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      • Record: found
      • Abstract: found
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      Design and Implementation of a Digitally Enabled Care Pathway to Improve Management of Depression in a Large Health Care System: Protocol for the Implementation of a Patient Care Platform

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          Abstract

          Background

          Major depressive disorder (MDD) is a serious public health concern worldwide. A treatment approach that incorporates measurement-based care (MBC) and shared decision-making between patients with MDD and their providers may foster patient engagement and improve clinical outcomes. While digital tools such as mobile apps show promise for expanding health interventions, these apps are rarely integrated into clinical practice.

          Objective

          The primary objective of this ongoing study is to determine whether implementation of a digital tool—the Pathway Platform—in primary care improves adherence to MBC practices; here, we present the study methods.

          Methods

          This large-scale, real-world implementation study is based on a pilot study of an earlier iteration of a mobile app (the Pathway app) that confirmed the feasibility of using the app in patients with MDD and showed a positive trend in patient engagement in the app arm. In addition, a user-centered design approach that included qualitative assessments from patients and providers was used to improve understanding of the patient journey and care team workflows. User feedback highlighted the need for enhanced features, education modules, and real-time data sharing via integration with the electronic health record. The current iteration of the Platform includes the newest version of the Pathway app, education modules for both patients and providers, and real-time patient-level data sharing with the electronic health record. The study takes place in primary care sites within the Advocate Aurora Health system in Illinois and includes adult patients with MDD who were recently prescribed monotherapy antidepressant medication (defined as a new start, medication switch, or dose change in the past 3 months). Clinical performance and selected patient outcomes will be compared before and after the implementation of the Platform.

          Results

          Patient recruitment was completed in July 2022, with initial results expected in mid-2023.

          Conclusions

          This study will provide useful insights into real-world integration of a digital platform within a large health system. The methods presented here highlight the unique user-centric development of the Pathway Platform, which has resulted in an enhanced digital tool with the potential to foster MBC and shared decision-making, improve patient-provider communication, and ultimately lead to optimized treatment outcomes for patients with MDD.

          Trial Registration

          ClinicalTrials.gov NCT04891224; https://clinicaltrials.gov/ct2/show/NCT04891224

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/43788

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          Most cited references30

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          The PHQ-9: validity of a brief depression severity measure.

          K Kroenke, R L Spitzer, J. Williams (2001)
          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            The Patient Health Questionnaire-2: validity of a two-item depression screener.

            Kurt Kroenke, Robert L Spitzer, Janet B W Williams (2003)
            A number of self-administered questionnaires are available for assessing depression severity, including the 9-item Patient Health Questionnaire depression module (PHQ-9). Because even briefer measures might be desirable for use in busy clinical settings or as part of comprehensive health questionnaires, we evaluated a 2-item version of the PHQ depression module, the PHQ-2. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). The PHQ-2 was completed by 6000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-2 depression severity increased from 0 to 6, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-2 score > or =3 had a sensitivity of 83% and a specificity of 92% for major depression. Likelihood ratio and receiver operator characteristic analysis identified a PHQ-2 score of 3 as the optimal cutpoint for screening purposes. Results were similar in the primary care and obstetrics-gynecology samples. The construct and criterion validity of the PHQ-2 make it an attractive measure for depression screening.
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              Development and testing of a short form of the patient activation measure.

              Judith Hibbard, Eldon R. Mahoney, Jean Stockard … (2005)
              The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure. The current analysis is aimed at reducing the number of items in the measure while maintaining adequate precision. We relied on an iterative use of Rasch analysis to identify items that could be eliminated without loss of significant precision and reliability. With each item deletion, the item scale locations were recalibrated and the person reliability evaluated to check if and how much of a decline in precision of measurement resulted from the deletion of the item. The data used in the analysis were the same data used in the development of the original 22-item measure. These data were collected in 2003 via a telephone survey of 1,515 randomly selected adults. Principal Findings. The analysis yielded a 13-item measure that has psychometric properties similar to the original 22-item version. The scores for the 13-item measure range in value from 38.6 to 53.0 (on a theoretical 0-100 point scale). The range of values is essentially unchanged from the original 22-item version. Subgroup analysis suggests that there is a slight loss of precision with some subgroups. The results of the analysis indicate that the shortened 13-item version is both reliable and valid.
              Article 0 comments Cited 610 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Chris Blair:
                ORCID: https://orcid.org/0000-0001-7594-8523
                Takeda Pharmaceuticals U.S.A., Inc.95 Hayden AveLexington, MA, 02421United States1 781 482 0426chris.blair@takeda.com
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: 2023
                Publication date (Electronic): 23 June 2023
                Volume: 12
                Electronic Location Identifier: e43788
                Affiliations
                [1 ] Advocate Aurora Research Institute Advocate Health Milwaukee, WI United States
                [2 ] Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA United States
                [3 ] Advocate Aurora Health Downers Grove, IL United States
                [4 ] Cognition Kit Cambridge United Kingdom
                [5 ] Ctrl Group / Fora Health London United Kingdom
                [6 ] Advocate Research Institute Advocate Health Care Downers Grove, IL United States
                Author notes
                Corresponding Author: Chris Blair chris.blair@ 123456takeda.com
                Author information
                https://orcid.org/0000-0002-8046-9559
                https://orcid.org/0000-0003-1953-1795
                https://orcid.org/0000-0001-7594-8523
                https://orcid.org/0000-0002-1880-8898
                https://orcid.org/0000-0001-5800-140X
                https://orcid.org/0000-0002-5371-2154
                https://orcid.org/0000-0001-9969-9541
                https://orcid.org/0000-0002-0586-265X
                https://orcid.org/0000-0001-7822-9364
                https://orcid.org/0000-0003-0475-1162
                https://orcid.org/0000-0002-4712-4372
                https://orcid.org/0000-0003-2653-5663
                Article
                Publisher ID: v12i1e43788
                DOI: 10.2196/43788
                PMC ID: 10337403
                PubMed ID: 37351941
                SO-VID: 7c01015b-15d4-4118-bbc3-96694ffafbd2
                Copyright © ©Rasha Khatib, Maggie McCue, Chris Blair, Anit Roy, John Franco, Ben Fehnert, James King, Sara Sarkey, Lambros Chrones, Michael Martin, Christopher Kabir, David E Kemp. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.06.2023.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 25 October 2022
                Date revision requested : 28 November 2022
                Date revision received : 3 May 2023
                Date accepted : 3 May 2023
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: mental health,depression,depressive,major depressive disorder,depression management,primary care,patient engagement,measurement-based care,shared decision-making,user-centered design,mobile app,digital platform,mobile phone,mobile health,adherence
                Data availability:
                Keywords: mental health, depression, depressive, major depressive disorder, depression management, primary care, patient engagement, measurement-based care, shared decision-making, user-centered design, mobile app, digital platform, mobile phone, mobile health, adherence

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