A Pilot Study to Improve Patient-Doctor Communication

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. Test the feasibility of a simple patient-centered intervention.
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. Develop a coding tool that will quantify patient activation in clinical encounters.
4. Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.

Study Overview

• Status: Completed
• Conditions: Hypertension; Cardiovascular Disease; Diabetes Mellitus; Osteoarthritis; Chronic Disease; Hyperlipidemia; COPD
• Intervention / Treatment: Behavioral: Patient Primer Tool

Detailed Description

Chronic illness requires a greater participation by the patient in the management of their own disease process. Patients now increasingly find themselves dealing with multiple illnesses over the span of their lifetime.

Patient-provider communication is key to optimal patient outcomes. Numerous studies have shown adverse effects of poor communication on a number of outcomes, including patient and provider satisfaction as well as medical compliance and health related outcomes.

An important next step in this field is to study whether it is possible to improve chronic illness care in real world settings by improving the quality of patient-provider interaction through feasible interventions focused on efficient, motivational, and empathic communication, targeted at both patients and providers.

There is little information on the best patterns of communication in dealing with patients with multiple comorbidities. The investigators believe that an optimal healing relationship between these patients and their healthcare providers includes shared decision-making, partnering between patients and clinicians to foster health and healthy behaviors in an environment of trust, and effective open communication.

An important outcome for this pilot study is feasibility. The investigators intend to conduct a follow-up multi-centered trial; planning and budgeting for such a trial will require information gleaned from this study. What is the rate of accrual and how many patients can realistically be enrolled and followed within the current study personnel. What outcomes are sensitive to change and how much change can the investigators expect to see? Will this intervention effect change in patient behavior? This study will give us insight to allow us to build a right-sized project.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Medical Military Center (WRNMMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group; Group will see their physician without receiving the "activation" instrument.
Active Comparator: "Activated" Group; 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; 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.; Other Names: Patient Activation Tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool	Baseline
Clinician rating of patient as "difficult"	Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).	Baseline
Patient Trust in their physician at baseline	Validated Trust in Physician (11-item) Instrument	Baseline
Patient Trust in their physician at one month	Validated Trust in Physician (11-item) Instrument	one month
Patient Trust in their physician at three months	Validated Trust in Physician (11-item) Instrument	Three months
Systolic and Diastolic Blood Pressure at baseline	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	Baseline
Systolic and Diastolic Blood Pressure at one month	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	One month
Systolic and Diastolic Blood Pressure at three months	Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.	three months

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: University of Wisconsin, Milwaukee
• Investigators: Principal Investigator: Patrick O'Malley, MD, MPH, Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 28, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 23, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Shared Decision Making; Patient Satisfaction; Patient Activation; Patient Doctor Communication
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Chronic Disease; Hyperlipidemias
• Other Study ID Numbers: A-14352.4