will be provided a clinical decision framework for management of chronic conditions in hospitalized older adults, reviewing guiding principles for managing chronic disease in the hospital, and working through case-based hypothetical examples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician - Change in Prescribing Self-Efficacy
Time Frame: Baseline and three months post-intervention
|
For each clinician participant the investigators will ask their self-efficacy to individualize blood pressure and diabetes treatment decisions for hospitalized older adults.
Measured through ten 7-point Likert scale questions measured [Strongly Disagree - Strongly Agree].
Scores will be summed and range from 10 (all Strongly Disagree) to 70 (all Strongly Agree).
|
Baseline and three months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient - Change in Medication Discrepencies
Time Frame: Single time survey within a week of discharge from clinician participants care.
|
The investigators will ask each enrolled patient how they are taking each of their cardiometabolic medications and compare their current reported medication use to the hospital discharge summary.
The investigators will compare the proportion of patient participants reported a medication discrepancy (taking medication differently than hospital discharge summary) in the pre-intervention period to the post-intervention period.
|
Single time survey within a week of discharge from clinician participants care.
|
|
Clinician - Change in Attitudes
Time Frame: Baseline and three months post-intervention
|
The investigators will ask clinicians 8 questions about their attitudes towards individualizing antihypertensive and diabetes treatment decisions on a 7-point Likert scale. Individualizing antihypertensive and diabetes treatment decisions for hospitalized older adults is: Necessary - Unnecessary Beneficial - Harmful High-priority - Low-priority Worthless - Useful. Scores will be summed and range from 8 to 56. |
Baseline and three months post-intervention
|
|
Clinician - Discharge Prescribing
Time Frame: Pre-intervention and post-intervention (2 months before and 3 months after the intervention)
|
For each clinician participant, the investigators will review the electronic health record for all hospitalized patients aged 65 years and older who were discharged alive under the clinician participant's care in the 2 months before and 3 months after the intervention to identify all antihypertensive and diabetes medication changes made during hospitalization.
The investigators will compare the proportion of patients discharged with cardiometabolic medication changes in the 2 months prior to the intervention to the 3 months after the intervention.
The investigators will examine proportion of patients receiving medication intensifications and the proportion receiving any medication change.
|
Pre-intervention and post-intervention (2 months before and 3 months after the intervention)
|
|
Clinician - Acceptability of Clinical Decision Framework
Time Frame: 3 months post-intervention
|
The investigators will ask clinicians if they used the clinical decision framework and 7 questions on a 7 point Likert scale (strongly disagree to strongly agree) regarding the framework's clarity, length, and whether it was useful.
The investigators will ask what they liked about the framework and what would they change.
The investigators will ask about facilitators and barriers to using the framework and whether they plan to keep using it.
Scores will be summed and range from 7 to 49.
|
3 months post-intervention
|
|
Clinician - Change in Intentions
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled clinician two questions to assess choice predisposition (leaning) towards individualizing blood pressure and diabetes medications prescribing decisions during hospitalization using two 7-point Likert Scales (Strongly Disagree to Strongly Agree).
Scores will be summed and range from 2 (all Strongly Disagree) to 14 (all Strongly Agree).
|
Baseline and three months post-intervention
|
|
Clinician - Change in Perceived Norms
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled clinician six questions on their perceptions on norms on individualizing blood pressure and diabetes treatment decisions for hospitalized older adults.
Measured through 7-point Likert scale questions measured [Strongly Disagree - Strongly Agree].
Scores will be summed and range from 6 (all Strongly Disagree) to 42 (all Strongly Agree).
|
Baseline and three months post-intervention
|
|
Clinician - Awareness of Evidence Base
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled clinician to respond to four questions regarding their familiarity with the evidence base for the treatment of blood pressure and diabetes while a patient is hospitalized.
These will be framed as four 7-point Likert Scales (Strongly Disagree to Strongly Agree).
Scores will be summed and range from 4 (all Strongly Disagree) to 28 (all Strongly Agree).
|
Baseline and three months post-intervention
|
|
Patient - Change in Overall Hospital Experience
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled patient to rate their overall hospital experience from 0 to 10.
Where 0 is I had a very poor experience and 10 is I had a very good experience.
Scores will be summed from 0 to 10.
The investigators will compare average scores of patients in the pre-intervention period to the post-intervention period
|
Baseline and three months post-intervention
|
|
Patient - Change in Experience in the Hospital
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled patient a 4 question survey on communication during their hospital stay.
Possible answers include never (1), sometimes (2), usually (3), and always (4).
Scores will be summed from 4 to 16.
The investigators will compare mean scores of patients in the pre-intervention period to the post-intervention period.
|
Baseline and three months post-intervention
|
|
Patient - Change in Experience Leaving the Hospital
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled patient a 3 question survey on communication when they left the hospital.
Possible answers include not at all (1), partly (2), quite a bit (3), completely (4), and not applicable (0).
Scores will be summed from 0 to 12.
The investigators will compare mean scores of patients in the pre-intervention period to the post-intervention period.
|
Baseline and three months post-intervention
|
|
Patient - Change in Understanding of Medication Changes
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each enrolled patient their understanding of the reason for each cardiometabolic medication change made at hospital discharge and compare their understanding to the hospital discharge summary rationale to identify concordant versus discordant understanding.
The investigators will compare the proportion of patients with discordant understanding of cardiometabolic medication changes in the pre-intervention period to the post-intervention period.
|
Baseline and three months post-intervention
|
|
Patient - Change in Comprehension of Disease Monitoring
Time Frame: Baseline and three months post-intervention
|
The investigators will ask each patient participant enrolled if the hospital discussed their blood pressure and/or provided guidance on disease monitoring (e.g.
blood pressure or blood glucose) after discharge.
The investigators will compare the proportion of patients reporting guidance on disease monitoring from the pre-intervention to post-intervention period.
|
Baseline and three months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy S Anderson, MD, MAS, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY24070027
- K76AG074878 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on Clinical Decision Framework for Managing older adults' chronic conditions during hospitalization.
-
Corporació de Salut del Maresme i la SelvaConsorci Sanitari de TerrassaRecruitingHeart Failure | Chronic Obstructive Lung Disease (COLD)Spain