A Pilot Study to Improve Patient-Doctor Communication

NCT01606930 | Completed

• 1 other identifier: A-14352.4
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this controlled pilot study is to determine whether an intervention aimed at patients will improve partnering, shared decision-making and open communication. Results from this pilot study will inform how to best proceed with a larger multi-centered randomized controlled trial. The specific hypothesis for this pilot study is to:

1. 1.Test the feasibility of a simple patient-centered intervention.
2. 2.Test the correlation between patient readiness to actively engage in conversation (assessed using a pre-visit patient survey) and actual patient behaviors in the encounter.
3. 3.Develop a coding tool that will quantify patient activation in clinical encounters.
4. 4.Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.

Conditions

Chronic Disease; Hypertension; Hyperlipidemia; Diabetes Mellitus; Osteoarthritis; COPD; Cardiovascular Disease

Keywords

Patient Satisfaction; Patient Doctor Communication; Shared Decision Making; Patient Activation

Outcome Measures

Primary Outcomes (4)

• Degree of shared medical decision-making

  Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).

  Baseline

• Adherence to anti-hypertensive drug treatment at baseline

  This outcome will be assessed using pill counts by the pharmacists.

  Baseline

• Adherence to anti-hypertensive drug treatment at one month

  This outcome will be assessed using pill counts by the pharmacists.

  One month

• Adherence to anti-hypertensive drug treatment at three months

  This outcome will be assessed using pill counts by the pharmacists.

  Three months

Secondary Outcomes (8)

• Patient satisfaction

  Baseline

• Clinician rating of patient as "difficult"

  Baseline

• Patient Trust in their physician at baseline

  Baseline

• Patient Trust in their physician at one month

  one month

• Patient Trust in their physician at three months

  Three months

Study Arms (2)

Usual Care Group

NO INTERVENTION

Group will see their physician without receiving the "activation" instrument.

"Activated" Group

ACTIVE COMPARATOR

Group will be given an "activation" instrument to complete before their appointment and instructed to refer to and use the instrument during their clinical encounter.

Behavioral: Patient Primer Tool

Interventions

Patient Primer Tool BEHAVIORAL

The instrument is completed before the scheduled appointment and is designed to prompt patients to reflect on their specific goals for the medical encounter, prioritize those goals, and to "Prime" them to engage in a discussion centered on their concerns and expectations. In addition, participants will be encouraged to bring this form into their physician visit and use it to engage their clinician in a discussion about their health needs.

Also known as: Patient Activation Tool

"Activated" Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Military health care beneficiaries presenting for chronic medical care with their primary care clinician
• Over the age of 18
• At least 2 and no more than 10 visits with their primary care provider in the previous year
• Receiving pharmacological treatment for hypertension
• At least 2 of the following common chronic illnesses: hyperlipidemia, chronic obstructive pulmonary disease, asthma, congestive heart failure, chronic pain, ischemic heart disease, osteoarthritis, depression, back pain, chronic headaches, or diabetes

You may not qualify if:

• Over the age of 80
• Incapable of completing the questionnaires, either due to cognitive impairment or lack of English-literacy

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• University of Wisconsin, Milwaukee: collaborator

Study Sites (1)

Walter Reed National Medical Military Center (WRNMMC)

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Chronic Disease; Hypertension; Hyperlipidemias; Diabetes Mellitus; Osteoarthritis; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Patient Satisfaction; Patient Participation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Study Officials

• Patrick O'Malley, MD, MPH

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: May 28, 2012
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (1)