A Pilot Study to Improve Patient-Doctor Communication

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

Detailed Description
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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.

Official Title
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A Pilot Study to Improve Patient-Doctor Communication

Conditions
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Chronic Disease, Hypertension, Hyperlipidemia, Diabetes Mellitus, Osteoarthritis, COPD, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Patient Primer Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>Group will see their physician without receiving the activation instrument. | |
| Active Comparator: Activated Group<br>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<br>* 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.<br>* Other names: Patient Activation Tool;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation