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A Pilot Study to Improve Patient-Doctor Communication

Primary Purpose

Chronic Disease, Hypertension, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Primer Tool
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed National Medical Military Center (WRNMMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care Group

"Activated" Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Degree of shared medical decision-making
Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Adherence to anti-hypertensive drug treatment at baseline
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at one month
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at three months
This outcome will be assessed using pill counts by the pharmacists.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2012
Last Updated
May 23, 2012
Sponsor
Walter Reed National Military Medical Center
Collaborators
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT01606930
Brief Title
A Pilot Study to Improve Patient-Doctor Communication
Official Title
A Pilot Study to Improve Patient-Doctor Communication
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
University of Wisconsin, Milwaukee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Hypertension, Hyperlipidemia, Diabetes Mellitus, Osteoarthritis, COPD, Cardiovascular Disease
Keywords
Patient Satisfaction, Patient Doctor Communication, Shared Decision Making, Patient Activation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Group will see their physician without receiving the "activation" instrument.
Arm Title
"Activated" Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Primer Tool
Other Intervention Name(s)
Patient Activation Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of shared medical decision-making
Description
Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Time Frame
Baseline
Title
Adherence to anti-hypertensive drug treatment at baseline
Description
This outcome will be assessed using pill counts by the pharmacists.
Time Frame
Baseline
Title
Adherence to anti-hypertensive drug treatment at one month
Description
This outcome will be assessed using pill counts by the pharmacists.
Time Frame
One month
Title
Adherence to anti-hypertensive drug treatment at three months
Description
This outcome will be assessed using pill counts by the pharmacists.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Post-encounter survey using the validated Rand-9 Patient Satisfaction Tool
Time Frame
Baseline
Title
Clinician rating of patient as "difficult"
Description
Clinician Rating of the Encounter Using the Difficult Doctor-Patient Relationship Questionaire (DDPRQ).
Time Frame
Baseline
Title
Patient Trust in their physician at baseline
Description
Validated Trust in Physician (11-item) Instrument
Time Frame
Baseline
Title
Patient Trust in their physician at one month
Description
Validated Trust in Physician (11-item) Instrument
Time Frame
one month
Title
Patient Trust in their physician at three months
Description
Validated Trust in Physician (11-item) Instrument
Time Frame
Three months
Title
Systolic and Diastolic Blood Pressure at baseline
Description
Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Time Frame
Baseline
Title
Systolic and Diastolic Blood Pressure at one month
Description
Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Time Frame
One month
Title
Systolic and Diastolic Blood Pressure at three months
Description
Each blood pressure data point was the average of 3 measurements measured 5 minutes apart while seated.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick O'Malley, MD, MPH
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Medical Military Center (WRNMMC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States

12. IPD Sharing Statement

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A Pilot Study to Improve Patient-Doctor Communication

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