MedPath

A Pilot Study to Improve Patient-Doctor Communication

Not Applicable
Completed
Conditions
Chronic Disease
Hypertension
Hyperlipidemia
Diabetes Mellitus
Osteoarthritis
COPD
Cardiovascular Disease
Interventions
Behavioral: Patient Primer Tool
Registration Number
NCT01606930
Lead Sponsor
Walter Reed National Military Medical Center
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. 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
"Activated" GroupPatient Primer ToolGroup will be given an "activation" instrument to complete before their appointment and instructed to refer to and use the instrument during their clinical encounter.
Primary Outcome Measures
NameTimeMethod
Adherence to anti-hypertensive drug treatment at baselineBaseline

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

Adherence to anti-hypertensive drug treatment at one monthOne month

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

Degree of shared medical decision-makingBaseline

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

Adherence to anti-hypertensive drug treatment at three monthsThree months

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

Secondary Outcome Measures
NameTimeMethod
Patient satisfactionBaseline

Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool

Clinician rating of patient as "difficult"Baseline

Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).

Patient Trust in their physician at baselineBaseline

Validated Trust in Physician (11-item) Instrument

Patient Trust in their physician at one monthone month

Validated Trust in Physician (11-item) Instrument

Patient Trust in their physician at three monthsThree months

Validated Trust in Physician (11-item) Instrument

Systolic and Diastolic Blood Pressure at baselineBaseline

Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.

Systolic and Diastolic Blood Pressure at one monthOne month

Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.

Systolic and Diastolic Blood Pressure at three monthsthree months

Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.

Trial Locations

Locations (1)

Walter Reed National Medical Military Center (WRNMMC)

🇺🇸

Bethesda, Maryland, United States

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