Translating The GOLD COPD Guidelines Into Primary Care Practice

NCT01237561 | Completed DMC

• 2 other identifiers: 08-19R01HL093090
• Study Type: interventional
• Target: 3,593
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the translation of the Gold (the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD guidelines into primary care practice. During phase I, a needs assessment will evaluate barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from the focus groups, three tools will be developed, refined and pilot tested. The effectiveness of the materials developed in phase I will be tested in phase II (a randomized clinical trial conducted with one year of intervention within non-academic primary care practices) regarding physician performance of COPD guideline implementation and improvement in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD) compared to usual care.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; COPD Guidelines; Patient Activation; Lung Age

Outcome Measures

Primary Outcomes (1)

• Adherence to COPD guidelines

  An adherence tool will be developed and reviewed by an expert panel. They will review the suggested criterion and make recommendations regarding an item's status on the tool. The panel may also suggest additional criteria for inclusion in the tool. The tool will be modified based on expert consensus. Once the tool is finalized, a detailed algorithm will be developed for scoring the primary care practice data which will include an adherence score for each visit and an overall adherence score and will be piloted the first 2 months of chart review.

  Twelve months post intervention

Secondary Outcomes (1)

• patient activation

  Baseline and 12 months post intervention

Study Arms (2)

spirometry, patient activation tool

EXPERIMENTAL

* Receive Portable Spirometer * Spirometry training of staff * Provide clinician with web-based COPD interactive guideline tool * Provide clinician with patient activation tool * Train clinicians (tools, integration into workflow) * Academic Detailing

Other: provider support tools plus spirometer

Usual Care

NO INTERVENTION

Spirometer and spirometry training of staff

Interventions

provider support tools plus spirometer OTHER

Patient Activation Tool, Provider Web-based decision support tool, academic detailing

Also known as: Determine the effectiveness of tools developed in improving guideline implementation and adherence.

spirometry, patient activation tool

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 40 years or older
• Seen at least once in the past 2 years (active patients) by their PCP
• And/or 40 years of age and less than 81 years of age who smoke.

You may not qualify if:

• \< 40 years of age

Sponsors & Collaborators

• Memorial Hospital of Rhode Island: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Related Publications (1)

• Parker DR, Eaton CB, Ahern DK, Roberts MB, Rafferty C, Goldman RE, McCool FD, Wroblewski J. The study design and rationale of the randomized controlled trial: translating COPD guidelines into primary care practice. BMC Fam Pract. 2013 May 6;14:56. doi: 10.1186/1471-2296-14-56.

  PMID: 23641803 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Participation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Donna R Parker, Sc.D.

  MHRhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Family Med & Epidemiology

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: October 25, 2013
• Study Completion: October 25, 2013
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)